Philanthropist Bill Gates has lost confidence in the Food and Drug Administration to regulate coronavirus treatments and vaccines without folding under political pressure.
“Historically, just like the [Centers for Disease Control and Prevention] was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said in an appearance on Bloomberg Television. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”
Gates said that FDA Commissioner Stephen Hahn, who has appeared often by President Trump’s side at White House press briefings, hurt the agency’s credibility after echoing Trump about the benefits of convalescent plasma therapy, only to backtrack the following day.
“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails,” Gates said.
Gates cautioned that inconsistencies about vaccine timelines coming from the Trump White House are eroding confidence in the public that the FDA will approve a vaccine that is clinically proven safe and effective. Recent polling has shown that roughly two-thirds of people in the United States would think twice about getting the coronavirus vaccine if it were approved by Election Day.
The Trump administration has poured billions into Operation Warp Speed, a major effort to accelerate the development and production of a COVID-19 vaccine, but the rush has sparked fears that the FDA’s approval process will come at the expense of safety or will be influenced by Trump, who wants a vaccine to be made available before Nov. 3.
Gates has instead decided to trust the biotech and pharmaceutical companies conducting late-stage clinical trials on nine different vaccine candidates.
“These companies are very professional, and the benefits of the vaccine here are very dramatic,” Gates said. “Thank goodness that we have this private-sector expertise that we want to shape into a global public good that gets to everybody on the planet.”
The FDA announced in June that vaccine makers applying for regulatory approval will have to show that they are 50% more effective than the placebo in preventing infection, though some epidemiologists say the benchmark for efficacy is not high enough. For instance, George Rutherford, the director of the Prevention and Public Health Group at the University of California, San Francisco, told the Washington Examiner last week that COVID-19 “is so widespread, you might want a little bit more.”
Meanwhile, recognizing the public’s apprehension about the accelerated timeline, nine vaccine developers signed a joint pledge earlier this month to uphold “high ethical standards,” suggesting they won’t seek premature government approval before making sure their vaccine candidates are both safe and effective.
