Virus Expert Says When We Can Finally Relax Mandates
When will COVID mitigation strategies be less strict? Former FDA Commissioner Scott Gottlieb joined SiriusXM Doctor Radio's "Doctor Radio Reports" and explained to host Dr. Marc Siegel that "we need to lean in and remove these things as circumstances improve as aggressively as we put them in place. And that's gonna be a struggle with the public health community because everyone is weary and has been sort of burned before."Read on—and to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.
Dr. Gottlieb Shares His Thoughts on the Need to Re-Evaluate & Withdraw Mitigation Strategies
"I think we need to think about how we start to lean in and withdraw all the measures we've put in place. We can't be in this perpetual state of public health emergency, and as conditions improve, we should lift the mask mandates. The first thing we should do is try to relax the restrictions in schools, so children can have as normal of a school year as they can for what remains left of the school year. There's a lot of reluctance to do that. We need to lean in and remove these things as circumstances improve as aggressively as we put them in place. And that's gonna be a struggle with the public health community because everyone is weary and has been sort of burned before. We've relaxed provisions before only to see new waves of infection emerge. And so we gotta be willing to take that risk now. We're two years into this and the mitigation has had an impact on the public."
Dr. Gottlieb Discusses the FDA's Speed Of Approvals For Vaccines & Therapeutics
"In terms of just the authorization of the drugs, I think the agency's done an admirable job. You haven't seen the scientific constructs that they use for regulatory decision-making advance as quickly on the drug side, as you have on the vaccine side. So for example, the clearest example is on the vaccine side, clearly over time, the vaccine division has decided based on the science that they reviewed, that they can use immunogenicity data. Data around the ability of a vaccine to stimulate antibody development as a proxy for assuming that the vaccines are gonna deliver a therapeutic effect. And so you didn't need new outcome studies every time you changed the vaccine. You were able to just rely on the ability of the vaccine to stimulate antibody development when you went to, for example, the pediatric formulation or the lower dose formulation in teenagers, as long as these new formulations were able to stimulate a level of antibodies against the coronavirus that was commensurate with what you saw in these older people. FDA used that as a proxy that the vaccine would deliver the same clinical effect. You haven't seen that on the drug side for example, yet. I mean, you're starting to see the agency moving in this direction, but it's been slow. So the clearest example is with the monoclonal antibodies. We now know, we should accept, that if you can develop an antibody drug that targets the virus, that binds to the virus, that doesn't cause an allergic reaction, that stays in the system for a certain amount of time, it's gonna deliver a therapeutic benefit. An antibody that's designed a certain way that binds the virus a certain way is going to help neutralize and clear that virus. And so you should be willing to approve new antibody drugs as new variants come along based on laboratory studies, based on evidence in a laboratory that the new antibody binds the virus the same way the old antibody did, and then some compliment of clinical data. But you shouldn't require outcome studies. Now, initially FDA was. FDA was saying, every time a new virus variant came along and you wanted to fashion a new antibody against it, they wanted outcomes data, data to prove that there was a clinical benefit, which required very long and large studies. And that's why you couldn't have rapid cycle innovation as new variants emerged with these antibodies. I think that that's evolving. And I think the agency's changed its posture, but it's been a slow evolution. We're now two years into this. So you haven't seen the regulatory constructs on the drug side advance as quickly as the regulatory constructs on the vaccine side."
Dr. Gottlieb Weighs in on the Disappointing Level of Uptake Of COVID Vaccines For Kids
"I said that the uptake of the five to 11 would be more brisk than what we saw with 12 to 18. And that was based on survey data that I was seeing and I felt pretty confident around that, and it's been far, far less than that. The other piece which is exceedingly disappointing, and I can't say, I don't have one reason why, but I think the misinformation and the sort of confusion around the vaccine and the criticism of the vaccine, or people who sort of sowed doubt about the vaccine has bled most clearly into what people do with their children. Like adults who are skeptical might decide, okay, I'll just, you know, I'll take it, my employer wants me to, my peer group wants me to, I'll just do it. But I think people have more resistance if they're skeptical that resistance is gonna become manifest in what they do with their children, because you're naturally very cautious about what you do with your children. So I think that that's part of it, but I don't think that there's one thing to sort of explain this. But this has been for our country, given the diversity of our nation, the complexity, the size of it, this has been a huge public health achievement. How many people we've gotten vaccinated in such a short period of time. And so we kind of lose sight of that because we focus on the percentage that isn't vaccinated. But I think we've done remarkably well for us. I mean, we're not Sweden, we're not Denmark, we're not Singapore. We were never gonna achieve their vaccination rates. We've done well for the United States, and certainly better than I thought we would get, but it just hasn't been good enough because of these variants."
Dr. Gottlieb Weighs in on How Home Testing Has Changed the Paradigm for Consumer Self-Diagnoses
"I think it's ubiquitous. I think we've changed the paradigm for diagnosis of infectious diseases, where we've fully empowered consumers to self-diagnose for what is a reportable pathogen. That precedent that we've created in the context, and I think that this has been one of the biggest sort of regulatory policy innovations coming out of COVID where the FDA now fully embraces the idea of putting a diagnostic test into the hands of a consumer that doesn't require clinical intervention. I mean, the consumer is on their own to do the right thing with the result of a test. I think you're gonna see this spill over into flu and all kinds of things where you're now gonna see innovation put into the homework. Consumers are gonna be all self-diagnosed for reportable pathogens and infectious diseases.
But in terms of supply, supply is gonna be ubiquitous. We had that shortage right around Christmas because we had the biggest wave of infection, literally in the history of the world. I mean, we've never seen an infection move through a population as fast as Omicron moved through the United States. Never. There's no proxy, no modern proxy for it so you had that up against Christmas when everyone wanted a test. And so the two things colliding created a bottleneck in testing. I don't think you're gonna see that again. I think that there's gonna be a lot of supply in the market. People are gonna stockpile these things and going forward that just won't happen again."
How to Stay Safe Out There
Follow the public health fundamentals and help end this pandemic, no matter where you live—get vaccinated or boosted ASAP; if you live in an area with low vaccination rates, wear an N95 face mask, don't travel, social distance, avoid large crowds, don't go indoors with people you're not sheltering with (especially in bars), practice good hand hygiene, and to protect your life and the lives of others, don't visit any of these 35 Places You're Most Likely to Catch COVID.