General Recommendations on Immunization = </P><P>Recommendations of the Advisory Committee on Immunization = Practices (ACIP)

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Recommendations of the Advisory Committee on Immunization Practices (ACIP) Date: Mon, 15 Oct 2007 19:36:09 -0700 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C80F62.A341F6C0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C80F62.A341F6C0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm General Recommendations on Immunization = </P><P>Recommendations of the Advisory Committee on Immunization = Practices (ACIP)

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General Recommendations = on=20 Immunization=20

Recommendations of the Advisory Committee on = Immunization=20 Practices (ACIP)

Please note: = Errata have=20 been published for this article. To view the errata, please click = here = and=20 here.<= /I>=20

Prepared by
Andrew T. Kroger, MD¹ =
William L. Atkinson, MD¹
Edgar K. Marcuse,=20 MD²
Larry K. Pickering, MD^{3=20

1}Immunization Services Division, National = Center for=20 Immunization and Respiratory Diseases (proposed)=20
²Children's Hospital and Regional Medical Center, = Seattle,=20 Washington
³Office of the Director, National Center = for=20 Immunization and Respiratory Diseases (proposed), CDC

The material in this report was prepared for = publication=20 by the National Center for Immunization and Respiratory Diseases, = Anne=20 Schuchat, MD, Director; and the Immunization Services Division, = Lance E.=20 Rodewald, MD, Director.

Corresponding author: Andrew T. Kroger, = MD,=20 National Center for Immunization and Respiratory Diseases = (proposed), CDC,=20 1600 Clifton Road, NE, MS E-52, Atlanta, GA 30333. Telephone:=20 404-639-1958; Fax: 404-639-8828; E-mail: akroger@cdc.gov.
Summary =

This report is a revision of General Recommendations on = Immunization=20 and updates the 2002 statement by the Advisory Committee on = Immunization=20 Practices (ACIP) (CDC. General recommendations on immunization:=20 recommendations of the Advisory Committee on Immunization = Practices and=20 the American Academy of Family Physicians. MMWR 2002;51[No. = RR-2]). This=20 report is intended to serve as a general reference on vaccines and = immunization. The principal changes include 1) expansion of the = discussion=20 of vaccination spacing and timing; 2) an increased emphasis on the = importance of injection technique/age/body mass in determining = appropriate=20 needle length; 3) expansion of the discussion of storage and = handling of=20 vaccines, with a table defining the appropriate storage = temperature range=20 for inactivated and live vaccines; 4) expansion of the discussion = of=20 altered immunocompetence, including new recommendations about use = of=20 live-attenuated vaccines with therapeutic monoclonal antibodies; = and 5)=20 minor changes to the recommendations about vaccination during = pregnancy=20 and vaccination of internationally adopted children, in accordance = with=20 new ACIP vaccine-specific recommendations for use of inactivated = influenza=20 vaccine and hepatitis B vaccine. The most recent ACIP = recommendations for=20 each specific vaccine should be consulted for comprehensive = discussion.=20 This report, ACIP recommendations for each vaccine, and other = information=20 about vaccination can be accessed at CDC's National Center for=20 Immunization and Respiratory Diseases (proposed) (formerly known = as the=20 National Immunization Program) website at http//:www.cdc.gov/nip.
Introduction

This report provides technical guidance about common = vaccination=20 concerns for clinicians and other health-care providers who = administer=20 vaccines to infants, children, adolescents, and adults. Vaccine=20 recommendations are based on characteristics of the immunobiologic = product, scientific knowledge about the principles of active and = passive=20 immunization, epidemiology and burden of diseases (i.e., = morbidity,=20 mortality, costs of treatment, and loss of productivity), vaccine = safety=20 considerations, cost analysis of preventive measures, published = and=20 unpublished studies, and expert opinion of public health officials = and=20 specialists in clinical and preventive medicine.

Benefits and risks are associated with using all = immunobiologics (i.e.,=20 an antigenic substance or antibody-containing preparation). No = vaccine is=20 completely safe or effective. Benefits of vaccination include = partial or=20 complete protection against infection for the vaccinated person = and=20 overall benefits to society as a whole. Benefits include = protection from=20 symptomatic illness, improved quality of life and productivity, = and=20 prevention of death. Societal benefits include creation and = maintenance of=20 herd immunity against communicable diseases, prevention of disease = outbreaks, and reduction in health-care--related costs. = Vaccination risks=20 range from common, minor, and local adverse effects to rare, = severe, and=20 life-threatening conditions. Therefore, recommendations for = vaccination=20 practices balance scientific evidence of benefits for each person = and to=20 society against the potential costs and risks for vaccination for = the=20 individual and programs.

Standards for child and adolescent vaccination practices and = standards=20 for adult vaccination practices (1,2) have been published = to assist=20 with implementing vaccination programs and maximizing their = benefits. Any=20 person or institution that provides vaccination services should = adopt=20 these standards to improve vaccination delivery and protect = infants,=20 children, adolescents, and adults from vaccine-preventable = diseases.

To maximize the benefits of vaccination, this report provides = general=20 information about immunobiologics and provides practical = guidelines about=20 vaccine administration and technique. To minimize risk from = vaccine=20 administration, this report delineates situations that warrant = precautions=20 or contraindications to using a vaccine. These recommendations are = intended for use in the United States because vaccine availability = and use=20 and epidemiologic circumstances differ in other countries. = Individual=20 circumstances might warrant deviations from these recommendations. =

The relative balance of benefits and risks can change as = diseases are=20 controlled or eradicated. For example, because wild poliovirus=20 transmission has been interrupted in the United States since 1979, = the=20 only indigenous cases of paralytic poliomyelitis reported since = that time=20 have been caused by live oral poliovirus vaccine (OPV) (3)= .=20 In 1999, to eliminate the risk for vaccine-associated paralytic=20 poliomyelitis (VAPP), exclusive use of inactivated poliovirus = vaccine=20 (IPV) was recommended for routine vaccination in the United = States.=20 However, because of superior ability to induce intestinal immunity = and to=20 prevent spread among close contacts, OPV remains the vaccine of = choice for=20 areas where wild poliovirus is still present (4)= .=20 Until worldwide eradication of poliovirus is accomplished, = continued=20 vaccination of the U.S. population against poliovirus will be = necessary.=20
Timing and Spacing of=20 Immunobiologics

General Principles for Vaccine Scheduling

Optimal response to a vaccine depends on multiple factors, = including=20 the nature of the vaccine and the age and immune status of the = recipient.=20 Recommendations for the age at which vaccines are administered are = influenced by age-specific risks for disease, age-specific risks = for=20 complications, ability of persons of a certain age to respond to = the=20 vaccine, and potential interference with the immune response by = passively=20 transferred maternal antibody. Vaccines are recommended for = members of the=20 youngest age group at risk for experiencing the disease for whom = efficacy=20 and safety have been demonstrated.

Certain products, including inactivated vaccines, toxoids, = recombinant=20 subunit, and polysaccharide conjugate vaccines, require = administering 2 or=20 more doses for development of an adequate and persisting antibody=20 response. Tetanus and diphtheria toxoids require periodic = reinforcement or=20 booster doses to maintain protective antibody concentrations. = Unconjugated=20 polysaccharide vaccines do not induce T-cell memory, and booster = doses are=20 not expected to produce substantially increased protection. = Conjugation=20 with a protein carrier improves the effectiveness of = polysaccharide=20 vaccines by inducing T-cell--dependent immunologic function. = Vaccines that=20 stimulate both cell-mediated immunity and neutralizing antibodies = (e.g.,=20 live-attenuated virus vaccines) usually can induce prolonged = immunity,=20 even if antibody titers decline over time (5). Subsequent = exposure=20 to infection usually does not lead to viremia but to a rapid = anamnestic=20 antibody response.

Approximately 90%--95% of recipients of a single dose of = certain live=20 vaccines administered by injection at the recommended age (i.e., = measles,=20 rubella, and yellow fever) have protective antibody (generally = within 2=20 weeks of the dose). For varicella and mumps vaccines, 80%--85% of=20 vaccinees are protected after a single dose. However, because a = limited=20 proportion of recipients (5%--15%) of measles-mumps-rubella (MMR) = or=20 varicella vaccine fail to respond to 1 dose, a second dose is = recommended=20 to provide another opportunity to develop immunity (6)= .=20 The majority of persons who fail to respond to the first dose of = MMR or=20 varicella vaccine respond to a second dose (7,8)= .=20

The Recommended Childhood and Adolescent Immunization Schedule = and the=20 Recommended Adult Immunization Schedule are revised annually. = Physicians=20 and other health-care providers should ensure that they are = following the=20 most up-to-date schedules, which are available from CDC's National = Center=20 for Immunization and Respiratory Diseases (proposed) website (http://www.cdc.gov/nip).=20
Spacing of Multiple Doses of the Same Antigen

Vaccination providers should adhere as closely as possible to=20 recommended vaccination schedules. Recommended ages and intervals = between=20 doses of multidose antigens provide optimal protection or have the = best=20 evidence of efficacy. Recommended vaccines and recommended = intervals=20 between doses are provided in this report (Table= =20 1).

In certain circumstances, administering doses of a multidose = vaccine at=20 shorter than the recommended intervals might be necessary. This = can occur=20 when a person is behind schedule and needs to be brought = up-to-date as=20 quickly as possible or when international travel is impending. In = these=20 situations, an accelerated schedule can be implemented that uses = intervals=20 between doses shorter than those recommended for routine = vaccination.=20 Although the effectiveness of all accelerated schedules has not = been=20 evaluated in clinical trials, ACIP believes that when accelerated=20 intervals are used, the immune response is acceptable and will = lead to=20 adequate protection. The accelerated or minimum intervals and ages = that=20 can be used for scheduling catch-up vaccinations are provided in = this=20 report (Table= =20 1). Vaccine doses should not be administered at intervals less = than=20 these minimum intervals or earlier than the minimum age.*

In clinical practice, vaccine doses occasionally are = administered at=20 intervals less than the minimum interval or at ages younger than = the=20 minimum age. Doses administered too close together or at too young = an age=20 can lead to a suboptimal immune response. However, administering a = dose a=20 limited number of days earlier than the minimum interval or age is = unlikely to have a substantially negative effect on the immune = response to=20 that dose. Therefore, ACIP recommends that vaccine doses = administered 4 or=20 fewer days before the minimum interval or age be counted as=20 valid.⁼⁸⁶ However, because of its unique schedule, this = recommendation does not apply to the rabies vaccine (9)= .=20 Doses administered 5 or more days earlier than the minimum = interval or age=20 of any vaccine should not be counted as valid doses and should be = repeated=20 as age-appropriate. The repeat dose should be spaced after the = invalid=20 dose by the recommended minimum interval (Table= =20 1). For example, if Haemophilus influenzae type b (Hib) = doses=20 one and two were administered only 2 weeks apart, because the = minimum=20 interval from dose one to dose two is 4 weeks, dose two is invalid = and=20 should be repeated. The repeat dose should be administered 4 or = more weeks=20 after the invalid (second) dose. The repeat dose would be counted = as the=20 second valid dose. Doses administered 5 or more days before the = minimum=20 age should be repeated on or after the child reaches the minimum = age and 4=20 or more weeks after the invalid dose. For example, if the first = dose of=20 varicella vaccine were administered at age 10 months, the repeat = dose=20 would be administered no earlier than the child's first birthday. = If the=20 first dose of varicella vaccine were administered at age 11 months = and 2=20 weeks, the repeat dose could be administered 2 weeks after the = first=20 birthday.

Certain vaccines produce increased rates of local or systemic = reactions=20 in certain recipients when administered too frequently (e.g., = adult=20 tetanus-diphtheria toxoid [Td]; pediatric diphtheria-tetanus = toxoid [DT];=20 tetanus toxoid; and tetanus, reduced diphtheria acellular = pertussis=20 vaccine for adolescents and adults) (10,11). Such reactions = might=20 result from formation of antigen-antibody complexes. Optimal = record=20 keeping, maintaining patient histories, and adhering to = recommended=20 schedules can decrease the incidence of such reactions without = adversely=20 affecting immunity.=20
Simultaneous Administration

Experimental evidence and extensive clinical experience provide = the=20 scientific basis for administering vaccines simultaneously (i.e., = during=20 the same office visit, not combined in the same syringe). = Simultaneously=20 administering all vaccines for which a person is eligible is = critical,=20 including for childhood vaccination programs, because simultaneous = administration increases the probability that a child will be = vaccinated=20 fully at the appropriate age (1). A study conducted during = a=20 measles outbreak demonstrated that approximately one third of = measles=20 cases among unvaccinated but vaccine-eligible preschool children = could=20 have been prevented if MMR had been administered at the same visit = when=20 another vaccine was administered (12). Simultaneous = administration=20 also is critical when preparing for foreign travel and/or if = uncertainty=20 exists that a person will return for further doses of vaccine. =

Simultaneously administering the most widely used live and = inactivated=20 vaccines have produced seroconversion rates and rates for adverse=20 reactions similar to those observed when the vaccines are = administered=20 separately (13--16). Routinely administering all = age-appropriate=20 doses of vaccines simultaneously is recommended for children for = whom no=20 specific contraindications exist at the time of the visit. = Administering=20 combined MMR (or measles-mumps-rubella-varicella [MMRV] vaccine) = yields=20 safety and immunogenicity results similar to administering = individual=20 measles, mumps, and rubella vaccines at different sites. = Therefore, no=20 medical basis exists for administering these vaccines separately = for=20 routine vaccination instead of the preferred MMR combined vaccine = (6)= .=20 Administering separate antigens would result in a delay in = protection for=20 the deferred components. Response to MMR and varicella vaccines=20 administered on the same day is identical to vaccines administered = a month=20 apart (17), and administration of MMRV combined vaccine is = similar=20 to administration of MMR and varicella vaccines on the same day = (18= ).=20 No evidence exists that oral rotavirus vaccine (RV) interferes = with live=20 vaccines administered by injection or intranasally (e.g., MMR and=20 live-attenuated influenza vaccine [LAIV]). RV can be administered=20 simultaneously or at any interval before or after injectable or = intranasal=20 live vaccines (19= ).=20 No data exist about the immunogenicity of oral Ty21a typhoid = vaccine when=20 administered concurrently or within 30 days of other live virus = vaccines.=20 In the absence of such data, if typhoid vaccination is warranted,=20 administration should not be delayed because of administration of=20 live-attenuated virus vaccines (20= ).=20

Simultaneously administering pneumococcal polysaccharide = vaccine (PPV)=20 and inactivated influenza vaccine elicits a satisfactory antibody = response=20 without increasing the incidence or severity of adverse reactions=20 (21). Simultaneously administering PPV and inactivated = influenza=20 vaccine is recommended for all persons for whom both vaccines are=20 indicated.

Hepatitis B vaccine (HepB) administered with yellow fever = vaccine is as=20 safe and immunogenic as when these vaccines are administered = separately=20 (22). Measles and yellow fever vaccines have been = administered=20 safely at the same visit and without reduction of immunogenicity = of each=20 of the components (23,24= ).=20

Depending on vaccines administered in the first year of life, = children=20 aged 12--15 months might receive up to nine injections during a = single=20 visit (MMR, varicella, Hib, pneumococcal conjugate, diphtheria and = tetanus=20 toxoids and acellular pertussis [DTaP], IPV, hepatitis A, HepB, = and=20 influenza [seasonal] vaccines). To reduce the number of injections = at the=20 12--15-month visit, the IPV and HepB series can be expedited and = completed=20 before the child's first birthday. MMRV can be administered as = soon as=20 possible on or after the first birthday and the fourth dose of = DTaP=20 administered at age 15 months. The majority of children aged 1 = year who=20 have received 2 (polyribosylribitol phosphate-meningococcal outer = membrane=20 protein [PRP-OMP]) or 3 (PRP-tetanus [PRP-T], diphtheria CRM197 = [CRM,=20 cross-reactive material] protein conjugate [HbOC]) previous doses = of Hib=20 vaccine and 3 previous doses of DTaP and pneumococcal conjugate = vaccine=20 (PCV) have had protection (25,26= ).=20 The third (PRP-OMP) or fourth (PRP-T, HbOC) dose of the Hib = series, and=20 the fourth doses of DTaP and PCV are critical in boosting antibody = titer=20 and ensuring continued protection (26--29= ).=20 However, the booster dose of the pneumococcal conjugate series can = be=20 deferred until age 15--18 months for children who are likely to = return for=20 future visits. The fourth dose of DTaP is recommended at age = 15--18 months=20 but can be administered as early as age 12 months under certain=20 circumstances (27= ).=20 For infants at low risk for infection with hepatitis B virus = (i.e., the=20 mother tested negative for hepatitis B surface antigen [HBsAg] at = the time=20 of delivery), the HepB series can be completed at any time for = children=20 aged 6--18 months. With use of certain HepB combination vaccines = (i.e.,=20 combination Hib-HepB vaccine), the minimum age of administration = of the=20 final dose is 12 months because of the minimum age requirement for = the=20 last dose of the Hib series (30= ).=20 Recommended spacing of doses should be maintained (Table= =20 1).

Use of combination vaccines can reduce the number of injections = required at an office visit. Licensed combination vaccines can be = used=20 whenever any components of the combination are indicated and its = other=20 components are not contraindicated and if licensed by the Food and = Drug=20 Administration (FDA) for that dose in the series. Use of licensed=20 combination vaccines is preferred to separate injection of their=20 equivalent component vaccines to reduce the number of injections = and=20 missed opportunities to protect through vaccination (31= ).=20 Only combination vaccines licensed by FDA should be used. = Individual=20 vaccines should never be mixed in the same syringe unless they are = approved specifically for mixing by FDA. Only one vaccine (DTaP = and PRP-T=20 Hib vaccine, marketed as TriHIBit^=AE [manufactured by = sanofi=20 pasteur]) is licensed by FDA for mixing in the same syringe. This = vaccine=20 should not be used for primary vaccination in infants aged 2, 4, = and 6=20 months, but it can be used as the last dose of the Hib vaccine = series on=20 or after age 12 months.=20
Nonsimultaneous Administration

No evidence exists that inactivated vaccines interfere with the = immune=20 response to other inactivated vaccines or to live vaccines. An = inactivated=20 vaccine can be administered either simultaneously or at any time = before or=20 after a different inactivated vaccine or live vaccine (Table= =20 2).

