The new coronavirus variant Omicron has many virus experts “concerned, if not panicked”—and you may feel the same way, now that the first case has been discovered in America. With this in mind, former FDA Commissioner Dr. Scott Gottlieb joined SiriusXM Doctor Radio’s “Doctor Radio Reports” and told host Dr. Marc Siegel about “three things that we need to watch-out for with the Omicron variant, said whether or not he believes the Omicron variant is more virulent than the Delta variant, and the level of confidence that exists over current COVID vaccines’ ability to protect us against Omicron,” per the network. “Dr. Gottlieb also discussed barriers to world vaccination against COVID-19, antigen tests and their ability to detect the new variant, and what’s in store for the U.S. in the coming months.” Read on—and to ensure your health and the health of others, don’t miss these Sure Signs You’ve Already Had COVID.

“I think what’s causing a lot of concern is three things,” said Gottlieb. “Number one, the features of the virus itself, the fact that the virus sequence has a lot of mutations that we know are associated not just with increased immune evasion, the ability to evade the immunity that we’ve acquired through vaccination of prior infection, but also potentially virulence that could make it more contagious and a more fearsome virus. Second is the presumption that it just originated. That this is a relatively new virus, that its first entry into the human population was maybe early October, but more likely early November. So the South Africans based on the data that they have right now think that the first entry of this virus was in early November. And the third thing that’s causing concern is that they’re seeing data that suggests that there’s a lot of cases of it. And so if you have a virus that looks scary based on sequence, looks like it originated three or four weeks ago, and looks like there’s already thousands of cases. Those are three very concerning principles because it means it’s a fast moving virus, it’s spreading very quickly so it’s clearly evading immunity and causing infection. And you presume that it’s just a matter of time before you start to see people show up in the hospital and getting very sick from it. I think the key detail that’s going to get nailed down this week, or very soon is, when did this first make its entry into the human population. And here I think, that there might be some misimpression or misestimation of when it first made its entry into the human population. They’re basing the current conjecture about the fact that this may have arisen very recently in the last three or four weeks, on how much genetic diversity they see in the strains that they’re sequencing. So we know as viruses circulate in human population, they pick up a lot of mutations and most of them are inconsequential. But by looking at those small mutations, as viruses circulate over time, you can date when they first made their entry into the human population. And so they were looking at these virus sequences that they have, and they have about a hundred and they’re saying, wow, there’s not a lot of genetic diversity between these different virus samples so this must be a relatively recent entry. It’s possible that they’ve over-sampled the same cluster of illnesses and therefore they’re getting a skewed interpretation of just how long this has been circulating. So it might be widespread. It might’ve made its first entry into the human population two or four months ago, but the sequences that they have in the samples that they have are all from the same cluster of infections. So we’ll know we’ll have a better answer to that towards the end of this week, as we sequence more samples, just how much diversity there is between the sequences and how long this has been circulating. But I think there is a possibility this has been circling for quite some time. And if that is the case, then this becomes a little less worrisome than it is right now, because it means it’s probably not spreading that quickly. And it’s been spreading in South Africa against the backdrop of declining hospitalizations, declining deaths, declining number of cases, which means you have fewer people presenting for testing, fewer people getting sick. So this might’ve been spreading against the backdrop of a clinical picture that’s overall improving. One final point Marc, the best data point we have so far to try to gauge prevalence such that it is, this sort of best hard epidemiological data point, was that plane that went from South Africa to the Netherlands where there were about 650 passengers, 61 tested positive for coronavirus when they got off, which in and of itself was concerning because everyone was either vaccinated or had a negative antigen test getting on a plane, and of the 61 who tested positive 13 or 14 had this new variant, the other 48 presumably had Delta infections. So that’s a rate of 20%. And so that gives you at least one snapshot into what the prevalence might be in the community in South Africa.”

