Court Nixes Challenge |to Anthrax Vaccination

     (CN) – The D.C. Circuit refused to reinstate the claims of eight U.S. military service members who challenged a mandatory anthrax vaccination, despite its classification as safe and effective.




     The three-judge panel in Washington, D.C., said the service members “fail[ed] to proffer any scientific evidence” to counter the Food and Drug Administration’s effectiveness findings.
     In 1972, the FDA assumed responsibility for licensing biological products, including those previously regulated by the National Institutes of Health. The next year, it reviewed the effectiveness and safety of several vaccines approved by the NIH, including the anthrax vaccine.
     The FDA found it safe and effective, citing a field trial performed by Dr. Philip Brachman, who tested an anthrax vaccine developed by the Department of Defense on textile workers in the 1950s.
     Inoculation proved 92.5 percent effective for preventing infection through skin contact, but Brachman noted that there were too few inhalation cases to claim the vaccine worked against that type of exposure.
     The Defense Department nonetheless required troops to get inoculated.
     Other service members challenged the vaccine, resulting in a 2005 FDA order classifying the anthrax vaccine as safe and effective for preventing bacterial infection, regardless of how workers are exposed to anthrax.
     Eight service members challenged this order, saying the Brachman study doesn’t back up the FDA’s effectiveness finding. They did not challenge its safety.
     The FDA argued that the route of exposure – skin contact, inhalation, ingestion – is not relevant to the vaccine’s effectiveness.
     The appeals court deferred to the agency’s judgment, saying the plaintiffs even conceded that there’s no scientific evidence to contradict this finding.
     Similarly, the court rejected the service members’ claim that the agency improperly relied on the Brachman study, because the study involved an earlier generation of the vaccine.
     “Once again, we are presented with a scientific judgment by the FDA to which we owe considerable deference,” Judge Garland wrote. “And once again, the plaintiffs fail to proffer any scientific evidence to rebut it.”
     The panel affirmed dismissal of the challenge, including a claim that the Defense Department subjected military personnel to mandatory immunization on an unapproved schedule of inoculations.

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