US regulators seek advice on thorny issues as vaccines near

WASHINGTON — With vaccines against COVID-19 inching closer, U.S. regulators took an unusual step Thursday in asking outside scientists: Are the government's standards high enough to adequately judge the shots?

The Food and Drug Administration may have to decide by year's end whether to allow use of the first vaccines against the coronavirus, amid growing public fears that politics are overriding science. Thursday, a federal advisory committee pulled back the curtain on that decision process in daylong discussions to be sure corners aren't cut.

“Vaccine development can be expedited. However, I want to stress that it cannot — and must not — be rushed,” Dr. Marion Gruber, director of FDA's vaccine research office, told the advisers.

Gruber said the public scrutiny “is critical to build trust and confidence” in whichever vaccines emerge.

Exactly how much data FDA needs to be sure a vaccine is safe and effective is a key question for the advisers, and one looming as a key vaccine developer, Moderna Inc., announced Thursday the final study of its shot has completed enrollment.

An even tougher question: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well those shots — and maybe competitors still being studied — really work?

Any vaccine allowed for emergency use will still be experimental. It may not be clear if the first vaccines prevent people from spreading the coronavirus or just from getting seriously ill, for example. And with multiple shots in the pipeline — made with different technologies that each have pros and cons — the first may not be the best.

FDA's Dr. Doran Fink made clear the agency wants vaccine makers to keep as many volunteers enrolled in their studies for as long as possible to determine long-term vaccine safety and effectiveness.

“Once a decision is made to unblind an ongoing placebo- controlled trial, that decision cannot be walked back and that controlled follow- up is lost forever,” Fink said. But asked how to avoid losing that crucial information, he acknowledged: “I don't have any specific remedies to offer at this time.”

[HANS PENNINK/ASSOCIATED PRESS FILE PHOTO] Nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y. The U.S. Food and Drug Administration will hold a meeting to discuss the approval process for COVID-19 vaccines.