Anxieties over the process that could lead to the approval of a coronavirus vaccine are escalating as President Donald Trump, desperate to stamp an end date on the deadly pandemic nightmare, ratchets up pressure on top regulatory officials to deliver him a medical and political panacea ahead of the November election.
Democratic vice presidential nominee Kamala Harris registered her concerns during an interview with CNN’s Dana Bash on “State of the Union” airing Sunday, saying she would cast a skeptical eye on a vaccine made available in the less than nine weeks to go before Election Day – a goal scientists have roundly said would be next-to-impossible to meet.
Harris also suggested that public health officials were likely to face pushback, potentially at the expense of their jobs, from the White House if they expressed reservations over a would-be vaccine or the standard for greenlighting it.
“If past is prologue, they will not, they’ll be muzzled, they’ll be suppressed, they will be sidelined,” Harris said. “Because he’s looking at an election coming up, in less than 60 days, and he’s grasping for whatever he can get to pretend he has been a leader on this issue, when he is not.”
The widespread distribution of a dodgy vaccine, with a shove from a President whose reelection campaign has been laid low by the pandemic and its crushing effect on the economy, would heap calamity on top of catastrophe. But it has emerged as a very real concern – enough so that, according to the Wall Street Journal, at least three of the companies working to develop a coronavirus vaccine are now drafting a pledge to assure the public they would not seek approval for their vaccines before they are proven safe and effective.
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News of the companies’ joint messaging plans came as Trump once again peddled unrealistic dates – and hopes – during a White House news conference.
“We remain on track to deliver a vaccine before the end of the year and maybe even before November 1st,” Trump said Friday. “We think we can probably have it sometime during the month of October.”
Political pressure
On Thursday, White House press secretary Kayleigh McEnany claimed that “no one is pressuring the FDA to do anything.” But a CNN investigation found something close to the opposite – that Trump is pushing for any scrap of good news, or the impression of it, and then pressing those around him to dress it up as a historic breakthrough.
That pressure-packed environment has already exposed potential cracks in the Food and Drug Administration’s armor of supposed independence. After dramatically overstating the therapeutic benefits of convalescent plasma – which is donated by people who have recovered from Covid-19 – two weeks ago, FDA Commissioner Dr. Stephen Hahn subsequently apologized for using a misleading statistic.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn, who insisted the agency was acting independently, said in a series of tweets the next day. “The criticism is entirely justified.”
It wasn’t the first time the FDA was forced to backtrack after giving substantive backing to a dubious coronavirus therapy. In June, the agency revoked an “emergency use authorization” for hydroxychloroquine, a Trump favorite that studies suggest is likely to do more harm than help, after the FDA determined the anti-malaria drug is “unlikely to be effective in treating COVID-19.”
“What I’m concerned about is there could be a gray zone where a vaccine looks partially protective and it goes on the market without a full formal review process,” Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine, recently told CNN. Dr. Robert Califf, a former FDA commissioner, said he has long worried Trump would impose himself on the FDA’s processes, but believes that the President is, in the end, “extraordinarily unlikely” to go against top scientists.
And if he does, Califf added, there was still be one final, formidable line of defense.
“The medical community,” he said, “is not going to accept it and most people won’t get a vaccine if their doctor tells them not.”
Undermining public confidence
The Trump administration’s meddling, overt and by insinuation, also threatens to set off a vicious circle that could undermine public confidence in a vaccine that credibly meets the strict, long-held standards set by scientists and public health officials.
It’s a two-tiered irony that Trump, the author of untold conspiracy theories, who tweeted anti-vaxxer propaganda before running for president, could now end up casting doubt on a legitimate vaccine – that he desperately wants and apparently believes he needs – to make its debut ahead of the coming election. A recent academic study out of Australia found Trump supporters online are more likely to “hold anti-vaccination” views, another complicating factor.
The mixed and misleading messages from the White House appear to be taking a toll on public confidence, which could undermine the political benefits Trump believes a vaccine would deliver.
According to a new CBS News/YouGov poll, only 21% of voters nationwide said they would immediately seek out a vaccine if one was made available in 2020. That number is down from 32% in July. Sixty-five percent said they believed a vaccine announced this year would, by definition, be the product of a “rushed” process. Only 35% would regard it positively, as a “scientific achievement.”
The President’s insistence that a vaccine is near and, as he put it during a Friday news conference at the White House, that the country is “rounding the corner on the virus,” baffled Dr. Anthony Fauci, the widely trusted, longtime director of the National Institute of Allergy and Infectious Diseases.
“I’m not sure what he means,” Fauci said on CNN, during an interview after the President’s Friday remarks. Fauci noted that while “there are certain states that are actually doing well in the sense of that the case numbers are coming down,” at least five others had reported rising positivity rates – a development that would indicate the virus is spreading, not abating.
Pressed on his characterization during the new conference – and how it could possibly jibe with a new model, from the University of Washington’s Institute for Health Metrics and Evaluation, which projects that more than 410,000 people in the US could die from the coronavirus by the end of the year – Trump spun through a variety of his old hits, including one that contends his handling of the crisis would be more accurately viewed if “you took out New York,” one of the hardest hit states, from the totals.
But New York is, and remains, part of the country and Trump never came close to squaring his claim with reality. In the process, he sought to further muddy the already murky waters surrounding his and his administration’s handling of a historic crisis that has killed, to date, nearly 190,000 people in the US alone.
Harris, in her interview with CNN, skewered Trump as a deeply untrustworthy figure. She also got a question that many Americans are asking themselves now: Would she take a vaccine that was approved and distributed before November 3?
“I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he’s talking about,” the California senator told Bash. “I will not take his word for it.”
This story has been updated with findings from a CBS News/YouGov poll.