Below is a transcript of an interview with former FDA Commissioner Scott Gottlieb, which aired on April 18, 2021 on “Face the Nation”.
MARGARET BRENNAN: Now let’s move on to former FDA Commissioner Dr. Scott Gottlieb. He is also a member of the Pfizer board of directors and accompanies us from Westport, Connecticut. Good morning, doctor.
DR. SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: Dr. Fauci said we would know by Friday at the latest if this break in J&J would be eliminated. You may not want to answer this question, but if you are still an FDA commissioner, would you have moved on with this break?
DR. GOTTLIEB: Well, look, I think this is a decision the FDA has to make. Right now he is facing the CDC advisory committee, which I think creates some of the challenges around the process that they have outlined on how it will be decided to resume and resume the use of this vaccine. 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 it to market with perhaps additional warnings, perhaps additional information on who is best suited for this vaccine, as these risks appear to be related to the vaccine based on what we know now.
MARGARET BRENNAN: When you say restrictions, do you mean certain age groups or certain genders?
DR. GOTTLIEB: Yeah, I think you could see a situation where there’s an age restriction, because a lot of people who had this side effect associated with the Johnson & Johnson vaccine and also the side effects associated with the AstraZeneca vaccine, which also seemed a similar mechanism, they were younger individuals. And therefore, they were less likely to suffer from covid disease. And they seem to run more risks from this side effect. Now, we don’t know much about it, so it’s hard to draw firm conclusions. But as far as we know, this is the pattern that is emerging. Therefore, you may see a situation where the vaccine is reserved for use in the elderly who have a lower potential risk of this side effect and a higher risk of having a poor COVID result. This is a possibility in terms of how the FDA would recover this. The other possibility is that they will only return it with additional warnings and advice to doctors and patients about what to be alert to, so that if these cases appear, patients can be treated more immediately and, hopefully, a bad result can be avoided.
MARGARET BRENNAN: So, starting this coming week, the vaccine should be available to all adults. When you last met us, you said we were about to see more vaccine supply than demand. Does this equation change now that 5% of the vaccine is off the market? Or does any part of this J&J complication change the forecast?
DR. GOTTLIEB: I don’t think the equation changes that much. Maybe they kick you out for a week, a week and a half. I think there is still a lot on offer in the market. And we will have a situation where vaccines will be readily available. What does change, though, is that the J&J vaccine, as you know, was a unique vaccine. It could also be stored in easier environments. You have been able to keep it at room temperature for extended periods of time in normal refrigeration. Therefore, it was an easier vaccine to administer in austere environments. Thus, to the extent that we have problems reaching certain communities with vaccination due to the complexity of the distribution of current vaccines, the J&J vaccine was a beneficial alternative. So I think the challenge will be that we have 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 environments. . But I think the J&J vaccine will be back on the market in a reasonable amount of time, I hope this week, and I hope it is, you know, that it can be used in those populations given what we know about its safety profile.
MARGARET BRENNAN: You said on this show in February that you expected reinforcing shots from, you know, Moderna and Pfizer to be needed. The two companies confirmed this this week. So what else do you know about what they are developing? Does it have to be a new type of vaccine or is it the same version of the same old shot, just a third dose?
DR. GOTTLIEB: Yes, both are being tested right now in big rehearsals. So, we will have some data on this very soon. If you look at the flagship study in Denmark where people who were previously infected with COVID were observed, how long did their immunity last, once they went from six to six, eight months in people over 65, their immunity went reduce to approximately 47%. Now, that was due to natural infection. We know the vaccines or we believe that vaccines provide more robust immunity than natural infection. But you see a decrease in the immune protection offered by previous infection in older individuals and expect to see some degradation with vaccines as well. So I think we will increase. Now the question is whether or not we use a specific vaccine for 1,351, which is being developed by both Moderna and Pfizer, or whether you only use a third dose of the existing vaccine that needs to be developed. But we must be careful that we do not use a specific vaccine variant for 1,351 that provides better protection against 1,351, but protection is lost against everything else. And that is a possibility. And we will have a lot of data on current vaccines and how they are protected against current variants. All we will really have about the 1.351 variant is how it protects against 1.351. We will not have so much data. So I think this is going to be a difficult decision. I lost the sound.
MARGARET BRENNAN: being 1,351 the variant, also known as the South African variant. There we just lost audio. So I will take a break here.
DR. GOTTLIEB: I’ll be back.
MARGARET BRENNAN: FACE THE NATION we’ll be back in a minute with -I’m sorry and I hope you all can too. So, Dr. Gottlieb, if you can still hear me …
DR. GOTTLIEB: I am.
MARGARET BRENNAN: I was clarifying what you were talking about with 1,351. Another question about a P1 variant, which we are seeing as the Brazilian version spread to Canada, is really very close to the US border. What concern should Americans have?
DR. GOTTLIEB: Well, look, I think we have to worry about P1, I think we have to worry about the variant that also extends to India, which has two mutations, the 484K mutation that is in P1, and also the mutation found in this variant of Los Angeles. Therefore, these variants are worrisome. Right now, their prevalence isn’t high enough in the United States that I think will take off this summer. So I don’t think they’re a short-term risk. I think it’s a risk when we go into fall and winter that one of these new variants becomes the predominant strain. Now that said, B.1.1.7 right now is the most common strain. And there are some people who believe that B.1.1.7 will partially eliminate these other variants. And so it can be harder for those …
MARGARET BRENNAN: Mm-hm.
DR. GOTTLIEB: –Variants 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.