How the FDA will vet the Covid-19 vaccine candidates

Source Reference

The evaluation of the applications for coronavirus vaccine candidates is rigorous. The individual responsible for this due diligence at the FDA wants the American public to hear their message: Trust the process. The agency might take weeks before this assessment is completed.

“Look at the process that we’re following,” Dr. Peter Marks, the leader of the Food and Drug Administration’s biologics center, said in a Friday phone interview with Business insider. “We’re going to have a very open process.”

Pfizer and its German partner BioNTech indicated on November 9 its vaccine candidate might be more than 90% effective, meanwhile Moderna indicated that their vaccine candidate might be more than 94.5% effective. Besides, many Americans are reluctant to receive a vaccine for COVID-19 based on surveys. 

“It’s ultimately up to the FDA to decide whether it will authorize the experimental coronavirus vaccines, and the vetting process is expected to take weeks”, Dr. Marks expressed. The process requires time in order to properly evaluate the science behind the vaccine candidate. More people can be confident in the product after careful methodical steps to assess it.

“What we need here is confidence,” Marks said. “Everything that we are trying to do here, this is all about ensuring the public re-develops the kind of trust they once had in vaccines.”

Moreover, we have seen a press release so far from Pfizer and Moderna. It is now necessary to analyze the clinical data before any vaccination is made available to the public.

Hence Dr. Marks, as the director of the FDA’s Center for Biologics Evaluation and Research, will examine the data on these vaccine candidates with his team. He has articulated the transparency that will be key to this evaluation process.

“We have to take the amount of time that we need to take,” Marks said. “The caveat here with saying this word ‘weeks’ is there are situations whereby the quality of what comes in and the complexity of what comes in will determine how long it will take to do a review that we can feel very confident in.”

Furthermore, if that vetting process isn’t followed, Marks said he would resign from the agency. 

“You will see me leave if somebody said ‘we’re not going to look at the data, just get the thing approved,'” he said. 

Our Editorial Note: We have summarized an article that first appeared in Business Insider. You would need a subscription to read the content in its entirety. Contact us if you would like to learn more about regenerative medicine to treat patients with Covid-19.


0 0 votes