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The FDA Faces Mounting Pressure To Grant Full Approval For COVID-19 Vaccines


Here in the U.S., the FDA is facing mounting pressure to grant full approval for COVID vaccines that are currently under emergency use. Some experts and lawmakers feel the approval would help persuade those still skeptical about getting the vaccine. And that includes Dr. Leana Wen, an emergency physician and public health professor at George Washington University. She joins us via Skype. Doctor, what does the FDA typically look for in deciding whether to grant a vaccine full approval?

LEANA WEN: Good morning. There is a process involved, a very thorough process which we want. I mean, we want for our federal regulators to do their job and make sure that whatever they're approving meet all the standards. In this case, we are in the middle of a pandemic. And exactly as you said, I think it does make a big difference if and when the vaccines that we have receive full approval. There are individuals who are saying, well, I'm not entirely sure that I want to get the vaccine yet. There is some misconception out there about how these vaccines are, quote, "experimental," even though they're not. I mean, they've been given to hundreds of millions of people around the world. But I think it will help to convince some individuals and I think very importantly it will convince a lot of businesses that are currently on the fence about vaccine requirements to actually go that step and make the vaccines mandatory for employees.

MARTÍNEZ: But is there a number or a stat or something that the FDA looks at and says, OK, it's full approval now?

WEN: Yeah. So the emergency use authorization was granted after two months of safety data. For full approval, there needs to be at least six months of safety data. We are well past that six-month mark, which is the reason why Pfizer back in May submitted their application for full approval. It's now August. And I understand that the regulatory process is complicated, but right now, it feels like a black box. And I think this is what I and other public health experts are calling for the FDA to not make this process so opaque. I mean, it would be really important, I think, for public credibility and understanding for them to say, for example, here are the 50 steps that we need in order for full approval to occur. We already have these 30 taken care of, 10 are in process, 10 are still to be determined.

I mean, there are some other things that are pretty obscure but are important for the FDA - so, for example, manufacturing capacity or long-term storage. I mean, these are things that I think if the public understood that that's what we were waiting on but actually the safety and effectiveness is all taken care of, I think that that would actually help to reassure the public. And I also think that that level of transparency would really help because when full approval comes, people will know that it wasn't politics somehow driving this process, that all the steps were very deliberately and carefully followed.

MARTÍNEZ: Dr. Wen, why don't they do that? I mean, we're all on this ride together.

WEN: Right. I mean, that is a very good point. I hope that more transparency is going to come. I also think that at this point, is there any more urgent priority anywhere in the federal government? I mean, this really should be an all-hands-on-deck effort. And I think that it would just help the American people understand. I mean, if they said, hey, look, we are putting all of our resources to bear here, but this one step just takes a really long time because we're waiting for, I don't know, for something about the manufacturing capacity, I mean, I think that would help people to really understand. And by the way, just two more reasons as to why full approval is important. One is that it actually allows for the manufacturer, for the pharmaceutical company, to do marketing. And in this case, it would actually help, I think, to have more public education.

And the other reason is once full approval comes as well, it allows for the - what we call the off-label use, meaning that there are a lot of patients who are eager to get a booster dose. The FDA has not yet ruled on whether a booster dose is allowed. And at the moment, there are immunocompromized individuals who are basically having to sneak around. Their physicians think they need a booster. They want to get a booster, but they have to go to pharmacies across state lines and pretend that they didn't get the initial shot. I mean, that shouldn't be happening. There are patients who may need to get a booster dose. And I think that decision should be made between a patient and their doctor. And full approval allows the doctor to actually start giving patients boosters, even if it's not yet authorized for everyone.

MARTÍNEZ: Aside from everything we've just talked about, is there anything else the FDA can do to make sure that this expedited process doesn't scare people even further? Because that's another argument that I keep hearing, Doctor, is like, oh, well, this is moving too fast for it to be safe.

WEN: Right. And I think this is why that transparency is going to be so important. I mean, we know - we have seen in this pandemic and, just in general, we know that public health depends on public trust. The last thing that we want to happen is for the approval to finally come and people say, well, why? Why did this happen so quickly? I mean, first, the FDA said January and then they said September. And so if we get an authorization sooner, some people might be skeptical. This is the reason why that total transparency, I think, is so important because that is key to fostering the credibility and trust that we really need in this process.

MARTÍNEZ: And I'm asking all these questions, Doctor, because I've had all these discussions with family members who are unvaccinated, and they've given me a million different reasons as to why they're unvaccinated. So that's where a lot of these questions are coming from, at least on my end. And there are people like my family that just don't trust the government with their health care decisions. So why do you think approval by the FDA, which is another government agency, is going to maybe suddenly change people's minds?

WEN: I mean, there are definitely going to be people who are not swayed by full approval. The one thing we do know based on polling data, based on interviews with individuals, is that something about the emergency use authorization, that term has been mischaracterized and has been part of disinformation. And so because there are individuals who have specifically said that once there is full approval that they'll take the vaccine, that's one of the reasons why expediting this process is going to be very important.

MARTÍNEZ: Dr. Leana Wen is an emergency physician and public health professor at George Washington University. Doctor, thank you very much.

WEN: Thank you.