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

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 criterion 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 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.

Though political leaders, health experts, and media reports have suggested the Trump administration influenced the FDA’s initial decision to issue an EUA, Hahn has denied this. In a Congressional hearing June 23, he testified: “I have not felt political pressure nor has the FDA to make any decision in any specific direction.”

He echoed the point in today’s announcement of the vaccine guidelines, saying, “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data.”

In the announcement, the FDA noted that, although the guidelines lay out what’s needed for full approval, the agency may still consider issuing an EUA to candidate COVID-19 vaccines on a “case-by-case” basis. The agency said it would consider an EUA based on “the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness.”