FDA says a coronavirus vaccine would have to be at least 50% effective to be approved
A coronavirus vaccine would need to be at least 50% more effective than a placebo in preventing or at least decreasing the severity of COVID-19 in order for the Food and Drug Administration to approve it, the agency said Tuesday.
That threshold "would have been what I would have chosen since that is around what flu vaccines do that save lives," said Barry Bloom, an immunologist and professor of public health at the Harvard T.H. Chan School of Public Health in Boston. "Greater would, of course, be ideal."
Some have expressed concern the FDA might face pressure from the White House to approve a COVID-19 vaccine as quickly as possible, under an Emergency Use Authorization rather than the agency's typical process.
FDA guidance issued Tuesday indicates that at least the first vaccine to be approved must go through the full FDA licensure process, including Phase 3 clinical trials to show it protects people against disease or infection.
Phase 3 trials would need to show people have developed protection against the virus, not just that their blood indicates they may be protected, several vaccine experts said.
Bloom's interpretation is that the FDA will be more stringent in approving an initial vaccine.
"They will insist on disease/infection protection in initial trials and not make a guess about a biomarker for protection until the correlation with disease protection is established," he said. "That seems to suggest no shortcut in the front-running trials."
Subsequent vaccines likely would rely on the presence of biomarkers, Bloom said ...
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