Data are limited about interference between live vaccines. The = immune=20 response to one live-virus vaccine might be impaired if = administered=20 within 30 days of another live-virus vaccine (32,33). In a = study=20 conducted in two U.S. health maintenance organizations, persons = who=20 received varicella vaccine <30 days after MMR vaccination had = an=20 increased risk for varicella vaccine failure (i.e., varicella = disease in a=20 vaccinated person) of 2.5-fold compared with persons who received=20 varicella vaccine before or >30 days after MMR (34). In=20 comparison, another study determined that the response to yellow = fever=20 vaccine is not affected by monovalent measles vaccine administered = 1--27=20 days earlier (23). The effect of nonsimultaneously = administering=20 rubella, mumps, varicella, and yellow fever vaccines is unknown. =

To minimize the potential risk for interference, injectable or = nasally=20 administered live vaccines not administered on the same day should = be=20 administered >4 weeks apart whenever possible (Table= =20 2). If injectable or nasally administered live vaccines are = separated=20 by <4 weeks, the vaccine-administered second should not be = counted as a=20 valid dose and should be repeated. The repeat dose should be = administered=20 >4 weeks after the last invalid dose. Yellow fever vaccine can = be=20 administered at any time after single-antigen measles vaccine. = Oral=20 vaccines (Ty21a typhoid vaccine and RV) can be administered = simultaneously=20 or at any interval before or after other live vaccines (injectable = or=20 intranasal) if indicated.=20
Spacing of Vaccines and Antibody-Containing Products =

Live Vaccines

Ty21a typhoid, yellow fever, and LAIV vaccines can be = administered at=20 any time before, concurrent with, or after administering any = immune=20 globulin, hyperimmune globulin, or intravenous immune globulin = (IGIV).=20 Blood (e.g., whole blood, packed red blood cells, and plasma) and = other=20 antibody-containing blood products (e.g., immune globulin, = hyperimmune=20 globulin, and IGIV) can inhibit the immune response to measles and = rubella=20 vaccines for 3 or more months. The effect of blood and immune = globulin=20 preparations on the response to mumps and varicella vaccines is = unknown,=20 but commercial immune globulin preparations contain antibodies to = these=20 viruses. Blood products available in the United States are = unlikely to=20 contain a substantial amount of antibody to yellow fever vaccine = virus.=20 The length of time that interference with injectable live = vaccination=20 (except yellow fever vaccine) can persist after the = antibody-containing=20 product is a function of the amount of antigen-specific antibody = contained=20 in the product (35--37). Therefore, after an = antibody-containing=20 product is received, live vaccines (except yellow fever vaccine, = oral=20 Ty21a typhoid vaccine, and LAIV) should be delayed until the = passive=20 antibody has degraded (Table= =20 3). If a dose of injectable live-virus vaccine (except yellow = fever=20 vaccine) is administered after an antibody-containing product but = at an=20 interval shorter than recommended in this report, the vaccine dose = should=20 be repeated unless serologic testing is feasible and indicates a = response=20 to the vaccine. The repeat dose or serologic testing should be = performed=20 after the interval indicated for the antibody-containing product = (Table= =20 4).

Although passively acquired antibodies can interfere with the = response=20 to rubella vaccine, the low dose of anti-Rho(D) globulin = administered to=20 postpartum women has not been demonstrated to reduce the response = to the=20 RA27/3 strain rubella vaccine (38). Because of the = importance of=20 rubella and varicella immunity among childbearing-aged women = (6,39= ),=20 the postpartum vaccination of women without evidence of immunity = to=20 rubella or varicella with single-antigen rubella, MMR, varicella, = or MMRV=20 vaccine should not be delayed because of receipt of anti-Rho(D) = globulin=20 or any other blood product during the last trimester of pregnancy = or at=20 delivery. These women should be vaccinated immediately after = delivery and,=20 if possible, tested 3 or more months later to ensure immunity to = rubella=20 and, if appropriate, to measles (6)= .=20

Interference can occur if administering an antibody-containing = product=20 becomes necessary after administering MMRV or its individual = components.=20 Usually, vaccine virus replication and stimulation of immunity = will occur=20 1--2 weeks after vaccination. If the interval between = administering any of=20 these vaccines and subsequent administration of an = antibody-containing=20 product is <14 days, vaccination should be repeated after the=20 recommended interval (Table= s=20 3 and 4= ),=20 unless serologic testing indicates an antibody response. RV should = be=20 deferred for 6 weeks after receipt of an antibody-containing = product if=20 possible. However, if the 6-week deferral would cause the first = dose of RV=20 to be scheduled for a child aged >13 weeks, a shorter = deferral=20 interval should be used to ensure the first dose of RV is = administered no=20 later than age 13 weeks (19= ).=20

A humanized mouse monoclonal antibody product (palivizumab) is=20 available for prevention of respiratory syncytial virus infection = among=20 infants and young children. This product contains only antibody to = respiratory syncytial virus and will not interfere with immune = response to=20 currently licensed live or inactivated vaccines.

Inactivated Vaccines

Antibody-containing products interact less with inactivated = vaccines,=20 toxoids, recombinant subunit, and polysaccharide vaccines than = with live=20 vaccines (40). Therefore, administering inactivated = vaccines and=20 toxoids either simultaneously with or at any interval before or = after=20 receipt of an antibody-containing product should not substantially = impair=20 development of a protective antibody response (Table= =20 3). The vaccine or toxoid and antibody preparation should be=20 administered at different sites by using the standard recommended = dose.=20 Increasing the vaccine dose volume or number of vaccinations is = not=20 indicated or recommended.=20
Interchangeability of Vaccines from Different Manufacturers =

Certain vaccines are available from different manufacturers, = and these=20 vaccines usually are not identical in antigen content or amount or = method=20 of formulation. Manufacturers use different production processes, = and=20 their products might contain different concentrations of antigen = per dose=20 or a different stabilizer or preservative.

Available data indicate that infants who receive sequential = doses of=20 different Hib conjugate, HepB, and hepatitis A (HepA) vaccines = produce a=20 satisfactory antibody response after a complete primary series=20 (41--44). All brands of Hib conjugate, HepB,^=A7 = and HepA=20 vaccines are interchangeable within their respective series. If = different=20 brands of Hib conjugate vaccine are administered, 3 doses are = considered=20 adequate for the primary series among infants. If PRP-OMP is used, = the=20 primary series consists of 2 doses. After completing the primary = series,=20 any Hib conjugate vaccine can be used for the booster dose at age = 12--18=20 months.

Data are limited about the safety, immunogenicity, and efficacy = of=20 using acellular pertussis (e.g., DTaP) vaccines from different=20 manufacturers for successive doses of the pertussis series. Data = from one=20 study indicate that, for the first 3 doses of the DTaP series, = 1--2 doses=20 of Tripedia^=AE followed by Infanrix^=AE for = the remaining=20 doses(s) is comparable to 3 doses of Tripedia with regard to=20 immunogenicity, as measured by antibodies to diphtheria, tetanus, = and=20 pertussis toxoid, and filamentous hemagglutinin (45). = However, in=20 the absence of a clear serologic correlate of protection for = pertussis,=20 the relevance of these immunogenicity data for protection against=20 pertussis is unknown. Whenever feasible, the same brand of DTaP = vaccine=20 should be used for all doses of the vaccination series. If = vaccination=20 providers do not know or have available the type of DTaP vaccine=20 previously administered to a child, any DTaP vaccine should be = used to=20 continue or complete the series. For vaccines in general, = vaccination=20 should not be deferred because the brand used for previous doses = is not=20 available or is unknown (27,46= ).=20
Lapsed Vaccination Schedule

Vaccination providers should administer vaccines as close to = the=20 recommended intervals as possible. However, = longer-than-recommended=20 intervals between doses do not reduce final antibody = concentrations,=20 although protection might not be attained until the recommended = number of=20 doses has been administered. With the exception of oral typhoid = vaccine,=20 an interruption in the vaccination schedule does not require = restarting=20 the entire series of a vaccine or toxoid or addition of extra = doses.=20
Unknown or Uncertain Vaccination Status

Vaccination providers frequently encounter persons who do not = have=20 adequate documentation of vaccinations. Providers should only = accept=20 written, dated records as evidence of vaccination. With the = exception of=20 influenza vaccine and PPV (47,48= ),=20 self-reported doses of vaccine without written documentation = should not be=20 accepted. Although vaccinations should not be postponed if records = cannot=20 be found, an attempt to locate missing records should be made by=20 contacting previous health-care providers, reviewing state or = local=20 immunization information systems (IIS), and searching for a = personally=20 held record. If records cannot be located, these persons should be = considered susceptible and should be started on the = age-appropriate=20 vaccination schedule. Serologic testing for immunity is an = alternative to=20 vaccination for certain antigens (e.g., measles, rubella, = hepatitis A, and=20 tetanus).=20
Contraindications and = Precautions=20

Contraindications and precautions to vaccination dictate = circumstances=20 when vaccines should not be administered. The majority of = precautions are=20 temporary, and the vaccination can be administered later. A=20 contraindication is a condition in a recipient that increases the = risk for=20 a serious adverse reaction. A vaccine should not be administered = when a=20 contraindication is present. For example, administering influenza = vaccine=20 to a person with an anaphylactic allergy to egg protein could = cause=20 serious illness in or death of the recipient.

National standards for pediatric vaccination practices have = been=20 established and include true contraindications and precautions to=20 vaccination (Table= =20 5) (1). The only contraindication applicable to all = vaccines is=20 a history of a severe allergic reaction after a previous dose of = vaccine=20 or to a vaccine constituent (unless the recipient has been = desensitized).=20 In addition, severely immunocompromised persons should generally = not=20 receive live vaccines. Children who experience encephalopathy = within 7=20 days after administration of a previous dose of diphtheria and = tetanus=20 toxoids and whole-cell pertussis vaccine (DTP), DTaP, or Tdap not=20 attributable to another identifiable cause should not receive = further=20 doses of a vaccine that contains pertussis. Because of the = theoretical=20 risk for the fetus, women known to be pregnant should generally = not=20 receive live-attenuated virus vaccines.

A precaution is a condition in a recipient that might increase = the risk=20 for a serious adverse reaction or that might compromise the = ability of the=20 vaccine to produce immunity (e.g., administering measles vaccine = to a=20 person with passive immunity to measles from a blood transfusion). = A=20 person might experience a more severe reaction to the vaccine than = would=20 have otherwise been expected; however, the risk for this happening = is less=20 than expected with a contraindication. In general, vaccinations = should be=20 deferred when a precaution is present. However, a vaccination = might be=20 indicated in the presence of a precaution because the benefit of=20 protection from the vaccine outweighs the risk for an adverse = reaction.=20 For example, caution should be exercised in vaccinating a child = with DTaP=20 who, within 48 hours of receipt of a previous dose of DTP or DTaP, = experienced fever of >104=B0F (>40.5=B0C); had persistent, = inconsolable=20 crying for 3 or more hours; collapsed or experienced a shock-like = state;=20 or had a seizure <3 days after receiving the previous dose of = DTP or=20 DTaP. However, administering a pertussis-containing vaccine should = be=20 considered if the risk for pertussis is increased (e.g., during a=20 pertussis outbreak) (27= ).=20 These precautions do not apply to administration of=20 tetanus-reduced-diphtheria-acellular-pertussis vaccine for = adolescents and=20 adults. The presence of a moderate or severe acute illness with or = without=20 a fever is a precaution to administration of all vaccines (Table= =20 5).

Clinicians or other health-care providers might inappropriately = consider certain conditions or circumstances to be true = contraindications=20 or precautions to vaccination. This misconception results in = missed=20 opportunities to administer recommended vaccines (49). = Likewise,=20 clinicians and other health-care providers might fail to = understand what=20 constitutes a true contraindication or precaution and might = administer a=20 vaccine when it should be withheld. This practice can result in an = increased risk for an adverse reaction to the vaccine. Among the = most=20 common conditions often inappropriately considered = contraindications are=20 diarrhea, minor upper-respiratory tract illnesses (including = otitis media)=20 with or without fever, mild-to-moderate local reactions to a = previous dose=20 of vaccine, current antimicrobial therapy, and the convalescent = phase of=20 an acute illness (Table= =20 5).

The decision to administer or delay vaccination because of a = current or=20 recent acute illness depends on severity of symptoms and etiology = of the=20 disease. All vaccines can be administered to persons with minor = acute=20 illness (e.g., diarrhea or mild upper-respiratory tract infection = with or=20 without fever). Studies indicate that failure to vaccinate = children with=20 minor illnesses can seriously impede vaccination efforts = (50--52).=20 Among persons whose compliance with medical care cannot be = ensured, use of=20 every opportunity to provide appropriate vaccinations is critical. =

The safety and efficacy of vaccinating persons who have mild = illnesses=20 have been documented (53--56). Vaccination should not be = delayed=20 because of the presence of mild respiratory tract illness or other = acute=20 illness with or without fever.

Persons with moderate or severe acute illness should be = vaccinated as=20 soon as the acute illness has improved, after screening for=20 contraindications. This precaution avoids superimposing adverse = effects of=20 the vaccine on the underlying illness or causing diagnostic = confusion=20 between manifestations of the underlying illness and possible = adverse=20 effects of vaccination.

Routine physical examinations and procedures (e.g., measuring=20 temperatures) are not prerequisites for vaccinating persons who = appear to=20 be healthy. Asking the parent or guardian if the child is ill and = then=20 postponing vaccination for children with moderate-to-severe = illness or=20 proceeding with vaccination if no contraindications exist are = appropriate=20 procedures in childhood vaccination programs.

A family history of seizures or other central nervous system = disorders=20 is not a contraindication to administration of pertussis or other=20 vaccines. However, delaying pertussis vaccination for infants and = children=20 with a history of previous seizures until the child's neurologic = status=20 has been assessed is prudent. Pertussis vaccine should not be = administered=20 to infants with evolving neurologic conditions until the condition = has=20 stabilized (Table= =20 5) (27= ).=20
Vaccine Administration =

Infection Control and Sterile Technique

Persons administering vaccines should follow appropriate = precautions to=20 minimize risk for spread of disease. Hands should be cleansed with = an=20 alcohol-based waterless antiseptic hand rub or washed with soap = and water=20 between each patient contact (57= ).=20 Occupational Safety and Health Administration (OSHA) regulations = do not=20 require gloves to be worn when administering vaccinations, unless = persons=20 administering vaccinations are likely to come into contact with=20 potentially infectious body fluids or have open lesions on their = hands.=20 Needles used for injections must be sterile and disposable to = minimize the=20 risk for contamination. A separate needle and syringe should be = used for=20 each injection. Changing needles between drawing vaccine from a = vial and=20 injecting it into a recipient is not necessary. Different vaccines = should=20 never be mixed in the same syringe unless specifically licensed = for such=20 use, and no attempt should be made to transfer between syringes. =

To prevent inadvertent needle-stick injury or reuse, needles = and=20 syringes should be discarded immediately after use in labeled,=20 puncture-proof containers located in the same room where the = vaccine is=20 administered. Needles should not be recapped before being placed = in the=20 container. Safety needles or needle-free injection devices should = be used=20 if available to reduce the risk for injury.=20
Injection Route and Injection Site

With the exception of Bacillus Calmette-Guerin (BCG) vaccine,=20 injectable vaccines are administered by the intramuscular and = subcutaneous=20 route. The method of administration of injectable vaccines is = determined,=20 in part, by the presence of adjuvants in some vaccines. The term = adjuvant=20 refers to a vaccine component distinct from the antigen that = enhances the=20 immune response to the antigen. The majority of vaccines = containing an=20 adjuvant (e.g., DTaP, DT, Td, Tdap, PCV, Hib, HepA , HepB, and = human=20 papillomavirus [HPV]) should be injected into a muscle because=20 administration subcutaneously or intradermally can cause local = irritation,=20 induration, skin discoloration, inflammation, and granuloma = formation.=20 Anthrax vaccine, an inactivated vaccine with adjuvant, is an = exception to=20 this rule and is recommended to be administered subcutaneously. = Routes of=20 administration are recommended by the manufacturer for each = immunobiologic=20 (Table= =20 6). Deviation from the recommended route of administration = might=20 reduce vaccine efficacy (58,59) or increase local adverse = reactions=20 (60--62).=20
Intramuscular Injections and Needle Length

Injectable immunobiologics should be administered where local, = neural,=20 vascular, or tissue injury is unlikely. Use of longer needles has = been=20 associated with less redness or swelling than occurs with shorter = needles=20 because of injection into deeper muscle mass (60). = Appropriate=20 needle length depends on age and body mass.

For all intramuscular injections, the needle should be long = enough to=20 reach the muscle mass and prevent vaccine from seeping into = subcutaneous=20 tissue, but not so long as to involve underlying nerves, blood = vessels, or=20 bone (59,63--65). Vaccinators should be familiar with the = anatomy=20 of the area into which they are injecting vaccine. Intramuscular=20 injections are administered at a 90-degree angle to the skin, = preferably=20 into the anterolateral aspect of the thigh or the deltoid muscle = of the=20 upper arm, depending on the age of the patient (Table= =20 7).

Decision on needle size and site of injection must be made for = each=20 person on the basis of the size of the muscle, the thickness of = adipose=20 tissue at the injection site, the volume of the material to be=20 administered, injection technique, and the depth below the muscle = surface=20 into which the material is to be injected (Figur= e=20 1). Aspiration before injection of vaccines or toxoids (i.e., = pulling=20 back on the syringe plunger after needle insertion, before = injection) is=20 not required because no large blood vessels exists at the = recommended=20 injection sites.

Infants (Aged <12 Months)

For the majority of infants, the anterolateral aspect of the = thigh is=20 the recommended site for injection because it provides a large = muscle mass=20 (Figur= e=20 2). The muscles of the buttock have not been used for = administration=20 of vaccines in infants and children because of concern about = potential=20 injury to the sciatic nerve, which is well documented after = injection of=20 antimicrobial agents into the buttock. If the gluteal muscle must = be used,=20 care should be taken to define the anatomic = landmarks.^=B6=20 Injection technique is the most important parameter to ensure = efficient=20 intramuscular vaccine delivery. If the subcutaneous and muscle = tissue are=20 bunched to minimize the chance of striking bone (63), a = 1-inch=20 needle is required to ensure intramuscular administration in = infants. For=20 the majority of infants, a 1-inch, 22--25-gauge needle is = sufficient to=20 penetrate muscle in an infant's thigh. For newborn (first 28 days = of life)=20 and premature infants, a 5/8 inch long needle usually is adequate = if the=20 skin is stretched flat between thumb and forefinger and the needle = inserted at a 90-degree angle to the skin (65).

