A top U.S. health regulator who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective, Reuters has learned.
Peter Marks, director of the Food and Drug Administration's Center for Biologics Evaluation and Research, made the statement in response to concerns raised on a conference call late last week of government officials, pharmaceutical executives and academics who serve on a vaccine working group organized by the National Institutes of Health, according to three sources familiar with the matter.
Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services, which oversees FDA and NIH, said the government aims to identify a safe and effective vaccine by January 2021. Marks said the trials were enrolling volunteers "reasonably well" and that it was "possible" data could be available to interpret as early as October. If not, the committee could still discuss broader regulatory issues regarding a vaccine, he said.
Marks, a hematologist, has worked at FDA since 2012 and oversees a division responsible for regulating cutting-edge biotech treatments, vaccines and gene therapies. Hahn, Marks and another FDA official penned an article in the Journal of the American Medical Association this month acknowledging public anxiety about lowering regulatory standards to approve a coronavirus vaccine.
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