Q&A: COVID Variants Don’t Pose That Much of a Threat

Doctor Anthony Harris didn’t hesitate in the least when Infection Control Today® asked him if the new strains of coronavirus disease 2019 (COVID-19) concerned him. “No,” said Harris, MD, MBA, MPH. Harris is the chief innovation officer and associate medical director at WorkCare, a company that helps businesses with their infection prevention and control problems. WorkCare does a lot on the occupational health safety front. Harris also thinks that the COVID-19 vaccines are safe and that federal agencies have more or less given businesses the OK to make employment contingent on employees getting those vaccines. That’s because the agencies agree that COVID-19 “meets the litmus test that’s been used in the past of an imminent threat. That COVID is an imminent threat in the workplace.” As for COVID-19’s ability to mutate into variants? “So far, it’s not alarming because it hasn’t caused any more severeness of illness,” Harris tells ICT®. “And to the contrary, it actually may cause less severe illness, even though it’s more transmissible, if you would. We’ll see how this plays out in terms of a safety standpoint.”

Infection Control Today®: How do companies handle the whole vaccination process? Or how should private industry handle the whole vaccination process?

Anthony Harris, MD, MBA, MPH: First and foremost, determining the approach to vaccine requirements for your workforce, right? And that’s probably one of the most prominent considerations at this point in time with the vaccine now being in that 1a, 1b phase of distribution. And so, when we talk about what’s required and what’s not, it’s going to be industry specific. Obviously, health care, where you’re having high interactions between the employee workforce and the general public—patients, in this case—it’s required. But considerations should be looked at in terms of those industries that have a lot of employee and customer or patron interactions. And those are the considerations that the company should maybe perhaps require vaccines for their workforce. And if we look at the opportunity from a legal standpoint, we know that ADA [Americans with Disabilities Act], EEOC [Equal Employment Opportunity Commission], CDC [Centers for Disease Control and Prevention] have all kind of greenlighted that process for companies to make those requirements, because it meets the litmus test that’s been used in the past of an imminent threat. That COVID is an imminent threat in the workplace. And we’ll see how it plays out with companies in regard to these requirements outside of the health care industry.

ICT®: That’s interesting. You’re saying that those agencies that you just mentioned greenlighted employers to say, “You can’t work for us unless you get the COVID vaccines.” Is that an accurate paraphrase?

Harris: It is. Now EEOC has not come out and made a statement saying we are clearly supporting mandated requirements for vaccination. They haven’t done that yet. It may be coming. But what CDC has said is that we know that employers have a requirement under the general duty clause of OSHA [Occupational Safety and Health Administration] to keep the workforce safe. And this current pandemic, as some have been in the past, passes the litmus test for the definition of what’s called an imminent threat. And because of that, companies then are permitted to require vaccination. And interestingly, on the flip side of it, there may be litigation from the workforce if companies don’t require vaccinations to keep everyone in the workplace safe because of that threat. And the litigation would follow because the companies would be called to the mat on not keeping the workforce safe under that general duty clause. So again, there’s been legal arguments on both sides of the opportunity to protect the workforce with required versus voluntary vaccination.

ICT®: What do strong unions have to say about this? Might they get caught in the middle?

Harris: Just from my own anecdotal experience with unions: My profession is occupational medicine specialist, right? We’re seeing perhaps teacher unions come down on the conservative side. They’re saying, “Look, we want to do everything within reason to keep our members safe.” We’ve seen it play out in cities amongst the teacher workforce, to say, “Look, we want to continue to be remote. We want to be remotely teaching our students because of the risks of being there in person. Likewise, it would follow that we see the vaccine as an opportunity to keep our workforce safe, our members safe. We want to have that as an offering for those teachers.” It may not be required. But certainly, it would be something that they would push for in terms of access, and early access as a means to protect their members.

ICT®: I have to ask you this question. I often ask experts this. Did you get the vaccine?

Harris: You bet. I received my vaccine several weeks ago. I get my second dose next Monday. I received the Pfizer vaccine. You bet I’m going to be the front of the line because I want to set the tone and the example for the physicians we work with across the country and in our organization that work here, as well as the workforce that we work with. We take care of several million lives in terms of the touch that we have with the companies we support. And we want to continue to undergird the safety of the vaccines—the Moderna, the Pfizer—and the efficacy. Because at the end of the day, the magic number here in the US to reach that herd immunity is approximately 196 million individuals. Either from natural immunity having recovered from COVID or vaccinated. And we’re not going to get there anytime soon if we don’t have people lining up to receive the vaccine. And if you look at the polls, it’s as few as 40% to 60% who say they’ll actually get the vaccine in the general public. And you know, we need higher numbers than that. Because, again, it’s not going to be everyone who develops immunity from these vaccines themselves.

