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Hepatitis B vaccines
Letter Hepatitis B vaccines Sir, In an article on hepatitis B vaccine by Dr J.B. Griffiths published in the December 1983 issue ~, the author questions the safety of the presently available hepatitis vaccines and suggests that their use may predispose to the development of the acquired immune deficiency syndrome (AIDS). The safety profile of our vaccine has been closely followed by both ourselves as manufacturers and by a number of medical and scientific advisory bodies including the Center for Disease Control Atlanta ~, W H O 3, American Association of Blood Banks 4 and the American College of PhysiciansL None of these agencies shares Dr Griffiths ' pessimistic views about the safety of the vaccine, nor does the available clinical data on persons followed up after receiving the vaccine lend any support to his opinion. No cases of A I D S have occurred among 442 medical staff who received the vaccine during clinical trials in
Table 1
AIDS in vaccinated and non-
vaccinated groups 7
Frequency AIDS of AIDS cases per
Number No.
the USA two to three years ago 6. The • safety of the vaccine in t h e USA has been reviewed recently by the C D C Atlanta 7. As of D e c e m b e r 1983 it was thought that 450,000 subjects, the majority of whom were health care workers, had received the vaccine. In this population there have been 17 cases of A I D S reported, 16 were in homosexual men and one in a bisexual male. No cases of A I D S have occurred in health care workers receiving the vaccine. In addition the C D C has continued to follow up homosexual subjects from previously published trials of the vaccine*. The results as of December 1983 are given in Table 1. The results of these studies would seem to indicate that in the homosexual population the incidence of A I D S in vaccine recipients is equal to or less than that in the control groups. In conclusion, there is no evidence to suggest that the incidence of A I D S in the recipients of hepatitis B vaccine is higher than in nonrecipients despite the fact that the groups vaccinated include those most at risk of developing AIDS. The dangers of following D r Griffiths' advice is that persons at risk from hepatitis B will decline vaccination through fears of A I D S and develop hepatitis. Unfortunately such cases have already occurred in the USA8 and could have been prevented if the vaccine had been used. Yours sincerely,
thousand
(A) San Francisco screened vaccinated
6875 320
82 3
11.93 9.38
(8) Denver screened vaccinated
2150 250
9 1
4.17 4.0
Dr John H. Young
Director of Medical Services, Merck Sharp and Dohme Limited, Hoddesdon, Hertfordshire ENll 9BU, UK
1 2 3 4 5
6 7 8
Griffiths, J.B. Hepatitis B vaccines. Vaccine 1983, 1, 3 Center for Disease Control. The safety of hepatitis B vaccine. M M W R 1983, 32, 134 Anon. WHO meeting on AIDS. Lancet 1983, ii, 1297 American Association of Blood Banks. Hepatitis B vaccine receives a clean bill of health. News Briefs 1983, 6(3), 1 Health and Public Policy Committee. American College of Physicians. Hepatitis B vaccine. Ann. Intern. IVied. 1984, 100, 149 Stevens, C.E. No increased incidence of AIDS in recipients of hepatitis B vaccine. N Engl. J. Med, 1983, 308, 1163 Shaw, F. CDC Atlanta. Personal Communication Francis, D.P. et al. The prevention of hepatitis B with vaccine. Ann. Intern. Med, 1982, 97, 362
Dr. Griffiths replies: The data presented by Dr Young in his letter is welcome and reassuring. It is accepted by epidemiologists that from a scientific point of view the risk of transmitting AIDS with this vaccine is remote. Nevertheless, until the causative agent of A I D S is known, there must be concern over the adequacy of quality control procedures for products from h u m a n blood. This view is unfortunately shared by many potential recipients of this vaccine, hence the reduced d e m a n d for it, and other products derived from h u m a n blood. The comment feature on hepatitis B in the first issue of V A C C I N E did not presume to advise on what vaccine should be used, as suggested by Dr Young. The aim was to review all aspects concerned with hepatitis vaccines and the opinions expressed were not necessarily the author's, but a statement based on available facts regarding scientific progress, public opinion and the commercial issues. Dr B. Griffiths
Vaccine, Vol. 2, J u n e 1 9 8 4
167
Table 1
AIDS in vaccinated and non-
vaccinated groups 7
Frequency AIDS of AIDS cases per
Number No.
the USA two to three years ago 6. The • safety of the vaccine in t h e USA has been reviewed recently by the C D C Atlanta 7. As of D e c e m b e r 1983 it was thought that 450,000 subjects, the majority of whom were health care workers, had received the vaccine. In this population there have been 17 cases of A I D S reported, 16 were in homosexual men and one in a bisexual male. No cases of A I D S have occurred in health care workers receiving the vaccine. In addition the C D C has continued to follow up homosexual subjects from previously published trials of the vaccine*. The results as of December 1983 are given in Table 1. The results of these studies would seem to indicate that in the homosexual population the incidence of A I D S in vaccine recipients is equal to or less than that in the control groups. In conclusion, there is no evidence to suggest that the incidence of A I D S in the recipients of hepatitis B vaccine is higher than in nonrecipients despite the fact that the groups vaccinated include those most at risk of developing AIDS. The dangers of following D r Griffiths' advice is that persons at risk from hepatitis B will decline vaccination through fears of A I D S and develop hepatitis. Unfortunately such cases have already occurred in the USA8 and could have been prevented if the vaccine had been used. Yours sincerely,
thousand
(A) San Francisco screened vaccinated
6875 320
82 3
11.93 9.38
(8) Denver screened vaccinated
2150 250
9 1
4.17 4.0
Dr John H. Young
Director of Medical Services, Merck Sharp and Dohme Limited, Hoddesdon, Hertfordshire ENll 9BU, UK
1 2 3 4 5
6 7 8
Griffiths, J.B. Hepatitis B vaccines. Vaccine 1983, 1, 3 Center for Disease Control. The safety of hepatitis B vaccine. M M W R 1983, 32, 134 Anon. WHO meeting on AIDS. Lancet 1983, ii, 1297 American Association of Blood Banks. Hepatitis B vaccine receives a clean bill of health. News Briefs 1983, 6(3), 1 Health and Public Policy Committee. American College of Physicians. Hepatitis B vaccine. Ann. Intern. IVied. 1984, 100, 149 Stevens, C.E. No increased incidence of AIDS in recipients of hepatitis B vaccine. N Engl. J. Med, 1983, 308, 1163 Shaw, F. CDC Atlanta. Personal Communication Francis, D.P. et al. The prevention of hepatitis B with vaccine. Ann. Intern. Med, 1982, 97, 362
Dr. Griffiths replies: The data presented by Dr Young in his letter is welcome and reassuring. It is accepted by epidemiologists that from a scientific point of view the risk of transmitting AIDS with this vaccine is remote. Nevertheless, until the causative agent of A I D S is known, there must be concern over the adequacy of quality control procedures for products from h u m a n blood. This view is unfortunately shared by many potential recipients of this vaccine, hence the reduced d e m a n d for it, and other products derived from h u m a n blood. The comment feature on hepatitis B in the first issue of V A C C I N E did not presume to advise on what vaccine should be used, as suggested by Dr Young. The aim was to review all aspects concerned with hepatitis vaccines and the opinions expressed were not necessarily the author's, but a statement based on available facts regarding scientific progress, public opinion and the commercial issues. Dr B. Griffiths
Vaccine, Vol. 2, J u n e 1 9 8 4
167