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Even after FDA’s coronavirus vaccine guidance, the emergency path remains a mystery

In reviewing potential COVID-19 vaccines, FDA Commissioner Stephen Hahn, M.D., has pledged to “not cut corners” or allow politics to affect decision-making. But while the agency has laid out clear efficacy requirements for a full approval, the emergency use authorization pathway isn’t so clear, analytics firm GlobalData said.

Even after the agency presented its COVID-19 vaccine guidance to industry Tuesday, requirements to secure a COVID-19 vaccine emergency use authorization, or EUA, “remain vague,” GlobalData pharma writer Reynald Castañeda wrote Tuesday.

After the chloroquine debacle—when the agency issued an EUA and later revoked it for lack of evidence—the FDA may “raise the bar” for a vaccine emergency authorization, Castañeda added. But the process is still “sensitive to political pressure, even if it is designed to be evidence-based,” he wrote.

His concern follows other experts’ warnings that the Trump administration might pressure the FDA to authorize a COVID-19 vaccine ahead of the November presidential election for a political win. Jefferies healthcare strategist Jared Holz has told MarketWatch an approval before the election is possible, and University of Pennsylvania professors Ezekiel Emanuel and Paul Offit warned about a possible COVID-19 vaccine “October surprise” in a New York Times op-ed last month.

On Monday, the FDA unveiled its COVID-19 vaccine guidance for developers, requiring vaccines to “prevent disease or decrease its severity” in at least half of people who are vaccinated for a full approval.

On the last page of the guidance, the FDA details its requirements for an emergency use authorization. For that endorsement, the agency must decide the “known and potential benefits … outweigh the known and potential risks of the product.” The reviews would be conducted “on a case by case basis,” weighing the target population, vaccine characteristics, and “totality of the available scientific evidence relevant to the product.”

Still, the agency says that an emergency approval before a large efficacy study could reduce investigators’ ability to conduct clinical trials that prove a vaccine can prevent disease. The agency said an EUA could be appropriate once a developer has proven safety and efficacy, but before it’s able to submit an application or before the FDA can complete the full review.

In dissecting the guidance Monday, Jefferies analyst Michael Yee wrote that an FDA emergency authorization is the “likely scenario” for early vaccine rollouts.

That type of endorsement would allow Operation Warp Speed to meet its stated goals and “get vaccines available for controlled use and designated for high-risk populations … or people willing to sign waivers and accept risk,” Yee wrote. EUAs would be likely based on antibody data, safety and more, he added.

At the same time, large controlled efficacy studies would likely continue into next year, the analyst said.

As COVID-19 vaccine programs race ahead, experts can’t yet predict how quickly efficacy trials will generate data sufficient for an approval, FDA Center for Biologics Evaluation and Research director Peter Marks said in a statement. He stressed the agency “will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency.”

Also in the FDA’s vaccine guidance, the agency recommends developers include diverse populations in their clinical studies such as racial and ethnic minorities, elderly individuals, and people with complicating health conditions. The agency further recommends developers provide data on vaccination in pregnant women and studies to track safety and efficacy in children.

As of Monday, 17 COVID-19 vaccines are in human testing, and more than 130 are in preclinical research stages, according to the World Health Organization.