FDA Chief Says Panel Must Review COVID Vaccine

Oct. 7, 2020 — FDA Commissioner Stephen Hahn, MD, says no COVID-19 vaccine will be approved without the OK from its vaccine advisory panel — a step that will slow the process down and require public input.

That step will be required whether a drugmaker seeks approval for an emergency use authorization or through the regular approval process, Hahn said Wednesday during an interview on “Coronavirus in Context,” a video series hosted by John Whyte, MD, WebMD’s chief medical officer.

Hahn’s comments come the day after Trump accused the FDA of a “political hit job” with tougher COVID-19 vaccine approval standards and concerns among citizens about the safety of the vaccine.

“There will be a transparent, open-to-the-public discussion about the data,” Hahn said. “We want the public to comment. This dialogue is very important.”

The Vaccines and Related Biological Products Advisory Committee is scheduled to meet Oct. 22, but only general information about vaccine development will be discussed, he said. Public comments for that FDA meeting will be accepted through 11:59 p.m. on Oct. 15, the FDA says.

The FDA released new safety standards for COVID-19 vaccines Tuesday that will make it nearly impossible to get a vaccine to market before the election — as Trump had asked. The new rules require vaccine makers to follow clinical trial participants for at least 2 months to rule out safety issues before seeking emergency use authorization for a vaccine.

On Tuesday night Trump put out a critical tweet and tagged Hahn, saying: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA”

While Hahn said political interference, media coverage, and other issues can “take a toll” on people who work at the FDA, he said morale at the agency is good.

When asked if a vaccine might be approved before the end of the calendar year, Hahn said, “It’s possible. I won’t speculate on it because I don’t know when the data will be mature.” He added, “The time frame will depend on complexity and amount of data.”

On the topic of testing, Hahn said the FDA is focusing on three kinds of tests: point-of-care, rapid-result, and home collection.

He said rapid-result tests appear to be the most accurate when used according to the label. The label for the Abbott ID NOW test, for example, says its use is for people showing symptoms of having the coronavirus. According to news reports, White House staff have relied heavily on rapid tests as a way to prevent COVID transmission instead of mask wearing and social distancing.

Trump and his wife, first lady Melania Trump, tested positive for the virus Thursday. Since then, numerous close associates to the president have tested positive.

WebMD Health News


“Coronavirus in Context,” October 7, 2020. 

FDA.gov: “Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement,” “Emergency Use Authorization for Vaccines to Prevent COVID-19.”

Twitter: @realDonaldTrump, Oct. 6, 2020.


© 2020 WebMD, LLC. All rights reserved.

Source link




Nestle to buy Aimmune Therapeutics for $2.6 billion

A pedestrian passes a Nestle SA logo at the Nescafe factory, operated by Nestle SA, in Tutbury, U.K., on Thursday, Aug. 23, 2018.Simon...

Renault will develop and build the next-generation Nissan Micra

PARIS — French carmaker Renault will develop and assemble the next generation of partner Nissan’s Micra models, a senior executive at the Japanese...

Broadway to remain closed through May 30

A man in a surgical mask walks through Manhattan's Broadway Theatre district after Broadway shows announced they will cancel performances due to the...

BMW M4 GTS spied for the first time with wild center-exit exhaust

The standard (and still yet-to-be-revealed) BMW M4 has a relatively normal quad-tipped exhaust with twin pipes on each side of the bumper. The...

Need to increase HPV vaccine uptake in adolescents

submitted by /u/shallah Source link