As the United States approaches 50 million confirmed COVID-19 cases and 800,000 deaths, but only 60% of the population is fully vaccinated, the USA TODAY Editorial Board spoke Tuesday with Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration who now serves on the board of Pfizer. Questions and answers have been edited for length, clarity and flow:
Q. Give us an overview of where we are right now.
A. Unfortunately, because we haven’t achieved the kind of vaccination levels that we need to create a sufficient firewall, delta has been a highly regionalized epidemic. Many parts of the country have gotten through their delta wave; we’ve seen prevalence come way down. On the back end of this delta wave, there was a presumption by me and others that delta would be the last major wave of infection, because all the mutations that would arise would be within the delta lineage. Omicron has the potential to change the equation. It’s still a big unknown about how it’s going to behave, if this is a virus that is innately more virulent, and some of the genetic data suggests it could be. But it’s just not presenting as a serious disease. You do worry that if it becomes widely epidemic, eventually it’s going to seep into pockets of vulnerability and could cause bad outcomes. We’re also going to have much more sequencing data becoming available. The South Africans have gotten more access to sequencing resources, so I think you’re going to see many more samples get sequenced, and that’s also going to provide a better window into the genetic diversity of this virus.
Responding to omicron:We don’t know much about omicron, but we know how to respond. We have this whole time.
Q. On the weekend talk shows, Dr. Anthony Fauci was saying that America may have to just learn to live with COVID. What does that look like to you? How will we know when we’ve gotten cases to as low as we can hope to, and then, how do we get there with variants popping up?
A. This is going to eventually become a seasonal virus. It will spread alongside flu, and we’re going to have to do things differently in the wintertime to mitigate the risk of respiratory pathogens, because the twin impact of COVID and flu circling the same time is going to cause a sufficiently high level of death and disease. We’re not going to be able to be as complacent as we are now or were before COVID about the risk of respiratory pathogens in the winter. What does that mean? I think mask wearing is going to become more common, culturally. It may even be required at certain points of the year in certain congregate settings. I think home testing is going to become ubiquitous. There’s going to be much more effort to get people vaccinated for both COVID and flu. We’re going to have to think about air quality in congregate settings. We’re going to have to think about how to try to have more prudent gatherings in the height of COVID and flu season, you know, the idea of crowding 40 people into a small room in a restaurant for a Christmas party, we might do things differently. Eventually, we’ll migrate the vaccines down to younger kids. We have tools to try to address some of the pockets of immune vulnerability in the population, while for most individuals the vaccine will be sufficient, and this will continue to circulate at some level. This is going to probably continue to cause in the foreseeable future upwards of 80,000 to 100,000 deaths each winter. That’s equivalent to a very bad flu season. Then you have flu as well. That’s not a sustainable impact. We’re going to have to be more cautious around respiratory diseases in the wintertime.
Q: Are there steps President Joe Biden should be taking that he isn’t yet? On the flip side, is there a possibility that some of the things that he’s trying to do around, say, workplace vaccination mandates, that there is a counterproductive side? It seems to be reinforcing a situation where vaccines are very much a political issue and diluting the message that vaccines are a good thing for your health, the health of your loved ones and the health of people around you.
A. The administration’s done a very good job scaling some of the tools that we’ve been using to combat this virus. We have a massive testing and sequencing enterprise in this country now that was basically built out of last year – 100,000 samples a week is pretty massive, given the fact that we started with like 5,000 eight or 10 months ago. The administration made good decisions around boosters. The lesson of the rollout of the initial vaccine was that you can’t just sort of throw it over the transom; you have to put in place the infrastructure to actually roll it out and deliver it. Mandating vaccination for health care workers, that makes eminent sense. We require health care workers to get vaccinated for chickenpox, for hepatitis, for flu. Why wouldn’t we require them to get vaccinated for COVID? Mandating vaccination for the federal workforce is well within the purview of the president and the issue of federal readiness. I think when you went to the private businesses, though, I worry that this sort of created that political fault line. No matter what they do, there’s going to be 10% of Americans that are not going to get vaccinated. We’ve reached the limits of sensible policy. The booster is going to provide much more robust protection against variants.
Q. What are you telling your own family and relatives about mixing up the boosters?
A. I don’t think it’s better or worse to mix it up. My advice would be try to stick with what you got if you can. But don’t worry about it if you can’t. The bottom line is, these are all very effective vaccines. I wouldn’t have any hesitation about using these things interchangeably. What I’m telling my family is get what you can get.
