NATIONAL VACCINE ADVISORY COMMITTEE

Resolution:

Hepatitis B

May 14, 1999

Hepatitis B is a common and dangerous infection. Currently used hepatitis B vaccines are highly safe and effective, and offer the hope of preventing many deaths that would otherwise occur due to cirrhosis or liver cancer.

Infants and young children who become infected with hepatitis B have the highest risk of developing later cirrhosis or liver cancer. Recommendations for use of hepatitis B vaccine reflect years of thoughtful discussion of the scientific evidence and are widely supported by medical, public health, and government advisory panels and expert groups.

Although vaccines are among the safest and most effective medical intervention, and pose vastly less risk than the diseases they prevent, no medical intervention--indeed, no human activity--is entirely risk-free.

Vaccines are extensively tested prior to licensure, but even a study involving (for example) 100,000 participants is incapable of detecting a problem that arises only a few times per million uses. Thus, despite the most rigorous pre-licensure testing, it will always remain true that a rare adverse effect might become apparent only after a vaccine is in widespread use. At the same time, adverse events that occur after vaccination, but that are known also to occur in unvaccinated persons, may have nothing to do with vaccination.

Our current ability to detect and understand the causal mechanisms of rare and very rare adverse events that are temporally related to vaccination is too limited. It is essential to have additional resources allocated to conduct clinical, epidemiological, and laboratory studies that will enable better understanding of potential or perceived rare adverse events.

In light of the foregoing, therefore, be it resolved that the NVAC supports maintaining current recommendations for hepatitis B vaccine, which are based on the best available knowledge. At the same time, NVAC also supports the allocation of additional resources for further understanding and prevention of potential rare adverse events, as outlined in the Department of Health and Human Services Vaccine Safety Action Plan which has been endorsed by the NVAC.

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