Public health experts are concerned that pressure from President Donald Trump, who has vowed there will be a coronavirus vaccine before the end of the year and is facing reelection in November, will result in regulators approving the first possible vaccine to show promise even without the long-term clinical trials that usually provide proof of a drug’s effectiveness, Politico reported on Monday.
The political interference, experts say, could push the Food and Drug Administration to grant emergency-use authorization to vaccines, which could make millions of doses available outside of clinical trials and thus decrease the chances of enrolling enough people in the trials to obtain the data needed to determine if it actually works.
“If you give an emergency use authorization, you’re likely going to make it hard to assess all these vaccines and to assess the thing we really care about: Are they effective in preventing infection?” said Ezekiel Emanuel, health adviser to Democratic presidential candidate Joe Biden.
FDA Commissioner Stephen Hahn has pushed aside such concerns, saying “Under no circumstances will the FDA allow political pressure to affect our decision-making.”
But critics point to the FDA decision in March to authorize emergency use of the malaria drug hydroxychloroquine as a COVID-19 treatment after weeks of Trump touting it despite scant evidence. Recent trial results suggest hydroxychloroquine has no benefit for coronavirus patients.
Nicole Lurie, an HHS official during the Obama administration, said “Public confidence in the FDA has really been eroded" by the Trump administration.
A Reuters/Ipsos poll last month showed the public’s confidence in vaccination overall has dropped, with 36% saying they would be less willing to take it if Trump declared it safe.
Brian Freeman ✉
Brian Freeman, a Newsmax writer based in Israel, has more than three decades writing and editing about culture and politics for newspapers, online and television.
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