At issue was the FDA's planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues.
and called for the release of the pending vaccine guidelines. The former FDA chiefs warned that public fears that a vaccine was rushed out for political reasons could derail efforts to vaccinate millions of Americans.
Only one drugmaker, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before Election Day. And a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer's competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.Trump says COVID-19 vaccines are coming soon. Scientists say they're not.
Instead, Marks said, releasing the guidelines was “an attempt to help the public see what we're requiring of COVID-19 vaccines.” He added that the guidelines would explain that all upcoming vaccines would be reviewed by FDA's independent panel of outside vaccine advisers, before the agency makes its own final decision.
When asked about the potential timing for a first vaccine, Marks said an emergency authorization could come “before the end of the year.” The lack of specifics around using the emergency authorization for a vaccine became a flashpoint for outside experts, physicians and even politicians. FDA officials then began drafting a second guidance document with additional details.
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