- Vaccine experts are worried that President Trump will exert political pressure to put a Covid-19 vaccine on the market before it's ready, and they want assurances from the US Food and Drug Administration that it won't authorize a vaccine unless it has first been studied on at least 30,000 people in clinical studies.
Art Caplan, a bioethicist who has been a consultant to the federal government and the World Health Organization on vaccine development, said he'd like to see the FDA make a similar statement to encourage trust in the vaccine. Michael Felberbaum, a spokesman for the FDA said the agency is not allowed to say how many study subjects will be involved, but that the FDA"will only approve a vaccine to prevent COVID-19 following a thorough review of the data" and"only after the agency makes a determination that there is evidence of the vaccine's effectiveness and that its benefits outweigh its risks."
The University of Oxford has started a Phase 3 trial on its vaccine candidate. Together with its partner, AstraZeneca, they expect to vaccinate 42,000 people.Some vaccine experts worry that even if a company intends to enroll those numbers, the Trump administration will prematurely approve their vaccines before their trials are over.
"Given how this president has behaved, this incredibly dangerous scenario is not far-fetched," he said.
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