Regulators, experts take up thorny vaccine study issues

The US regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough. The Food and Drug Administration may have to decide by year's end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.

"We will not cut corners, and we will only use science and data to make that determination," FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday. Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work? "We can't lose sight of the fact that it is in our societal interest to see these trials to completion," said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers' debate.

Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons. "The first vaccine is not necessarily the best vaccine," cautioned Dr M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren't allowed to finish, it may be difficult or impossible to ever know for sure.

It's a critical moment in FDA's 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science..