Many experts believe the U.S. Defense Department could have avoided the current shortage of vaccines to protect soldiers and possibly civilians against biological weapons, the Washington Post reported today.  Pentagon planners ignored warnings that vaccine supplies were inadequate, allowed the vaccine program to lose funding and made several other mistakes, experts said (see GSN, April 9).

“There seemed to be no mechanism so that a good vaccine idea could be manufactured and clinically tested with all the assurances we associate with that,” said Franklin Top, executive vice president of Medimmune Inc. and chair of a Pentagon-funded panel that produced a disapproving report of the military’s vaccine program.

“You needed to set up some sort of management structure,” Top said.  “It was incoherent.”

“The decisions for management for this were badly run and could have been much better,” said Donald Burke, director for the Center for Immunization Research at Johns Hopkins University.

The United States has an old smallpox vaccine (see GSN, April 3) and an anthrax vaccine most experts say should be replaced (see GSN, April 2).  There are basically no other vaccines ready to use to protect people against potential biological warfare agents, according to the Washington Post.

FDA Regulations

Attempts to develop other vaccines have often failed due to Food and Drug Administration regulations requiring proof that a drug is safe and useful in human tests.  Producing such evidence is difficult because scientists are not legally or ethically allowed to inject people with experimental vaccines and then subject them to deadly diseases.

The Pentagon previously had used a legal provision that allowed doctors to administer experimental vaccines if a patient gives written informed consent and medical authorities maintain records.  With that provision in mind, the Pentagon hired a company to produce investigational drugs.

“The attitude was, ‘We’ll never use these vaccines, and if we have to use them, the risk would be so high, the benefit would far outweigh the risk,’” said Army Col. David Danley, project manager of the Pentagon’s Joint Vaccine Acquisition Program.

Gulf War veterans, however, began complaining of illnesses after that war, raising concerns that experimental vaccines caused the symptoms (see GSN, Jan. 25).  Investigators said the Pentagon did not obtain informed consent from all the soldiers and did not keep accurate records.

By 1992, the Pentagon had basically abandoned experimental drugs and instituted a new policy of seeking FDA approval for all vaccines.  The human trial requirement, however, still made developing vaccines and gaining approval difficult to impossible.

Time-consuming FDA regulations kept a new anthrax vaccine from gaining approval, the Post reported.  With all the focus on the new drug’s potential, however, the Pentagon did not pursue studies to examine whether the old vaccine, which requires six shots, could be effective using fewer shots, which scientists said they thought was possible.

Poor Facilities

Many facilities that produced vaccines also failed to meet FDA standards.  Only in January did the FDA allow BioPort Corp., the sole U.S. producer of anthrax vaccine, to reopen after being shuttered for four years (see GSN, April 8).

In 1995, the FDA said Greer Labs Inc. had to retest its plague vaccine, but the Defense Department refused to help with funding, and Greer closed its facility.  “They lost plague … because of really short-sighted decisions,” said James Kenimer, a vaccine specialist (see GSN, April 3).

After the Gulf War, the Pentagon presented a plan to build its own $400 million vaccine factory that would require five to seven years to build.  Lawmakers and military officials killed the plan in 1993, saying it was “not cost-effective,” said Anna Johnson-Winegar, deputy assistant to the defense secretary and Pentagon vaccine factory advocate.

In 1997, the Pentagon hired the company DynPort to work for approval of up to 17 vaccines, but DynPort had only seven vaccines in research four years later.  A smallpox drug predicted to be ready in 2005 is the closest to being licensed.

Top’s committee report said the DynPort project is “insufficient.”

Changes Since Sept. 11

The Sept. 11 attacks and following anthrax mailings have created a new sense of urgency.  Anthrax vaccine research has more attention, and scientists are now testing the current vaccine to try to reduce the number of necessary shots.

Scientists have resumed studying tularemia and botulism vaccines and are preparing them for licensing in 2009 and 2012.

Also, the FDA is now preparing a new regulation that might allow researchers to use animal test data in place of human trials (Guy Gugliotta, Washington Post, April 12).

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