Hepatitis b - The latest vaccine

New Zealand, which led the world in launching a national immunization campaign against hepatitis B, abandoned it after extensive side effects began showing up.

As we write, the World Health Assembly is considering a recommendation that hepatitis B (HB) vaccination be included in the routine vaccination schedule for babies or children all over the world by 1997, regardless of whether they are at high risk of contracting the disease, which can damage the liver and kill one in five carriers. The American Academy of Pediatrics has already recommended that America follow the lead of 33 countries, which have national policies on HB shots; in Italy, the jab is compulsory. In the US, the HB shot is included in the schedules for infants: in the UK, the Health Secretary has embarked upon the largest scheme of its kind since the mass smallpox immunization programme of the 1960s, recommending that adolescents on the brink of sexual activity be vaccinated against what is primarily a sexually transmitted disease.

Since 1979, when a hepatitis vaccine was released on the market, the strategy in the UK and the US has been to identify and vaccinate high risk groups, including intravenous drug abusers, the sexually promiscuous and health care workers who handle bodily fluids and blood. Despite these efforts, hepatitis cases have risen by a third between 1979 and 1989. Since the exact source of the infection is unknown, the authorities now believe we should nip it in the earliest possible bud in infants. This means they believe we should exploit the immune systems of children to prevent the spread of what is primarily a sexually transmitted disease. The recommendation in America and elsewhere is that children receive the shot with their other jabs soon after birth. Britain at least is willing to hold off until children are 12 before submitting them to a series of injections.

Amid near universal consensus about the adoption of this new policy, virtually a lone voice of dissent is our panel member,Dr J. Anthony Morris, former member of the Food and Drug Administration and the National Institutes of Health and an expert on (and now chief critic of) immunizations. On 4 May, 1992, Dr Morris presented a report to the Vaccine Safety Committee, Institute of Medicine of the National Academy of Sciences in Washington D. C. Dr. Morris and Hilary Butler, of the Immunization Awareness Society in Tuakau, in Auckland, New Zealand, compiled a report on the experience of the New Zealand authorities, one of the first to adopt a wholesale programme of HB vaccination of all newborn babies in seven districts of the country as they put it, the "most extensive national immunization programme in the world".

Morris and Butler's report, "The Nature and Frequency of Adverse Reactions following the Hepatitis B vaccine injection in Children in New Zealand from 1985-88", is the first to track the reported side effects of the BH vaccine in one country over three years, and also the first to provide a fairly comprehensive list of reported side effects from the shot. Dr Morris shared this report with me in the hope that it would help our readers. What follows is a virtual copy of the report in its entirety, with minor edits made to decipher medicalese.

Plasma derived hepatitis B vaccine was licensed for use in the United States in 1981. Before it was given a licence, the most common side effects in adults in trials of pre licensed hepatitis B vaccines (derived from human blood plasma) were soreness at the injection site and mild dizziness, according to the Centers for Disease Control report published in the Morbidity and Mortality Weekly Report on 7 June 1985. Four years later, results of a post marketing surveillance study published in the American Journal of Epidemics 1988 (127: 337-352) showed that among an estimated 750,000 recipients of the early vaccine, only about 100 episodes of severe illness were reported.

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."

In 1989, Edwards released a report on the incidence of adverse events following injection of low dose hepatitis B vaccine in children ranging in age from two months to five years. In his report tabular data are given for 33 hospital admissions. The likelihood that these hospitalizations were caused by hepatitis B vaccine injection fell into three categories: probable (9 cases), possible (16) and unlikely (8). Tabular data was also supplied concerning those who suffered post vaccination illnesses who were not hospitalized.

The report also offered specific details and comments on the condition of the children. Some examples follow (italicizing ours to emphasize the conclusions tacitly made):

Lethargy and malaise: ". . . have been frequently reported in association with the vaccine and the present findings confirm that these symptoms can occur as a reaction to vaccination in children."

Diarrhoea: ". . . it may be that children in this age group are prone to developing diarrhoea as a reaction to the vaccine or to the stress of vaccination."

