Expedited H1N1 Vaccine Approvals – Safety Questions Will Arise

Given the concern that the autumn version of swine flu will be more deadly the rush for a vaccine is understandable but a 1976 vaccination programme killed or harmed more than it saved. Many may be saved but some will be harmed.

Normally, clinical trials are completed before the FDA would even accept an application for a drug or vaccine. But given the perceived urgency of the H1N1 situation, the agency might approve a vaccine based on incomplete or very small studies, according to a briefing document from the FDA’s Center for Biologics Evaluation and Research Office of Vaccines Research and Review. In fact, the document suggested, the agency might even waive its customary demands for compelling safety and immunogenicity data. The government expects Novartis, Sanofi Pasteur, CSL, and GlaxoSmithKline to supply inactivated H1N1 vaccines to the U.S. market, while MedImmune will produce a live attenuated H1N1 vaccine, according to the document.

The FDA said it would like the sponsors of the study to perform double-blind or observer-blinded studies in which patients are administered two doses of the vaccine, 21 days apart. Manufacturers should stratify their patients into four age groups: infants and toddlers, ages 3 to 9, 18- to 64-year-olds, and older than 65.

via Pandemic Information News: FDA Lays Framework for Expedited H1N1 Vaccine Approvals.

The UK situation is much the same reports the Independent

The Government has placed advance orders for up to 132 million doses of vaccine with two manufacturers, GlaxoSmithKline and Baxter. The manufacturers have tested and licensed in advance three “core” vaccines in preparation for a pandemic. These are vehicles into which the H1N1 pandemic strain of the virus is inserted.

A spokesman for the EMEA said the first samples of the fully functional pandemic vaccine were expected by the end of July and a decision on whether to approve them would be taken within five days. Trials involving 200 to 400 patients would be conducted, but the vaccine would be made available for use by the NHS before the results came in.