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How the FDA is trying to soothe coronavirus vaccine fears

FDA chief Stephen Hahn is stepping up efforts to convince Americans that his agency won’t sacrifice the safety or efficacy of a coronavirus vaccine for the sake of speed — even as President Donald Trump is urging the agency to move faster on Covid-19 cures.

Hahn, the nation’s top drug regulator, has been pumping out op-eds and popping up at scientific conferences in recent weeks to make the case for his agency’s independence. “FDA commissioner: No matter what, only a safe, effective vaccine will get our approval,” read the headline on a Washington Post piece Hahn wrote this month. “Unwavering regulatory safeguards for Covid-19 vaccines,” read another, published days later in the medical journal JAMA.

Within FDA, “the discussion has been: How do we communicate to the public and how do we push back on the misinformation — from all directions?” said one current health official. Asked about the president’s sometimes contradictory statements about the vaccines in development, the official said: “We just march forward.”

But it’s not clear whether Hahn’s efforts will persuade Americans who are hesitant about taking a coronavirus vaccine to do so.

Polls show that nearly a fifth of adults would refuse a coronavirus vaccine if one were available, in some cases over fears that any approval would be motivated by politics rather than science. Trump has repeatedly promised that a vaccine will be available by the end of the year — perhaps even before the November election, contradicting timetables laid out by top federal scientists. Just 14 percent of voters would be more likely to take a vaccine recommended by Trump, according to a POLITICO/Morning Consult poll this month.

The president has also taken direct aim at the FDA in recent days, accusing it of slow-walking its coronavirus response for political reasons. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

POLITICO spoke to three current health officials familiar with discussions ongoing among Hahn and a small group of advisers — as well as three former FDA commissioners and several other health policy and vaccine experts, some of whom have advised the government during this pandemic.

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