Toddlers and Older Children (Aged 12 Months--10 Years) =

The deltoid muscle should be used if the muscle mass is = adequate. The=20 needle size for deltoid site injections can range from 22--25 = gauge and=20 from 5/8 to 1 inch on the basis of the size of the muscle and the=20 thickness of adipose tissue at the injection site (Figur= e=20 3). A 5/8-inch needle is adequate only for the deltoid muscle = and only=20 if the skin is stretched flat between thumb and forefinger and the = needle=20 inserted at a 90-degree angle to the skin. For toddlers, the = anterolateral=20 thigh can be used, but the needle should be at least 1 inch in = length.=20

Adolescents and Adults (Aged >11 Years)

For adults and adolescents, the deltoid muscle is recommended = for=20 routine intramuscular vaccinations. The anterolateral thigh also = can be=20 used. For men and women weighing <130 lbs (<60 kg) a = 5/8--1-inch=20 needle is sufficient to ensure intramuscular injection. For women = weighing=20 130--200 lbs (60--90 kg) and men 130--260 lbs (60--118kg), a = 1--1=BD-inch=20 needle is needed. For women weighing >200 lbs (>90 kg) or = men=20 weighing >260 lbs (>118 kg), a 1=BD-inch needle is required = (Table= =20 7) (64).=20
Subcutaneous Injections

Subcutaneous injections are administered at a 45-degree angle = usually=20 into the thigh for infants aged <12 months and in the = upper-outer=20 triceps area of persons aged >12 months. Subcutaneous = injections=20 can be administered into the upper-outer triceps area of an = infant, if=20 necessary. A 5/8-inch, 23--25-gauge needle should be inserted into = the=20 subcutaneous tissue (Figur= es=20 4 and 5= ).=20
Multiple Vaccinations

If multiple vaccines are administered at a single visit, = administration=20 of each preparation at a different anatomic site is desirable. For = infants=20 and younger children, if more than two vaccines must be injected = in a=20 single limb, the thigh is the preferred site because of the = greater muscle=20 mass; the injections should be sufficiently separated (i.e., 1 = inch or=20 more if possible) so that any local reactions can be = differentiated=20 (60,66). For older children and adults, the deltoid muscle = can be=20 used for more than one intramuscular injection. If a vaccine and = an immune=20 globulin preparation are administered simultaneously (e.g., = Td/Tdap and=20 tetanus immune globulin [TIG], HepB and hepatitis B immunoglobulin = [HBIG]), separate anatomic sites should be used for each = injection. The=20 location of each injection should be documented in the patients' = medical=20 record.=20
Jet Injection

Jet injectors (JIs) are needle-free devices that drive liquid=20 medication through a nozzle orifice, creating a narrow stream = under high=20 pressure that penetrates skin to deliver a drug or vaccine into=20 intradermal, subcutaneous, or intramuscular tissues = (67,68). JIs=20 have the potential to reduce the frequency of needle-stick = injuries to=20 health-care workers (69) and to overcome the improper reuse = and=20 other drawbacks of needles and syringes in economically developing = countries (70--72). JIs have been safe and effective for=20 administering different live and inactivated vaccines for viral = and=20 bacterial diseases (72). The immune responses generated are = equivalent to, and occasionally greater than, immune responses = induced by=20 needle injection. However, local reactions or injury (e.g., = redness,=20 induration, pain, blood, and ecchymosis at the injection site) can = be more=20 frequent when vaccines are delivered by JIs compared with needle = injection=20 (68,72).

In the 1990s, a new generation of JIs was introduced with = disposable=20 cartridges serving as dose chambers and nozzle (72). With = the=20 provision of a new sterile cartridge for each patient and correct = use,=20 these devices avoid the safety concerns for multiple-use--nozzle = devices=20 (72--76). These devices should be used in accordance with = their=20 labeling for intradermal, subcutaneous, or intramuscular = administration.=20
Methods for Alleviating Discomfort and Pain Associated with = Vaccination

Comfort measures, such as distraction (e.g., playing music or=20 pretending to blow away the pain), ingestion of sweet liquids, = breast=20 feeding, cooling of the injection site, and topical or oral = analgesia, can=20 help infants or children cope with the discomfort associated with=20 vaccination (77,78). Pretreatment (30--60 minutes before = injection)=20 with 5% topical lidocaine-prilocaine emulsion can decrease the = pain of=20 vaccination by causing superficial anesthesia (79,80). = Evidence=20 indicates that this cream does not interfere with the immune = response to=20 MMR (81). Topical lidocaine-prilocaine emulsion should not = be used=20 on infants aged <12 months who are receiving treatment with=20 methemoglobin-inducing agents because of the possible development = of=20 methemoglobinemia (82).

Acetaminophen has been used among children to reduce the = discomfort and=20 fever associated with DTP vaccination (83). However, = acetaminophen=20 can cause formation of methemoglobin and might interact with=20 lidocaine-prilocaine cream if used concurrently (82). Use = of a=20 topical refrigerant (vapocoolant) spray immediately before = vaccination can=20 reduce the short-term pain associated with injections and can be = as=20 effective as lidocaine-prilocaine cream (84).=20
Nonstandard Vaccination Practices

Recommendations for route, site, and dosage of immunobiologics = are=20 derived from data from clinical trials, from practical experience, = and=20 from theoretical considerations. ACIP discourages variations from = the=20 recommended route, site, volume, or number of doses of any = vaccine.

Variation from the recommended route and site can result in = inadequate=20 protection. In adults but not in infants (85), the = immunogenicity=20 of HepB is substantially lower when the gluteal rather than the = deltoid=20 site is used for administration (58). HepB administered=20 intradermally can result in a lower seroconversion rate and final = titer of=20 hepatitis B surface antibody than when administered by the deltoid = intramuscular route (86,87). HepB administered by any route = other=20 than intramuscularly, or in adults at any site other than the = deltoid or=20 anterolateral thigh, should not be counted as valid and should be=20 repeated. Similarly, doses of rabies vaccine administered in the = gluteal=20 site should not be counted as valid doses and should be repeated=20 (88). Meningococcal conjugate vaccine (MCV4) should be = administered=20 intramuscularly; however, revaccination is not necessary when = administered=20 subcutaneously (89= ).=20 Inactivated influenza vaccine is immunogenic when administered in = a lower=20 than standard dose by the intradermal (ID) route to healthy adult=20 volunteers (90). However, the immunogenicity for = persons=20 aged >60 years is inadequate, and variance from the = recommended=20 route and dose is not recommended.

Live-attenuated injectable vaccines (e.g., MMR, varicella, and = yellow=20 fever) and certain inactivated vaccines (e.g., meningococcal=20 polysaccharide and anthrax) are recommended by the manufacturers = to be=20 administered by subcutaneous injection. PPV and IPV are = recommended by the=20 manufacturer to be administered by the subcutaneous or = intramuscular=20 route. Response to vaccines recommended by the subcutaneous route = probably=20 will not be affected if the vaccines are administered by the = intramuscular=20 rather than subcutaneous route. Repeating doses of vaccine = administered by=20 the intramuscular route rather than by the subcutaneous route is = not=20 necessary.

Administering volumes smaller than that recommended (e.g., = split doses)=20 can result in inadequate protection. Using larger than recommended = dosages=20 can be hazardous because of excessive local or systemic = concentrations of=20 antigens or other vaccine constituents. Using reduced doses = administered=20 at multiple immunization visits that equal a full dose or using = smaller=20 divided doses are not endorsed or recommended. Any vaccination = using less=20 than the standard dose should not be counted, and the person = should be=20 revaccinated according to age, unless serologic testing indicates = that an=20 adequate response has been achieved.=20
Preventing Adverse Reactions

Vaccines are intended to produce active immunity to specific = antigens.=20 An adverse reaction is an untoward effect that occurs after a = vaccination=20 that is extraneous to the vaccine's primary purpose of producing = immunity.=20 Vaccine adverse reactions are classified by three general = categories:=20 local, systemic, and allergic (91= ).=20 Local reactions are usually the least severe and most frequent. = Systemic=20 reactions (e.g., fever) occur less frequently than local = reactions.=20 Serious allergic reactions (e.g., anaphylaxis) are the most severe = and=20 least frequent. Severe adverse reactions are rare.

Persons who administer vaccines should screen their patients = for=20 contraindications and precautions to the vaccine before each dose = of=20 vaccine is administered (Table= =20 5). Screening can be facilitated by consistent use of = screening=20 questionnaires, which are available from certain state vaccination = programs and other sources (e.g., the Immunization Action = Coalition at http://www.immunize.org/). =

Syncope (vasovagal or vasodepressor reaction) can occur after=20 vaccination, most commonly among adolescents and young adults. = During=20 1990--2004, a total of 3,168 reports to Vaccine Adverse Event = Reporting=20 System (VAERS) were coded as syncope; 35% of these episodes were = reported=20 among persons aged 10--18 years (CDC, unpublished data, 2005).=20 Approximately 14% of reported syncopal episodes resulted in=20 hospitalization because of injury or medical evaluation. Serious = injury,=20 including skull fracture and cerebral hemorrhage, has resulted = from=20 syncopal episodes after vaccination (92). A review of = syncope after=20 vaccination indicated that 63% of syncopal episodes occurred = <5=20 minutes after vaccination, and 89% occurred within 15 = minutes after=20 vaccination (93). Although syncopal episodes are uncommon = and=20 severe allergic reactions are rare, vaccine providers should = strongly=20 consider observing patients for 15 minutes after they are=20 vaccinated (94). If syncope develops, patients should be = observed=20 until the symptoms resolve.=20
Managing Acute Vaccine Reactions

Although rare after vaccination, the immediate onset and=20 life-threatening nature of an anaphylactic reaction require that = all=20 personnel and facilities providing vaccinations have procedures in = place=20 for managing a reaction. All vaccine providers should be familiar = with the=20 office emergency plan and be certified in cardiopulmonary = resuscitation.=20 Epinephrine and equipment for maintaining an airway should be = available=20 for immediate use.

Anaphylaxis usually begins within minutes of vaccine = administration=20 (95,96). Rapidly recognizing and initiating treatment are = required=20 to prevent possible progression to cardiovascular collapse. If = flushing,=20 facial edema, urticaria, itching, swelling of the mouth or throat, = wheezing, difficulty breathing, or other signs of anaphylaxis = occur, the=20 patient should be placed in a recumbent position with the legs = elevated.=20 Treatment options for management of anaphylaxis using = pharmaceuticals have=20 been recommended (Table= =20 8) (94,97). Maintenance of an airway and oxygen = administration=20 might be necessary. Arrangements should be made for immediate = transfer to=20 an emergency facility for further evaluation and treatment.=20
Occupational Safety Regulations

Bloodborne diseases (e.g., hepatitis B, hepatitis C, and human=20 immunodeficiency virus [HIV]) are occupational hazards for = physicians and=20 other health-care providers. To reduce the incidence of = needle-stick=20 injury and the consequent risk for bloodborne diseases acquired = from=20 patients, the Needlestick Safety and Prevention Act was enacted in = November 2000. The Act directed OSHA to strengthen its existing = bloodborne=20 pathogen standards. Those standards were revised and became = effective in=20 April 2001 (69). These federal regulations require that = safer=20 injection devices (e.g., needle-shielding syringes or needle-free=20 injectors) be used for injectable vaccination in all clinical = settings.=20 The rules also require that records be kept documenting injuries = caused by=20 medical sharps and that nonmanagerial employees be involved in the = evaluation and selection of safer devices to be procured.

Needle-shielding or needle-free devices that might satisfy the=20 occupational safety regulations for administering injectable = vaccines are=20 available in the United States (72,98,99).** Additional = information=20 about implementation and enforcement of these regulations is = available=20 from OSHA (http://www.osha.gov/pls/oshaweb<= /A>).=20
Storage and Handling = of=20 Immunobiologics

Failure to adhere to recommended specifications for storage and = handling of immunobiologics can reduce their potency, resulting in = an=20 inadequate immune response in the recipient. Recommendations in = the=20 product package inserts, including methods for reconstitution of = the=20 vaccine, should be followed carefully. Vaccine quality is the = shared=20 responsibility of all handlers of vaccines from the time a vaccine = is=20 manufactured until administration. All vaccines should be = inspected upon=20 delivery and monitored during storage to ensure that the cold = chain has=20 been maintained. Vaccines should continue to be stored at = recommended=20 temperatures immediately upon receipt until use.=20
Storage Temperature

The majority of recommended vaccines require storage = temperatures of=20 35=B0F--46=B0F (2=B0C--8=B0C), and they must not be exposed to = freezing=20 temperatures (100).=20 Certain vaccines are sensitive to freezing temperatures because = they=20 contain an aluminum adjuvant (e.g., anthrax, DTaP, DT, Td, Tdap, = Hib=20 [PRP-OMP], HepA, HepB, PCV, rabies, and HPV) that precipitates = when=20 exposed to temperatures of <32=B0F (<0=B0C) = (100,10= 1).=20 Other vaccines (e.g., MMR, varicella, MMRV, LAIV, and yellow = fever) lose=20 potency when exposed to increased temperature because they contain = live=20 viruses (Table= =20 9).

Vaccine storage units must be carefully selected, used = properly, and=20 consistently monitored to ensure that recommended temperatures are = maintained. Refrigerators without freezers and stand-alone = freezers=20 (either manual defrost or automatic defrost) usually perform best = at=20 maintaining the precise temperatures required for vaccine storage, = and=20 such single-purpose units sold for home use are less expensive=20 alternatives to medical specialty equipment (100).=20 A combination refrigerator/freezer unit sold for home use is = acceptable=20 for storage of limited quantities of vaccines if the refrigerator = and=20 freezer compartments each have a separate external door. In these = units, a=20 freezer thermostat usually controls the freezer temperature and a=20 refrigerator thermostat controls the volume of freezer = temperature=20 air entering the refrigerator, possibly resulting in different = temperature=20 zones within the refrigerator. In such units, vaccines should not = be=20 stored on the top shelf near the cold air outlet from the freezer = to the=20 refrigerator (usually located at the top of the refrigerator = compartment).=20 Any refrigerator or freezer used for vaccine storage must maintain = the=20 required temperature range year-round, be large enough to hold the = year's=20 largest inventory, and be dedicated to storage of biologics. = Before use of=20 the refrigerator for vaccine storage, the temperature should be = measured=20 in various locations within the refrigerator compartment to = document that=20 a stable temperature can be maintained (Table= =20 9) within the compartment (102). The refrigerator = temperature=20 should be set at the midpoint of the recommended range (i.e., = 40=B0F [5=B0C])=20 (103,104). Frequent opening and closing of doors can cause=20 fluctuations of storage temperature; food, beverages, and clinical = specimens should not be stored in vaccine storage units.=20
Temperature Monitoring

Temperature monitoring is a critical component of cold chain=20 management. One person in the office should be assigned primary=20 responsibility for maintaining temperature logs (Figur= e=20 6), with a second person assigned as backup. Temperatures for = both the=20 refrigerator and freezer should be documented twice a day and = recorded.=20 The backup person should review the log each week. Temperature = logs should=20 be maintained for 3 years unless state or local statutes mandate a = longer=20 time period. An automated monitoring system that alerts staff when = a=20 temperature deviation occurs is optimal. However, even if an = automated=20 monitoring system is used, temperatures should still be manually = checked=20 and recorded twice a day.

Thermometers should be placed in a central location in each = compartment=20 near the vaccine. Different types of thermometers can be used, = including=20 standard fluid-filled, minimum-maximum, and continuous chart = recorder=20 thermometers (Tabl= e=20 10). Standard fluid-filled thermometers are the simplest and = least=20 expensive products, but some models might perform poorly. Product=20 temperature thermometers (i.e., those encased in biosafe liquids)=20 generally reflect refrigerator temperature more accurately.=20 Minimum-maximum thermometers monitor the temperature range. = Continuous=20 chart recorder thermometers monitor temperature range and duration = and can=20 be recalibrated at specified intervals. All thermometers used for=20 monitoring vaccine storage temperatures should be calibrated and = certified=20 by an appropriate agency (e.g., National Institute of Standards = and=20 Technology or the American Society for Testing and Materials). = Because all=20 thermometers are calibrated as part of the manufacturing process, = this=20 recommendation refers to a second calibration process that occurs = after=20 manufacturing but before marketing and is documented with a = certificate=20 that comes with the product.=20
Response to Out-of-Temperature- Range Storage

An out-of-range temperature reading should prompt immediate = action. A=20 plan should be developed to transfer vaccine to a predesignated=20 alternative emergency storage site if a temperature problem cannot = be=20 resolved immediately (i.e., unit unplugged or door left open). = Vaccine=20 should be marked "do not use" and moved to the alternate site. = After the=20 vaccine has been moved, determine if the vaccine is still useable = by=20 contacting the manufacturer or state/local health department. = Changes to=20 vaccine exposed to temperatures outside of the recommended range = and that=20 affects its immunogenicity usually are not apparent visually.=20
Expiration Dates and Windows

All vaccines have an expiration date determined by the = manufacturer=20 that must be observed. When vaccines are removed from storage, = physicians=20 and health-care providers should note whether an expiration window = exists=20 for vaccine stored at room temperature or at an intermediate = temperature.=20 For example, live-attenuated influenza vaccine that is stored = frozen must=20 be discarded after 60 hours at refrigerator temperature. An = expiration=20 window also applies to vaccines that have been reconstituted. For = example,=20 after reconstitution, MMR vaccine must be administered within 8 = hours and=20 must be kept at refrigerator temperature during this time. Doses = of=20 expired vaccines that are administered inadvertently generally = should not=20 be counted as valid and should be repeated. Additional information = about=20 expiration dates is available at http://www.cdc.gov/nip.=20
Multidose Vials

Certain vaccines (i.e., DT, Td, Typhoid Vi, meningococcal=20 polysaccharide vaccine [MPSV], TIV, JE, MMR, IPV, and yellow = fever) might=20 be distributed in multidose vials. For multidose vials that do not = require=20 reconstitution, after entering the vial, the remaining doses in a=20 multidose vial can be administered until the expiration date = printed on=20 the vial or vaccine packaging if the vial has been stored = correctly and=20 the vaccine is not visibly contaminated, unless otherwise = specified by the=20 manufacturer. Multidose vials that require reconstitution must be = used=20 within an interval specified by the manufacturer. After = reconstitution,=20 the new expiration date should be written on the vial.=20
Prefilling Syringes

