Vaccination section -Autoimmune diseases

Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the Advisory Committee on Immunization Practices (ACIP)

 

Summary

This report provides updated information concerning the potential adverse events associated with vaccination for hepatitis B, poliomyelitis, measles, mumps, diphtheria, tetanus, and pertussis. This information incorporates findings from a series of recent literature reviews, conducted by an expert committee at the Institute of Medicine (IOM), of all evidence regarding the possible adverse consequences of vaccines administered to children. This report contains modifications to the previously published recommendations of the Advisory Committee on Immunization Practices (ACIP) and is based on an ACIP review of the IOM findings and new research on vaccine safety. In addition, this report incorporates information contained in the "Recommendations of the Advisory Committee on Immunization Practices: Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence" (MMWR 1993;42{No. RR-4}) and the "General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (MMWR 1994;43{No. RR-1}). Major changes to the previous recommendations are highlighted within the text, and specific information concerning the following vaccines and the possible adverse events associated with their administration are included: hepatitis B vaccine and anaphylaxis; measles vaccine and a) thrombocytopenia and b) possible risk for death resulting from anaphylaxis or disseminated disease in immunocompromised persons; diphtheria and tetanus toxoids and pertussis vaccine (DTP) and chronic encephalopathy; and tetanus-toxoid-containing vaccines and a) Guillain-Barre syndrome, b) brachial neuritis, and c) possible risk for death resulting from anaphylaxis. These modifications will be incorporated into more comprehensive ACIP recommendations for each vaccine when such statements are revised. Also included in this report are interim recommendations concerning the use of measles and mumps vaccines in

1. persons who are infected with human immunodeficiency virus and
2. persons who are allergic to eggs; ACIP is still evaluating these recommendations.

INTRODUCTION

Immunization has enabled the global eradication of smallpox (1), the elimination of poliomyelitis from the Western hemisphere (2), and major reductions in the incidence of other vaccine-preventable diseases in the United States (Table_1). However, although immunization has successfully reduced the incidence of vaccine-preventable diseases, vaccination can cause both minor and, rarely, serious side effects. Public awareness of and controversy about vaccine safety has increased, primarily because increases in vaccine coverage resulted in an increased number of adverse events that occurred after vaccination. Such adverse events include both true reactions to vaccine and events coincidental to, but not caused by, vaccination. Despite concerns about vaccine safety, vaccination is safer than accepting the risks for the diseases these vaccines prevent. Unless a disease has been eradicated (e.g., smallpox), failure to vaccinate increases the risks to both the individual and society.

In response to concerns about vaccine safety, the National Childhood Vaccine Injury Act of 1986 established a no-fault compensation process for persons possibly injured by selected vaccines (3). The Act also mandated that the Institute of Medicine * (IOM) review scientific and other evidence regarding the possible adverse consequences of vaccines administered to children.

IOM constituted an expert committee to review all available information on these vaccine adverse events; such information included epidemiologic studies, case series, individual case reports, and testimonials. To derive their conclusions, the IOM committee members created five categories of causality to describe the relationships between the vaccines and specific adverse events. The first IOM review examined certain events occurring after administration of pertussis and rubella vaccines (Table_2) (4). The second IOM review examined events occurring after administration of all other vaccines usually administered during childhood (i.e., diphtheria and tetanus toxoids and measles, mumps, hepatitis B, Haemophilus influenzae type b {Hib}, and poliovirus vaccines) (Table_3) (5). Two other IOM committees have met since the findings of the second review were published. These two committees have published their findings concerning both the diphtheria and tetanus toxoids and pertussis vaccine (DTP) and chronic nervous system dysfunction (Figure_1) (6) and research strategies for vaccine-associated adverse events (7).

The Advisory Committee on Immunization Practices (ACIP) recently reviewed the findings of the IOM committees and modified the previously published ACIP recommendations to ensure consistency with IOM conclusions. These recommendations, which are included in this report, update all previously published ACIP recommendations pertaining to the precautions, contraindications, side effects, and adverse reactions ** associated with specific vaccines. ACIP accepted the IOM conclusions for almost all vaccine adverse events; the few exceptions generally occurred because new information that was available to ACIP had not been available when the IOM committees published their recommendations. These exceptions included a) oral poliovirus vaccine (OPV) and Guillain-Barre syndrome (GBS), b) tetanus-toxoid- containing vaccines and GBS, and c) DTP and chronic nervous system dysfunction.

