Is Bill Gates Right About the FDA’s Vaccine Credibility?

(Bloomberg Opinion) -- Prior to the pandemic, the U.S. Food and Drug Administration was the gold standard for American food and pharmaceutical safety. That’s no longer the case, according to Bill Gates. “Historically, just like the CDC was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said in an interview with Bloomberg Television. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”

With the election less than two months away, Americans view politics as the main culprit for a steady rise in vaccine hesitancy. In a recent poll by STAT and the Harris Poll, 78% of respondents said they worried the vaccine approval process was being driven more by politics than science. President Donald Trump has been clear about his desire to get a vaccine approved before Election Day, predicting the FDA “could even have it during the month of October.”

Bloomberg Opinion columnists around the globe have been covering the race for a vaccine, and the need to build trust in it, since the pandemic began:

• Rushing Vaccine Trials Is Unwise. We Must Be Patient: “The FDA and drugmakers have laid the groundwork for proper evaluation, with the agency requesting and pharma running 30,000 person trials to prove that the vaccine can prevent or cut the severity of disease by at least 50%. If everyone is patient, these studies will give reliable answers, which is what you want for shots that will eventually be used by millions. But the president's calls for speed and seemingly limited resistance from FDA commissioner Stephen Hahn have created concern that the agency might prematurely approve a vaccine and sow dangerous doubts.”  — Max Nisen
• How to Fight Back Against Coronavirus Vaccine Phobia: “In the U.S. and U.K., large numbers of people — at least 30% — have said in recent surveys that they would hesitate to take or refuse a vaccine that could protect them from the coronavirus and slow its spread. These numbers probably understate the problem. People might tell a researcher that they will get vaccinated even if they won’t. And the problem might be even worse if a vaccine is made available under a speeded up ‘emergency use’ exception to the usually lengthy approval process, amplifying public concerns about rushing it out.” — Cass Sunstein
• Operation Warp Speed Must Focus on Building Trust: “Political controversy has haunted every discussion of Warp Speed and its timeline for delivering a vaccine. And for good reason. Trump has frequently highlighted the possibility that a vaccine will arrive much sooner than experts and Warp Speed’s own leaders predict, and he has forced agencies such as the CDC and the Food and Drug Administration — both part of the Warp Speed effort — to bend to his will or follow his lead on medically dubious initiatives.” — Timothy L. O’Brien and Max Nisen
• The More Covid-19 Vaccines, the Merrier: “All the novel vaccines work through the same well-established scientific principles, and are very likely to be safe. Still, he says, it’s well known that vaccines don’t work as well in the elderly and immunocompromised. Imperfect vaccines could still eradicate the virus through herd immunity but only if the bulk of the population gets vaccinated. Once the technical hurdles are overcome, there will be social hurdles — already, there are movements among anti-vaxxers to resist — but it’s not too soon to plan to surmount them.” — Faye Flam
• It’s Not Just Anti-Vaxxers Who Worry About Vaccines: “Countering the anti-vaxxers is important work, but it’s only part of the picture. The bigger danger is a broader vaccine hesitancy: What if rational people who get their flu shots and vaccinate their children, and who are eager to be part of the solution to this pandemic, have worries that public health authorities and governments don’t address?” — Therese Raphael

More Reading

• The FDA Wants a Covid-19 Vaccine That Really Works: Max Nisen

• A Cure For Covid-19 Could Be Right Under Our Noses: Lionel Laurent

• Give the Covid Vaccine to Healthy Young People First: Faye Flam

• The Big Question: Can a Covid Vaccine Reach Enough People?: Max Nisen

• Why I Just Volunteered for a Covid-19 Vaccine Trial: Faye Flam

• Operation Warp Speed Needs to Waste Money on Vaccines: Max Nisen

• Russia's Sputnik Vaccine Gamble Is All About Vladimir Putin: Clara Ferreira Marques

• The Pandemic Is Exposing the Limits of Science: Ferdinando Giugliano

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

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