The FDA faces increasing pressure to give full approval of the COVID-19 vaccineExBulletin

Martinez, Host:

Here in the United States, the FDA is facing increasing pressure to give full approval for the COVID vaccine currently in emergency use. Some experts and lawmakers find approval to help convince people who are still skeptical about getting the vaccine. This includes Dr. Linawen, an emergency physician and professor of public health at George Washington University. She joins us via Skype. What does the FDA usually ask for when deciding whether to fully approve a doctor, vaccine?

Riana Wen: Good morning. There are processes involved. It’s a very thorough process we want. That is, we want federal regulators to do their job and make sure that what they approve meets all the criteria. In this case, we are in the middle of a pandemic. And, as you said, if we had a fully approved vaccine, I think it would make a big difference. Well, some say they still don’t know exactly if they want to get the vaccine. There is a misconception that these vaccines are “” when they are not. That is, they have been given to hundreds of millions of people around the world. But I think it helps to persuade some individuals. It is very important to convince many companies that are currently at stake about vaccine requirements to actually take that step and require their employees to vaccinate.

Martinez: But are there any numbers or statistics that the FDA looks up and says “OK, now fully approved”?

Wen: Yeah. Therefore, an emergency use authorization was granted after two months of safety data. At least 6 months of safety data is required for full approval. Pfizer filed a full approval application in May because it’s well over the six months. It’s August now. I understand that the regulatory process is complicated, but now it feels like a black box. And I think this is what I and other public health professionals are asking the FDA not to make this process too opaque. So I think it’s very important here to show here the 50 steps needed to get full approval, for example, for the trust and understanding of the people. We have already taken care of these 30 and 10 are in progress and 10 have not yet been determined.

So while there are some other pretty ambiguous ones, there are some that are important to the FDA. For example, manufacturing capacity and long-term storage. So if the public understands that’s what we’ve been waiting for, I think it’s actually all about safety and effectiveness. I think it actually helps to reassure the people. Also, when full approval is obtained, people know that it is not politics that drives this process, but that all steps have been taken very carefully and carefully, so that level of transparency. I think it really helps.

Martinez: Dr. Wen, why don’t they do that? In other words, we are all riding this vehicle together.

Wen: That’s right. So that’s a very good point. I hope it will be more transparent. Also, are there any urgent priorities somewhere in the federal government at this time? So this really needs to be a full-fledged effort. And I think it only helps Americans understand. So, if they say, hey, look, we’re putting all the resources here, but this one step takes a very long time as we’re waiting for something about manufacturing Capacity, that is, I think it really helps people to understand. By the way, there are only two more reasons why full approval is important. One is that it actually allows pharmaceutical companies to market their manufacturers. And in this case, getting more public education would actually help.

And another reason is that with full approval, what is called off-label use is possible. This means that many patients want booster immunity. The FDA has not yet decided whether booster immunization is allowed. And now there are individuals with weakened immunity who basically have to sneak around. Their doctors think they need a booster. They want to get a booster, but they have to go across state boundaries to the pharmacy and pretend they didn’t get the first shot. That is, it shouldn’t happen. There are patients who may need to obtain booster doses. And I think we should make a decision between the patient and the attending physician. And with full approval, doctors can actually start giving boosters to patients, even if it has not yet been approved for everyone.

Martinez: Other than what I just talked about, is there anything else the FDA can do to make this rapid process less scary to people? Doctor, well, this is like moving too fast and unsafe, as that’s another argument I’ve been listening to.

Wen: That’s right. And I think this is why that transparency is so important. That is, we know-we saw in this pandemic, and just in general, we know that public health depends on public trust. The last thing we want to do is finally get approval, and why are people, well? Why did this happen so early? That is, the FDA first said January, then September. Therefore, some people can be skeptical if they get approval earlier. I think that’s why its complete transparency is so important, as this is the key to developing the trust and trust that is really needed in this process.

Martinez: And I’m asking all these questions, Doctor, I had all these discussions with my unvaccinated family, so millions to me why they weren’t vaccinated He gave me a different reason. So, at least on my part, many of these questions come from it. And some, like my family, don’t trust the government for medical decisions. So why do you think the approval of another government agency, the FDA, will suddenly change people’s minds?

Wen: So there are definitely people who don’t depend on full approval. One of the things we know based on polling data based on interviews with individuals is that something about emergency use authorization, the term is mischaracterized and is part of disinformation. is. And some individuals have specifically stated that once vaccination is fully approved, it is one of the reasons why facilitating this process is so important.

Martinez: Dr. Lina Wen is an emergency physician and professor of public health at George Washington University. Thank you very much, doctor.

Wen: Thank you.

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