In addition, this report incorporates information contained in the "Recommendations of the Advisory Committee on Immunization Practices: Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence" (MMWR 1993; 42{No. RR-4}) and the "General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (MMWR 1994;43{No. RR-1}). To facilitate recognition of the new recommendations in this report, all major changes that are being made to the previously published ACIP statements are highlighted within the text. These changes include information on the following vaccines and the possible adverse events associated with their administration:

• Hepatitis B vaccine and anaphylaxis;
• Measles vaccine and a) thrombocytopenia and b) possible risk for death resulting from anaphylaxis or disseminated disease in immunocompromised persons;
• DTP and chronic encephalopathy; and
• Tetanus-toxoid-containing vaccines and a) GBS, b) brachial neuritis, and c) possible risk for death resulting from anaphylaxis.

The modifications contained in this report, and possibly other changes as new information becomes available, will be incorporated into more comprehensive ACIP recommendations for each vaccine when such statements are revised.

HEPATITIS B VACCINE

The following recommendations concerning adverse events associated with hepatitis B vaccination update those applicable sections in "Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination -- Recommendations of the Immunization Practices Advisory Committee (ACIP)" (MMWR 1991;40{No. RR-13}).

Vaccine Side Effects and Adverse Reactions

Hepatitis B vaccines are safe to administer to adults and children. More than an estimated 10 million adults and 2 million infants and children have been vaccinated in the United States, and at least 12 million children have been vaccinated worldwide.

Vaccine-Associated Side Effects

Pain at the injection site (3%-29%) and a temperature greater than 37.7 C (1%-6%) have been among the most frequently reported side effects among adults and children receiving vaccine (8-12). In placebo-controlled studies, these side effects were reported no more frequently among vaccinees than among persons receiving a placebo (11,12). Among children receiving both hepatitis B vaccine and DTP, these mild side effects have been observed no more frequently than among children receiving only DTP.

The recommendation to begin hepatitis B vaccination soon after birth has raised the concern that a substantial number of infants will require an extensive medical evaluation for elevated temperatures secondary to hepatitis B vaccination. Several population-based studies to evaluate this possibility are in progress.

Adverse Events

In the United States, surveillance of adverse reactions indicated a possible association between GBS and receipt of the first dose of plasma-derived hepatitis B vaccine (CDC, unpublished data; 13). However, an estimated 2.5 million adults received one or more doses of recombinant hepatitis B vaccine during 1986-1990, and available data concerning these vaccinees do not indicate an association between receipt of recombinant vaccine and GBS (CDC, unpublished data).

Based on reports to the Vaccine Adverse Events Reporting System (VAERS), the estimated incidence rate of anaphylaxis among vaccine recipients is low (i.e., approximately one event per 600,000 vaccine doses distributed). Two of these adverse events occurred in children (CDC, unpublished data). In addition, only one case of anaphylaxis occurred among 100,763 children ages 10-11 years who had been vaccinated with recombinant vaccine in British Columbia (D. Scheifele, unpublished data), and no adverse events were reported among 166,757 children who had been vaccinated with plasma-derived vaccine in New Zealand (5). Although none of the persons who developed anaphylaxis died, this adverse event can be fatal; in addition, hepatitis B vaccine can -- in rare instances -- cause a life-threatening hypersensitivity reaction in some persons (5). Therefore, subsequent vaccination with hepatitis B vaccine is contraindicated for persons who have previously had an anaphylactic response to a dose of this vaccine.

Large-scale hepatitis B immunization programs for infants in Alaska, New Zealand, and Taiwan have not established an association between vaccination and the occurrence of other severe adverse events, including seizures and GBS (B. McMahon and A. Milne, unpublished data; 14). However, systematic surveillance for adverse reactions in these populations has been limited, and only a minimal number of children have received recombinant vaccine. Any presumed risk for adverse events that might be causally associated with hepatitis B vaccination must be balanced with the expected risk for hepatitis B virus (HBV)-related liver disease. Currently, an estimated 2,000-5,000 persons in each U.S. birth cohort will die as a result of HBV-related liver disease because of the 5% lifetime risk for HBV infection.

