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3 reasons why FDA advisors rejected Pfizer’s booster for the general public

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Meg Fitzgerald, “Ascending Davos” Author and Columbia University Healthcare Policy Professor, joins Yahoo Finance Live to discuss the future of vaccines, the FDA rejecting Pfizer's booster shot for the general public and the importance of getting young children vaccinated as soon as possible.

Video Transcript

- We're continuing to track updates on the coronavirus and vaccine front. And the topic of booster shots has been closely watched this past week with an FDA Advisory Panel rejecting a booster shot recommendation for most recipients of the two-dose Pfizer vaccine, while endorsing booster shots for those 65 and older or at high risk of contracting a severe case of COVID-19. Now Dr. Anthony Fauci supported the panel's decision. And here's what he had to say in recent public remarks.

DR. ANTHONY FAUCI: The real proper regimen will turn out to be the original two shots plus a boost. But you want to do that according to what the data tells you, including the risk benefit ratio, particularly for the younger people who do not generally get as much severe disease as the elderly and others.

So I believe that there's a good chance that as we get into the coming months into the next year, that you will see the data pointing to the benefit of having a much broader blanket of people. We don't know that for sure now, and that's the reason why data are going to continue to come to the FDA and they're going to continue to evaluate it.

- For more on this, we're welcoming in Meg Fitzgerald, PE Investor, Author of "Ascending Davos" and Healthcare Policy Professor at Columbia University. And Meg, thank you so much for joining us on this topic. Now of course, the topic of booster shots, whether they should be offered, and to whom in the US has been one that's been hotly debated. What do you make of the FDA Advisory Panel's latest decision?

MEG FITZGERALD: I think what we're seeing is a transparent process, which is what the American public would like to see. They don't want to know anyone's front running the FDA in the normal process for evaluating vaccines. And I think the FDA Advisory Panel spoke pretty clear for three reasons.

One, the evidence just wasn't there. They would like US data, a lot of the evidence was in that elderly population, which guided them. Second, the vaccines are doing their job. The primary job was to prevent hospitalizations and deaths, and we're still seeing that at north of 90% for most of the vaccines. So I think they also felt like those at risk are really the group that they wanted to focus on.

And I think the last part of Dr. Fauci's commentary is probably the most important, and that is the data is going to continue to roll in. Over the weekend, we saw some data that Moderna was not showing as much of a waning and immunity. And they also want to look at that. This morning, we got data in from Pfizer on one of their cohorts.

So I think we're going to be talking about this every week. And the FDA and the CDC are going to continue to meet as the data comes in. And they're going to stage-gate this. So the guidance will continue to be updated.

- Meg, I could certainly appreciate the focus on booster shots in the US. But shouldn't officials here be more focused on getting the rest of the world vaccinated?

MEG FITZGERALD: It's a great question, Brian. And in fact, that even came up. That was one of the other reasons they said we rather see people in the US get a first dose.

And this week, the UN General Assembly is meeting to talk about this. Less than 1% of low income countries have been fully vaccinated. We've sent around the world about $6 billion doses. 75% have gone to high income countries.

It's a major problem because we know as long as this virus can find a host, it's going to find more variants. It's going to continue to infect people at highest risk. And the data is pretty unanimous that we need to get those at highest risk a first dose. So it'll be interesting to see if the UN General Assembly takes this on. I actually think the meeting this week is just as important as the FDA meeting last week.

- You know, given that, Meg, still so many people around the world have yet to get vaccinated. Now, of course, we're focusing here in the US on boosters. I haven't heard this debate come up for a little bit. But can we find the raw materials to make all these vaccines? Do you expect another supply shortage?

MEG FITZGERALD: I think I'm not hearing that, except for in Africa. They're saying a few reasons aside from just supply from the US. They don't have raw material. There's challenges with export restrictions. They also don't have the logistical manpower and talent.

We saw how hard it was to roll out the vaccines here in the United States. You can imagine in places where it's hard to find people how difficult it is. So I don't think that's really the debate to be had. I think, you know, even is why we talked about the J&J vaccine on this broadcast several times.

One dose doesn't have to be handled as special as the other vaccines. Might be a way to get it to these remote locations. But I'm not hearing that raw material is totally the problem. And we certainly if we have extra supply, we should be sending it there. And that's what the WHO is asking of us.

- Meg, you briefly mentioned this in your earlier response. But of course on the topic of the Pfizer data, the company is saying that the COVID-19 vaccine did produce a robust antibody response for 5 to 11-year-olds. I'm wondering, as we move ahead with this age group, how does this change the game, if at all, in terms of the public health crisis that we're in right now with so many parents of course concern for their children who to date had been too young to actually get the vaccine?

MEG FITZGERALD: Yeah, I think it's major news now. I don't know what type of review this will go through. It'll be either four, six weeks. But we could have emergency use authorization for this cohort by Halloween, which would be huge because we know that children are not at higher risk of death. But we're seeing a straight uptick in hospitalizations.

And so we know that they are being affected by the Delta variant. And a lot of parents are very worried about that. There are also vectors, kids can spread this as well. So I think it's really important news. What's interesting is that the vaccine is currently approved for older teenagers.

But when I looked at the data this morning, it looks as though only you know mid 40% of that group is fully vaccinated. So it'll be interesting to see even with an emergency use authorization in a younger cohort, are parents going to get their kids vaccinated? It'll be an interesting stories that unfolds.

- And then one other thing that I want to ask is it does seem like the Delta variant cases are starting to peak and perhaps start to plateau in the US. Are there other variants of concern that you're monitoring right now?

MEG FITZGERALD: Yeah, I mean, they list variants of concern, variants under investigation. It goes back to the comment we made. As long as you have large swaths of the global population unvaccinated, variants are going to find a way. Well, we'll go through the whole Alphabet. Every week on this show, we'll be talking about a new variant of interest or variant of concern.

So I'm not as concerned. I think Delta was pretty bad and the evidence of the data is showing how significantly more, you know, communicable that variant was compared to, say alpha. But you never know. I think we'll always be talking about variants, which is why we really need to vaccinate the world.

All right, thank you so much for breaking that down for us. Meg Fitzgerald, PE Investor, Author of "Ascending Davos" and Health Care Policy Professor at Columbia University.