Influenza-Lebendimpfstoffe – eine Nutzen-Risiko-Bewertung

Zusammenfassung

Zur Klärung der Nutzen-Risikobeziehung von Influenza-Lebendimpfstoffen hat das Paul-Ehrlich-Institut im Dezember 1998 einen Workshop „Fact Finding and Assessment Workshop for Cold Reassortant Influenza Vaccine” mit 23 Experten aus sechs Nationen organisiert. Dies ermöglichte die Erörterung des Themas aus verschiedenen Blickwinkeln, ausgehend von grundlegenden virologischen, molekularbiologischen, epidemiologischen und klinischen Aspekten bis hin zu regulatorischen, politischen und praktischen Betrachtungsweisen. Die Bedeutung dieses Workshops lag insbesondere in der Tatsache, daß das amerikanische Biotechnologieunternehmen AVIRON einen trivalenten Influenza-Lebendimpfstoff in den USA bereits zur Zulassung eingereicht hat.

Summary

A workshop on attenuated cold-adapted influenza virus vaccines (CAIV) was organized in Langen, Germany on December 16–17, 1998 by Prof. Reinhard Kurth, President of the Paul Ehrlich Institute.

23 experts from 6 nations attended the meeting. With their knowledge and expertise in viral influenza, basic virology, molecular biology, epidemiology, clinical investigations, world health, industry, engagement in regulatory control and licensure and distribution of biological products it was possible to discuss the subject from different points of view.

The main purpose was to review the information currently available about the Maassab temperature-sensitive cold mutant influenza virus vaccine (CAIV). Special reference was given to safety and efficacy of reassortant vaccines in human subjects and to feasibility for use in controlling viral influenza in man. When appropriate, comparisons were made with inactivated influenza vaccines that have been used successfully since the early 1940’s. The attendees were not asked to give judgement as to acceptability of CAIV for general use and were not expected to provide a consensus agreement on the various facets that were discussed. Instead, the workshop provided commentary on what is known and what should be known before CAIV vaccine may be considered by national and international regulatory authorities if and when asked to give judgement and decision for licensure and routine application at some future time.

The workshop itself might have been of special significance since there has been announced intent by a commercial U.S. company (AVIRON) to develop and seek licensure of a CAIV product. Selected literature references have been listed at the end of this report.