As hepatitis B vaccine is introduced for routine vaccination of infants, surveillance for vaccine-associated adverse events will continue to be an important part of the program despite the current record of safety. Any adverse event suspected to be associated with hepatitis B vaccination should be reported to VAERS. VAERS forms can be obtained by calling (800) 822-7967.

POLIOMYELITIS PREVENTION

The following recommendations concerning adverse events associated with poliomyelitis vaccination update those applicable sections in "Poliomyelitis Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP)" (MMWR 1982;31:22-6,31-4) and "Poliomyelitis Prevention: Enhanced-Potency Inactivated Poliomyelitis Vaccine -- Supplementary Statement" (MMWR 1987;36:795-8).

Precautions and Contraindications Pregnancy

Although no conclusive evidence documents the adverse effects of OPV or inactivated poliovirus vaccine (IPV) in pregnant women and their developing fetuses, vaccination of pregnant women should be avoided. However, if immediate protection against poliomyelitis is necessary, OPV or IPV can be given.

Immunodeficiency

Persons who have congenitally acquired immune-deficiency diseases (e.g., combined immunodeficiency, hypogammaglobulinemia, and agammaglobulinemia) should not be given OPV because of their substantially increased risk for vaccine-associated disease. Furthermore, persons who have altered immune status resulting from acquired conditions (e.g., human immunodeficiency virus {HIV} infection, leukemia, lymphoma, or generalized malignancy) or who have immune systems compromised by therapy (e.g., treatment with corticosteroids, alkylating drugs, antimetabolites, or radiation) should not receive OPV because of the theoretical risk for paralytic disease.

IPV -- and not OPV -- should be used to vaccinate immunodeficient persons and their household contacts. Many immunosuppressed persons are already immune to polioviruses because of previous vaccination or exposure to wild-type virus when they were immunocompetent. Although such persons should not receive OPV, their risk for paralytic disease may be less than that of persons who have congenitally acquired immunodeficiency. Although a protective immune response to IPV in the immunodeficient patient cannot be ensured, the vaccine is safe and some protection may result from its administration. If a household contact of an immunodeficient person is vaccinated inadvertently with OPV, the OPV recipient should avoid close physical contact with the immunodeficient person for approximately 4-6 weeks after vaccination (i.e., during the period of maximum excretion of vaccine virus). If such contact cannot be avoided, rigorous hygiene and hand washing after contact with feces (e.g., after diaper changing) and avoidance of contact with saliva (e.g., by not sharing eating utensils or food) should be practiced. These practices are an acceptable, but probably less effective, alternative than refraining from contact. Because immunodeficiency is possible in other children born to a family in which one child is immunodeficient, OPV should not be administered to a member of such a house-hold until the immune status of the recipient and other children in the family is documented.

Adverse Reactions OPV

In rare instances, administration of OPV has been associated with paralytic poliomyelitis in healthy recipients and their contacts. Very rarely, OPV has caused fatal paralytic poliomyelitis in immunocompromised persons (5). Other than efforts for identifying persons with immune-deficiency conditions, no procedures are currently available to identify persons likely to experience such adverse reactions. Although the risk of vaccine-associated paralysis is extremely small for vaccinees and their susceptible, close, personal contacts, they should be informed of this risk.

Available data do not indicate a measurable increased risk for GBS after receipt of OPV. Initial reports (at the time of IOM review) of two studies conducted in Finland suggested that OPV might cause GBS. These studies identified an apparent increased incidence of GBS that was temporally associated with mass OPV vaccination of children and adults who had previously received IPV (15,16). Since the IOM review, a reanalysis of the data derived from the studies conducted in Finland and an analysis of an observational study conducted in the United States have not demonstrated a causal relationship between OPV and GBS in infants (17).

Because OPV contains trace amounts of streptomycin, bacitracin, and neomycin, its use is contraindicated in persons who have previously had an anaphylactic reaction to OPV or to these antibiotics.

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