Aventis to give millions of smallpox vaccine doses to US government

Mar 29, 2002 (CIDRAP News) Aventis Pasteur announced today that it will give its decades-old supply of smallpox vaccine, estimated at 75 million to 90 million doses, to the federal government for its stockpile to protect the nation against bioterrorism.

The Aventis vaccine inventory had not been publicly disclosed until it was reported yesterday in a Washington Post article. But the Swiftwater, Pa., company said it has been working with the government since last October on preparations to add the vaccine to the federal stockpile.

The Aventis announcement came less than a day after publication of a study indicating that the existing US vaccine stockpile of 15.4 million doses can be diluted at least five-fold without losing its efficacy. Such a move would increase the stockpile to 77 million doses. The report was published online yesterday by the New England Journal of Medicine (see related story).

Tommy G. Thompson, secretary of health and human services (HHS), announced today that HHS plans to obtain the Aventis vaccine provided it proves to be safe and effective. Initial results of studies on the vaccine are very encouraging, but more studies are needed, according to an HHS news release.

The Aventis announcement said the exact number of doses in its inventory will be determined by clinical studies. The company estimated the commercial value of the supply at $150 million.

"We are offering both short-term and what we hope will be long-term relief from concerns about vulnerability to smallpox as an agent of bioterrorism," said Richard J. Markham, chief executive officer of Aventis Pharma. "It's very important to usas citizens, not just in our role as a vaccine producerto be able to make a contribution during this time of uncertainty. We hope that a dose will never be needed, but we are gratified that we will be able to contribute to the immediate need for building the stockpile."

Aventis Pasteur, an arm of French-based Aventis, said its vaccine inventory has been in storage since routine smallpox vaccination ended in 1972. The vaccine is stored at an unspecified off-site location, the company said.

The company stated that it "has worked closely with numerous U.S. government agencies since October 2001 to prepare the vaccine for addition to the existing emergency stockpile. However, government agencies had been aware of the existence of the vaccine for many years prior to that date." According to a report in today's New York Times, the reason HHS kept the supply a secret until this week is that, in Thompson's words, "We didn't know if it was going to work."

Thompson said that if preliminary studies show that the Aventis vaccine is acceptable, the Food and Drug Administration will classify it as an investigational new drug available for emergency use.

HHS has contracted with another company, Acambis Inc, to supply 209 million doses of smallpox vaccine by the end of this year.