Bronchospasm and asthma: " . . . it should certainly be regarded as a possible reaction to vaccination."

Swelling, oedema, angioedema: ". . . it is probable that the reports of swelling or oedema did describe reactions to the vaccine."

Arthritis: "These events were almost certainly reactions to the vaccine."

Urticaria and erthema multiforme [similar to hives]: "The majority of events reported within 48 hours of vaccination are likely to be vaccine reactions."

Guillain-Barre syndrome: "The possibility that this condition may rarely be caused by hepatitis B vaccine must be acknowledged. . . and the present finding adds evidence for this possibility."

Faintness, pallor, syncope [loss of consciousness]: "It is likely that many of these episodes were of psychological origin and related to circumstances surrounding vaccination rather than to the vaccine itself."

Hypotonic/hyporesponsive episodes [drop in blood pressure, slowed reaction]: "It is likely that at least eight of the reported events were reactions to the vaccine."

Validity of results: "Under reporting must be expected in a study of this kind . . . Under reporting of events following the third dose certainly occurred and reporting was much higher from some areas (particularly Christchurch) than from others. . . A case could be put forward for accepting the rate of adverse events reported after the first vaccine dose in Christchurch. . . as . . . more representative of the true incidence. The incidence of adverse events. . . would then be closer to 2 per cent than to the 0.56 per cent reported over all areas and the three doses."

Physician Report

In April 1992, a concerned New Zealand physician prepared a report dealing primarily with the use of the new yeast based hepatitis B vaccine in newborns. In it, he says: "I believe giving the hepatitis B vaccine with DPT (diphtheria pertussis tetanus triple jab) and/or polio vaccine causes a significant immune suppression in a significant number of children, as witnessed by the number of recurrent infections. . . These events often happen when previous DPT, DT (diphtheria tetanus only) or polio vaccines have been well tolerated on their own. . . When we were giving hepatitis B vaccination at birth, there were a number of children who had prolonged post natal jaundices, lasting up to two or three weeks. This was not something that I had observed in the preceding 15 years, and, again, I have not seen it since the early immunization has been stopped."

Conclusion

In the early post marketing surveillance of adverse episodes carried out in 1982-1985, it was found that in a few hours or days following injection of plasma derived hepatitis B vaccine, occasionally the vaccinee experienced bouts of nervous system disorders. Except for GBS, it was believed the occurrence of the other reported neuropathies did not exceed that which would be expected to occur in nonvaccinated cohorts.

The authors of the original study (two American government agencies and Merck Sharp and Dohme Research Laboratories, which made the vaccine) point out that the preventive benefits in persons at high risk would outweigh the risks of any neurologic event. These sentences imply that it would not be illogical for a concerned parent to reject injection of hepatitis B vaccine into a healthy child, because of the risk of neurological injury, especially GBS, which outweighs their risk of contracting the illness.

Accurate and sensitive techniques have recently shown that the hepatitis B carrier rate in New Zealand in the early 1980s was 10 per cent in the Maori and less than 1 per cent in the non Maori; 5.8 per cent in pregnant Maori women and 0.9 per cent in pregnant non Maori women. Is this a population at high risk? Does the benefit derived in this population by hepatitis B vaccine injection exceed the risks listed in the New Zealand medical assessor's report?

The proposed programme to inject hepatitis B vaccine in all babies of less infectious mothers and all newborn babies in seven districts in New Zealand has come to a halt. This was due principally to two reasons: (1) A memorandum was issued by the Health Department advising delay in injecting the first dose of vaccine; and (2) the reluctance of many medical practitioners to administer the vaccine in the manner suggest by the Health Department.

When the HB programme was zealously launched in 1985, the national coordinator of the programme said that New Zealand was leading the world by initiating such a comprehensive national campaign, that the eyes of the worldwould be on New Zealand.

In one respect, the national coordinator is right.

For more information on this and other jabs, WDDTY has available its Vaccination Handbook, a 32 page booklet. To order, send £5.25 to our offices at 4 Wallace Rd, London N1 2PG.