President Donald Trump called on the Food and Drug Administration to “move quickly” on coronavirus vaccines, following Johnson & Johnson’s announcement its candidate has reached a final-stage trial.
Johnson & Johnson announced it has begun dosing up to 60,000 volunteers in a study of its Covid-19 vaccine, the first major U.S. trial of a shot that may work after just one dose. The vaccine candidate joins three others in late-stage trials in the U.S., amid the administration’s Operation Warp Speed push to develop and distribute an inoculation by year’s end.
If the company can enroll enough participants, the trial could yield results as soon as the end of 2020, which could allow the company to seek emergency authorization early next year if the vaccine proves effective, Johnson & Johnson Chief Scientific Officer Paul Stoffels said Tuesday.
But Trump’s repeated promises that a coronavirus vaccine could be ready within weeks, a timetable far more ambitious than that of any drug maker or public-health official, have raised concerns the government could cut corners and authorize a shot to deliver the president a political victory ahead of the November election.
Trump and the FDA have said that electoral politics will not determine whether a vaccine received authorization or approval.
The FDA is poised to release tougher standards for issuing emergency use authorizations that could make it very difficult for the agency to sign off on a vaccine before Election Day on Nov. 3, The Washington Post reported Wednesday. Drug makers seeking the authorization would need to follow participants in a late-stage trial for an an average of two months, the paper reported. The proposed guidance is reportedly being reviewed by the White House but parts have been shared with vaccine manufacturers.
A group of nine pharmaceutical and biotechnology companies publicly pledged last week they would only seek approval for Covid-19 vaccines shown to be safe and effective, an effort to assuage fears that the process of developing the inoculation might be influenced by the political calendar.
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