Pediatric Vaccine Stockpile at Risk
With just 13.2 million vaccine doses, the U.S. government's Pediatric Vaccine Stockpile is currently more than two-thirds below its target of 41 million doses and is in danger of dwindling even further as vaccine makers and federal regulators fail to reach an agreement on accounting rules governing sales of stockpiled vaccine doses. When the U.S. Centers for Disease Control and Prevention (CDC) last summer asked four vaccine manufacturers to sell fresh doses to the stockpile, only Merck agreed. The other three companies-- Sanofi Pasteur, Wyeth, and GlaxoSmithKline-- cited a variety of reasons for refusing to sell new doses, with the primary reason being U.S. accounting rules that prohibit them from "recognizing" income from the sales as revenue until the shots are delivered. Under the "buy-and-hold" stockpile contracts, the shots are sold and promised to the government for use in the case of a shortage or public health emergency, but the companies are not paid to store and rotate the vaccine stocks until they are needed. Because millions of vaccine doses are sold through the contracts, manufacturers are unhappy that the proceeds of the sales cannot be recognized as revenue. Vaccine companies have engaged in informal discussions on the issue with officials from the CDC, Department of Health and Human Services, Securities and Exchange Commission, and congressional staffers, but lawmakers and health officials are expressing concern over the lack of a speedy resolution to the problem. "I don't care how they solve it-- they should just solve it," says Rep. Henry A. Waxman, ranking Democrat on the House Committee on Government Reform, who says he would sponsor legislation to change accounting rules for vaccine stockpile contracts if necessary.
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