« Home | EU to Fund Biological Weapons Treaty Efforts » | FDA Warns Maker of Anthrax Vaccine » | VaxGen ordered to stop exaggerating anthrax vaccin... » | Vaccine Crisis Developing » | U.S. to Test Kits with Bioterrorism Countermeasures » | DOD starts new vaccine development » | New vaccine preservative proves harmful » | Pentagon Anthrax Scare Leads to Response Changes » | Bush Looked for Non-WMD Reasons for War, Memo Says » | Bioterror Threat Real, Interpol Chief Says »

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).

Archives