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Pfizer could apply for COVID-19 vaccine emergency use by November

Dr. Michael Saag, Associate Dean for Global Health at the University of Alabama at Birmingham, joins Yahoo Finance’s Akiko Fujita to discuss U.S. surpassing 64,000 new COVID-19 infections for the first time since late July.

Video Transcript

AKIKO FUJITA: The number of daily coronavirus infections continues to point to a troubling trend– on Thursday alone, 65,151 new cases reported. That is a 25% increase from two weeks ago, according to data out from “The New York Times.” And that is the most in a single day since July. Overall we’ve seen the total number of cases now pass 8 million here in the US. This comes on the back of some new developments on the vaccine front. Pfizer CEO now coming out and saying that he will not apply for emergency use of the vaccine until mid-November after the presidential election.

Let’s bring in Dr. Michael Saag. He’s the associate dean for global health at the University of Alabama at Birmingham. And, Dr. Saag, let’s start by talking about this very latest coming out of Pfizer– the CEO coming out with this letter saying essentially that yes, we’re going to go through the proper protocols here, and we won’t likely know the efficacy of this vaccine until the end of the month. We’ve seen a number of developments on the vaccine front this week. Largely seems to point to the fact that these drug makers, despite the political pressure, are putting the protocols in place into right way.

DR. MICHAEL SAAG: Right. So the earliest they would be applying for early use authorization would be mid-November, based on that report. But I want to emphasize– that’s assuming that the vaccine works. And so I don’t know that Pfizer would have any access to information because it goes in a confidential way to Data Safety Monitoring Board.

For the vaccine to be approved at that level, it has to be about 70% efficacious. It has to be preventing about 70% of cases, and they won’t know that until the end of this month. So if they’re not seeing that type of efficacy, the release of the application will be delayed probably into the first quarter of 2021, if it works at all. So that’s what we have to wait and see.

AKIKO FUJITA: Where is Pfizer positioned right now in the larger vaccine race? We had Johnson & Johnson this week as well as AstraZeneca pause their trials because of some concerns with at least one patient. Where is Pfizer positioned?

DR. MICHAEL SAAG: So Pfizer and Moderna both have what’s called mRNA vaccines, which are fragments of nucleic acid that are used as a vaccination. It’s important to note there’s not a single vaccine ever used with that technology before. So this is all brand new, new frontier stuff. The AstraZeneca and the J&J product are more traditional vaccines that use kind of an attenuated or a live virus that’s been modified, and those are the ones that have a little bit more immunogenicity– [AUDIO OUT] –profile could be more intense.

And I think both of those studies have been halted or at least paused, so I would– they’re paused, not halted– because of some safety effects noted in one or two patients. That’s to be expected. We see that a lot in vaccine development. We’re not seeing that yet with the mRNA vaccines.

AKIKO FUJITA: Doctor, let’s talk about the increase in these case counts, certainly a troubling trend. We’ve seen a big uptick in the Midwest but also rural areas, which is sort of a new development. When you look at what has played out over the last six or seven months, what are you seeing there, and why did it take so long to see that kind of uptick in those rural areas?

DR. MICHAEL SAAG: You know, it’s really pretty straightforward. The vaccine just wants to infect people. And when we give it an opportunity to infect, it we’ll do just that. And that’s what we’re seeing. When the virus goes into a community, if that community is letting their guard down, that they’re not wearing masks, they’re not keeping distance, washing hands frequently– all the stuff we know to do. When that’s not happening, the virus just says, great, let’s have a party. And it does.

You know, Yogi Berra said years ago, predictions are always difficult, especially when they involve the future. Well, these predictions aren’t so hard to make. We’re having people now going back indoors. We’re having less outdoor activity, and we’re having epidemic fatigue. Everyone’s tired of this. Everyone’s tired of all the stuff that is being put on them, and I think it’s starting to show in the numbers.

What we have to do is double down on our efforts to do all the things we know that work. We’ve seen outbreaks in the White House. We see what Chris Christie said yesterday. Let’s triple down on mask wearing and keep ourselves safe.

AKIKO FUJITA: Doctor, you’re in Alabama there were obviously college football a big part of the culture. And on that front, we got some developments this week from the University of Alabama. The head coach there, Nick Saban, testing positive for the virus. It feels like we’ve gone a few weeks into the season pretty smoothly. Are we starting to see some of the cracks here in the system? And what does that say about the rest of the season when we have yet to have the Pac-12 come on board? We’re looking to expand the season even further, and we’re already starting to see these case counts go up.

DR. MICHAEL SAAG: Yeah, to me it’s pretty remarkable. Nick Saban, who I’ve watched from a distance for many years, is one of the most careful, methodical, disciplined individuals that you can think of. And the fact that he might become infected tells you that even when you’re doing everything possible, it still can happen.

So the protocols are pretty good for college football. They’re maybe even better for professional football. They were great for the NBA because they had the bubble. So there’s a scale– there’s a gray scale of risk. But I think that the colleges and universities are doing a really good job overall, but I think the fact that Nick Saban could get infected with this virus tells us that even when the best procedures are applied it still can happen.

But I want to emphasize that if we did all those procedures ourselves, we would see the numbers coming down. We wouldn’t see these spiking up to 60,000. We would see more of a return to where we want to be in terms of reduced cases. So if we can double down on that we’ll be better off.

AKIKO FUJITA: I mean, the reality is when you look at the professional sports leagues, it’s only basketball and hockey that have actually come out without any positive cases on the other end because they had a bubble in place. Is this still worth the risk? When you talk about college football, the fact that we’re already seeing starting to see some of these case counts, is it still worth playing?

DR. MICHAEL SAAG: That’s a judgment I guess we’d all have to make. I think it’s a balancing act between safety and degrees of how much we value football or other sports in our society. So I don’t want to take a position on that too strongly. I think as long as we’re aware we– this is not rocket science. This is Epidemiology 101. This is a lot easier to forecast than, say, the market or what you guys do all the time.

We know that if we do the protocols properly, we stick to that, that the risk can be minimized. And I believe it can be safe to engage in the activities. But we have to understand that there’s still risk, and infections will occur, hopefully at very low rates.

AKIKO FUJITA: Yeah, no question. Nothing is fail proof. That’s what we’ve learned about the virus so far. Dr. Michael Saag, the associate dean for global health at the University of Alabama at Birmingham. Good to talk to you.

DR. MICHAEL SAAG: Good talking with you. Thank you.

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