>>Aventis donates millions of smallpox vaccine doses to government
LAURAN NEERGAARD, AP Medical Writer
Friday, March 29, 2002 Breaking News Sections
(03-29) 07:16 PST WASHINGTON (AP) --
A pharmaceutical company agreed Friday to donate between 75 million and 90 million doses of smallpox vaccine to the government.
The exact number won't be known until studies conducted by the National Institutes of Health confirm how many of the doses, kept frozen for 30 years, still are effective.
The announcement by Pennsylvania-based Aventis Pasteur comes a day after newly published research confirmed that 15.4 million doses of vaccine already in a federal stockpile could be stretched to make up to 10 times more inoculations.
The two events mean the nation has much more vaccine on hand in case of a bioterrorist attack than previously realized. An additional 200 million brand-new doses of vaccine ordered from a British manufacturer are expected to be produced later this year, but they, too, will have to undergo testing to prove they're safe and they work.
"We hope that a dose will never be needed," said Richard J. Markham, chief executive of Aventis Pharma, the French parent company of Aventis Pasteur, which estimated the commercial value of the vaccine at more than $150 million. But "it's very important to us as citizens, not just in our role as a vaccine producer, to be able to make a contribution during this time of uncertainty."
Aventis had the stocks left over since the nation quit routine smallpox vaccinations in 1972. The company said federal officials knew about the leftovers for years but had no one had moved to add the doses to a federal stockpile. Aventis said it formally offered to turn over the vaccine after the Sept. 11 terrorist attacks -- but despite widespread anxiety about whether the nation had access to enough vaccine, the Department of Health and Human Services didn't acknowledge the potential extra source until this week.
Although there now is more vaccine than previously thought, the government still doesn't want mass inoculations, cautioned Dr. Anthony Fauci, the NIH's infectious disease chief. The vaccine can cause some severe, even fatal, side effects. Scientists believe if everyone were vaccinated, anywhere from 180 to 400 people would die.
"If we could vaccinate people with virtually no incidence of any serious toxicity ... we tomorrow could eliminate the threat of a smallpox bioterrorist attack. Unfortunately, that is not the case," Fauci said.
Smallpox was declared eradicated worldwide in 1980. But the U.S. and Russian governments hold stocks of the deadly virus, and bioterrorism experts worry that samples could fall into terrorists' hands and be used as a weapon, although health officials believe the risk is low.
Still, the government is buying up vaccine as a precaution. If an attack occurred, doctors would quickly vaccinate people in the vicinity, because inoculations up to four days after exposure still offer protection.
Already stockpiled are 15.4 million doses left over from the 1970s. That vaccine could be diluted, turning each dose into five to 10 additional doses, and still protect, say two studies released Thursday by The New England Journal of Medicine. The studies of more than 700 previously unvaccinated young adults found about 97 percent responded to diluted or undiluted inoculations, although some required two doses.
No one became severely ill. But one person had blister-like lesions erupt over a swath of his body. More than a third had pain bad enough to miss school, work or other activities. Fever, headache, nausea, muscle aches, lesions and swelling were fairly common.
One catch: A few people never responded, and blood tests suggest they had been vaccinated decades earlier and forgotten. Thus, more study is needed to tell if diluted vaccine can boost the presumed waning immunity of millions vaccinated 30 years ago. <<
sfgate.com |