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“Too early,” said Dr. Gottlieb. “There’s anecdotal reports in the press from South African physicians that they believe this is causing less severe illness, but the composition of people who are presenting infected with this also seems to be younger. That may be a founders effect because if there’s been some early clusters in some universities and so we don’t know. If you look at the positivity rate in South Africa right now, the highest positivity rate is among adolescents and teens. And so if you presume that a lot of the infection is this new variant and what makes this new variant transmissible is the fact that it evades immunity, it’s unusual to see the biggest number of positive cases in younger people, because they’re the ones who are least likely to have pre-existing immunity. Because they haven’t really rolled out vaccines in any appreciable amount to kids. And presumably kids have been somewhat sheltered from prior infection. So there’s some things that kind of look funky here with the data, but it’s too early to tell whether this is causing more serious illness, because a lot of the infections that have been presenting are in younger people. Now, if you determine that this has been circulating for three months, four months, then you get a much more reassuring picture because you say to yourself, this has been circling for three or four months, it’s been spreading clearly, there’s community spread and over the last two months the overall impact of COVID has been declining, less hospitalizations, less deaths, less people presenting with symptomatic disease. So this has been spreading against the backdrop of an improving overall clinical picture. So that gives you some reassurance that well, this wasn’t causing a huge spike in the number of hospitalizations, for example. So that’s going to be again, getting back to my original point, figuring out when this made its first entry into human circulation is going to be an important data point that we might have relatively soon.”

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“As you know, I’m on the board of Pfizer, I’ve had the opportunity to talk to my colleagues there as well as other people. There’s a degree of confidence, and I would say a reasonably high degree of confidence that the vaccine is going to be protective against this variant. There’s probably going to be some decline in the efficacy of the vaccine relative to this variant, but we’re certainly not going to lose the vaccine. I think people feel very assure to that. And the presumption is you’re going to have a high degree of effectiveness, so maybe a vaccine that used to be 95% effective against the sort of native strain of Delta, will be 80% effective against this new variant. It’s hard to put a point estimate on it now. You’re going to need a lot more data, but you’re still going to have an effective vaccine, but it’s probably going to require a booster. So the three doses is probably going to be appreciably better than just two doses, but we’ll have data soon. We’ll have data from test tubes where what you do is you take the plasma from people who’ve gotten three doses of vaccine, people who’ve gotten two doses of vaccine, people who’ve just had prior Delta infection and you basically take the antibodies out of that plasma and you test it against the virus itself. And you see how effective the antibodies that these different people have, are at neutralizing this new virus. It’s called neutralization studies. But we need to remember from those neutralization studies, is you could see a substantial decline in neutralization, in vitro in test tubes, but still have a clinically effective vaccine. So for example, with 1351, the old South African variant, which also had immune evasion, but never really took off, it became epidemic in South Africa. It never really circulated around the world because Delta crowded it out. The neutralization studies showed a two-thirds reduction in the ability of the vaccine induced antibodies to neutralize the virus. But then when you went and looked at the performance of the vaccine in South Africa, in the real world, the vaccine was almost as effective against 1351 as it was against the Wuhan variant or the Delta variant. So you didn’t see a declining of the clinical efficacy of the vaccine, even though you saw a decline in the neutralization. And that’s because it doesn’t take a lot of antibodies to neutralize this virus in the real world. So even if you see a big decline in the test tube, as long as you still have some neutralization, that’s going to correlate to a clinically effective vaccine in the real world in most cases. So when we get that neutralization data, which we should have in the next week or two, we need to interpret it through that prism.”