ACIP discourages the routine practice of prefilling syringes = because of=20 the potential for administration errors. The majority of vaccines = have a=20 similar appearance after being drawn into a syringe. Vaccine doses = should=20 not be drawn into a syringe until immediately before = administration. When=20 the syringes are filled, the type of vaccine, lot number, and date = of=20 filling must be labeled on each syringe, and the doses should be=20 administered as soon as possible after filling. In certain = circumstances=20 in which a single vaccine type is being used (e.g., in advance of = a=20 community influenza vaccination campaign), filling a small number = of=20 syringes can be considered. Unused syringes filled by the end user = (i.e.,=20 not filled by the manufacturer) should be discarded at the end of = the=20 vaccination session. In addition to administration errors, = prefilling of=20 syringes is a concern because FDA does not license administration = syringes=20 for vaccine storage. When in doubt about the appropriate handling = of a=20 vaccine, vaccination providers should contact the manufacturer. =

As a general rule, vaccines that have been mishandled or stored = at=20 inappropriate temperatures should not be administered. Guidance = for=20 specific situations is available from the state health department = or CDC.=20 For certain vaccines (i.e., MMR, MMRV, or varicella vaccine), a = serologic=20 test can be performed and, if evidence of immunity can be = documented for=20 all antigens, revaccination is not necessary.=20
Altered = Immunocompetence=20

General Principles

Altered immunocompetence is a term often used synonymously with = immunosuppression and immunocompromise that includes conditions = commonly=20 classified as primary immunodeficiency and secondary = immunodeficiency.=20

Primary immunodeficiencies generally are inherited and include=20 conditions defined by an absence or quantitative deficiency of = cellular=20 and/or humoral components that provide immunity. Examples = include=20 congenital immunodeficiency diseases (e.g., X-linked = agammaglobulinemia),=20 severe combined immunodeficiency disease, and chronic = granulomatous=20 disease. Secondary immunodeficiency generally is acquired and is = defined=20 by loss or qualitative deficiency in cellular and humoral immune=20 components that occurs as a result of a disease process or its = therapy.=20 Examples of secondary immune deficiency include HIV infection,=20 hematopoetic malignancies, treatment with radiation, and treatment = with=20 immunosuppressive drugs, including alkylating agents and = antimetabolites.=20 The degree to which immunosuppressive drugs cause clinically = significant=20 immunodeficiency generally is dose-related and varies by drug. = Primary and=20 secondary immunodeficiencies might display a combination of = deficits in=20 both cellular and humoral immunity. In this report, the general = term=20 altered immunocompetence also will be used to include conditions = such as=20 asplenia and chronic renal disease and treatments with therapeutic = monoclonal antibodies (specifically the tumor-necrosis-factor = alpha=20 inhibitors) (105--110)=20 and prolonged high-dose corticosteroids.

Determination of altered immunocompetence is important to the = vaccine=20 provider because the incidence or severity of certain = vaccine-preventable=20 diseases is higher in persons with altered immunocompetence; = therefore,=20 certain vaccines (e.g., inactivated influenza and pneumococcal = vaccines)=20 are recommended specifically for persons with these diseases = (47,111--<= A=20 = href=3D"http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5440-Immunizationa1.ht= m">113).=20 Vaccines might be less effective during the period of altered=20 immunocompetence. Live vaccines generally should be deferred until = immune=20 function has improved. Inactivated vaccines administered during = the period=20 of altered immunocompetence might need to be repeated after immune = function has improved. Finally, persons with altered = immunocompetence=20 might be at increased risk for an adverse reaction after = administration of=20 live-attenuated vaccines because of reduced ability to mount an = effective=20 immune response.

The degree of altered immunocompetence in a patient should be=20 determined by a physician. The challenge for clinicians and other=20 health-care providers is in assessing the safety and effectiveness = of=20 vaccines for conditions associated with primary or secondary=20 immunodeficiency, especially when new therapeutic modalities are = being=20 used and information about the safety and effectiveness of = vaccines has=20 not been characterized fully in persons receiving these drugs (Tabl= e=20 11). Laboratory studies can be useful for assessing the = effects of a=20 disease or drug on the immune system. Tests useful to assess = humoral=20 immunity include immunoglobulin (and immunoglobulin subset) levels = and=20 specific antibody levels (tetanus, diphtheria, and response to=20 pneumococcal vaccine). Tests that demonstrate the status of = cellular=20 immunity include lymphocyte numbers (i.e., a complete blood count = with=20 differential), a test that delineates concentrations and = proportions of=20 lymphocyte subsets (i.e., B and T-lymphocytes, CD4+ versus CD8+=20 lymphocytes), and tests that measure T-lymphocyte proliferation in = response to specific or nonspecific stimuli (e.g., lymphocyte=20 proliferation assays) (114--115). The ability to = characterize a=20 drug or disease condition as affecting cellular or humoral = immunity is=20 only the first step; using this information to draw inferences = about=20 whether particular vaccines are indicated or whether caution is = advised=20 with use of live or inactivated vaccines is more complicated and = might=20 require consultation with an infectious disease or immunology = specialist.=20
Altered Immunocompetence as an Indication to Receive a = Vaccine=20

Persons with altered immunocompetence generally are advised to = receive=20 TIV and polysaccharide-based vaccines (i.e., PCV, PPV, MCV4, MPSV, = and Hib=20 vaccines) on the basis of demonstrated effectiveness and an = increased risk=20 for disease if the vaccine is withheld.

Pneumococcal Vaccines

Two types of vaccine against invasive pneumococcal disease are=20 available in the United States: PCV and PPV. PCV is routinely = recommended=20 for all children beginning at age 2 months. PCV is not recommended = for=20 persons aged >59 months. PPV is approved for persons aged = >2=20 years with certain underlying medical conditions (including = altered=20 immunocompetence) and routinely for persons aged >65 = years.=20 Complete recommendations on use of PCV and PPV are available in = the=20 Recommended Child and Adolescent Immunization Schedule and the = Recommended=20 Adult Immunization Schedule (113,116).=20

Influenza Vaccine

Two types of influenza vaccine are available in the United = States: TIV=20 and LAIV. Vaccination with TIV is indicated specifically for = persons with=20 altered immunocompetence, including HIV infection. LAIV usually is = contraindicated for persons with altered immunocompetence, = although=20 healthy persons with anatomic or functional asplenia and household = and=20 other close contacts of persons with altered immunocompetence can = receive=20 this vaccine.

Meningococcal Vaccine

Two types of meningococcal vaccine are available in the United = States:=20 MCV4 and MPSV. Persons with asplenia, C3 complement deficiency = (117),=20 or terminal complement component deficiency are at increased risk = for=20 meningococcal disease and should receive MCV4 or MPSV. Persons = with HIV=20 infection can elect to receive MCV4 or MPSV. MCV4 is licensed for = persons=20 aged 11--55 years⁼⁸⁶⁼⁸⁶; children aged 2--10 years or = persons aged=20 >56 years should receive MPSV.

Haemophilus influenzae type b Vaccine

Hib conjugate vaccines are available in single or combined = antigen=20 preparations. Hib vaccine is recommended routinely for all = children=20 through age 59 months. However, a single dose of Hib vaccine also = can be=20 considered for asplenic older children, adolescents, and adults = who did=20 not receive the vaccine series in childhood. Clinicians and other=20 health-care providers might consider use of Hib vaccine among = persons with=20 HIV infection who did not receive the vaccine as an infant or in = childhood=20 (112).=20
Vaccination of Contacts of Persons with Altered=20 Immunocompetence

Household and other close contacts of persons with altered=20 immunocompetence should receive all age-appropriate vaccines, with = the=20 exception of live OPV and smallpox vaccine. MMR, varicella, and = rotavirus=20 vaccines should be administered to susceptible household and other = close=20 contacts of immunocompromised patients when indicated. MMR vaccine = viruses=20 are not transmitted to contacts, and transmission of varicella = vaccine is=20 rare (6,118).=20 No special precautions are needed unless the varicella vaccine = recipient=20 has a rash after vaccination, in which case direct contact with=20 susceptible household contacts should be avoided until the rash = resolves=20 (8,119<= /I>).=20 To minimize potential rotavirus transmission, all members of the = household=20 should employ hand hygiene measures after contact with feces of a=20 rotavirus-vaccinated infant for at least 1 week (19= ).=20 Household and other close contacts of persons with altered=20 immunocompetence should receive annual influenza vaccination. LAIV = can be=20 administered to otherwise eligible contacts (47= ).=20
Vaccination with Inactivated Vaccines

All inactivated vaccines can be administered safely to persons = with=20 altered immunocompetence whether the vaccine is a killed whole = organism or=20 a recombinant, subunit, toxoid, polysaccharide, or polysaccharide=20 protein-conjugate vaccine. If inactivated vaccines are indicated = for=20 persons with altered immunocompetence, the usual doses and = schedules are=20 recommended. However, the effectiveness of such vaccinations might = be=20 suboptimal.

Except for influenza vaccine, which should be administered = annually=20 (47= ),=20 vaccination during chemotherapy or radiation therapy should be = avoided if=20 possible because antibody response might be suboptimal. However,=20 administration of inactivated vaccines during chemotherapy or = radiation is=20 not contraindicated. Patients vaccinated within 2 weeks before = starting=20 immunosuppressive therapy or while receiving immunosuppressive = therapy=20 should be considered unvaccinated and should be revaccinated at = least 3=20 months after therapy is discontinued if immune competence has been = restored.=20
Vaccination with Live-Attenuated Vaccines

Severe complications have followed vaccination with = live-attenuated=20 viral and live-attenuated bacterial vaccines among persons with = altered=20 immunocompetence (120--127).=20 Persons with most forms of altered immunocompetence should not = receive=20 live vaccines (MMR, varicella vaccine, LAIV, yellow fever vaccine, = oral=20 typhoid, BCG, and rotavirus) except in certain circumstances. = Patients=20 with leukemia, lymphoma, or other malignancies whose disease is in = remission and whose chemotherapy has been terminated for at least = 3 months=20 can receive live-virus vaccines.

Children with defects in phagocyte function (e.g., chronic=20 granulomatous disease or myeloperoxidase deficiency) can receive=20 live-attenuated viral vaccines in addition to inactivated = vaccines, but=20 should not receive live-attenuated bacterial vaccines (e.g., BCG = and Ty21a=20 oral typhoid vaccine). Children with deficiencies in complement or = with=20 asplenia can receive live-attenuated viral and live-attenuated = bacterial=20 vaccines (94).

Persons with severe cell-mediated immune deficiency should not = receive=20 live attenuated vaccines. However, children with HIV infection are = at=20 increased risk for complications of primary varicella and herpes = zoster=20 compared with immunocompetent children (118,12= 8).=20 Limited data among HIV-infected children (specifically CDC class = N1, N2,=20 A1, A2, B1, or B2) with age-specific CD4⁺ lymphocyte=20 percentages of >15% indicate that varicella vaccine is = immunogenic,=20 effective, and safe (129).=20 Varicella vaccine should be considered for children meeting these=20 criteria. Eligible children should receive 2 doses of varicella = vaccine=20 with a 3-month interval between doses (118).=20

Persons with HIV infection are at increased risk for severe=20 complications if infected with measles. No severe or unusual = adverse=20 events have been reported after measles vaccination among = HIV-infected=20 persons who did not have evidence of severe immunosuppression=20 (130--133). Therefore, MMR vaccination is recommended for = all=20 asymptomatic HIV-infected persons who do not have evidence of = severe=20 immunosuppression (age-specific CD4⁺ lymphocyte = percentages of=20 >15%) and for whom measles vaccination would otherwise be = indicated.=20 Similarly, MMR vaccination should be considered for mildly = symptomatic=20 (Pediatric Category A1, A2 or Adolescent/adult Category A) (129,134)=20 HIV-infected persons who do not have evidence of severe = immunosuppression=20 (age-specific CD4+ lymphocyte percentages of >15%) for whom = measles=20 vaccination would otherwise be indicated.

HIV-infected persons who are receiving regular doses of IGIV = might not=20 respond to varicella vaccine or MMR or its individual component = vaccines=20 because of the continued presence of passively acquired antibody. = However,=20 because of the potential benefit, MMR and varicella vaccines = should be=20 considered approximately 2 weeks before the next scheduled dose of = IGIV=20 (if not otherwise contraindicated), although an optimal immune = response=20 might not occur depending on the dose and interval since the = previous dose=20 of IGIV. Unless serologic testing indicates that specific = antibodies have=20 been produced, vaccination should be repeated (if not otherwise=20 contraindicated) after the recommended interval (Table= =20 4). An additional dose of IGIV should be considered for = persons on=20 maintenance IGIV therapy who are exposed to measles or varicella 3 = or more=20 weeks after administering a standard dose (100--400 mg/kg body = weight) of=20 IGIV.

Persons with impaired humoral immunity (e.g., = hypogammaglobulinemia or=20 dysgammaglobulinemia) should receive varicella vaccine (118,13= 5).=20 However, the majority of persons with these disorders also receive = periodic doses of IGIV. Appropriate spacing should be maintained = between=20 administration of IGIV and varicella vaccine to prevent an = inadequate=20 response to vaccination caused by the presence of neutralizing = antibodies=20 from the IGIV. Household and other close contacts of persons with = altered=20 immunocompetence should receive all age appropriate vaccines, with = the=20 exception of live OPV and smallpox vaccine.=20
Recipients of Hematopoietic Stem Cell Transplant

Hematopoietic stem cell transplantation (HSCT) results in=20 immunosuppression from the hematopoietic ablative therapy = preceding=20 transplant, from drugs used to prevent or treat graft-versus-host = disease,=20 and in certain cases from the underlying disease process = necessitating=20 transplantation (136).=20 HSCT involves ablation of the bone marrow with reimplantation of = the=20 person's own stem cells or stem cells from a donor. Antibody = titers to=20 vaccine-preventable diseases (e.g., tetanus, poliovirus, measles, = mumps,=20 rubella, and encapsulated bacteria) decline 1--4 years after = autologous or=20 allogeneic HSCT if the recipient is not revaccinated. HSCT = recipients of=20 all ages are at increased risk for certain vaccine-preventable = diseases,=20 including diseases caused by encapsulated bacteria (i.e., = pneumococcal,=20 meningococcal, and Hib infections). As a result, HSCT recipients = should be=20 revaccinated routinely after HSCT, regardless of the source of the = transplanted stem cells (136).=20 Revaccination with inactivated vaccines should begin 12 months = after HSCT,=20 except inactivated influenza vaccine, which should be administered = beginning at least 6 months after HSCT and annually thereafter for = the=20 life of the patient. PPV should be administered at 12 and 24 = months after=20 HSCT. Data are limited about the use of heptavalent PCV in this=20 population. Sequential administration of 2 doses of heptavalent=20 pneumococcal conjugate vaccine followed by a dose of pneumococcal=20 polysaccharide vaccine (with 8 weeks between doses) can be = considered,=20 especially for children aged <60 months. A 3-dose regimen of = Hib=20 vaccine should be administered at ages 12, 14, and 24 months after = transplantation for all age groups (136).=20 MMR vaccine should be administered 24 months after transplantation = if the=20 HSCT recipient is immunocompetent. Because of insufficient = experience=20 using varicella vaccine among HSCT recipients, physicians should = assess=20 the immune status of each recipient on a case-by-case basis and = determine=20 the risk for infection before using these vaccines. If a decision = is made=20 to vaccinate with varicella vaccine, the vaccine should be = administered a=20 minimum of 24 months after transplantation if the HSCT recipient = is=20 presumed to be immunocompetent (137).=20
Situations in Which Some Degree of Immunodeficiency Might = be=20 Present

Asplenia and use of corticosteroids or certain drugs have the = potential=20 to be immunosuppressive and in each, some degree of altered=20 immunocompetence is presumed to exist.

Anatomic or Functional Asplenia

Persons with anatomic (e.g., surgical removal or congenital = absence) or=20 functional (as occurs with sickle cell disease) asplenia are at = increased=20 risk for infection by encapsulated bacteria, especially with S. = pneumoniae (pneumococcus), N. meningitidis = (meningococcus), and=20 Hib (26,48,117).=20 Persons with anatomic or functional asplenia should receive = pneumococcal=20 vaccine, depending on their age and previous pneumococcal = vaccination=20 status, as recommended (29,48,113,116).=20

Meningococcal vaccine is recommended for persons with anatomic = or=20 functional asplenia. Children aged 2--10 years and persons aged=20 >56 years should receive MPSV. MCV4 is approved for = persons aged=20 11--55 years⁼⁸⁶⁼⁸⁶ and is preferred for persons in this = age group,=20 but MPSV is an acceptable alternative (117).=20 A second dose of MPSV can be considered at least 5 years after the = initial=20 dose. The duration of immunity after MCV4 is not known, but is = thought to=20 be long-lasting like other conjugate vaccines, and revaccination = is not=20 recommended.

No efficacy data are available on which to base a = recommendation about=20 use of Hib vaccine for older children and adults with the chronic=20 conditions associated with an increased risk for Hib disease. = However,=20 studies suggest good immunogenicity in patients who have sickle = cell=20 disease or have had splenectomies; administering Hib vaccine to = these=20 patients is not contraindicated (112).=20

Pneumococcal, meningococcal, and Hib vaccines should be = administered at=20 least 2 weeks before elective splenectomy, if possible. If = vaccines are=20 not administered before surgery, they should be administered as = soon as=20 the person's condition stabilizes after the procedure.

