PANEL VOTES IN FAVOR OF SANOFI PASTEUR'S BIRD-FLU VACCINE

An FDA advisory panel has voted 14-0 to recommend approval for sanofi pasteur's H5N1 bird flu vaccine, deeming the vaccine effective.

The Vaccines and Related Biological Products Advisory Committee agreed Feb. 27 that the data are sufficient to support the vaccine's effectiveness during a pandemic or during situations of potential high-risk exposure, Karen Riley, an FDA spokeswoman, said.

The committee then considered whether the data were sufficient to support the safety of the product, with 13 voting affirmatively and one abstention, Riley added.

The committee was asked to comment on the option of more studies to collect additional information on the safety and effectiveness of the vaccine. Riley said it approved of the idea and of the possibility that the Department of Defense would collect some of that information. "They recognized that it might be difficult to collect it during a pandemic," she said.

Sanofi pasteur recently won a $117.9 million contract from HHS to make 3.7 million doses of its prepandemic vaccine. The company said in November 2006 that it had already begun production of the H5N1 antigen vaccines, which work against a virus class called clade 2, an Indonesian strain of bird flu.