Pennsylvania company donates 85M smallpox vaccine doses

WASHINGTON - A pharmaceutical company agreed Friday to donate about 85 million doses of smallpox vaccine to the government. <br> <br> The exact number won&#39;t be known until studies conducted by the National Institutes of Health confirm how many of the doses, frozen for 30 years, still are effective. <br> <br> ``But all indications are that it would be as effective as the supply we already have,&#39;&#39; said Health and Human Service Secretary Tommy Thompson. ``This is just a huge insurance policy.&#39;&#39; <br> <br> 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 as many inoculations. <br> <br> 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&#39;re safe and effective. <br> <br> ``We hope that a dose will never be needed,&#39;&#39; 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&#39;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.&#39;&#39; <br> <br> 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 no one 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&#39;t acknowledge the potential extra source until this week. <br> <br> ``We didn&#39;t know if it was going to work,&#39;&#39; Thompson explained. ``There was no sense heightening expectations of the American people&#39;&#39; until officials knew if the vaccine was good. <br> <br> Clinical trials at the NIH will begin soon to prove the vaccine&#39;s value. But laboratory testing already conducted suggests Aventis&#39; vaccine is just as potent as vaccine the government had already stockpiled, said Dr. D. A. Henderson, HHS bioterrorism chief. <br> <br> Although there now is more vaccine than previously thought, the government still doesn&#39;t want mass inoculations, cautioned Dr. Anthony Fauci, the NIH chief of infectious diseases. The vaccine can cause some severe, even fatal, side effects. Scientists say if everyone were vaccinated, 180 to 400 people would die. <br> <br> ``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,&#39;&#39; Fauci said. <br> <br> 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&#39; hands and be used as a weapon. Health officials believe the risk is low. <br> <br> 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. <br> <br> 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. <br> <br> No one became severely ill. But one person had blisterlike 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. <br> <br> 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.