Hepatitis B birth dose vaccines | NITAG RESOURCE CENTER

Safety of the intervention

Type, including severity, consequences and frequency of short- and long-term adverse events following vaccination

The Global Advisory Committee on Vaccine Safety (GACVS) has confirmed the safety profile of hepatitis B vaccine.^{Go to footnote 11}

In general, there are minimal adverse reactions, such as local pain, myalgia and transient fever, mostly within 24 hours. Mild reactions tend to be less common in children than in adults (<10% vs 30%). The estimated incidence of the severe adverse event of anaphylaxis among vaccine recipients is 1.1 per million vaccine doses (95% CI: 0.1–3.9).^{Go to footnote 22}

Data do not indicate a causal association between hepatitis B vaccine and neurological disease (including Guillain-Barré syndrome and multiple sclerosis), diabetes mellitus, demyelinating disorders, chronic fatigue syndrome, arthritis, autoimmune disorders, asthma, hair loss, or sudden infant death syndrome.^{Go to footnote 11, Go to footnote 33, Go to footnote 44, Go to footnote 55}

Sources

Go back to footnote reference 1
Global Advisory Committee on Vaccine Safety - hepatitis b. World Health Organization; ,(https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/hepatitis-b-vaccines, accessed 26 August 2026.)
Go back to footnote reference 2
World Health Organization. Information sheet: observed rates of vaccine reactions - hepatitis B vaccines. World Health Organization; 2012 (https://cdn.who.int/media/docs/default-source/pvg/global-vaccine-safety/hep-b-vaccine-rates-information-sheet.pdf, accessed 26 August 2026).
Go back to footnote reference 3
Duclos P. Safety of immunisation and adverse events following vaccination against hepatitis B. Expert Opin Drug Saf. 2003;2(3):225–31. doi:10.1517/14740338.2.3.225.
Go back to footnote reference 4
Mikaeloff Y, Caridade G, Assi S, Tardieu M, Suissa S et al. Hepatitis B vaccine and risk of relapse after a first childhood episode of CNS inflammatory demyelination. Brain. 2007;130(Pt 4):1105–10. doi:10.1093/brain/awl368.
Go back to footnote reference 5
Yu O, Bohlke K, Hanson CA, Delaney K, Rees TG et al. Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study. Pharmacoepidemiol Drug Saf. 2007;16(7):736–45. doi:10.1002/pds.1354.