NOEL KING, HOST:
The CDC now says fully vaccinated people should wear masks indoors in places with high infection rates. Now, that includes most of this country, with the exception of parts of the Northeast and parts of the upper Midwest. Back in May, the agency said masks weren't necessary for people who were fully vaccinated, but two things have changed. Vaccination rates have stalled, and the delta variant is causing cases to surge. Here's CDC director Dr. Rochelle Walensky.
ROCHELLE WALENSKY: Our health systems are in some places being overrun for what is preventable. And I know in the context of all of that, it is not a welcome piece of news that masking is going to be a part of people's lives who have already been vaccinated.
KING: Dr. Scott Gottlieb is the former head of the Food and Drug Administration. He's also a member of Pfizer's board, and he's joined us throughout the pandemic. Good morning, Doctor.
SCOTT GOTTLIEB: Good morning.
KING: Do you think the CDC's guidance is wise?
GOTTLIEB: Well, look, I think that there is some transmission occurring among people who are vaccinated, and we've been saying that for a while. I've been pointing out for a while at this point, the vaccine doesn't make you impervious to infection. There's probably some people becoming mildly or asymptomatically infected, even with the vaccine, given how transmissible this variant is. But I think at this point, where we are with this delta wave, which is probably closer to the end than the beginning, and the fact that probably a very small percentage of the transmission is occurring among vaccinated people, I don't know how prudent this is and practical it is.
I think the bottom line is people who are vaccinated shouldn't assume that they're completely impervious to the infection. They can get a mild infection or asymptomatic infection, so if they're around people who are at high risk - young children, elderly individuals - they should be mindful of that. They should potentially wear a mask. They should certainly get tested if they feel like they could have symptoms of mild COVID because the vaccine doesn't make you impervious. But I think in terms of telling everyone who's been vaccinated that they need to now start wearing a mask again - I think that's going to be very little bang for our buck in terms of trying to reduce transmission right now in the context of this wave of infection.
KING: Why do you think we're closer to the end of this wave of infection than the beginning?
GOTTLIEB: I don't think we're doing a good job of measuring how much spread is actually underway in this country. I think that we have far more spread than what we're picking up. First of all, we're not doing a lot of testing. A lot of the testing that's being done is antigen-based tests that are being done at home and not getting reported. A lot of the people who are getting infected right now are younger people who aren't presenting with significant symptoms, so they're not even seeking out testing.
If you're someone who is vaccinated and you develop mild symptoms of COVID, you're unlikely to get tested because you're unlikely to assume that you have COVID. If you're someone who's in your 30s or 40s and you develop mild symptoms of a cold, you're unlikely to seek out testing because once again, you're unlikely to think that you have COVID. So generally speaking, the people who are presenting for testing are either people who are getting very sick or people who are developing telltale symptoms of COVID, like loss of taste or smell. So we're picking up probably a very small fraction of the overall infections.
At the height of the epidemic in the winter, we were probably diagnosing 1 in 3 or 1 in 4 infections. Probably during the wave of infection last summer, we were diagnosing probably 1 in 10 infections. I wouldn't be surprised if we're only turning over 1 in 10 infections right now, maybe less than that. So if you start to impute that and you factor in how many people remain unvaccinated and vulnerable to this infection, it's about maybe 80 million Americans that are unvaccinated and remain vulnerable to this infection. Probably a lot of them have now been infected with this delta wave. We probably have a lot more infection in the states where vaccination rates are low than what we're picking up.
KING: But we don't have, like, solid numbers that tell us that's true. Is that part of the problem, we're speculating?
GOTTLIEB: Well, that's the biggest part of the problem. You know, CDC has a retrospective mindset in terms of how they operate. They really don't have a perspective mindset. They don't do real-time forecasting, and they don't collect all the data that's necessary to make real-time decision-making. They'll come out with a very good analysis on how wide this delta wave was, what the scope of it was, and how much infection we actually had and where we were in the epidemic. Probably in about eight months, they'll publish that in the Morbidity and Mortality Weekly Report. So we don't have good real-time information to guide these decisions.
CDC made a unilateral decision to stop tracking outpatient infections among vaccinated individuals, I'm told for cost reasons. They didn't have the resources to do that. So they don't know. They don't have data on how many infections, for example, are occurring among unvaccinated individuals. They're making an estimate that there probably is some infection among vaccinated individuals, and so they want to urge them to be prudent as well and be cautious with this new vaccine - with this new mask mandate. But they don't actually have that data 'cause it's not being collected.
KING: OK. California and New York City have now mandated that some state and city workers, and health care workers in the case of California, have to get the vaccine or submit to regular testing. And our reporters at NPR have told us that they're talking to people who say, look, the FDA has not fully approved the vaccine yet. I don't want to do it. You used to head the FDA. What do you think about this concern?
GOTTLIEB: Well, look, I long felt that the FDA would approve the vaccine probably within a three or four-month time frame from when the application was submitted. Those applications were submitted about 2 1/2, three months ago, including the application from Pfizer, the company I'm on the board of. I think they submitted the application in late May. So I think that puts you on an end of August, September time frame in terms of when these are going to be approved.
A lot of what FDA is doing right now is going through what we call the CMC portion of the application - basically, the portion of the application that deals with the manufacturing of the vaccine so that they can put appropriate language in the labeling on what the storage and handling requirements are going to be for the vaccine when it's put into general distribution 'cause remember, we've been distributing the vaccine through special vaccine distribution sites. A vaccine comes off the production line, gets shipped, gets used.
Once you fully license the vaccine and it's put into normal distribution, it's going to sit in warehouses. It'll sit in pharmacies. It might sit in doctor's offices. So you have to inform what the appropriate handling and shelf life is of the vaccine. And a lot of the information they're reviewing right now probably deals with that. Probably the clinical portion of the review - a lot of that's already done because that information has been coming into the agency on a rolling basis, and they've been evaluating the clinical performance of this vaccine all the way through. So I think that you're going to see these get fully licensed.
But the reality is the bulk of the work and what people think of in terms of the core of the application and the clinical data - a lot of that's already been reviewed. The agency has gotten comfort around that, in my estimation. I do think once these get fully licensed, though, which is probably in short order - I do think you're going to probably see more businesses step in and mandate vaccines within the workplace.
KING: Oh, you think we're going to have companies saying, you need to get a vaccine if you want to come back in here?
GOTTLIEB: Certainly if we see government agencies do it, municipalities, we're going to start to see businesses do it as well. And I'm talking to a lot of businesses that are contemplating this, and they're waiting for full approval to make that decision.
KING: OK. Dr. Scott Gottlieb is the former head of the FDA. Thank you for joining us this morning. We appreciate it.
GOTTLIEB: Thanks a lot. Transcript provided by NPR, Copyright NPR.
