U.S. Says Anthrax Vaccine Maker Made False Claims
Global Security Newswire
The U.S. Food and Drug Administration in a letter released yesterday accused the manufacturer of the next-generation anthrax vaccine of making exaggerated claims about the purity and efficacy of the drug, the Washington Post reported (see GSN, March 17).
VaxGen Inc. of California made "false or misleading statements" about the countermeasure by using biased interpretations of studies on the vaccine, the agency said.
The letter cited a promotional document distributed in October in Washington that claimed VaxGen's manufacturing practices created a vaccine "at nearly 100 percent purity" that offered immunity similar to an earlier drug. The agency said that early research does not back these claims.
VaxGen spokesman Paul Leland said the company was reviewing the letter.
"We'll review it internally, and we're going to respond, and if needed we'll put a plan together," he said. "If there is something that's incorrect, then we will take corrective action" (Justin Gillis, Washington Post, April 5).
The U.S. Food and Drug Administration in a letter released yesterday accused the manufacturer of the next-generation anthrax vaccine of making exaggerated claims about the purity and efficacy of the drug, the Washington Post reported (see GSN, March 17).
VaxGen Inc. of California made "false or misleading statements" about the countermeasure by using biased interpretations of studies on the vaccine, the agency said.
The letter cited a promotional document distributed in October in Washington that claimed VaxGen's manufacturing practices created a vaccine "at nearly 100 percent purity" that offered immunity similar to an earlier drug. The agency said that early research does not back these claims.
VaxGen spokesman Paul Leland said the company was reviewing the letter.
"We'll review it internally, and we're going to respond, and if needed we'll put a plan together," he said. "If there is something that's incorrect, then we will take corrective action" (Justin Gillis, Washington Post, April 5).
