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FDA vaccine advisors weigh need for booster shots

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Anjalee Khemlani joins Julie Hyman to take an in-depth analyst on the FDA meeting to determine the efficacy of promoting COVID-19 booster shots at this moment in time and what the impact of this decision could mean for the nation going forward.

Video Transcript

ANJALEE KHEMLANI: It really is the big day where the FDA'S advisory panel is discussing what to do about boosters. The question before them right now, as this panel is discussing, as we speak, is whether or not to approve Pfizer's booster shots for the broader population in the US. Specifically, knowing that we are dealing with the Delta surge, as well as generally speaking, the outlook for the future when it comes to the fall and winter months. And that's really top of mind right now.

We know that there has been data coming out of the UK, out of Israel, and some coming from the company of Pfizer specifically itself, and that is all being discussed at the FDA advisory panel today. And the panel is going to need to vote on whether or not to approve, broadly speaking, that booster shot for Americans.

Now, we had a chance to speak to Moderna President Stephen Hoge, about what is being really discussed here. What they're looking at in terms of the data. What does it tell them, and what are some of the maybe segments of the population that might benefit the most from a booster. Here's what he has to say about that.

STEPHEN HOGE: This is the key scientific question we're all wrestling with right now, which isn't how the vaccines are doing today. It's how are they going to do this winter, three months from now, when we would expect there to be an increase in cases as people go traveling for the holidays and come together. It's important to note that there's a higher risk for those who are older and those who have co-morbidities. And so while we do see breakthrough cases across the entire adult population, and we ultimately do think there's a benefit to boosters for the whole adult population, it's clear the need is most acute in those over the age of 65 or those who have diabetes, obesity, or chronic pulmonary diseases, other things that put them at high risk of severe disease if they ever did get COVID-19.

ANJALEE KHEMLANI: So as you can hear, there's a very specific focus on parts of the population. And part of what some health experts have discussed, it's also important to note that there's been a lot of criticism about two things. Number one, if you recall, there was a "Lancet" article where the two FDA top officials who oversee the vaccine discussion, who are departing at the end of October, discussed along with World Health Organization officials, the need for global distribution of vaccines and vaccine equity there.

And secondly, the idea that much of the data is actually not coming from the US and so that puts a question mark on exactly how that can translate. We know that the FDA did look at the data and did say in briefing documents that they are not independently able to verify the information in some of this data and therefore, it could entail some known and unknown biases that sort of puts a question mark on the reliability. So that's also on the table for them to discuss.

We know FDA'S Peter Marks at the start of the meeting today, did say that vaccine equity for global distribution was off the table. And if the discussion did pivot, he would sort of gently pivot it back to the focus, which is, of course, the broad distribution of a booster. So a lot to really focus on today and to see where things land.

It does seem based on the question posed to the FDA, that there may not be room to decide on whether certain segments of the population might benefit more and whether or not to then approve for those certain segments of the population. But instead to have a broader approval. And we also know, of course, that once they decide on it, it will sort of be a blanket in terms of authorization for any other upcoming discussions, whether it be from Moderna or for Johnson & Johnson other vaccines down the line. Back to you.

JULIE HYMAN: You know, Anjalee, at least on an anecdotal basis, some people are going out and getting them already. They're going out and finding a way to get those booster shots. It seems to me a bit of a-- I don't know, disingenuous of that Moderna executive you spoke to say, well, in the winter things are probably going to get worse. Because with the Delta variant numbers now, we've already seen spikes, even with the warm weather. So one would think that would be already a pretty good test of the efficacy of the double shots that people have gotten. It just, it's very confusing, as you know, for people to figure out if they should be worrying about getting these things.

ANJALEE KHEMLANI: That's true. It is kind of confusing. And that's something that they are looking at, is there was a graph that was shared that looked at specifically the unvaccinated that are hospitalized and then the vaccinated that are hospitalized. And broadly speaking, most health experts seem to be on the same page, in terms of breakthroughs are specifically expected because those might be milder cases or not as severe as you would see across the broader population if there were no vaccines involved.

And in fact, that is one of the things that the FDA panel is contending with right now, is the question really is about severe cases and the focus on that. So that's important to keep in mind is that the FDA is not looking at necessarily preventing infections altogether and have acknowledged that the Delta variant is responsible for some of these breakthrough cases. So it really is a matter of right now, we know that there are still some segments of the population, like children who are not vaccinated and that's been pushing the numbers up, as well as the idea that adults who are unvaccinated are also pushing the numbers up.

So there's a lot going on right now. And we of course, know that the administration is pursuing private sector vaccinations in hopes of pushing those numbers up before the fall and winter anticipated surge.

JULIE HYMAN: Hey Anjalee, one more follow up question for you. Isn't part of the problem here is that here in the United States, we're not collecting complete data pictures anymore. I don't know if we ever were, but is the FDA, is the administration, is anyone addressing the need to do that?

ANJALEE KHEMLANI: I mean, they're aware. We don't know much more than the fact that they haven't been able to collect and in fact, in some instances have stopped collecting. The system unfortunately, is very fractured in how it's collected and relies largely on the state level collection in order to inform federal decisions. And so that's where that disruption really keeps coming from, is whether or not states have decided to stop collecting or what level of detail they're willing to collect and whether or not it's an electronic system or something that is done by hand.

In some parts of the country, data is still being collected by hand and that's why the Israeli data is so important because they have had a centralized system in place from the beginning, in order to inform. And that's where that relationship with Pfizer even came from. It's important to note, by the way, I'm glad you brought this up because it's important to remember, that the Israeli data is a result of Pfizer specifically creating that contract with them in order to collect the data and use it as part of real world observational studies and create, or basically borrow from that to make decisions like the one we're facing today.