Former FDA chief: Americans can trust COVID vaccine authorization process

Joel Brown Image
Tuesday, August 3, 2021
Former FDA chief: Americans can trust COVID vax authorization process
Mark McClellan, who is serving as director of Duke University's Margolis Center for Health Policy said the American people can trust the process.

DURHAM, N.C. (WTVD) -- On Monday, Food and Drug Administration officials confirmed the agency is fast-tracking its process of issuing final and full approval for Pfizer's COVID-19 vaccine, as first reported by the Washington Post.

"The American people can trust the process -- that's reviewing all the data quickly," said former FDA commissioner Mark McClellan, who is currently serving as director of Duke University's Margolis Center for Health Policy.

The FDA acceleration toward final approval comes as millions of Americans continue to resist getting the shot under its current emergency use authorization.

FDA says it's working as fast as possible to fully approve COVID vaccines

"I think it's understandable because I think sometimes people hear 'emergency authorization' and think experimental authorization. But actually there's a huge amount of evidence that's gone into authorizing these vaccines for emergency use," Dr. McClellan said. "In fact, because we're in this public health emergency, we've gotten way more data on the COVID vaccine than we have on most vaccines that go through the full approval process."

Dr. McClellan knows the pressures of leading the Food and Drug Administration. He was FDA commissioner in the second Bush White House, before arriving at Duke. He also currently serves as independent director on the board of Johnson & Johnson.

He says while full authorization is important for crafting key rules including the proper shelf life for a vaccine, he believes the most important questions about the vaccines' safety and efficacy are already answered.

"I think what we're going to see when the FDA full approvals come, and I expect that won't be that far off, is we're not going to learn anything new about the safety and efficacy of the vaccine," McClellan said.

The FDA has faced rising calls from some experts to move faster to fully approve the COVID-19 vaccines

"The FDA has to be very careful about going as quickly as possible but not rushing it, not cutting any corners," said McClellan, who thinks full approval may come this month but certainly before the start of fall.

It remains a question whether full and final FDA authorization can fully and finally convince vaccine-resistant Americans to get the shot.