Corticosteroids

The amount of systemically absorbed corticosteroids and the = duration of=20 administration needed to suppress the immune system of an = otherwise=20 immunocompetent person are not well defined. Corticosteroid = therapy=20 usually is not a contraindication to administering live-virus = vaccine when=20 administration is short-term (i.e., <2 weeks); a = low-to-moderate dose=20 (<20 mg or prednisone or equivalent per day); long-term, = alternate-day=20 treatment with short-acting preparations; maintenance physiologic = doses=20 (replacement therapy); or administered topically (skin or eyes), = inhaled,=20 or by intra-articular, bursal, or tendon injection (138). = No=20 evidence of increased severity of reactions to live-attenuated = vaccines=20 has been reported among persons receiving corticosteroid therapy = by=20 aerosol, and such therapy is not a reason to delay vaccination. = The=20 immunosuppressive effects of steroid treatment vary, but the = majority of=20 clinicians consider a dose equivalent to either >2 mg/kg of = body weight=20 or 20 mg/day of prednisone or equivalent for persons who weigh = >10 kg=20 when administered for >2 weeks as sufficiently=20 immunosuppressive to raise concern about the safety of vaccination = with=20 live-virus vaccines (112,13= 8).=20 Corticosteroids used in greater than physiologic doses also can = reduce the=20 immune response to vaccines. Vaccination providers should wait at = least 1=20 month after discontinuation of high dose systemically absorbed=20 corticosteroid therapy administered for more than 2 weeks before=20 administering a live-virus vaccine.

Other Immunosuppressive Drugs

Whenever feasible, clinicians should provide all indicated = vaccines to=20 all persons before initiation of chemotherapy, before treatment = with other=20 immunosuppressive drugs, and before radiation or splenectomy. = Persons=20 receiving chemotherapy or radiation for leukemia and other = hematopoetic=20 malignancies, solid tumors, or after solid organ transplant should = be=20 assumed to have altered immunocompetence. Live-attenuated vaccines = should=20 not be administered for at least 3 months after such = immunosuppressive=20 therapy. Inactivated vaccines administered during chemotherapy = might need=20 to be readministered after immune competence is regained. Persons=20 vaccinated before chemotherapy for leukemia, lymphoma, other = malignancies,=20 or radiation generally are thought to retain immune memory after=20 treatment, although revaccination following chemotherapy for acute = lymphoblastic leukemia might be indicated (139). = Revaccination of a=20 person after chemotherapy or radiation therapy is not thought to = be=20 necessary if the previous vaccination occurred before therapy and = not=20 during the therapy, with the exception of recipients of HSCT, who = should=20 be revaccinated as recommended previously. Determination of the = level of=20 immune memory and the need for revaccination should be made by the = treating physician.

Inactivated vaccines can be administered during low dose = intermittent=20 or maintenance therapy of immunosuppressive drugs. The safety and = efficacy=20 of live-attenuated vaccines during such therapy is unknown. = Physicians=20 should carefully weigh the risks for and benefits of providing = injectable=20 live vaccines to adult patients on low-dose therapies for chronic=20 autoimmune disease. The safety and efficacy of live-attenuated = vaccines=20 administered concurrently with recombinant human immune mediators = and=20 immune modulators is unknown. Evidence that use of therapeutic = monoclonal=20 antibodies, especially the antitumor necrosis factor agents = adalimumab,=20 infliximab, and etanercept, causes reactivation of latent = tuberculosis=20 infection and tuberculosis disease and predisposes to other = opportunistic=20 infections suggests caution in the use of live vaccines in = patients=20 receiving these drugs (105--110).=20 Until additional information becomes available, avoidance of live=20 attenuated vaccines during intermittent or low dose chemotherapy = or other=20 immunosuppressive therapy is prudent, unless the benefit of = vaccination=20 outweighs the hypothetical increased risk for an adverse reaction = after=20 vaccination.=20
Special = Situations=20

Concurrently Administering Antimicrobial Agents and = Vaccines=20

With limited exceptions, using an antimicrobial agent is not a=20 contraindication to vaccination. Antimicrobial agents have no = effect on=20 the response to live-attenuated vaccines, except live oral Ty21a = typhoid=20 vaccine, and have no effect on inactivated, recombinant subunit, = or=20 polysaccharide vaccines or toxoids. Ty21a typhoid vaccine should = not be=20 administered to persons receiving antimicrobial agents until 24 = hours=20 after any dose of antimicrobial agent (20= ).=20

Antiviral drugs used for treatment or prophylaxis of influenza = virus=20 infections have no effect on the response to inactivated influenza = vaccine=20 (47= ).=20 However, live-attenuated influenza vaccine should not be = administered=20 until 48 hours after cessation of therapy using antiviral = influenza drugs.=20 If feasible, antiviral medication should not be administered for 2 = weeks=20 after LAIV administration (47= ).=20 Antiviral drugs active against herpesviruses (e.g., acyclovir or=20 valacyclovir) might reduce the efficacy of live-attenuated = varicella=20 vaccine. These drugs should be discontinued at least 24 hours = before=20 administration of varicella-containing vaccines, if possible.

The antimalarial drug mefloquine could affect the immune = response to=20 oral Ty21a typhoid vaccine if both are taken simultaneously = (140).=20 To minimize this effect, administering Ty21a typhoid vaccine at = least 24=20 hours before or after a dose of mefloquine is prudent.=20
Tuberculosis Screening and Skin Test Reactivity

Measles illness, severe acute or chronic infections, HIV = infection, and=20 malnutrition can create a relatively anergic state during which = the=20 tuberculin skin test (TST) (previously referred to as purified = protein=20 derivative [PPD] skin test) might give a false negative reaction=20 (141--143). Although any live attenuated measles vaccine = can=20 theoretically suppress TST reactivity, the degree of suppression = is=20 probably less than that occurring from acute infection from = wild-type=20 measles virus. Although routine TST screening of all children is = no longer=20 recommended, TST screening is sometimes needed at the same time as = administering a measles-containing vaccine (e.g., for well-child = care,=20 school entrance, or for employee health reasons).

TST and measles-containing vaccine can be administered at the = same=20 visit (preferred option). Simultaneously administering TST and=20 measles-containing vaccine does not interfere with reading the TST = result=20 at 48--72 hours and ensures that the person has received measles = vaccine.=20

If the measles-containing vaccine has been administered = recently, TST=20 screening should be delayed for at least 4 weeks after = vaccination. A=20 delay in performing TST will remove the concern of any theoretical = but=20 transient suppression of TST reactivity from the vaccine.

TST screening can be performed and read before administering = the=20 measles-containing vaccine. This option is the least favored = because it=20 will delay receipt of the measles-containing vaccine.

No data exist for the potential degree of TST suppression that = might be=20 associated with other injectable, live-attenuated virus vaccines = (e.g.,=20 varicella and yellow fever). However, in the absence of data, = following=20 guidelines for measles-containing vaccine when scheduling TST = screening=20 and administering other live-attenuated virus vaccines is prudent. = If the=20 opportunity to vaccinate might be missed, vaccination should not = be=20 delayed only because of these theoretical considerations. Because = of=20 similar concerns about smallpox vaccine and TST suppression, a TST = should=20 not be performed until four weeks after smallpox vaccination = (144).=20

TST reactivity in the absence of tuberculosis disease is not a=20 contraindication to administration of any vaccine, including=20 live-attenuated virus vaccines. Tuberculosis disease is not a=20 contraindication to vaccination, unless the person is moderately = or=20 severely ill. Although no studies have reported the effect of MMR = vaccine=20 on persons with untreated tuberculosis, a theoretical basis exists = for=20 concern that measles vaccine might exacerbate the disease = tuberculosis=20 (6)= .=20 As a result, before administering MMR to persons with untreated = active=20 tuberculosis, initiating antituberculosis therapy is advisable = (7).=20 Considering if concurrent immunosuppression (e.g., = immunosuppression=20 caused by HIV infection) is a concern before administering live = attenuated=20 vaccines also is prudent.=20
Severe Allergy to Vaccine Components

Vaccine components can cause allergic reactions among certain=20 recipients. These reactions can be local or systemic and can = include=20 mild-to-severe anaphylaxis or anaphylactic-like responses (e.g.,=20 generalized urticaria or hives, wheezing, swelling of the mouth = and=20 throat, difficulty breathing, hypotension, and shock). Allergic = reactions=20 might be caused by the vaccine antigen, residual animal protein,=20 antimicrobial agents, preservatives, stabilizers, or other vaccine = components (145). Components of each vaccine are listed in = the=20 respective package insert. An extensive listing of vaccine = components,=20 their use, and the vaccines that contain each component has been=20 published (146) and is also available from CDC's National = Center=20 for Immunization and Respiratory Diseases (proposed) (http://www.cdc.gov/nip).

The most common animal protein allergen is egg protein, which = is found=20 in influenza and yellow fever vaccines, which are prepared using=20 embryonated chicken eggs. Ordinarily, persons who are able to eat = eggs or=20 egg products safely can receive these vaccines; persons with = histories of=20 anaphylactic or anaphylactic-like allergy to eggs or egg proteins = should=20 generally not receive these vaccines. Asking persons if they can = eat eggs=20 without adverse effects is a reasonable way to determine who might = be at=20 risk for allergic reactions from receiving yellow fever and = influenza=20 vaccines. A regimen for administering influenza vaccine to = children with=20 egg hypersensitivity and severe asthma has been developed = (147).=20

Measles and mumps vaccine viruses are grown in chick embryo = fibroblast=20 tissue culture. Persons with a serious egg allergy can receive = measles- or=20 mumps-containing vaccines without skin testing or desensitization = to egg=20 protein (6)= .=20 Rubella and varicella vaccines are grown in human diploid cell = cultures=20 and can safely be administered to persons with histories of severe = allergy=20 to eggs or egg proteins. The rare serious allergic reactions after = measles=20 or mumps vaccination or MMR are not believed to be caused by egg = antigens,=20 but to other components of the vaccine (e.g., gelatin) = (148--151).=20 MMR, MMRV, and their component vaccines and other vaccines contain = hydrolyzed gelatin as a stabilizer. Extreme caution should be used = when=20 administering vaccines that contain gelatin to persons who have a = history=20 of an anaphylactic reaction to gelatin or gelatin-containing = products.=20 Before administering gelatin-containing vaccines to such persons, = skin=20 testing for sensitivity to gelatin can be considered. However, no = specific=20 protocols for this approach have been published.

Certain vaccines contain trace amounts of antimicrobial agents = or other=20 preservatives (e.g., neomycin or thimerosal) to which patients = might be=20 severely allergic. The information provided in the vaccine package = insert=20 should be reviewed carefully before deciding if the rare patient = with such=20 allergies should receive the vaccine. No licensed vaccine contains = penicillin or penicillin derivatives.

Certain vaccines contain trace amounts of neomycin. Persons who = have=20 experienced anaphylactic reactions to neomycin should not receive = these=20 vaccines. Most often, neomycin allergy is a contact dermatitis, a=20 manifestation of a delayed type (cell-mediated) immune response, = rather=20 than anaphylaxis (152,153). A history of delayed type = reactions to=20 neomycin is not a contraindication for administration of these = vaccines.=20

Thimerosal is an organic mercurial compound in use since the = 1930s and=20 is added to certain immunobiologic products as a preservative. A = joint=20 statement issued by the U.S. Public Health Service and the = American=20 Academy of Pediatrics (AAP) in 1999 (154)=20 and agreed to by the American Academy of Family Physicians (AAFP) = later in=20 1999, established the goal of removing thimerosal as soon as = possible from=20 vaccines routinely recommended for infants. Although no evidence = exists of=20 any harm caused by low levels of thimerosal in vaccines and the = risk was=20 only theoretical (155), this goal was established as a=20 precautionary measure.

The public is concerned about the health effects of mercury = exposure of=20 any type, and the elimination of mercury from vaccines was judged = a=20 feasible means of reducing an infant's total exposure to mercury = in a=20 world where other environmental sources of exposure are more = difficult or=20 impossible to eliminate (e.g., common foods like tuna). Since = mid-2001,=20 vaccines routinely recommended for infants have been manufactured = without=20 thimerosal as a preservative. Live-attenuated vaccines have never=20 contained thimerosal. Thimerosal-free formulations of inactivated=20 influenza vaccine are available. Inactivated influenza vaccine = also is=20 available in formulations with trace thimerosal, in which = thimerosal no=20 longer functions as a preservative, and in formulations that = contain=20 thimerosal. Thimerosal that acts as a preservative is present in = certain=20 other vaccines that can be administered to children (e.g., Td and = DT).=20 Information about the thimerosal content of vaccines is available = from FDA=20 (http://www.fda.go= v/cber/vaccine/thimerosal.htm).=20

Receiving thimerosal-containing vaccines might lead to = induction of=20 allergy. However, limited scientific basis exists for this = assertion=20 (145). Allergy to thimerosal usually consists of local = delayed type=20 hypersensitivity reactions (156--158). Thimerosal elicits = positive=20 delayed type hypersensitivity patch tests in 1%--18% of persons = tested,=20 but these tests have limited or no clinical relevance = (159--160).=20 The majority of persons do not experience reactions to thimerosal=20 administered as a component of vaccines even when patch or = intradermal=20 tests for thimerosal indicate hypersensitivity (160). A = localized=20 or delayed type hypersensitivity reaction to thimerosal is not a=20 contraindication to receipt of a vaccine that contains thimerosal. =
Latex Allergy

Latex is sap from the commercial rubber tree. Latex contains = naturally=20 occurring impurities (e.g., plant proteins and peptides) that = might be=20 responsible for allergic reactions. Latex is processed to form = natural=20 rubber latex and dry natural rubber. Dry natural rubber and = natural rubber=20 latex might contain the same plant impurities as latex but in = lesser=20 amounts. Natural rubber latex is used to produce medical gloves,=20 catheters, and other products. Dry natural rubber is used in = syringe=20 plungers, vial stoppers, and injection ports on intravascular = tubing.=20 Synthetic rubber and synthetic latex also are used in medical = gloves,=20 syringe plungers, and vial stoppers. Synthetic rubber and = synthetic latex=20 do not contain natural rubber or natural latex and do not contain = the=20 impurities linked to allergic reactions. Latex or dry natural = rubber used=20 in vaccine packaging is generally noted in the manufacturer's = package=20 insert.

The most common type of latex sensitivity is contact-type (type = 4)=20 allergy, usually as a result of prolonged contact with = latex-containing=20 gloves (161). However, injection-procedure--associated = latex=20 allergies among patients with diabetes mellitus have been = described=20 (162--164). Allergic reactions (including anaphylaxis) = after=20 vaccination procedures are rare (165). Only one known = report of an=20 allergic reaction after administering HepB to a patient with known = severe=20 allergy (anaphylaxis) to latex has been published (166). =

If a person reports a severe (anaphylactic) allergy to latex, = vaccines=20 supplied in vials or syringes that contain natural rubber should = not be=20 administered unless the benefit of vaccination outweighs the risk = for a=20 potential allergic reaction. For latex allergies other than = anaphylactic=20 allergies (e.g., a history of contact allergy to latex gloves), = vaccines=20 supplied in vials or syringes that contain dry natural rubber or = natural=20 rubber latex can be administered.=20
Vaccination of Preterm Infants

In the majority of cases, infants born prematurely, regardless = of=20 birthweight, should be vaccinated at the same chronological age = and=20 according to the same schedule and precautions as full-term = infants and=20 children. Birthweight and size are not factors in deciding whether = to=20 postpone routine vaccination of a clinically stable preterm infant = (167--171), except for HepB. The full recommended dose of = each=20 vaccine should be used. Divided or reduced doses are not = recommended=20 (173).

Decreased seroconversion rates might occur among certain = preterm=20 infants with low birthweights (i.e., <2,000 g) after = administration of=20 HepB at birth (173). However, by chronological age 1 month, = all=20 preterm infants, regardless of initial birth weight or gestational = age,=20 are likely to respond as adequately as older and larger infants=20 (174--176). Preterm infants born to HBsAg-positive mothers = and=20 mothers with unknown HBsAg status must receive immunoprophylaxis = with HepB=20 and HBIG within 12 hours after birth. If these infants weigh = <2,000 g=20 at birth, the initial vaccine dose should not be counted towards=20 completion of the HepB series, and 3 additional doses of HepB = should be=20 administered, beginning when the infant is aged 1 month. Preterm = infants=20 weighing <2,000 g and born to HBsAg-negative mothers should = receive the=20 first dose of the HepB series at chronological age 1 month or at = hospital=20 discharge. (30= )=20
Breast Feeding and Vaccination

Neither inactivated nor live vaccines administered to a = lactating woman=20 affect the safety of breast feeding for women or their infants. = Breast=20 feeding does not adversely affect immunization and is not a=20 contraindication for any vaccine, with the exception of smallpox = vaccine.=20 Limited data indicate that breast feeding can enhance the response = to=20 certain vaccine antigens (177). Breast-fed infants should = be=20 vaccinated according to recommended schedules (178--180). =

Although live vaccines multiply within the mother's body, the = majority=20 have not been demonstrated to be excreted in human milk = (181).=20 Although rubella vaccine virus might be excreted in human milk, = the virus=20 usually does not infect the infant. If infection does occur, it is = well-tolerated because the virus is attenuated (182). = Inactivated,=20 recombinant, subunit, polysaccharide, conjugate vaccines and = toxoids pose=20 no risk for mothers who are breast feeding or for their infants.=20
Vaccination During Pregnancy

Risk for a developing fetus from vaccination of the mother = during=20 pregnancy primarily is theoretical. No evidence exists of risk = from=20 vaccinating pregnant women with inactivated virus or bacterial = vaccines or=20 toxoids (183,184). Live vaccines pose a theoretical risk to = the=20 fetus. Benefits of vaccinating pregnant women usually outweigh = potential=20 risks when the likelihood of disease exposure is high, when = infection=20 would pose a risk to the mother or fetus, and when the vaccine is = unlikely=20 to cause harm.

Recommendations for vaccination during pregnancy can be found = in the=20 adult immunization schedule (113).=20 Pregnant women should receive Td vaccine if indicated. Previously=20 vaccinated pregnant women who have not received a Td vaccination = within=20 the last 10 years should receive a booster dose. Pregnant women = who are=20 not vaccinated or only partially immunized against tetanus should = complete=20 the primary series (28,112).=20 Women for whom the vaccine is indicated but who have not completed = the=20 recommended 3-dose series during pregnancy should receive = follow-up after=20 delivery to ensure the series is completed. Pregnant adolescents = and=20 adults who received the last tetanus-containing vaccine <10 = years=20 previously are generally recommended to receive Tdap after = delivery. To=20 prevent neonatal tetanus, pregnant adolescents who received the = last dose=20 of tetanus-toxoid containing vaccine >10 years = previously should=20 generally receive Td in preference to Tdap while they are pregnant = (28= ),=20 although Tdap is not contraindicated during pregnancy.

Women in the second and third trimesters of pregnancy are at = increased=20 risk for hospitalization from influenza. Therefore, routine = influenza=20 vaccination is recommended for all women who will be pregnant (in = any=20 trimester) during influenza season (usually November--March in the = United=20 States) (47= ).=20

IPV can be administered to pregnant women who are at risk for = exposure=20 to wild-type poliovirus infection (4)= .=20 HepB is recommended for pregnant women at risk for hepatitis B = virus=20 infection (30= ).=20 HepA, pneumococcal polysaccharide, meningococcal conjugate, and=20 meningococcal polysaccharide vaccines should be considered for = women at=20 increased risk for those infections (48,117,185).=20 Pregnant women who must travel to areas where the risk for yellow = fever is=20 high should receive yellow fever vaccine because the limited = theoretical=20 risk from vaccination is substantially outweighed by the risk for = yellow=20 fever infection (24,186= ).=20

Pregnancy is a contraindication for smallpox (vaccinia), = measles,=20 mumps, rubella, and varicella-containing vaccines. Smallpox = (vaccinia)=20 vaccine is the only vaccine known to cause harm to a fetus when=20 administered to a pregnant woman. In addition to the vaccinee = herself,=20 smallpox (vaccinia) vaccine should not be administered to a = household=20 contact of a pregnant woman (144).=20 Although of theoretical concern, no cases of congenital rubella or = varicella syndrome or abnormalities attributable to fetal = infection have=20 been observed among infants born to susceptible women who received = rubella=20 or varicella vaccines during pregnancy (6,187<= /I>).=20 Because of the importance of protecting women of childbearing age = against=20 rubella and varicella, reasonable practices in any vaccination = program=20 include asking women if they are pregnant or might become pregnant = in the=20 next 4 weeks; not vaccinating women who state that they are or = plan to be=20 pregnant; explaining the theoretical risk for the fetus if MMR, = varicella,=20 or MMRV vaccine were administered to a women who is pregnant; and=20 counseling women who are vaccinated not to become pregnant during = the 4=20 weeks after MMR, varicella, or MMRV vaccination (6,39,188).=20 Routine pregnancy testing of women of childbearing age before=20 administering a live-virus vaccine is not recommended (6)= .=20 If vaccination of an unknowingly pregnant woman occurs or if she = becomes=20 pregnant within 4 weeks after MMR or varicella vaccination, she = should be=20 counseled about the theoretical basis of concern for the fetus; = however,=20 MMR or varicella vaccination during pregnancy should not be = regarded as a=20 reason to terminate pregnancy (6,8,189).=20

Persons who receive MMR vaccine do not transmit the vaccine = viruses to=20 contacts (6)= .=20 Transmission of varicella vaccine virus to contacts is extremely = rare=20 (118).=20 MMR and varicella vaccines should be administered when indicated = to the=20 children and other household contacts of pregnant women (6,8)= .=20

All pregnant women should be evaluated for immunity to rubella = and=20 varicella and be tested for the presence of HBsAg in every = pregnancy=20 (6,30,39= ).=20 Women susceptible to rubella and varicella should be vaccinated=20 immediately after delivery. A woman found to be HBsAg-positive = should be=20 followed carefully to ensure that the infant receives HBIG and = begins the=20 hepatitis B vaccine series no later than 12 hours after birth and = that the=20 infant completes the recommended HepB vaccine series on schedule = (30= ).=20 No known risk exists for the fetus from passive immunization of = pregnant=20 women with immune globulin preparations.=20
Persons Vaccinated Outside the United States, Including=20 Internationally Adopted Children

The ability of a clinician to determine that a person is = protected on=20 the basis of their country of origin and their records alone is = limited.=20 Vaccines administered outside the United States can generally be = accepted=20 as valid if the schedule was similar to that recommended in the = United=20 States (i.e., minimum ages and intervals). Only written = documentation=20 should be accepted as evidence of previous vaccination. Written = records=20 are more likely to predict protection if the vaccines, dates of=20 administration, intervals between doses, and the person's age at = the time=20 of vaccination are comparable to U.S. recommendations. Although = vaccines=20 with inadequate potency have been produced in other countries=20 (190,191), the majority of vaccines used worldwide is = produced with=20 adequate quality control standards and are potent.

The number of U.S. families adopting children from outside the = United=20 States has increased substantially in recent years (192). = Adopted=20 children's birth countries often have vaccination schedules that = differ=20 from the recommended childhood immunization schedule in the United = States.=20 Differences in the U.S. immunization schedule and those used in = other=20 countries include the vaccines administered, the recommended ages = of=20 administration, and the number and timing of doses.

Data are inconclusive about the extent to which an = internationally=20 adopted child's vaccination record reflects the child's = protection. A=20 child's record might indicate administration of MMR vaccine when = only=20 single-antigen measles vaccine was administered. A study of = children=20 adopted from orphanages in the People's Republic of China, Russia, = and=20 Eastern Europe determined that 67% of children with documentation = of more=20 than 3 doses of DTP before adoption had nonprotective titers to = these=20 antigens. By contrast, children adopted from these countries who = received=20 vaccination in the community (not only from orphanages) and who = possessed=20 records of 1 or more doses of DTP exhibited protective titers 67% = of the=20 time (193). However, antibody testing was performed by = using a=20 hemagglutination assay, which tends to underestimate protection = and cannot=20 directly be compared with antibody concentration (194). = Data are=20 likely to remain limited for countries other than the People's = Republic of=20 China, Russia, and Eastern Europe because of the limited number of = adoptees from other countries.

Clinicians and other health-care providers can follow one of = multiple=20 approaches if a question exists about whether vaccines = administered to an=20 international adoptee were immunogenic. Repeating the vaccinations = is an=20 acceptable option. Doing so usually is safe and avoids the need to = obtain=20 and interpret serologic tests. If avoiding unnecessary injections = is=20 desired, judicious use of serologic testing might be helpful in=20 determining which vaccinations are needed. For some vaccines, the = most=20 readily available serologic tests cannot document protection = against=20 infection. These recommendations provide guidance on possible = approaches=20 to evaluation and revaccination for each vaccine recommended = universally=20 for children in the United States (Tabl= e=20 12). Clinicians and other health-care providers should ensure = that=20 household contacts of internationally adoptees are adequately = vaccinated,=20 particularly for measles and hepatitis B.

MMR Vaccine

The simplest approach to resolving concerns about MMR = vaccination among=20 internationally adopted children is to revaccinate with 1 or 2 = doses of=20 MMR vaccine, depending on the child's age. Serious adverse events = after=20 MMR vaccinations are rare (6)= .=20 No evidence indicates that administering MMR vaccine increases the = risk=20 for adverse reactions among persons who are already immune to = measles,=20 mumps, or rubella as a result of previous vaccination or natural = disease.=20 Doses of measles-containing vaccine administered before the first = birthday=20 should not be counted as part of the series (6)= .=20 Alternatively, serologic testing for immunoglobulin G (IgG) = antibody to=20 vaccine viruses indicated on the vaccination record can be = considered.=20 Serologic testing is widely available for measles and rubella IgG=20 antibody. A child whose record indicates receipt of monovalent = measles or=20 measles-rubella vaccine on or after the first birthday and who has = protective antibody against measles and rubella should receive 1 = or 2=20 doses of MMR or MMRV as age-appropriate to ensure protection = against mumps=20 and varicella (and rubella if measles vaccine alone had been = used). If a=20 child whose record indicates receipt of MMR at age >12 = months=20 has a protective concentration of antibody to measles, no = additional=20 vaccination is needed unless required for school entry.

Hib Vaccine

Interpretation of a serologic test to verify protection from = Hib=20 bacteria for children vaccinated >2 months previously can be = difficult=20 to interpret. Because the number of vaccinations needed for = protection=20 decreases with age and adverse events are rare (26= ),=20 age-appropriate vaccination should be provided. Hib vaccination is = not=20 recommended routinely for children aged >5 years (116).=20

Hepatitis A Vaccine

Children without documentation of HepA vaccination or serologic = evidence of immunity should be vaccinated on arrival if aged = >12=20 months (185).=20

Hepatitis B Vaccine

Children not known to be vaccinated for hepatitis B should = receive an=20 age-appropriate series of HepB. A child whose records indicate = receipt of=20 3 or more doses of vaccine can be considered protected, and = additional=20 doses are not needed if 1 or more doses were administered at age=20 >24 weeks. Children who received their last HepB dose at = age=20 <24 weeks should receive an additional dose at age = >24 weeks.=20 Children who have received fewer than 3 doses of vaccine should = complete=20 the series at the recommended intervals and ages.

All foreign-born persons and immigrants, refugees, and = internationally=20 adopted children born in Asia, the Pacific Islands, Africa, and = other=20 regions in which HBV is highly endemic should be tested for HBsAg, = regardless of vaccination status. Those determined to be = HBsAg-positive=20 should be monitored for development of liver disease. Household = members of=20 HBsAg-positive children or adults should be vaccinated if not = already=20 immune.

Poliovirus Vaccine

The simplest approach is to revaccinate internationally adopted = children with IPV according to the U.S. schedule. Adverse events = after IPV=20 are rare (4)= .=20 Children appropriately vaccinated with 3 doses of OPV in = economically=20 developing countries might have suboptimal seroconversion, = including to=20 type 3 poliovirus (180). Serologic testing for neutralizing = antibody to poliovirus types 1, 2, and 3 can be obtained = commercially and=20 at certain state health department laboratories. Children with = protective=20 titers against all three types do not need revaccination and = should=20 complete the schedule as age-appropriate.

DTaP Vaccine

Vaccination providers can revaccinate a child with DTaP vaccine = without=20 regard to recorded doses; however, one concern about this approach = is that=20 data indicate increased rates of local adverse reactions after the = fourth=20 and fifth doses of DTP or DTaP (46= ).=20 If a revaccination approach is adopted and a severe local reaction = occurs,=20 serologic testing for specific IgG antibody to tetanus and = diphtheria=20 toxins can be measured before administering additional doses. = Protective=20 concentration^=A7=A7 indicates that further doses are = unnecessary=20 and subsequent vaccination should occur as age-appropriate. No = established=20 serologic correlates exist for protection against pertussis.

For a child whose record indicates receipt of 3 or more doses = of DTP or=20 DTaP, serologic testing for specific IgG antibody to both = diphtheria and=20 tetanus toxin before additional doses is a reasonable approach. If = a=20 protective concentration is present, recorded doses can be = considered=20 valid, and the vaccination series should be completed as = age-appropriate.=20 Indeterminate antibody concentration might indicate immunologic = memory but=20 antibody waning; serology can be repeated after a booster dose if = the=20 vaccination provider wants to avoid revaccination with a complete = series.=20

Alternately, for a child whose records indicate receipt of 3 or = more=20 doses, a single booster dose can be administered, followed by = serologic=20 testing after 1 month for specific IgG antibody to both diphtheria = and=20 tetanus toxins. If a protective concentration is obtained, the = recorded=20 doses can be considered valid and the vaccination series completed = as=20 age-appropriate. Children with indeterminate concentration after a = booster=20 dose should be revaccinated with a complete series.

Varicella Vaccine

Varicella vaccine is not administered in the majority of = countries. A=20 child who lacks reliable evidence of varicella immunity should be=20 vaccinated as age-appropriate (8,116).=20

Pneumococcal Vaccines

PCV and PPV are not administered in the majority of countries = and=20 should be administered as age-appropriate or as indicated by the = presence=20 of underlying medical conditions (29,48= ).=20
Vaccinating Persons with Bleeding Disorders and Persons = Receiving=20 Anticoagulant Therapy

Because of the risk for hematoma formation after injections,=20 intramuscular injections are often avoided among persons with = bleeding=20 disorders by using the subcutaneous or intradermal routes for = vaccines=20 that are administered normally by the intramuscular route. HepB=20 administered intramuscularly to 153 persons with hemophilia by = using a=20 23-gauge needle or smaller, followed by steady pressure to the = site for=20 1--2 minutes, resulted in a 4% bruising rate with no patients = requiring=20 factor supplementation (195). Whether antigens that produce = more=20 local reactions (e.g., pertussis) would produce an equally low = rate of=20 bruising is unknown.

When HepB or any other intramuscular vaccine is indicated for a = patient=20 with a bleeding disorder or a person receiving anticoagulant = therapy, the=20 vaccine should be administered intramuscularly if, in the opinion = of a=20 physician familiar with the patient's bleeding risk, the vaccine = can be=20 administered with reasonable safety by this route. If the patient = receives=20 antihemophilia or similar therapy, intramuscular vaccinations can = be=20 scheduled shortly after such therapy is administered. A fine = needle (23=20 gauge or smaller) should be used for the vaccination and firm = pressure=20 applied to the site, without rubbing, for at least 2 minutes. The = patient=20 or family should be instructed concerning the risk for hematoma = from the=20 injection.=20
Vaccination Records=20

Consent to Vaccinate

The National Childhood Vaccine Injury Act of 1986 (42 U.S.C. = =A7=20 300aa-26) requires that all health-care providers in the United = States who=20 administer any vaccine covered by the Act^=B6=B6 must = provide a copy=20 of the relevant, current edition of the vaccine information = materials that=20 have been produced by CDC before administering each dose of the = vaccine.=20 Vaccine information statements (VIS) are available at http://www.c= dc.gov/nip/publications/VIS/default.htm=20 and http://www.immunize.org/vis.=20 VIS must be provided to the parent or legal representative of any = child or=20 to any adult to whom the physician or other health-care provider = intends=20 to administer the vaccine. The act does not require that a = signature be=20 obtained, but documentation of consent is recommended or required = by=20 certain state or local authorities.=20
Provider Records

Documentation of patient vaccinations helps ensure that persons = in need=20 of a vaccine receive it and that adequately vaccinated patients = are not=20 administered excess doses, possibly increasing the risk for local = adverse=20 events (e.g., tetanus toxoid). Serologic test results for=20 vaccine-preventable diseases (e.g., those for rubella screening = and=20 antibody to hepatitis B surface antigen) and documented episodes = of=20 adverse events also should be recorded in the permanent medical = record of=20 the vaccine recipient.

Health-care providers who administer vaccines covered by the = National=20 Childhood Vaccine Injury Act are required to ensure that the = permanent=20 medical record of the recipient (or a permanent office log or = file)=20 indicates the date the vaccine was administered; the vaccine = manufacturer;=20 the vaccine lot number; and the name, address, and title of the = person=20 administering the vaccine. In addition, the provider is required = to record=20 the edition date of the VIS distributed and the date those = materials were=20 provided. In the Act, the term health-care provider is defined as = any=20 licensed health-care professional, organization, or institution, = whether=20 private or public (including federal, state, and local departments = and=20 agencies), under whose authority a specified vaccine is = administered. This=20 same information should be kept for all vaccines, not just for = those=20 required by the National Childhood Vaccine Injury Act.=20
Patients' Personal Records

Official childhood vaccination records have been adopted by = every=20 state, territory, and the District of Columbia to encourage = uniformity of=20 records and to facilitate assessment of vaccination status by = schools and=20 child care centers. The records also are key tools in vaccination=20 education programs aimed at increasing parental and patient = awareness of=20 the need for vaccines. A permanent vaccination record card should = be=20 established for each newborn infant and maintained by the parent = or=20 guardian. In certain states, these cards are distributed to new = mothers=20 before discharge from the hospital. Using vaccination record cards = for=20 adolescents and adults also is encouraged. Standardized adult = vaccination=20 records are available at http://www.immunize.org/.=20
Immunization Information Systems

IISs are confidential, population-based, computerized = information=20 systems that collect and consolidate vaccination data from = multiple=20 health-care providers within a geographic area. IISs are a = critical tool=20 that can increase and sustain increased vaccination coverage by=20 consolidating vaccination records of children from multiple = providers,=20 generating reminder and recall vaccination notices for each child, = and=20 providing official vaccination forms and vaccination coverage = assessments=20 (196).=20 A fully operational IIS also can prevent duplicate vaccinations, = limit=20 missed appointments, reduce vaccine waste, and reduce staff time = required=20 to produce or locate vaccination records or certificates. The = National=20 Vaccine Advisory Committee strongly encourages development of = community-=20 or state-based IISs and recommends that vaccination providers = participate=20 in these systems whenever possible (196).=20 One of the national health objectives for 2010 is 95% = participation of=20 children aged <6 years in a fully operational population-based = IIS=20 (objective 20.1) (197).=20
Reporting Adverse = Events after=20 Vaccination

Modern vaccines are safe and effective; however, adverse events = have=20 been reported after administration of all vaccines (91= ).=20 These events range from frequent, minor, local reactions to = extremely=20 rare, severe, systemic illness (e.g., anaphylaxis). Establishing = evidence=20 for cause-and-effect relations on the basis of case reports and = case=20 series alone is impossible because temporal association alone does = not=20 necessarily indicate causation. Unless the symptom or syndrome = that occurs=20 after vaccination is clinically or pathologically distinctive, = more=20 detailed epidemiologic studies to compare the incidence of the = event among=20 vaccinees with the incidence among unvaccinated persons are = necessary.=20 Reporting adverse events to public health authorities, including = serious=20 events, is a key stimulus to developing studies to confirm or = refute a=20 causal association with vaccination. More complete information = about=20 adverse reactions to a specific vaccine is available in the ACIP=20 recommendations for that vaccine and in a specific statement on = vaccine=20 adverse reactions (91= ).=20

The National Childhood Vaccine Injury Act requires health-care=20 providers to report selected events occurring after vaccination to = VAERS.=20 Events for which reporting is required appear in the Reportable = Events=20 Table.*** Persons other than health-care providers also can report = adverse=20 events to VAERS. All clinically significant adverse events other = than=20 those that must be reported or that occur after administration of = vaccines=20 not covered by the Act also should be reported to VAERS, even if = the=20 physician or other health-care provider is uncertain they are = related=20 causally to vaccination. VAERS forms and instructions are = available in the=20 FDA Drug Bulletin by contacting VAERS (800-822-7967), or from the = VAERS=20 website (http://www.vaers.hhs.gov/vaer= s.htm).=20
National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program, established = by the=20 National Childhood Vaccine Injury Act, is a no-fault system in = which=20 persons thought to have suffered an injury or death as a result of = administration of a covered vaccine can seek compensation. The = program=20 became operational on October 1, 1988, and is intended as an = alternative=20 to civil litigation under the traditional tort system in that = negligence=20 need not be proven. Claims arising from covered vaccines must = first be=20 adjudicated through the program before civil litigation can be = pursued.=20

The program relies on a Reportable Events Table listing the = vaccines=20 covered by the program and the injuries, disabilities, illnesses, = and=20 conditions (including death) for which compensation might be = awarded. The=20 table defines the time during which the first symptom or = substantial=20 aggravation of an injury must appear after vaccination. Successful = claimants receive a legal presumption of causation if a condition = listed=20 in the table is proven, thus avoiding the need to prove actual = causation=20 in an individual case. Claimants also can prevail for conditions = not=20 listed in the table if they prove causation. Injuries after = administration=20 of vaccines not listed in the legislation authorizing the program = are not=20 eligible for compensation through the program. Additional = information is=20 available from the National Vaccine Injury Compensation Program, = Health=20 Resources and Services Administration, Parklawn Building, Room = 11C-26,=20 5600 Fishers Lane, Rockville, MD 20857; telephone: 800-338-2382; = Website:=20 http://www.hrsa.gov/osp/vicp.=20

Persons wanting to file a claim for vaccine injury should = contact the=20 following: U.S. Court of Federal Claims, 717 Madison Place, N.W.,=20 Washington, DC 20005; telephone: 202-357-6400.=20
Benefit and Risk Communication

Parents, guardians, legal representatives, and adolescent and = adult=20 patients should be informed about the benefits of and risks for = vaccines=20 in understandable language. Opportunity for questions should be = provided=20 before each vaccination. Discussion of the benefits of and risks = for=20 vaccination is sound medical practice and is required by law.