Q. Let’s turn to testing, specifically rapid antigen testing. The U.S. has been a little bit slower to adopt this than some other countries. Most recently, the Biden administration announced that people with private insurance will be able to get reimbursement for rapid antigen testing. Are we doing all we can to provide access to this type of testing?
A. The advent of at-home rapid test is probably the biggest paradigm change in regulation of medical products to come out of the pandemic. If you would have said to me when I was at FDA that we will authorize tests to allow people to test at home for infectious diseases, I would have told you it’s never going to happen. And you saw all the resistance of the agency going back a couple decades, and I was there during this time, of allowing at-home HIV tests. There was a view that if you allowed someone to self-diagnose for something that was a serious illness, there was no guarantee that they’re going to take appropriate actions on the basis of that test result. And with COVID they just got over it. This is going to open up a whole new field of at-home testing for a range of pathogens. We really kind of have a critical window here. We still have three, four, hard months ahead. We have the back end of the delta wave, and then we have omicron to deal with. Flooding the market with home diagnostic tests for the next four months to me makes eminent sense, and the best way to do that is to directly subsidize it. If you get enough tests out there, people aren’t going to hoard them, because they’re going to recognize they’re just widely available. You go to the U.K., they offer you tests in pharmacy now people turn them down – like I have enough already.
Q. What about the broader public health infrastructure in this country?Respect for public health has plummeted nationwide. How do we rebuild that?
A. I think we have an inadequate public health infrastructure, and I think we need to look at public health through the lens of national security and public health preparedness through a national security lens. We don’t have a consensus around this. This isn’t just a right, left divide. There is a broader section of the population that is skeptical, and some of that skepticism is for good reason. Public health officials weren’t transparent about the basis for their decision-making. At times it seemed arbitrary, and so a lot of people have become skeptical. We’re going to have to address that before we get to the second question of how do we properly empower and resource public health agencies.
Q. With the emergence of omicron we saw a lot of countries react with updating travel restrictions, whether that’s changing the testing requirements or banning travel from certain countries. What do you think are good steps at this point and what steps are unnecessary?
A. We can’t just erect travel bans every time a country raises their hand and discloses that they’ve discovered a new variant. If we’re going to be punitive every time a country does the right thing, the subset of countries that do the right thing is going to get smaller and smaller and smaller. We could have achieved most of what we wanted to achieve by slowing the introduction of this virus into the United States, by putting in place additional enhanced measures – requiring people to vaccinate if they’re going to travel to the U.S., requiring them to be tested in the prior 24 hours. That in and of itself is intrusive and onerous; it’s going to dramatically cut down the number of people who travel, but it’s not a complete travel ban. The countries that are really restricting travel completely in sort of perpetuity, countries like China, I don’t know that’s going to be sustainable in the long run. There’s been some countries that have done that to try to buy themselves time to get their population vaccinated, but doing that in perpetuity as a strategy I don’t know what the endgame is on that. You can use some enhanced measures like testing, like vaccination, as a way to try to mitigate spread, but you’re not going to eliminate it, especially a big country like ours, an open society.
Q. And then what are your thoughts on requiring boosters for travel?
A. If, in fact, the booster is seen as something that’s important to be a backstop against omicron and start to change the definition of what it means to be fully vaccinated – I don’t think we’re going to change the travel requirements until we change the definition of what it means to be fully vaccinated.
Q. The second largest school district in the country (the Los Angeles Unified School District) is looking at rolling back some of their testing. With a lot of reluctant populations about vaccinations, does that sound wise?
A. I’ve been a big proponent of testing in the schools and adopting what’s been called test to stay. Instead of a positive case leading to everyone having to be put in quarantine, when you identify a positive case, you test the people around that positive case, you know they’re all negative you let them stay, and then you serially test them and make sure they don’t develop an infection and introduce it into school settings. You actually use testing to keep kids in the classroom, not to create mass quarantines that force people to have to go to remote learning.
Q. Is there anything you wanted to say in closing?
A. The one thing that has allowed us to tolerate this pandemic better than we otherwise would have is that kids weren’t getting very sick. If kids were excessively vulnerable to this in the same way older people were, it would have changed how society grappled with this. And omicron – I’m not saying it represents that risk, but it represents some uncertainty about that potential risk. Because if you look at it, and you talk to the virologists, they say this looks like a stream that should be more virulent. Now it’s not behaving that way, so far, but we don’t know.