American Journal of Epidemiology Vol. 127, No. 2: 337-352
Copyright © 1988 by The Johns Hopkins University School of Hygiene and Public Health
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POSTMARKETING SURVEILLANCE FOR NEUROLOGIC ADVERSE EVENTS REPORTED AFTER HEPATITIS B VACCINATION
EXPERIENCE OF THE FIRST THREE YEARS
1Hepatitis Branch, Division of Viral Diseases, Center for Infectious Diseases, Centers for Disease Control Atlanta, GA
2Office of Epidemiology and Biostatistics, Center for Drugs and Biologies, Food and Drug Administration Rockville, MD
3Merck Sharp and Dohme Research Laboratories West Point, PA
4Office of Biologic Research and Review, Center for Drugs and Biologies, Food and Drug Administration Rockville, MD
5Statistical Services, Division of Viral Diseases, Centers for Disease Control Atlanta, GA
Reprint requests to Dr. Frederic E. Shaw, Jr, Hepatitis Branch, Division of Viral Diseases, Center for Infectious Diseases, Centers for Disease Control, Building 6, Room 164, Atlanta, GA 30333
In 1982, the Centers for Disease Control, the Food and Drug Administration, and the manufacturer created a surveillance system to monitor spontaneous reports of adverse events occurring after inoculation with the new plasma-derived hepatitis B vaccine (Heptavax-B, Merck Sharp and Dohme, West Point, PA). In the three years between June 1, 1982 and May 31, 1985, an estimated 850,000 persons received the vaccine. During that period, a total of 41 reports were received for one of the following neurologic adverse events: convulsions (five cases), Bell's palsy (10 cases), Guillain-Barré syndrome (nine cases), lumbar radicutopathy (five cases), brachial plexus neuropathy (three cases), optic neuritis (five cases), and transverse myelitis (four cases). Half of these occurred after the first of three required vaccine doses. There were no deaths. Calculation of the relative risks of these illnesses after hepatitis B vaccination was highly dependent on diagnostic classification of the cases, estimates of the size of the vaccinated population, background incidence of the diseases, and the length and distribution of the hypothetical at-risk Interval used in the analysis. Other factors important in judging the results of the study could not be measured, including underreporting. In some analyses, Guillain-Barré syndrome was reported significantly more often than expected (p < 0.05, Poisson probability distribution). However, no conclusive epidemiologic association could be made between any neurologic adverse event and the vaccine. Even if such an association did exist, the preventive benefits of the vaccine in persons at high risk for hepatitis B would unequivocally outweigh the risk of any neurologic adverse event
demyellnating diseases; hepatitis B; polyradiculoneuritis; product surveillance, postmarketing; vaccines
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