The reported episodes included anaphylaxis (dramatic and life threatening allergic reaction), arthralgias

( pains in joints), neurologic reactions such as Guillain-Barre Syndrome, or GBS (an inflammation of many nerves, causing pain and weakness in the arms and legs and possible polio like permanent paralysis), as well as other illnesses.

The rate of these problems following vaccine injection in adults appeared not be be significantly increased above the rate for these illnesses expected in unvaccinated adults. Thus, in 1985, or about three and a half years after vaccine licensure, the US Centers for Disease Control concluded that the association between early licensed hepatitis B vaccine and the reported post vaccination illnesses was within reasonable boundaries.

A post marketing surveillance for neurologic adverse events following hepatitis B vaccination was carried out in 1982-1985 involving an estimated 850 vaccinees. Adverse events occurring within seven weeks of vaccination included: Bell's palsy, paralysis of a facial nerve (10 cases); GBS (9); lumbar radiculopathy, another nervous system disorder (5); optic neuritis, an inflammation of a nerve of the eye, causing loss of sensation and even muscular atrophy (5); convulsions (5);transverse myelitis, inflammation of the spinal cord (4); and brachial plexus neuropathy, an abnormal condition in the nerves of the spine involving the neck, arms, hand and part of the shoulder (3). Underreporting of these events was among "factors important in judging the results [that] could not be measured," concluded the American Journal of Epidemics study mentioned above.

Of those events that were reported, only GBS occurred more often than expected. The authors of the study determined that: ". . . no conclusive epidemiological association could be made between any neurologic adverse event and the vaccine. Even if such an association did exist, the present benefits in persons at high risk from hepatitis B would outweigh the risk of any neurologic events. . . It would be illogical for a health care worker or a homosexual man to refuse hepatitis B vaccine because of a risk of Guillain-Barre syndrome. . ."

New Zealand Experience

Successive surveys carried out since 1972 in New Zealand showed widely different prevalence of hepatitis B infections: 10 per cent in the Maori (native NZ population), but less than 1 per cent in the non Maori, according to the New Zealand Department of Health in the Autumn 1988 Health Quarterly Magazine. With the advent of more accurate diagnostic tests in 1980 for use in surveys, it was shown in one survey by the New Zealand Department of Health that the hepatitis B carrier rate was 5.8 per cent in pregnant Maori women and 0.9 per cent in pregnant non Maori women.

In February 1988, according to its health department, New Zealand embarked on "the most extensive national immunization programme against hepatitis B in the world".

Three months later, the Hamilton Department of Health in Wellington faxed to hepatitis B coordinators in all area health boards an urgent message from the principal medical officer:

"We have received approximately 10 reports of anaphylactoid [allergic life threatening shock] reactions occurring in children receiving hepatitis B vaccine. This is. . . a matter of considerable concern. . . Professor Ralph Edwards [of the Otago Medical School in Dunedin, New Zealand, chief medical assessor for adverse events]. . . reports 14 similar reactions. . . . since 1985 in Australia and he feels sure that the potential for severe allergic response exists. Accordingly. . . the following policy should be adhered to . . . (1) for children who have developed vaccine related urticaria [hives] alone it is recommended that subsequent vaccinations be given in a hospital setting. . . (2) If the allergic response includes ANAPHYLACTIC SHOCK, HYPOTENSION [sudden drop in blood pressure], BRONCHOSPASM or true ANGIONEUROTIC OEDEMA [ life threatening fluid swelling ], then it is considered that any further vaccination is absolutely contraindicated. It is felt that for the above conditions to be classified as vaccine related, the onset of symptoms should be within 12 hours after an injection of hepatitis B vaccine."