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Sanofi's Bird-Flu Vaccine Gets Backing
posted by admin on 01/03/07
Outside Panel Advises FDA to Approve Use Of Likely Stopgap
An outside advisory committee told the Food and Drug Administration that a Sanofi-Aventis SA vaccine should win the first U.S. regulatory approval for use in an avian-influenza pandemic, despite limited evidence of its efficacy and safety.
FDA and advisory-panel members said the product is likely to be a stopgap measure as newer versions are developed. Several companies, including Sanofi-Aventis itself, are working on other vaccines expected to work better against the H5N1 bird flu that has killed more than 100 patients, mostly in Asia.
See complete coverage of efforts to contain avian flu, including an interactive graphic on the science of the virus and a look back at major flu epidemics.
Sanofi has said it doesn't plan to commercially market the first-generation vaccine reviewed yesterday. Rather, doses of the product are expected to comprise part of a national stockpile and could be provided to health workers and other first responders if they are at risk of infection.
The avian flu has so far spread only occasionally from birds to humans, and would need to mutate for any widespread outbreak to occur.
Committee members struggled with how to evaluate a vaccine that isn't aimed at broad use and may soon be made obsolete. The early Sanofi vaccine is "less than desirable" and "not a solution to the H5N1 problem," said Robert Couch, a professor at Baylor College of Medicine. "This is a Step One to move us in that direction" toward later, more advanced vaccines.
The panel voted unanimously in favor of the vaccine's safety and effectiveness for use during a pandemic or in cases of potential high-risk exposure, while saying the evidence for both was very limited. "I hope we never have to use it," said Melinda Wharton, an official at the Centers for Disease Control and Prevention. But, she added, "this is the vaccine we have now." One member abstained from the vote over safety.
In a statement, Sanofi-Aventis called the vaccine "first-generation" and said it is committed to a "robust" development program for flu-pandemic preparedness.
The H5N1 bird flu has infected at least 273 people world-wide, killing 166 since the virus re-emerged in late 2003, according to the World Health Organization. Vaccines developed to counter the current H5N1 strains might not work well against any future mutated pandemic version.
The early Sanofi vaccine was tested in a limited trial by the National Institutes of Health. The FDA said it raised no major safety concerns and produced the targeted immune response in about 45% of 91 people tested with the largest dose. Agency officials said that in guidelines drafted after the vaccine was in development, the FDA called for companies to aim at a rate closer to 70% for healthy adults between the ages of 18 and 64. But "even at lower levels, there's the possibility of protection," said Jesse Goodman, director of the FDA's biologics center.
Other companies with bird-flu vaccines in development include GlaxoSmithKline PLC, Novartis AG, CSL Ltd. of Australia and Baxter International Inc., of Deerfield, Illinois. Sanofi-Aventis itself is working on additional types of H5N1 vaccine that it believes will prove more effective. These newer shots contain an extra ingredient called an "adjuvant," which is designed to make the shots more powerful at lower doses. A Sanofi spokesman said yesterday that the company hasn't yet submitted these newer-generation shots to the FDA for review.
Glaxo is also developing an H5N1 vaccine containing an adjuvant, which it submitted to European regulators for review in January and plans to submit to the FDA later this year or early next year, a Glaxo spokeswoman said yesterday. In a Glaxo-run trial of 400 people, two doses of the vaccine produced a strong immune response against the H5N1 virus in more than 80% of people who received it, Glaxo reported last summer. Each dose contained 3.8 micrograms of antigen.
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