46ºF

How the FDA is working to make sure any COVID-19 vaccine would meet their standards for safety

There is a 2 month guideline

DETROIT – The New York Times reports top White House officials have blocked stricter federal guidelines proposed for the emergency authorization of any coronavirus vaccine.

The Food and Drug Administration is working to make sure any vaccine would meet or exceed their standards for safety.

READ: FDA discloses vaccine guidelines blocked by White House

The sticking point in the proposed guidelines is likely a provision that would require volunteers to be followed for a median of two months after they receive their second dose of the vaccine. A requirement that would essentially guarantee no vaccine could be authorized before election day.

Dr. Peter Marks is the director of the FDA center that will ultimately authorize or reject a vaccine. He said it’s critical to be transparent about the process with the public.

“Safety is what keeps me up at night because all we need is something happening with vaccine safety to create a real problem here,” Marks said. “The way we’re going to get over COVID-19 is if we get a vaccine that has 70 to 80 efficiency and we can deploy that to 70 or 80 percent of the population. We actually have a chance at herd immunity.”

Some vaccine makers, including Johnson and Johnson have already committed publically to following the two month guideline.

According to the Post, Marks in his current role is the highest-ranking career official involved in the approval of any potential vaccine candidate. If historical precedent holds true, that means Marks, rather than a political appointee, ultimately will be tasked with recommending for or against FDA approval of any potential vaccine.

That said, Stephen Hahn, as FDA’s current commissioner, typically holds the authority to issue an emergency use authorization for a vaccine, Reuters reports, and the HHS secretary technically could overrule any decision issued by FDA.


About the Authors: