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COVID-19 vaccine must protect 50% of people for approval, FDA says

Enlarge / Stephen Hahn, Commissioner of Food and Drugs at the US Food and Drug Administration (FDA), speaks during a Senate Health, Education, Labor and Pensions Committee hearing on June 30, 2020, in Washington, DC. Getty | Al Drago

Any experimental COVID-19 vaccines aspiring to earn regulatory approval from the Food and Drug Administration will need to prevent or decrease the severity of disease in at least 50 percent of people, the agency announced Tuesday.

The criterium is part of a larger set of guidelines released by the agency for developing a vaccine to halt the spread of pandemic coronavirus, SARS-CoV-2—which causes COVID-19 and is now accelerating in much of the country after months of sustained devastation.

With the guidelines, the FDA tried to dispel fears that the rush to develop a COVID-19 vaccine may come at the expense of adequate safety testing. “We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards.”

Exceptions

The agency also hopes to assuage concerns that it has succumbed to political pressure from the Trump administration in making regulatory decisions during the pandemic—eschewing its reliance on efficacy and safety data. Most notable is the case of hydroxychloroquine, a malaria drug known to have severe potential side effects, including triggering potentially fatal heart arrhythmias. Despite a lack of evidence for its efficacy against COVID-19, President Trump touted the drug as a “game changer” and even admitted to taking it himself.

The FDA made the unusual decision to issue an Emergency Use Authorization (EUA) for hydroxychloroquine and the related drug, chloroquine, in late March. The EUA allowed doctors to use the drugs to treat COVID-19 patients outside of clinical trials, despite the lack of the evidence. As data piled up that the drugs are ineffective against COVID-19 and come with serious risks, the FDA revoked the EUA in mid-June.

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