FDA releases promised COVID-19 vaccine guidance

WHAT YOU NEED TO KNOW:

• A list of requirements for pharmaceutical companies regarding the FDA’s formal approval of a vaccine has been published by the agency on Tuesday.
• The requirements include drug makers submitting data that they have monitored volunteers in the clinical trials for two months after the final administration of the vaccine.
• In addition, those companies that have reported at least five COVID-19 severe cases among test subjects who got the placebo can submit their vaccines for authorization.

The Food and Drug Administration (FDA) published guidance Tuesday enumerating the requirements for emergency authorization of a coronavirus vaccine after it was delayed by the White House review.

According to the guidelines posted on the agency’s website, pharmaceutical companies must submit data showing that they have kept track of clinical trial volunteers for an average of two months after their final vaccine injection.

The companies are also advised to provide vaccines for authorization only after at least five severe cases of COVID-19 have been reported in participants who received the placebo.

The requirements listed in the guidance prove why it’s improbable that a vaccine would be available before the elections.

In a statement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, explains that the reason behind the extended follow-up is to provide more real-life experience that can help in analyzing adverse reactions that may happen weeks after the vaccine is injected.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” he added.

Two administration officials who were unauthorized to speak about the issue publicly said the delayed release of the guidance was due to it having to go through the review process which involved an approval from the White House.

On Sept. 27, chief of staff Mark Meadows said on CBS’ Face the Nation that they are just making sure that the FDA guidance is not “an inhibitor to getting things out fast, but also doesn’t detract from it.”

So on Tuesday, it was quite surprising to note that most of the guidance is included as an appendix in the FDA briefing document published in advance of the Oct. 22 Vaccines and Related Biological Products Advisory Committee meeting.

While these briefing documents are normally released some days ahead of the meetings, this time, it was over two weeks.

Drug manufacturers have always proclaimed their independence from political pressure to have a vaccine ready for use by Election Day. Nine company executives have even signed a letter in September vowing not to submit their vaccines for formal approval by the FDA until they have been tested to be safe and effective.

Following the FDA’s release of the appendix, the Pharmaceutical Research and Manufacturers of America released a statement advocating the agency’s efforts to provide guidance and transparency to the approval process of the vaccine.

Source: NPR.org