The following is a transcript of an interview with former FDA Commissioner Scott Gottlieb, aired on April 18, 2021, on “Face the Nation.”
MARGARET BRENNAN: We now turn to former FDA Commissioner Dr. Scott Gottlieb. He is also on Pfizer’s board of directors and joins us from Westport, Connecticut. Good morning, doctor.
DR. SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: Dr. Fauci said that we will know no later than Friday if this break at J&J will be lifted. You may not want to answer this question, but if you were still an FDA commissioner, would you have gone ahead with this break?
DR. GOTTLIEB: Well, look, I think this is a decision the FDA has to make. Right now he is before the CDC advisory committee, which I believe creates some of the challenges around the process that they have highlighted for how it will be decided that this will be resumed, the use of this vaccine will be resumed. I think it was a reasonable step to stop using the vaccine while investigating these cases. But I think this vaccine will continue to play an important role and we need to find a way to bring this back to the market with probably additional warnings, maybe with more information about who is best for this vaccine, given that these risks appear to be related to the vaccine based on what we now know.
MARGARET BRENNAN: When you say restrictions, do you mean certain age groups or certain genders?
DR. GOTTLIEB: Yes, I think you could see a situation where there is an age restriction, because a lot of people who have had this side effect associated with the Johnson & Johnson vaccine and also the side effects associated with the AstraZeneca vaccine, which, it also seemed to be a similar mechanism, they were younger individuals. And so they had a lower risk of covid disease. And they seem to pose a higher risk because of this side effect. Now, we don’t know much, so it’s hard to draw firm conclusions. But based on what we know, this is the model that appears. So you might see a situation where the vaccine is reserved for use in the elderly, who are both at a lower risk of having this side effect and also at a higher risk of having a unpleasant result from COVID. This is a possibility in terms of how the FDA would bring this back. The other possibility is to bring them back with additional warnings and advice for doctors and patients about what to be alerted to, so that if these cases occur, you can bring patients to treatment immediately and hopefully eliminate a negative result.
MARGARET BRENNAN: So, starting next week, the vaccine should be available to all adults. When was the last time you were with us, you said we were going to see more supply of vaccine than demand. Is that equation changing now that 5% of the vaccine is on the market? Or does any of this J&J complication change your forecast?
DR. GOTTLIEB: I don’t think the equation changes that much. Maybe you’ve been kicked out for a week, a week and a half. I think there are still a lot of offers on the market. And we will have a situation where vaccines will be readily available. What is changing, though, is that the J&J vaccine, as you know, was a unique vaccine. It could also be stored in lighter environments. You could keep it at room temperature for long periods of time in normal refrigeration. Therefore, it was an easier vaccine to administer under austere conditions. So, as we have trouble reaching certain communities through vaccination because of the complexity of administering current vaccines, the J&J vaccine has been a beneficial alternative. So I think the challenge now will be to establish better logistics and try to reach communities that we know are hard to reach, where the J&J vaccine made it easier and now we have to use mRNA in these settings. But I think the J&J vaccine will be back on the market in a reasonable amount of time, hopefully this week, and hopefully it will be, you know, able to be used in those populations, given what we know about its safety profile.
MARGARET BRENNAN: In February, you said on this show that you expect reminder photos from Moderna and Pfizer to be needed. Both companies confirmed this this week. So what else do you know about what is developing? Does it have to be a new type of vaccine or is it the same version of the same old vaccine, only the third dose?
DR. GOTTLIEB: Yes, both are being tested right now in big tests. So we’ll have some data on that soon. If you look at the Danish reference study that looked at people who were previously infected with COVID, how long their immunity lasted, once you took out six to six to seven, eight months in people over 65, immunity their fell to about 47%. Now, that was due to a natural infection. We know the vaccines or we believe that vaccines offer a more robust immunity than the natural infection. But you see a decrease in the immune protection provided by the previous infection in the elderly and you expect to see some degradation with vaccines as well. So I think we’ll grow. Now, the question is whether or not we use a specific vaccine for 1,351, which is under development by both Moderna and Pfizer, or simply use a third dose of the existing vaccine to be developed. But we must be careful that we do not use a specific vaccine variant 1.351, which offers better protection against 1.351, but you lose protection against anything else. And this is a possibility. And we will have a lot of data about current vaccines and how to protect against current variants. All we will have about the 1,351 variant is how it protects against the 1,351. We won’t have that much data. So I think this is going to be a challenging decision. I lost the sound.
MARGARET BRENNAN: 1,351 being the- being the variant, also known as the South African variant. I just lost the sound there. So I’m going to take a break here.
DR. GOTTLIEB: I’m back.
MARGARET BRENNAN: FACE THE NATION, we’ll be right back in a minute with – I hear it and we hope you can too. So, Dr. Gottlieb, if you can still hear me …
DR. GOTTLIEB: I am.
MARGARET BRENNAN: Let’s clarify what you were talking about with 1,351. Another question about a P1 variant, which we see that the Brazilian version has spread to Canada, in fact quite close to the US border here. How concerned should Americans be?
DR. GOTTLIEB: Well, look, I think we need to be concerned about P1, I think we need to be concerned about the variant that is spreading in India, which has two mutations, the 484K mutation that is in P1 and also the mutation that is found in that variant in Los Angeles. So these options are worrisome. At the moment, their prevalence is not high enough in the United States that I think they will leave this summer. So I don’t think I’m a short-term risk. I think there is a risk as we move towards autumn and winter that one of these new variants becomes the predominant strain. That being said, B.1.1.7 is the most widespread strain right now. And there are some people who believe that B.1.1.7 will partially remove these other variants. And so it could be harder for those …
MARGARET BRENNAN: Mm-hm.
DR. GOTTLIEB: –variants to spread here in the US.
MARGARET BRENNAN: All right, Dr. Gottlieb, it’s always great to talk to you.
DR. GOTTLIEB: Thank you very much.
MARGARET BRENNAN: Thank you for your time today. We will be back in a minute with French President Emmanuel Macron.