Hepatitis A and B Vaccine Criticism

The German newspaper "Bild am Sonntag" of 28th July 2002 reported on a case of hepatitis A in a 55-year old man who had previously received a full immunisation against hepatitis A and B virus. This report is based on an article from the specialised medical journal "Deutsche Medizinische Wochenschrift" of 26th July 2002. Both reports conclude that the combined immunisation against hepatitis A and B with "Twinrix adult" does not assure sufficient protection.

Prof. Johannes Löwer, President of the Paul-Ehrlich-Institut, which is in charge of the approval and batch testing of vaccines in Germany, declares: "We take the published data seriously. The possible reasons why the vaccine failed must be analysed now, and, if required, additional examinations must be started. According to our findings, a case of hepatitis A in spite of a full immunisation is an extremely rare event. The current data and the state-of-the-art knowledge do not question the use of this immunisation. If there is any doubt, elderly vaccinees travelling to high-risk areas, for instance, can be tested for a sufficient protection by determining the quantity of specific antibodies."

The vaccine "Twinrix adult" was approved in 1996 by the European Commission after a positive evaluation by the CPMP (Committee for Proprietary Medicinal Products) of the European Medicines Evaluation Agency (EMEA). Within the framework of the approval procedure, the immune response, i.e. the reaction of the human body to the vaccination, was evaluated with special care and thoroughness in people aged 40 years and above, since it is known that the immune response can be reduced in elderly individuals. The approval study, which examined vaccinees aged between 40 and 63 years, revealed that the antibody titre was reduced in elderly vaccinees as compared to younger ones. The antibody titre is a unit of measure expressing the quantity of antibodies formed by the vaccinee. All vaccinees were protected against hepatitis A vaccination one month after the third administration of the vaccine. After the basic immunisation was completed, the vaccinees reached a level of antibody titres at which long-term protection can be assumed. Therefore, the benefit/risk balance of the immunisation was rated as positive for this age group, too. In the meantime, further studies have been conducted in elderly individuals which basically confirm these findings.

In addition to the case reported by "Bild am Sonntag", another case of a vaccine failure, i.e. an infection after prior complete immunisation has been reported to the Paul-Ehrlich-Institut. In addition, there are two published cases of hepatitis A after full vaccination in the international literature. Other vaccines were used in all these cases.

The vaccine batches described in the "Deutsche Medizinische Wochenschrift" were tested and certified by the competent Belgian authority. On the basis of these tests and certifications, the Paul-Ehrlich-Institut released the batches for the German market in compliance with the European and German regulations. The batches did not reveal any inadequacies as to quality.

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