With the Delta coronavirus variant posing a serious risk to unvaccinated Americans, some experts are calling for the FDA to fully approve the Pfizer and Moderna COVID-19 vaccines, which are currently being used under emergency use authorization. Yahoo News Medical Contributor, Dr. Kavita Patel, explains some of the reasons why the agency may have not given the full approval yet, and why it is important that they do at this crucial moment in the pandemic.
KAVITA PATEL: On average, when a company applies for full license approval, or a BLA, as we call it, it can take anywhere from three to six months. So currently– obviously the pandemic is very, very high priority, but it is not unusual to be waiting several months to have that approval.
Keep in mind the FDA, once they get that approval– then they no longer feel that there are as many risks to the population. And I think what you’re seeing is that the FDA is watching as we’re getting more real world evidence. For example, we are just now learning about a link with myocarditis, or inflammation of the heart, to the mRNA vaccines, including Pfizer. So I do think that the FDA is being as cautious as they can. And I don’t want them to speed up approval because people feel like they want the approval in order to get the vaccine. So the time frame is not in and of itself that unusual.
But having said that, we now have about a billion people that have received these vaccines, and so we have an incredible amount of evidence. And I think that we should demand some explanation or at least some accountability from the Food and Drug Administration as to what they’re doing. And even if the answer is we’re simply continuing to analyze data as it comes in, you know, we hope to have a decision in the next several months and that could be at least more information than we have today, it’s not knowing that’s really troubling the American public.
There are probably a lot of people who are waiting. That will be the sign of confidence that the vaccine is safe to take. So there is some real important stakes here to get the full approval. So, again, I do hope we get some communication, even if it’s an explanation that it might take more time than expected. But that will help the American public know that if it’s going to take two to three to six more months, they may want to get vaccinated today because we’re seeing newer cases of the variants in unvaccinated people almost exclusively.
I do think that full approval will allow businesses, including hospitals, and health systems, and nursing homes, to go ahead and enforce a mandate. You’re already seeing some employers and health systems mandate today, many of them have had to have those cases taken to court. It doesn’t seem like there’s a problem mandating an authorized vaccine, but an approved vaccine falls in line with what many of us in health care have to do for flu shots. For example, flu vaccines are mandated at most hospitals and clinics in the country.
The lack of an approval is also hard to swallow in the context that we know recently the FDA approved a drug, aducanumab, for Alzheimer’s which has received much criticism, has really had unremarkable trial data, and is very expensive, and not that effective per experts in the area. Compare that to the fact that we’ve got vaccines that are incredibly effective, desperately needed, and should be a no-brainer for approval. I think what’s critical to underscore there is the FDA is actually not one organization, it’s parts. And the part that deals with vaccine safety and approval is completely separate from the part that deals with drugs and other therapeutics. So it isn’t crazy that one part of the FDA has moved quickly and another part is moving but not at the same pace. However, I think it just undermines how much the FDA is doing unless somebody– and it has to be the acting commissioner– comes forward and just offers a timeline, because that’s what we want. We want clarity. Where are they in the process? Why is it taking, quote, “longer,” or how long will it take? Because if people are waiting for approval and it won’t happen for four to six months, then we need to make a case to the Americans that they need to get vaccinated today, which is what I would argue, and we should not wait for full approval since we have billions of people who have taken these vaccines and find them incredibly safe.