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“We should have testing deployed more widely than we do. I mean, the tests are still expensive and so hard for people to obtain. Certainly hard for people to thoroughly test when a test is $25 for a box of two, or $50 for a box of two tests. That’s a lot of money if you want to do frequent testing. If you look at the UK, they basically hand out tests to everyone. So they encourage people to test very frequently. The good news is it does look like the popular antigen tests that are available in pharmacies will detect this virus. So based on some of the preliminary work that’s been done, it doesn’t look like the antigen tests that we have on the market are going to miss this. So we will have effective tests available. We just have to make wider use of them. In the case of that flight into the Netherlands, those people actually were tested before they boarded. They used antigen tests. Clearly, it missed the infection, but that also speaks to the quality of the test. In many parts of the world, including South Africa, where there isn’t a regulatory process, they don’t undergo any kind of regulatory review so you really don’t know what you’re getting, and there’s a lot of variable quality of tests.”

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“We’re closer to the end of the Delta wave than the beginning. I think that after Delta finishes its course through the U.S. and it’s already coursed through a lot of parts of the U.S. Prevalence is very low in the south and the Southeast it’s coming down very sharply in the Southwest, the Pacific Northwest, even states like Colorado which were hard hit two weeks ago have rapidly declining cases in Nevada. Right now it’s deeply epidemic in the Great Lakes region, cases are picking up in New England, but Delta is doing exactly what we said. It’s an epidemic that’s moving around the country. At the backend of this, and we’re probably going to be on the back end of this as we get into January, prevalence is going to decline and things will start to improve rapidly. Look at Florida, six cases per a hundred thousand people per day. We haven’t seen prevalence levels that low since last summer before Delta first emerged, after B117 went away. So you’re going to see prevalence decline all around the country. I think the risk is that this new variant ruins that narrative. And as you get into February and March cases in certain parts of the country will start to pick up because this new variant is creating localized epidemics. I think that there is some real uncertainty, whether that actually comes to path. I think there’s some real questions about just how pervasive this new variant is, how transmissible it is, and we’re going to figure all that out, but that’s the risk. This is a risk to the spring and it’s a risk that Delta isn’t the last major wave of infection. But even if this does start to spread, I don’t think it’s going to be a waiver of infection like we’ve seen with Delta. I think it’s going to be something that we can manage much more effectively. We have the tools to do it. There’s a lot of immunity in the population. I don’t think you’re going to get the full escape where it completely evades the vaccines or the immunity offered by prior infection. So I think at least as we get into January, we’re going to see a rapidly improving situation around the country, and then we’re going to have to figure out what kind of risks this poses.”

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“The variants tend to emerge in people who become chronically infected with the virus. Obviously more people is more opportunity for people to come chronically infected if you have more people susceptible to the virus, but they don’t just emerge from rapid spread of the virus. But there’s obviously a lot of other reasons to want to get people vaccinated, and you want to protect populations. The bottom line is there’s a lot of supply right now. There’s not the capacity to distribute it. And I think we should be doing more to try to get infrastructure into many of these hard-to-reach populations, hard-to-reach nations, hard-to-reach communities, to actually distribute vaccines on the ground. Of the eight countries that fall under the travel ban that the Biden Administration closed on Africa, five of them have told Pfizer to stop shipping vaccines because they literally can’t distribute the supply that’s been made available. South Africa right now is sitting on 16 million doses of vaccine, and also told Pfizer and J&J to stop shipping the vaccine because they can’t distribute what they have. This is a nation of 60 million people that is sitting right now on 16 million doses of vaccine. Of the 30 million doses of vaccine that Pfizer sent to the country, they’ve only used 19 million of those doses. So there is a real distribution challenge. We haven’t done enough to actually provide resources to put the infrastructure in. We’ve been talking about this as a supply issue and probably will continue to talk about it as a supply issue as long as they can, because the issues of distribution, and getting infrastructure on the ground are hard. They’re hard to solve and they fall squarely within the remit of the WHO and the NGOs. So, I understand why they would rather talk about this being an issue of supply than it being an issue of distribution, because the issue of distribution is squarely their responsibility. But eventually we’re going to have to come around to that discussion.”

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Follow the public health fundamentals and help end this pandemic, no matter where you live—get vaccinated 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.