WASHINGTON -- Failure of a new anthrax vaccine production plant to pass FDA inspection has led DoD to postpone the second phase of vaccinations for at least six months.
Defense officials announced Dec. 13 the Pentagon will delay inoculating troops other than those deployed to Korea and the Persian Gulf until new batches of the vaccine are proven safe and effective. Dr. Sue Bailey, assistant secretary of defense for Health Affairs, said there are enough FDA-certified dosages to continue vaccinating troops headed to those high-threat areas.
Since the first phase of inoculations began last year, 383,000 soldiers, sailors, airmen and Marines have received anthrax shots. The second phase will cover first responders to military contingencies or those ready to deploy, Bailey said. The third and final phase will inoculate the remainder of the force.
But if the United States had to conduct a military buildup now, such as it did for Desert Storm, it couldn't fully protect those troops against anthrax, a senior officer said.
"We're not there, yet," said Marine Corps Maj. Gen. Randall West, a special adviser on anthrax and biological weapons to Rudy de Leon, undersecretary of defense for Personnel and Readiness. "We could not today do a full buildup to Desert Storm and have every serviceman and -woman that was sent there vaccinated."
Bailey said DoD has other ways to protect troops against anthrax attacks, including chemical/biological protection suits, gas masks and antibiotics. "We are able to provide, as we did during the Gulf [War], some significant protection against anthrax," she said. She said DoD also could decide to give every soldier a portion of the six prescribed inoculations, so they would have some protection.
In addition, Bioport -- the company that produces the vaccine -- has stockpiled more than 1 million doses that would have to be recertified before they are used, according to David Oliver, principal deputy undersecretary of defense for Acquisition and Technology.
Bailey said DoD has no plans to halt anthrax inoculations all together. "The program is safe, effective and necessary," she said, "and we will continue to meet the highest possible standards."
Defense Secretary William S. Cohen delayed the second phase of inoculations until the new production facility built by Bioport, the Michigan-based manufacturer, achieves FDA certification. Bioport built the new production facility after demolishing the smaller state-regulated facility on the same site. The larger facility is necessary to meet DoD production requirements of some 400,000 dosages a month. The old plant produced just 2,000 doses a month.
Defense officials thought the process -- from demolishing the old plant, building the new one and getting FDA certification -- would take less time than it has.
"Frankly, it has been more difficult than the department and Bioport expected to move from a small, state-regulated production facility to a large, modern production facility that meets state-of-the-art FDA requirements," Bailey said.
The Pentagon has left the date open as to when the second phase of inoculations will begin. In the meantime, the Army, as executive agent for the anthrax program, has assigned a general officer to provide full-time oversight and review of Bioport processes to help facilitate FDA certification.
Related Site of Interest: DoD News Briefing on the Anthrax Vaccination and Immunization Program, Dec. 13, 1999