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Trump may reject FDAs stricter regulations for COVID-19 vaccine

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland.Getty | Congressional Quarterly

President Donald Trump on Wednesday said he may reject the Food and Drug Administrations plan to issue stricter safety and efficacy standards for COVID-19 vaccines, calling the plan a “political move.”

The new standards are aimed at bolstering public confidence in the FDA and its vaccine review process, which has been severely damaged by many reports of political meddling and interference by the Trump administration. Those reports include claims that the FDA was pressured by the White House into allowing COVID-19 patients to be treated with unproven blood plasma and the anti-malaria drug hydroxychloroquine, which was personally touted by Trump. (The authorization of hydroxychloroquine was later revoked by the FDA.) Just last week, Trumps secretary of health and human services, Alex Azar, revoked the FDAs authority to sign new regulations.

Trump himself has continually undercut federal public health guidance and government scientists, particularly Robert Redfield, his director of the Centers for Disease Control and Prevention. Trump has also repeatedly pushed for a pre-election release of a vaccine, though experts have, in turn, repeatedly pointed out that such a speedy release is nearly impossible based on the timeline of the clinical trials underway and the amount of data needed to make even preliminary evaluations of safety and efficacy.

New standards

As such, public confidence in the FDAs vaccine review process has plummeted. The percentage of people who said they would be willing to get any COVID-19 vaccine greenlighted by the FDA dropped from 72 in May to 51 this month, according to polling by the Pew Research Center.

To try to pull those numbers back up, the FDA planned on shoring up its authorization process. News broke earlier this week that the agency was poised to introduce new, tough standards for a COVID-19 vaccine to earn an emergency use authorization, which is generally a faster, less rigid process than earning a full regulatory approval. The agency had already announced that a vaccine would have to prove at least 50 percent effective at preventing COVID-19 to earn full approval.

Though the new standards for an authorization have not yet been released, people familiar with them told The Washington Post that they would require vaccine developers to follow participants for a median of at least two months after their final dose of a vaccine (several of the vaccines currently in late-stage trials require two doses). The standards would also require vaccine developers to identify at least five cases of severe COVID-19 in trial participants who received a placebo, rather than an experimental vaccine. The new standards also require the trials to identify cases in older participants who received a placebo.

With the extra requirements, the two-month follow-up, and the necessary data analysis and FDA paperwork, experts say it is nearly impossible for any vaccine to earn an authorization before the election. Some of the Read More – Source

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