The National Childhood Vaccine Injury Act requires that vaccine = information materials be developed for each vaccine covered by the = Act.=20 These materials, known as Vaccine Information Statements, must be = provided=20 by all public and private vaccination providers each time a = vaccine is=20 administered. Copies of Vaccine Information Statements are = available from=20 state health authorities responsible for vaccination, or they can = be=20 obtained from CDC's National Center for Immunization and = Respiratory=20 Disease (proposed) website (http://www.cdc.gov/nip). = Translations of=20 Vaccine Information Statements into languages other than English = are=20 available from certain state vaccination programs and from the=20 Immunization Action Coalition website (http://www.immunize.org/). =

Health-care providers should anticipate that certain parents or = patients will question the need for or safety of vaccination, = refuse=20 certain vaccines, or even reject all vaccinations. A limited = number of=20 persons might have religious or personal objections to = vaccinations.=20 Others might want to enter into a dialogue about the risks for and = benefits of certain vaccines. Having a basic understanding of how = patients=20 view vaccine risk and developing effective approaches in dealing = with=20 vaccine safety concerns when they arise is imperative for = vaccination=20 providers.

Each person understands and reacts to vaccine information on = the basis=20 of different factors, including previous experience, education, = personal=20 values, method of data presentation, perceptions of the risk for = disease,=20 perceived ability to control those risks, and their risk = preference.=20 Increasingly, through the media and nonauthoritative Internet = sites,=20 decisions about risk are based on inaccurate information. Only = through=20 direct dialogue with parents and by using available resources can=20 health-care providers prevent acceptance of media reports and = information=20 from nonauthoritative Internet sites as scientific fact.

When a parent or patient initiates a discussion about a vaccine = controversy, the health-care provider should discuss the specific = concerns=20 and provide factual information, using appropriate language. = Effective,=20 empathetic vaccine risk communication is essential in responding = to=20 misinformation and concerns, recognizing that for certain persons, = risk=20 assessment and decision-making are difficult and confusing. = Certain=20 vaccines might be acceptable to the resistant parent. Their = concerns=20 should then be addressed using the VIS and offering other resource = materials (e.g., information available on the National Center for=20 Immunization and Respiratory Diseases (proposed) website [http://www.cdc.gov/nip]).

Although a limited number of providers might exclude from their = practice those patients who question or refuse vaccination, the = more=20 effective public health strategy is to identify common ground and = discuss=20 measures that need to be followed if the patient's decision is to = defer=20 vaccination. As part of a strong recommendation, health-care = providers can=20 reinforce key points about each vaccine, including safety, and = emphasize=20 risks encountered by unvaccinated children. Parents should be = advised of=20 state laws pertaining to school or child-care entry, which might = require=20 that unvaccinated children be excluded from school or child care = during=20 outbreaks. Documentation of these discussions in the patient's = record,=20 including the refusal to receive certain vaccines (i.e., informed=20 refusal), might reduce any potential liability if a = vaccine-preventable=20 disease occurs in the unvaccinated patient.=20
Vaccination Programs=20

The best way to reduce vaccine-preventable diseases is to have = a highly=20 immune population. Universal vaccination is a critical part of = quality=20 health care and should be accomplished through routine and = intensive=20 vaccination programs implemented in physicians' offices and in = public=20 health clinics. Programs should be established and maintained in = all=20 communities to ensure vaccination of all children at the = recommended age.=20 In addition, appropriate vaccinations should be available for all=20 adolescents and adults.

Physicians and other pediatric vaccination providers should = adhere to=20 the standards for child and adolescent vaccination practices = (1).=20 These standards define appropriate vaccination practices for both = the=20 public and private sectors. The standards provide guidance on = practices=20 that will result in eliminating barriers to vaccination. These = include=20 practices aimed at eliminating unnecessary prerequisites for = receiving=20 vaccinations, eliminating missed opportunities to vaccinate, = improving=20 procedures to assess vaccination needs, enhancing knowledge about=20 vaccinations among parents and providers, and improving the = management and=20 reporting of adverse events. In addition, the standards address = the=20 importance of recall and reminder systems and using assessments to = monitor=20 clinic or office vaccination coverage levels. Physicians and other = health-care providers should simultaneously administer as many = vaccine=20 doses as possible, as indicated on the Recommended Child and = Adolescent=20 Immunization Schedule (116).=20

Standards of practice also have been published to increase = vaccination=20 coverage among adults (2). These standards include ensuring = vaccine=20 availability, routine review of vaccination status, communicating = risks=20 for and benefits to the patient, using standing orders, and = recommending=20 simultaneous administration of all indicated doses according to = the=20 Recommended Adult Immunization Schedule (113).=20

Every visit to a physician or other health-care provider can be = an=20 opportunity to update a patient's vaccination status with needed=20 vaccinations. Official health agencies should take necessary = steps,=20 including, when appropriate, developing and enforcing child care = and=20 school vaccination requirements, to ensure that students at all = grade=20 levels (including college) and children in day care centers are = protected=20 against vaccine-preventable diseases. Agencies also should = encourage=20 institutions (e.g., hospitals and long-term--care facilities) to = adopt=20 policies about the appropriate vaccination of patients, residents, = and=20 employees (198).=20

Dates of vaccination (day, month, and year) should be recorded = on=20 institutional vaccination records (e.g., records kept in schools = and day=20 care centers). These records will facilitate assessments that a = primary=20 vaccination series has been completed according to an appropriate = schedule=20 and that needed booster doses have been administered at the = appropriate=20 time.

The independent, nonfederal Task Force on Community Preventive = Services=20 (the Task Force), whose membership is appointed by CDC, provides = public=20 health decision-makers with recommendations on population-based=20 interventions to promote health and prevent disease, injury, = disability,=20 and premature death. The recommendations are based on systematic = reviews=20 of the scientific literature about effectiveness and = cost-effectiveness of=20 these interventions. In addition, the Task Force identifies = critical=20 information about the other effects of these interventions and the = applicability to specific populations and settings and the = potential=20 barriers to implementation. This information is available at http://www.thecommunityguide.o= rg/.=20

Beginning in 1996, the Task Force systematically reviewed = published=20 evidence on the effectiveness and cost-effectiveness of = population-based=20 interventions to increase coverage of vaccines recommended for = routine use=20 among children, adolescents, and adults. A total of 197 articles = were=20 identified that evaluated a relevant intervention, met inclusion = criteria,=20 and were published during 1980--1997. Reviews of 17 specific = interventions=20 were published in 1999 (199--202). Using the results of = their=20 review, the Task Force made recommendations about the use of these = interventions (202). Several interventions were identified = and=20 recommended on the basis of published evidence. The interventions = and the=20 recommendations are summarized in this report (Tabl= e=20 13).=20
Vaccine Information=20 Sources

In addition to these general recommendations, other sources are = available that contain specific and updated vaccine information.=20
CDC-INFO Contact Center

The CDC-INFO contact center is supported by CDC's National = Center for=20 Immunization and Respiratory Diseases (proposed) and provides = public=20 health-related information, including vaccination information, for = health-care providers and the public, 24 hours a day, seven days a = week=20 (Telephone [English and Spanish]: 800-232-4636; Telephone [TTY]:=20 800-232-6348).=20
CDC's National Center for Immunization and Respiratory = Diseases=20 (proposed)

CDC's National Center for Immunization and Respiratory Diseases = (proposed) website provides direct access to immunization = recommendations=20 of ACIP, vaccination schedules, vaccine safety information, = publications,=20 provider education and training, and links to other = vaccination-related=20 websites (http://www.cdc.gov/nip).=20
MMWR

ACIP recommendations regarding vaccine use, statements of = vaccine=20 policy as they are developed, and reports of specific disease = activity are=20 published by CDC in the MMWR series. Electronic = subscriptions are=20 free (http://www.cdc.gov/subscribe.h= tml).=20 Printed subscriptions are available at

Superintendent of Documents

U.S. Government Printing Office

Washington, D.C. 20402-9235

202-512-1800=20
American Academy of Pediatrics (AAP)

Every 3 years, AAP issues the Red Book: Report of the = Committee on=20 Infectious Diseases, which contains a composite summary of AAP = recommendations concerning infectious diseases and immunizations = for=20 infants, children, and adolescents (Telephone: 888-227-1770; = Website: http://www.aap.org/).=20
American Academy of Family Physicians (AAFP)

Information from the professional organization of family = physicians is=20 available at http://www.aafp.org/.=20
Immunization Action Coalition

This source provides extensive free provider and patient = information,=20 including translations of Vaccine Information Statements into = multiple=20 languages. Printed materials are reviewed by CDC for technical = accuracy=20 (http://www.immunize.org/ = and http://vaccineinformation.org/).=20
National Network for Immunization Information

This information source is an affiliation of the Infectious = Diseases=20 Society of America, the Pediatric Infectious Diseases Society, = AAP, the=20 American Nurses Association, the AAFP, the National Association of = Pediatric Nurse Practitioners, the American College of = Obstetricians and=20 Gynecologists and the University of Texas Medical Branch. This = source=20 seeks to provide the public, health professionals, policy makers, = and the=20 media with up-to-date, scientifically valid information (http://www.immunizationinfo.org= /).=20
Vaccine Education Center

Located at the Children's Hospital of Philadelphia, this source = provides patient and provider information (http://www.vaccine.chop.edu/). =
Institute for Vaccine Safety

Located at Johns Hopkins University School of Public Health, = this=20 source provides information about vaccine safety concerns and = objective=20 and timely information to physicians and health-care providers and = parents=20 (http://www.vaccinesafety.edu/)= .=20
Group on Immunization Education of the Society of Teachers = of=20 Family Medicine

This organization provides information for clinicians, = including the=20 free personal digital assistant software called "Shots" which = includes the=20 childhood and adult schedule for Palm OS and for Windows handhelds = (http://www.immunizationed.org/).=20
State and Local Health Departments

State and local health departments provide technical advice = through=20 hotlines, electronic mail, and Internet sites, including printed=20 information regarding vaccines and immunization schedules, = posters, and=20 other educational materials.=20
Acknowledgments

The members of the Advisory Committee on Immunization Practices = are=20 grateful for the contributions of Lorry Rubin, MD, Schneider = Children's=20 Hospital, New Hyde Park, New York, Deborah Wexler, MD, = Immunization Action=20 Coalition; Stephan L. Foster, PharmD, University of Tennessee, = Memphis,=20 Geoffrey Evans, MD, Health Resources and Services Administration,=20 Rockville, Maryland; Richard Zimmerman, MD, University of = Pittsburgh=20 School of Medicine, Pennsylvania, and Richard Clover, MD, = University of=20 Louisville School of Public Health, Kentucky.=20
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Ljungman P, Engelhard D, de la Camara R, et al. Special = report:=20 vaccination of stem cell transplant recipients: recommendations = of the=20 Infectious Diseases Working Party of the EBMT. Bone Marrow = Transplant=20 2005;35:737--46.=20
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Bastyr EJ. Latex allergen allergic reactions [Letter]. = Diabetes Care=20 1996;19:546.=20
MacCracken J, Stenger P, Jackson T. Latex allergy in = diabetic=20 patients: a call for latex-free insulin tops [Letter]. Diabetes = Care=20 1996;19:184.=20
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Lau YL, Tam AY, Ng KW, et al. Response of preterm infants to = hepatitis B vaccine. J Pediatr 1992;121:962--5.=20
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Losonsky GA, Wasserman SS, Stephens I, et al. Hepatitis B=20 vaccination of premature infants: a reassessment of current=20 recommendations for delayed immunization. Pediatrics = 1999;103:14.=20
Pickering LK, Granoff DM, Erickson JR, et al. Modulation of = the=20 immune system by human milk and infant formula containing = nucleotides.=20 Pediatrics 1998;101:242--9.=20
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Bohlke K, Galil K, Jackson LA, et al. Postpartum varicella=20 vaccination: is the vaccine virus excreted in breast milk? = Obstet=20 Gynecol 2003;102:970--7.=20
Krogh V, Duffy LC, Wong D, Rosenband M, Riddlesberger KR, = Ogra PL.=20 Postpartum immunization with rubella virus vaccine and antibody = response=20 in breast-feeding infants. J Lab Clin Med 1989;113:695--9.=20
Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J = Med=20 1998;338:1128--37.=20
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CDC.=20 Prevention of hepatitis A through active or passive = immunization:=20 recommendations of the Advisory Committee on Immunization = Practices=20 (ACIP). MMWR 2006;55(No. RR-7).=20
Tsai TF, Paul R, Lynberg MC, Letson GW. Congenital yellow = fever=20 virus infection after immunization in pregnancy. J Infect Dis=20 1993;168:1520--3.=20
Shields KE, Galil K, Seward J, Sharrar RG, Cordero JF, = Slater E.=20 Varicella vaccine exposure during pregnancy: data from the first = 5 years=20 of the pregnancy registry. Obstet Gynecol 2001;98:14--9.=20
CDC.=20 Revised ACIP recommendation for avoiding pregnancy after = receiving a=20 rubella-containing vaccine. MMWR 2001;50:1117.=20
CDC.=20 Rubella vaccination during pregnancy---United States, = 1971--1988. MMWR=20 1989;38:289--93.=20
Hlady WG, Bennett JV, Samadi AR, et al. Neonatal tetanus in = rural=20 Bangladesh: risk factors and toxoid efficacy. Am J Public Health = 1992;82:1365--9.=20
de Quadros CA, Andrus JK, Olive J-M, de Macedo CG. Polio = eradication=20 from the Western Hemisphere. Ann Rev Public Health = 1992;13:239--52.=20
Murray TS, Groth E, Weitzman C, Cappello M. Epidemiology and = management of infectious diseases in international adoptees. = Clin=20 Microbiol Rev 2005;18:510--20.=20
Hostetter MK. Infectious diseases in internationally adopted = children: findings in children from China, Russia, and Eastern = Europe.=20 Advances in Pediatric Infectious Diseases 1999;14:147--61.=20
Kriz B, Burian V, Sladky K, et al. Comparison of titration = results=20 of diphtheric antitoxic antibody obtained by means of Jensen's = method=20 and the method of tissue cultures and haemagglutination. J Hyg = Epidemiol=20 Microbiol Immunol 1978;22:485--93.=20
Evans DI, Shaw A. Safety of intramuscular injection of = hepatitis B=20 vaccine in haemophiliacs. BMJ 1990;300:1694--5.=20
CDC.=20 Immunization information system progress---United States, 2004. = MMWR=20 2005;54:1156--7.=20
US Department of Health and Human Services. Immunization and = infectious diseases. In: Healthy People 2010 (conference ed, = vol. 1).=20 Washington, DC: US Government Printing Office; 2000.=20
CDC.=20 Immunization of health-care workers: recommendations of the = Advisory=20 Committee on Immunization Practices (ACIP) and the Hospital = Infection=20 Control Practices Advisory Committee (HICPAC). MMWR 1997;46(No.=20 RR-18).=20
Shefer A, Briss P, Rodewald L, et al. Improving immunization = coverage rates: an evidence-based review of the literature. = Epidemiol=20 Rev 1999;21:96--142.=20
CDC.=20 Vaccine-preventable diseases: improving vaccination coverage in=20 children, adolescents, and adults; a report on recommendations = of the=20 Task Force on Community Preventive Services. MMWR 1999;48(No. = RR-8).=20
Briss PA, Rodewald LE, Hinman AR, et al. Reviews of evidence = regarding interventions to improve vaccination coverage in = children,=20 adolescents, and adults. Am J Prev Med 2000;18:97--140.=20
Task Force on Community Preventive Services. Recommendations = regarding interventions to improve vaccination coverage in = children,=20 adolescents, and adults. Am J Prev Med 2000;18:92--6.

