Defense Department officials announced Monday they are restarting a modified anthrax vaccine immunization program now that the vaccine provider has passed Food and Drug Administration scrutiny.
Only service members, essential civilians and contractor personnel going to or serving in high-threat areas will receive the vaccine, said Dr. Bill Winkenwerder, assistant defense secretary for health affairs. This is because half the contractor's vaccine production will be stockpiled for civilian use.
"We recognize there is a domestic need for access to the vaccine," Winkenwerder said during a news conference at the Pentagon. "In collaboration with the Department of Health and Human Services and the Office of Homeland Security, we are reserving a portion of the anthrax vaccine for stockpiling ... to use in the event of a domestic emergency."
In 1998, Defense began a plan to vaccinate all military members against the deadly, potential biological weapon. The program was pared down several times in the intervening years as the sole provider of the vaccine shut down its factory for renovations and then had problems gaining FDA approval of its production process.
Vaccine shortages eventually caused Defense to vaccinate only limited numbers of service members serving in "designated special mission units."
The contractor, Bioport of Lansing, Mich., gained FDA approval of its renovated facility in January and is now ready to begin providing additional stocks of the vaccine to Defense.
Winkenwerder said the new policy is "more targeted" than the previous plan to vaccinate the total force. He said the numbers of service members and essential civilians vaccinated will jump, but he would not say how high. Nor would he say what areas of the world are considered "higher threat."
"We will identify those areas to the service members before they are deployed to those areas, but we don't intend to talk publicly about that as we describe the policy to the rest of the country, to the media," Winkenwerder said during an earlier interview with American Forces Press Service. "And the reason is, we don't intend to give our adversaries an indication of exactly who and when and where we've immunized people. We would like that to be a further deterrent to anybody who might think about using anthrax as a weapon."
The doctor said Defense medical officials hope to start vaccinating targeted service members 45 days before they deploy. The anthrax vaccine requires six shots over an 18-month period for maximum immunity, but a relatively high level of immunity is reached after the first three shots, he explained.
Winkenwerder and Vice Adm. Gordon Holder, director of logistics on the Joint Staff, said the vaccination program may return to total-force coverage if vaccine availability improves and if the biological threat changes.
Individuals who started the six-shot series under the previous guidelines will resume the series where they left off.
Others who started the shots previously but are not currently covered under the new program will receive the rest of their shots "later into 2002, possibly as late as 2003, and that's because the supply of the vaccine is limited," Winkenwerder said.
He insisted there is no danger in stopping and restarting the series of shots. "Protection lasts months to years at some level," he said.
Under the previous program, 525,000 service members have received a total of 2.1 million doses of the vaccine. Contrary to widespread media reports of service members refusing to be vaccinated, even at the cost of their careers, Winkenwerder said the true number is relatively small compared to the number of doses administered. Defense has no formal method of counting refusals, but service chiefs report 441 service members have refused to be vaccinated. He said there have been no deaths linked to the vaccine.
In the earlier interview, Winkenwerder dismissed widespread claims that the vaccine isn't safe or effective. He cited a study released March 6 by the Institute of Medicine that found the vaccine to be "effective protection against anthrax, including inhalation anthrax."
"The Institute of Medicine of the National Academy of Sciences-a very august, prominent body-has said in a very large, in a very important, comprehensive report that the vaccine is safe and effective," Winkenwerder said earlier. Several other studies by reputable independent agencies have released similar conclusions.
Even though it is scaled back, the vaccination program will remain mandatory for troops in areas covered by the policy. Winkenwerder said this is no different from any number of other vaccines and "medical interventions" that are mandatory for military people based on where they are serving.
Defense is working with HHS to develop a new anthrax vaccine that would require fewer shots and be made using a different, easier method, said William F. Raub, deputy director of public health preparedness at HHS. The two departments are also examining the current vaccine to see if its protocol can be changed.
"We fight and win as teams," he said. "If a team of people are in an environment deployed in a military situation, I think the commander as well as all the individuals want to know are we all protected."
The anthrax attacks on the U.S. East Coast last fall may have silenced some critics. "I think the attacks last fall brought home the point that this is a real threat and that it's possible to manufacture this kind of bioweapon, and it's not altogether difficult to disseminate it," Winkenwerder said. "This is something that's not just in people's imagination. It is real."
American Forces Press Service reporter Jim Garamone contributed to this report.