Hepatitis B Vaccine Safety
Common Side Effects
- The Centers for Disease Control and Prevention recommends that the hepatitis B vaccine is extremely safe for babies, with only minor side effects occurring at rates no higher than placebo, and serious adverse events being extraordinarily rare 1, 2
- Pain at injection site occurs in 3-29% of vaccinated babies, but placebo-controlled studies show this happens at the same rate in babies receiving placebo 3, 4, 5
- Fever >37.7°C (99.9°F) occurs in 1-6% of infants, again at rates identical to placebo 3, 4, 5
- Injection site erythema and swelling each occur in approximately 3% of babies 1
Serious Adverse Events
- The American Academy of Pediatrics states that the only proven serious adverse event causally linked to hepatitis B vaccine is anaphylaxis, which occurs at a rate of approximately 1 per 1.1 million vaccine doses in children and adolescents 2, 5, 6
Conditions NOT Caused by Hepatitis B Vaccine
- The Institute of Medicine concluded that evidence is inadequate to accept or reject a causal relation between hepatitis B vaccine and neurologic, chronic, and autoimmune diseases, but convincingly supports causation only for anaphylaxis in yeast-sensitive persons 1, 2
- Multiple high-quality studies and expert reviews have definitively ruled out causal associations between hepatitis B vaccine and Guillain-Barré syndrome 3, 4, 5, 6
- The hepatitis B vaccine has not been shown to cause multiple sclerosis, chronic fatigue syndrome, diabetes mellitus, rheumatoid arthritis, or autoimmune diseases 2, 5, 6
VAERS Surveillance Data
- Among 20,231 adverse event reports following hepatitis B vaccination at all ages, 78% involved vaccines given in combination with other vaccines 1, 2
- When given in combination, 16.7% of adverse events were classified as serious, with most common events being fever, injection site erythema, and vomiting 1, 2
Critical Context: Risk-Benefit Analysis
- The Centers for Disease Control and Prevention estimates that for each U.S. birth cohort, an estimated 2,000-5,000 persons will die from hepatitis B-related liver disease without vaccination 3, 4
- The vaccine prevents 90-100% of perinatal infections when given at birth with HBIG to infants of HBsAg-positive mothers 5, 6
- The vaccine prevents 70-95% of perinatal infections even without HBIG 6, 7