FDA Chief Says Panel Must Review COVID Vaccine

October 7, 2020 – FDA Commissioner Stephen Hahn, MD has said no COVID-19 vaccine will be approved without input from its Vaccine Advisory Committee – a step that will slow the process and require public comment .

This step will be necessary for a drug maker to apply for approval for an emergency use authorization or through the regular approval process, Hahn said Wednesday in an interview with “Coronavirus in Context” , a video series hosted by John Whyte, MD, Chief Medical Officer of WebMD.

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

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

The Advisory Committee on Vaccines and Related Biologics is scheduled to meet on October 22, but only general information on vaccine development will be discussed, he said. Public comments for this FDA meeting will be accepted until 11:59 p.m. Oct. 15, according to the FDA.

The FDA on Tuesday released new safety standards for COVID-19 vaccines that will make it nearly impossible to bring a vaccine to market before the election – as Trump had requested. The new rules require vaccine manufacturers to follow clinical trial participants for at least 2 months to rule out safety concerns before applying for emergency use authorization for a vaccine.

On Tuesday night, Trump posted a critical tweet and tagged Hahn, saying, “The new FDA rules make it harder for them to speed up vaccine approval before election day. Just another political hit! @SteveFDA »

While Hahn said political interference, media coverage and other issues can “wreak havoc” on people who work at the FDA, he said the agency’s morale is good.

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

Regarding testing, Hahn said the FDA is focusing on three types of testing: point-of-care, rapid result, and home collection.

He said rapid results tests appear to be the most accurate when used according to the label. The Abbott ID NOW test label, for example, says its use is for people with symptoms of coronavirus. According to press reports, White House staff have relied heavily on rapid testing as a means of preventing COVID transmission instead of wearing masks and social distancing.

Trump and his wife, First Lady Melania Trump, tested positive for the virus on Thursday. Since then, many close associates of the president have tested positive.

WebMD Health News

Sources

“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, October 6, 2020.

FDA: “ID NOW COVID-19”.


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Jothi Venkat

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