Tuesday, February 27, 2007

Sanofi Vaccine Gets Nod From Advisory Group

 

# 514

 

 

While it didn't come with a hearty endorsement, the FDA advisory panel today recommended the approval of the Sanofi Vaccine as both `safe and effective', despite concerns about the `effective' part of the equation.

 

 

 

Advisers Urge OK of Bird Flu Vaccine

By ANDREW BRIDGES
Associated Press Writer

WASHINGTON (AP) -- Federal health advisers recommended Tuesday that the government approve the first bird flu vaccine as a stopgap measure, despite evidence it wouldn't protect most people.

 

In separate votes, the outside panel said the vaccine was both safe and effective. A vaccine must meet both standards to win FDA approval. The votes came after Food and Drug Administration officials said the Sanofi Aventis SA vaccine still could play an important role in protecting against the increased likelihood of a pandemic, despite its limited effectiveness.

 

"I am of the view that anything is better than nothing," said panel member Dr. Robert Couch, of Baylor College of Medicine in Houston, prior to the vote.

 

The FDA isn't required to follow the advice of its advisory committees, but usually does. The vaccine is the first against the H5N1 influenza strain to seek government approval.

 

Anything is better than nothing.   

 

Sadly, that pretty much sums up the options we have right now.