EUA Guidance May Not Make It Out of the White House, FDA Official Says

Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said this week that the fate of the agency’s guidance on its expectations for COVID-19 vaccine Emergency Use Authorization (EUA) remains uncertain as it goes through the White House’s review.

Krause said that while it’s not clear the guidance will be released due to the unconventional review President Trump is putting it through (DID, Sept. 24), it’s vital that companies understand the agency’s requirements for issuing a COVID-19 vaccine EUA and realize that emergency authorization is not the end of the road for finding a safe, effective-enough vaccine for widespread use.

“It is a point of significant importance to make sure that the companies understand what is needed for an EUA,” he said. “The key point is that a vaccine under EUA is still investigational. That means clinical trials are continuing, more safety data is being collected and so by the time we switch from an EUA usage, we still collected more data that will give us even more confidence once the product is finally licensed.”

Krause emphasized the importance of continuing to gather data on the scientific, development and manufacturing, and cautioned that deploying a weak vaccine could do more damage in the long run, as it could weaken other initiatives against the pandemic and make it harder to prove the efficacy of subsequent vaccines.

“A vaccine that is only weakly effective could actually do more harm than good. The concern here came from the observation that a weakly effective vaccine might be deployed but then cause people or governments to relax other things that they were doing,” he said. “Also … if you make one vaccine available and start deploying it broadly, it then becomes much more difficult to show that other vaccines work, because they then need to be compared against that first vaccine.” — James Miessler