Abbreviations Used in = This=20 Publication

AAFP American Academy of Family Physicians

AAP American Academy of Pediatrics

ACIP Advisory Committee on Immunization Practices

DT pediatric diphtheria-tetanus toxoid

DTaP pediatric diphtheria and tetanus toxoids and acellular = pertussis=20 vaccine

DTP pediatric diphtheria and tetanus toxoids and whole-cell = pertussis=20 vaccine

EIA/ELISA enzyme immunoassay

FDA Food and Drug Administration

GBS Guillain-Barr=E9 syndrome

HBIG hepatitis B immune globulin

HbOC Haemophilus influenzae type b-diphtheria CRM197 (CRM,=20 cross-reactive material) protein conjugate

HBsAg hepatitis B surface antigen

Hib Haemophilus influenzae type b

HIV human immunodeficiency virus

HPV human papillomavirus

HSCT hematopoietic stem cell transplant

IgG immunoglobulin G

IGIV intravenous immune globulin

IPV inactivated poliovirus vaccine

JI jet injector

MCV4 meningococcal conjugate vaccine

MMR measles, mumps, rubella vaccine

MMRV measles-mumps-rubella-varicella vaccine

MPSV meningococcal polysaccharide vaccine

OPV oral poliovirus vaccine

OSHA Occupational Safety and Health Administration

PCV pneumococcal conjugate vaccine

PPD purified protein derivative

PRP-OMP Haemophilus influenzae type b-polyribosylribitol=20 phosphate-meningococcal outer membrane protein conjugate

PPV pneumococcal polysaccharide vaccine

RV pentavalent rotavirus vaccine

Td adult tetanus-diphtheria toxoid

Tdap Tetanus reduced diphtheria acellular pertussis vaccine for = adolescents and adults

TST tuberculin skin test

VAERS Vaccine Adverse Event Reporting System

VAPP vaccine-associated paralytic poliomyelitis

VICP Vaccine Injury Compensation Program

VIS Vaccine Information Statement=20
Definitions Used in = This Report=20

Adverse event. An untoward event that occurs after a = vaccination=20 that might be caused by the vaccine product or vaccination = process. It=20 includes events that are 1) vaccine-induced: caused by the = intrinsic=20 characteristic of the vaccine preparation and the individual = response of=20 the vaccinee; these events would not have occurred without = vaccination=20 (e.g., vaccine-associated paralytic poliomyelitis); 2)=20 vaccine-potentiated: the events would have occurred anyway, but = were=20 precipitated by the vaccination (e.g., first febrile seizure in a=20 predisposed child); 3) programmatic error: the event was caused by = technical errors in vaccine preparation, handling, or = administration; 4)=20 coincidental: the event was associated temporally with vaccination = by=20 chance or caused by underlying illness. Special studies are needed = to=20 determine if an adverse event is a reaction to the vaccine or the = result=20 of another cause (Sources: Chen RT. Special methodological = issues=20 in pharmacoepidemiology studies of vaccine safety. In: Strom BL, = ed.=20 Pharmacoepidemiology. 3rd ed. Sussex, England: John Wiley & = Sons;=20 2000:707--32; and Fenichel GM, Lane DA, Livengood JR, Horwitz SJ, = Menkes=20 JH, Schwartz JF. Adverse events following immunization: assessing=20 probability of causation. Pediatr Neurol 1989;5:287--90).

Adverse reaction. An undesirable medical condition that = has been=20 demonstrated to be caused by a vaccine. Evidence for the causal = relation=20 is usually obtained through randomized clinical trials, controlled = epidemiologic studies, isolation of the vaccine strain from the = pathogenic=20 site, or recurrence of the condition with repeated vaccination = (i.e.,=20 rechallenge); synonyms include side effect and adverse effect. =

Immunobiologic. Antigenic substances (e.g., vaccines and = toxoids) or antibody-containing preparations (e.g., globulins and=20 antitoxins) from human or animal donors. These products are used = for=20 active or passive immunization or therapy. The following are = examples of=20 immunobiologics:

Vaccine. A suspension of live (usually attenuated) or=20 inactivated microorganisms (e.g., bacteria or viruses) or = fractions=20 thereof administered to induce immunity and prevent infectious = disease or=20 its sequelae. Some vaccines contain highly defined antigens (e.g., = the=20 polysaccharide of Haemophilus influenzae type b or the = surface=20 antigen of hepatitis B); others have antigens that are complex or=20 incompletely defined (e.g., Bordetella pertussis antigens = or=20 live-attenuated viruses).

Toxoid. A modified bacterial toxin that has been made = nontoxic,=20 but retains the ability to stimulate the formation of antibodies = to the=20 toxin.

Immune globulin. A sterile solution containing = antibodies, which=20 are usually obtained from human blood. It is obtained by cold = ethanol=20 fractionation of large pools of blood plasma and contains 15%--18% = protein. Intended for intramuscular administration, immune = globulin is=20 primarily indicated for routine maintenance of immunity among = certain=20 immunodeficient persons and for passive protection against measles = and=20 hepatitis A.

Intravenous immune globulin. A product derived from = blood plasma=20 from a donor pool similar to the immune globulin pool, but = prepared so=20 that it is suitable for intravenous use. Intravenous immune = globulin is=20 used primarily for replacement therapy in primary = antibody-deficiency=20 disorders, for treatment of Kawasaki disease, immune = thrombocytopenic=20 purpura, hypogammaglobulinemia in chronic lymphocytic leukemia, = and=20 certain cases of human immunodeficiency virus infection (Table= =20 4).

Hyperimmune globulin (specific). Special preparations = obtained=20 from blood plasma from donor pools preselected for a high antibody = content=20 against a specific antigen (e.g., hepatitis B immune globulin,=20 varicella-zoster immune globulin, rabies immune globulin, tetanus = immune=20 globulin, vaccinia immune globulin, cytomegalovirus immune = globulin,=20 botulism immune globulin).

Monoclonal antibody. An antibody product prepared from a = single=20 lymphocyte clone, which contains only antibody against a single = antigen.=20

Antitoxin. A solution of antibodies against a toxin. = Antitoxin=20 can be derived from either human (e.g., tetanus immune globulin) = or animal=20 (usually equine) sources (e.g., diphtheria and botulism = antitoxin).=20 Antitoxins are used to confer passive immunity and for treatment. =

Vaccination and immunization. The terms vaccine and = vaccination=20 are derived from vacca, the Latin term for cow. Vaccine was the = term used=20 by Edward Jenner to describe material used (i.e., cowpox virus) to = produce=20 immunity to smallpox. The term vaccination was used by Louis = Pasteur in=20 the 19th century to include the physical act of administering any = vaccine=20 or toxoid. Immunization is a more inclusive term, denoting the = process of=20 inducing or providing immunity by administering an immunobiologic. = Immunization can be active or passive. Active immunization is the=20 production of antibody or other immune responses through = administration of=20 a vaccine or toxoid. Passive immunization means the provision of = temporary=20 immunity by the administration of preformed antibodies. Although = persons=20 often use the terms vaccination and immunization interchangeably = in=20 reference to active immunization, the terms are not synonymous = because the=20 administration of an immunobiologic cannot be equated = automatically with=20 development of adequate immunity.

*During measles outbreaks, if cases are occurring among infants = aged=20 <12 months, measles vaccination of infants as young as 6 months = can be=20 undertaken as an outbreak control measure. However, doses = administered at=20 ages <12 months should not be counted as part of the series=20 (Source: CDC. Measles, mumps, and rubella vaccine use and=20 strategies for elimination of measles, rubella, and congenital = rubella=20 syndrome and control of mumps: recommendations of the Advisory = Committee=20 on Immunization Practices [ACIP]. MMWR 1998;47[No. RR-8]).

⁼⁸⁶In certain situations, local or state = requirements might=20 mandate that doses of selected vaccines be administered on or = after=20 specific ages. For example, a school entry requirement might not = accept a=20 dose of MMR or varicella vaccine administered before the child's = first=20 birthday. ACIP recommends that physicians and other health-care = providers=20 comply with local or state vaccination requirements when = scheduling and=20 administering vaccines.

^=A7 The exception is the 2-dose HepB vaccination = series for=20 adolescents aged 11--15 years. Only Recombivax HB^=AE = (Merck=20 Vaccine Division) should be used in this schedule. = Engerix-B^=AE=20 (GlaxoSmithKline) is not approved by FDA for this schedule.

^=B6If the gluteal muscle is chosen, injection should = be=20 administered lateral and superior to a line between the posterior = superior=20 iliac spine and the greater trochanter or in the ventrogluteal = site, the=20 center of a triangle bounded by the anterior superior iliac spine, = the=20 tubercle of the iliac crest, and the upper border of the greater=20 trochanter.

**Internet sites with device listings are identified for = information=20 purposes only. CDC, the U.S. Public Health Service, and the = Department of=20 Health and Human Services do not endorse any specific device or = imply that=20 the devices listed would all satisfy the needle-stick prevention=20 regulations.

⁼⁸⁶⁼⁸⁶A supplement to the original MCV4 vaccine = Biologics=20 License Agreement was submitted to FDA in March 2005, for use of = MCV4 in=20 children aged 2--10 years.

^=A7=A7Enzyme immunoassay tests are available. = Physicians should=20 contact the laboratory performing the test for interpretive = standards and=20 limitations. Protective concentrations for antibody to diphtheria = and=20 tetanus toxins are defined as >0.1 IU/mL.

^=B6=B6As of May 2006, vaccines covered by the act = include=20 diphtheria, tetanus, pertussis, measles, mumps, rubella, = poliovirus, HepB,=20 Hib, varicella, pneumococcal conjugate, HepA, trivalent = inactivated=20 influenza vaccine, and pentavalent RV.

***The Reportable Events Table can be obtained from the Vaccine = Injury=20 Compensation Program Internet site at http://vaers.hhs.gov/reporta= ble.htm.=20

Advisory Committee on = Immunization=20 Practices
Membership List, February 2006

Chairman: Jon S. Abramson, MD, Weston M. Kelsey, = Professor and=20 Chair, Department of Pediatrics, Wake Forest University School of=20 Medicine, Winston-Salem, North Carolina.

Executive Secretary: Larry K. Pickering, MD, Senior = Advisor to=20 the Director, National Center for Immunization and Respiratory = Diseases=20 (proposed), CDC, Atlanta, Georgia.

Members: Ban Mishu Allos, MD, Vanderbilt University = School of=20 Medicine, Nashville, Tennessee; Robert L. Beck, Consumer = Representative,=20 Palmyra, Virginia; Judith Campbell, MD, Baylor College of = Medicine,=20 Houston, Texas; Reginald Finger, MD, Colorado Springs, Colorado; = Janet R.=20 Gilsdorf, M.D., University of Michigan, Ann Arbor, Michigan; Harry = Hull,=20 MD, Minnesota Department of Health, Minneapolis, Minnesota; Tracy = Lieu,=20 MD, Harvard Pilgrim Health Care and Harvard Medical School, = Boston,=20 Massachusettes; Edgar K. Marcuse, MD, Children's Hospital and = Regional=20 Medical Center, Seattle, Washington; Dale L. Morse, MD, New York = State=20 Department of Health, Albany, New York; Julia Morita, MD, Chicago=20 Department of Public Health, Chicago, Illinois; Gregory A. Poland, = MD,=20 Mayo Clinic and Foundation, Rochester, Minnesota; Patricia = Stinchfield,=20 The Children's Immunization Project, Children's Hospitals and = Clinics, St.=20 Paul, Minnesota; John J. Treanor, MD, University of Rochester, = Rochester,=20 New York; Robin J. Womeodu, MD, University of Tennessee Health = Science=20 Center, Memphis, Tennessee.

Ex-Officio Members: James Cheek, MD, Indian Health = Service,=20 Albuquerque, New Mexico; Wayne Hachey, DO, Department of Defense, = Falls=20 Church, Virginia; Geoffrey S. Evans, MD, Health Resources and = Services=20 Administration, Rockville, Maryland; Bruce Gellin, MD, National = Vaccine=20 Program Office, Washington, DC; Linda Murphy, Centers for Medicare = and=20 Medicaid Services, Baltimore, Maryland; George T. Curlin, MD, = National=20 Institutes of Health, Bethesda, Maryland; Norman Baylor, PhD, Food = and=20 Drug Administration, Rockville, Maryland; Kristin Lee Nichol, MD,=20 Department of Veterans Affairs, Minneapolis, Minnesota.

Liaison Representatives: American Academy of Family = Physicians,=20 Jonathan Temte, MD, Madison, Wisconsin; Doug Campos-Outcalt, MD, = Phoenix,=20 Arizona; American Academy of Pediatrics, Keith Powell, MD, Akron, = Ohio;=20 Carol Baker, MD, Houston, Texas; America's Health Insurance Plans, = Andrea=20 Gelzer, MD, Hartford, Connecticut; American College Health = Association,=20 James C. Turner, MD, Charlottesville, Virginia; American College = of=20 Obstetricians and Gynecologists, Stanley Gall, MD, Louisville, = Kentucky;=20 American College of Physicians, Kathleen M. Neuzil, MD, Seattle,=20 Washington; American Medical Association, Litjen Tan, PhD, = Chicago,=20 Illinois; American Pharmacists Association, Stephan L. Foster, = PharmD,=20 Memphis, Tennessee; Association of Teachers of Preventive = Medicine, Paul=20 W. McKinney, MD, Louisville, Kentucky; Biotechnology Industry=20 Organization, Clement Lewin, PhD, Orange, Connecticut; Canadian = National=20 Advisory Committee on Immunization, Monica Naus, MD, Vancouver, = British=20 Columbia, Canada; Healthcare Infection Control Practices Advisory=20 Committee, Steve Gordon, MD, Cleveland, Ohio; Infectious Diseases = Society=20 of America, Samuel L. Katz, MD, Durham, North Carolina; London = Department=20 of Health, David Salisbury, MD, London, England, United Kingdom; = National=20 Association of County and City Health Officials, Nancy Bennett, = MD,=20 Rochester, New York; Jeffrey Duchin, MD, Seattle, Washington; = National=20 Coalition for Adult Immunization, David A. Neumann, PhD, = Alexandria,=20 Virginia; National Foundation for Infectious Diseases, William = Schaffner,=20 MD, Nashville, Tennessee; National Immunization Council and Child = Health=20 Program, Mexico, Romeo S. Rodriquez, Mexico; National Medical = Association,=20 Patricia Whitley-Williams, MD, New Brunswick, New Jersey; = Pharmaceutical=20 Research and Manufacturers of America, Peter Paradiso, PhD, = Collegeville,=20 Pennsylvania; Society for Adolescent Medicine, Amy B. Middleman, = MD,=20 Houston, Texas.

Members of the General = Recommendations on=20 Immunization Working Group

Advisory Committee on Immunization Practices (ACIP), Edgar K. = Marcuse,=20 MD; Patricia Stinchfield; ACIP Liaison and Ex-Officio Members, = Geoffrey S.=20 Evans, MD, Health Resources and Services Administration; Stephan = L.=20 Foster, PharmD, American Pharmacists Association; CDC staff = members,=20 Andrew T. Kroger, MD, William L. Atkinson, MD, Larry K. Pickering, = MD;=20 other members and consultants, Lorry Rubin, MD, Schneider = Children's=20 Hospital; Deborah Wexler, MD, Immunization Action Coalition; = Richard=20 Zimmerman, MD, University of Pittsburgh School of Medicine; = Richard D.=20 Clover, MD, University of Louisville School of Public Health.=20

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Use of trade names and commercial sources is for=20 identification only and does not imply endorsement by the = U.S.=20 Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as = a=20 service to MMWR readers and do not constitute or = imply=20 endorsement of these organizations or their programs by CDC = or the=20 U.S. Department of Health and Human Services. CDC is not = responsible=20 for the content of pages found at these sites. URL addresses = listed=20 in MMWR were current as of the date of = publication.

Disclaimer=20 All MMWR HTML versions of articles are = electronic=20 conversions from ASCII text into HTML. This conversion may have = resulted=20 in character translation or format errors in the HTML version. = Users=20 should not rely on this HTML document, but are referred to the = electronic=20 PDF version and/or the original MMWR paper copy for the = official=20 text, figures, and tables. An original paper copy of this issue = can be=20 obtained from the Superintendent of Documents, U.S. Government = Printing=20 Office (GPO), Washington, DC 20402-9371; telephone: (202) = 512-1800.=20 Contact GPO for current prices.
**Questions or messages = regarding errors in formatting should be addressed to mmwrq@cdc.gov.=20

Date last=20 reviewed: 11/16/2006

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and=20 Human=20 = Services
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General Recommendations = on=20 Immunization=20 Recommendations of the Advisory Committee on = Immunization=20 Practices (ACIP)

Recommendations of the Advisory Committee on = Immunization=20 Practices (ACIP)

Summary =

Introduction

Timing and Spacing of=20 Immunobiologics

General Principles for Vaccine Scheduling

Spacing of Multiple Doses of the Same Antigen

Simultaneous Administration

Nonsimultaneous Administration

Spacing of Vaccines and Antibody-Containing Products =

Interchangeability of Vaccines from Different Manufacturers =

Lapsed Vaccination Schedule

Unknown or Uncertain Vaccination Status

Contraindications and = Precautions=20

Vaccine Administration =

Infection Control and Sterile Technique

Injection Route and Injection Site

Intramuscular Injections and Needle Length

Subcutaneous Injections

Multiple Vaccinations

Jet Injection

Methods for Alleviating Discomfort and Pain Associated with = Vaccination

Nonstandard Vaccination Practices

Preventing Adverse Reactions

Managing Acute Vaccine Reactions

Occupational Safety Regulations

Storage and Handling = of=20 Immunobiologics

Storage Temperature

Temperature Monitoring

Response to Out-of-Temperature- Range Storage

Expiration Dates and Windows

Multidose Vials

Prefilling Syringes

Altered = Immunocompetence=20

General Principles

Altered Immunocompetence as an Indication to Receive a = Vaccine=20

Vaccination of Contacts of Persons with Altered=20 Immunocompetence

Vaccination with Inactivated Vaccines

Vaccination with Live-Attenuated Vaccines

Recipients of Hematopoietic Stem Cell Transplant

Situations in Which Some Degree of Immunodeficiency Might = be=20 Present

Special = Situations=20

Concurrently Administering Antimicrobial Agents and = Vaccines=20

Tuberculosis Screening and Skin Test Reactivity

Severe Allergy to Vaccine Components

Latex Allergy

Vaccination of Preterm Infants

Breast Feeding and Vaccination

Vaccination During Pregnancy

Persons Vaccinated Outside the United States, Including=20 Internationally Adopted Children

Vaccinating Persons with Bleeding Disorders and Persons = Receiving=20 Anticoagulant Therapy

Vaccination Records=20

Consent to Vaccinate

Provider Records

Patients' Personal Records

Immunization Information Systems

Reporting Adverse = Events after=20 Vaccination

National Vaccine Injury Compensation Program

Benefit and Risk Communication

Vaccination Programs=20

Vaccine Information=20 Sources

CDC-INFO Contact Center

CDC's National Center for Immunization and Respiratory = Diseases=20 (proposed)

MMWR

American Academy of Pediatrics (AAP)

American Academy of Family Physicians (AAFP)

Immunization Action Coalition

National Network for Immunization Information

Vaccine Education Center

Institute for Vaccine Safety

Group on Immunization Education of the Society of Teachers = of=20 Family Medicine

State and Local Health Departments

Acknowledgments

References

Abbreviations Used in = This=20 Publication

Definitions Used in = This Report=20

General Recommendations = on=20 Immunization=20

Recommendations of the Advisory Committee on = Immunization=20 Practices (ACIP)