The FDA has vowed not to let political pressure to approve a COVID-19 vaccine as soon as possible interfere with the regulatory process, Anthony Fauci told Reuters. Fauci’s comments come ahead of an election season in which the availability of a vaccine could influence the vote.
While some companies have expressed hopes that they will win approval for COVID-19 vaccines by the end of the year, the consensus is that the FDA is unlikely to authorize a product before the U.S. goes to the polls in early November. The likelihood that a vaccine will nearly, but not quite, be ready for market in the run up to the election has raised concerns that political pressure may lead the FDA to authorize a product prematurely.
However, Fauci, the director of the National Institute of Allergy and Infectious Diseases, is confident the FDA will decide whether to approve a vaccine or not on the strength of the evidence alone.
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“They promise that they are not going to let political considerations interfere with a regulatory decision,” Fauci said. “We’ve spoken explicitly about that, because the subject obviously comes up, and the people in charge of the regulatory process assure us that safety and efficacy is going to be the prime consideration.”
Fauci went on to say he is “certain of what the White House would like to see” but is yet to see “any indication of pressure at this point to do anything different than what we’re doing.”
Approving a vaccine before sufficient data are available to evaluate its safety and efficacy could cause harm. Notably, as the most closely watched prophylactics ever, postapproval safety problems with the COVID-19 products could significantly exacerbate existing vaccine hesitancy.
President Donald Trump said this week that the approval of a COVID-19 vaccine in time for the election “wouldn’t hurt” his prospects but denied that was his motivation. “I want to save a lot of lives,” Trump said. Trump is optimistic the U.S. will have a vaccine against the coronavirus before the election, putting his stance at odds with the consensus of other observers.