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Commentary

FDA Meningitis Vaccine Delay Killing Americans


     
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The University of California-Santa Barbara began vaccinations for meningitis on Feb. 24. The vaccinations are welcome, but too late for UCSB lacrosse player Aaron Loy, whose feet were amputated after he contracted meningitis in November.

The reason Loy and other UCSB students hadn’t already been vaccinated is because the federal Food and Drug Administration has delayed the vaccine’s approval. In short, the FDA’s policy is that the vaccine can’t be deployed when doctors believe it could be most valuable (before an outbreak), but will approve its use when the vaccine is least helpful, after an outbreak has run its course for months.

Loy was one of four UCSB cases of meningitis B (MenB), a highly contagious and life-threatening bacterial infection of the membranes covering the brain and spinal cord. MenB strikes without warning and can cripple and kill victims in just 24 hours. About one in 10 people who contract the disease will die; one in five survivors will have permanent disabilities.

A year ago this month, a student at Princeton University was similarly diagnosed with MenB. After four confirmed cases, officials declared an official outbreak, which soon grew to eight cases, that might have been avoided if students had been immunized.

Unfortunately, MenB is the one form of meningitis for which there is no approved vaccine in the U.S., even though MenB was the cause of about one-third of the 500 meningitis cases reported in 2012.

Yet, a vaccine is available. The European Union, Australia and Canada all have approved use of a MenB vaccine. Likewise, U.S. Centers for Disease Control and Prevention officials stated during the Princeton outbreak that lab tests “confirm that the vaccine will help protect against the exact strain of ... bacteria that is causing the outbreak.”

The FDA provided no detailed, scientific reason for why it is delaying final testing to approve the vaccine, but critics, such as former FDA scientist Henry Miller, see the agency as “fanatically risk-averse.”

The FDA did finally approve the vaccine on the UCSB campus, but the lag from the first illness in November to the first vaccination on Feb. 24 remains troubling. Such an after-the-fact vaccination strategy should concern every parent across America.

The nation needs a comprehensive plan to address future meningitis B outbreaks, which are not limited to university campuses. As part of that plan, the FDA should immediately approve the widely used MenB vaccine for general use in the United States while final testing is allowed to go forward.

If the FDA continues to resist, Congress should intervene, empowering Americans to access the vaccine before outbreaks, when it might be useful in protecting lives, rather than months later when an overcautious health bureaucracy finally says it is OK.


K. Lloyd Billingsley is Policy Fellow and Communications Counsel at the Independent Institute.






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