Vaccine Safety Is Focus Of FDA Expert Panel’s Debate At Public Meeting
The daylong meeting was livestreamed on multiple outlets for public viewing as the FDA works to increase public confidence in the vaccine approval process.
The Washington Post:
FDA Advisory Committee Debates Safety And Efficacy Standards For A Coronavirus Vaccine
Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness. The FDA advisory committee, in an all-day virtual meeting, did not consider any specific vaccine. The session served in large part as a venue for the agency to try to reassure the public that any vaccine will be held to a high standard, not the relatively low bar used this year for emergency use authorization for treatments. The FDA said that though it probably will grant emergency use authorizations — which can be handed out faster than full approvals — for the early vaccines, it will use robust criteria similar to those applied in regular approvals. (McGinley and Johnson, 10/22)
AP:
US Regulators Seek Advice On Thorny Issues As Vaccines Near
Scientific advisers told U.S. regulators Thursday they’re concerned that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the coronavirus. Facing growing public fears that politics may override science, the FDA took the unusual step of assembling more than a dozen independent scientists to review if its standards are high enough to judge the shots. The panelists generally supported guidelines for the vaccines that the FDA recently issued, over White House objections. (Neergaard and Perrone, 10/23)
CNBC:
FDA Opens Private Covid Vaccine Meetings To The Public In Bid To Gain Trust
The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that’s weighing in on approving the coronavirus vaccine as the agency battles public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election. The Vaccines and Related Biological Products Advisory Committee, an outside group of researchers and physicians who are advising the Food and Drug Administration on whether to approve a Covid-19 vaccine, debated the standards needed to ensure a Covid-19 vaccine is safe and effective in a meeting broadcast on YouTube and C-SPAN. (Lovelace Jr., 10/22)
NPR:
Researchers Find Doubts About COVID-19 Vaccine Among People Of Color
At a meeting Thursday of experts advising the FDA on COVID-19 vaccines, the concerns of front-line workers and people of color were read aloud verbatim, highlighting the crucial project of communicating the safety and effectiveness of a vaccine in an environment of deep political distrust. (Wamsley, 10/22)
In related news about the FDA —
Politico:
An Angry Azar Floats Plans To Oust FDA’s Hahn
Infuriated by the FDA’s defiance in a showdown over the Trump administration’s standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster of FDA chief Stephen Hahn. Azar has vented to allies within the Health and Human Services Department about his unhappiness with the top official in charge of the vaccine process, and discussed the prospect of seeking White House permission to remove him, a half-dozen current and former administration officials said. (Cancryn and Diamond, 10/22)