ICT®: When you get the first dose, are you limited to what you can do and what interactions you have with people until you can actually get the second dose? How does that work?

Harris: The numbers play out in terms of risk, and what the efficacy of each vaccine is, which determines your, I call it, safety level, if you would, or the number of precautions you need to take from a personal health standpoint. If you get that first dose of Pfizer/Madonna, you’re about 80% likely to have developed immunity if you look at the phase three clinical trials. After that second dose, you’re about 95%. That means that 5% of people after the second dose may not have immunity. With that vaccine, if we look at AstraZeneca, that number is much lower in terms of the number of people who respond to the vaccine, only 70% efficaciousness. For the AstraZeneca, 30% of people may not be immune after their second dose of AstraZeneca. In terms of the practicality of a day-to-day precaution for an individual who’s received the vaccine, myself included: Still have to wear masks. Still have to practice safe social distancing, because until such time that we’re on the other side of having most people vaccinated, and we start to measure the immune response, i.e. what’s called a titer. If you’re familiar with how vaccines have worked in the past, that titer will say, “Yes, I’ve taken your blood, I see the immune cells and the antibodies in your blood against COVID.” And you should be protected. It won’t be until we have a use case like that more prominent in the general public, that we’ll probably start dialing back on precautions. And so far, we are not just this year away from it, but well into next year before we see those type of changes.

ICT®: Now these vaccines were granted under emergency use authorization by the FDA. Does that kind of possibly temper what employers can expect from employees as far as getting the vaccine? You know better than I do that the anti-vax movement has been growing over the last couple of decades.

Harris: In terms of that FDA EUA, emergency use authorization, and the kind of inference from that. Does that denote any lower level of safety than the full application and approval of a medication, in this case, the COVID vaccine? And the answer is not as far as we know. These manufacturers—Pfizer, Moderna, AstraZeneca—will still need to apply and receive their full approval from the FDA, not just EUA. But if we look at the robustness of the clinical data, the phase three clinical trials, I mean, we’re talking a powerful study that we would normally see in the full process done much more quickly. From a safety profile standpoint, the mRNA vaccines Moderna and Pfizer, have a far lower side effect profile than a lot of the common mainstream vaccines that we’ve been getting for decades. It’s that body of data that allows us in the clinical community to say, “Look, these vaccines are safe.” But you’re right. To your point earlier. We don’t know the long-term effects from these vaccines. The mRNA vaccine is new. First time it’s been approved for use in the US. We’ll see how clinically things play out over time. But there is no evidence to suggest that mRNA vaccines would cause any long-term side effects, because of the very nature of how the vaccine functions in the human body.

ICT®: Do you think that the COVID-19 vaccine will have to be given every year or every other year?

Harris: It’s likely. If we look at the seasonality potential of COVID, it’s there. And it will track with the flu season as well. And many have speculated that even back in the spring in the summertime, and what even Doctor Anthony Fauci has said is we’ll be likely dealing with COVID for five years at a minimum, with the cyclic nature of mutations that occur called genetic drift and genetic shifts that we’re seeing now in COVID. This new strain out of the UK, the strain out of South Africa. We’ve been seeing these strains from day one out of Wuhan, China, when there were only two strains identified at that point in time, the S and the L strain. But now we have multiple … what are called clades—families of mutations that have propagated around the world. And because of that, it may happen that each season, we have to re-up on our vaccines with a different formulation, just like we do with the flu. But we’ll see how it plays out with this round of vaccines protecting from the different mutations that are coming out that we’re identifying. They should still be efficacious. But long-term over the course of another year, the mutations may be substantial enough on that spike protein, which allows the virus to enter cells that our antibodies don’t recognize it. We’ll find that out over time for sure.

ICT®: A two-part question. How many people have to be vaccinated? I’ve heard anything from 80% to 90%. The second part of the question is, were you surprised by how fast we got the vaccines out? It’s kind of fashionable to paint the pharmaceutical companies as bad guys. Full disclosure, Infection Control Today® has a story on our website saying that the scientists and researchers at the pharma companies came through and are heroes. I don’t want to put you on the spot, but were you surprised by how fast it happened?

Harris: No, not at all, actually. We know that yes, traditionally, it can take up to 10 years for an FDA approval for a pharmaceutical. And that process is not necessarily predicated on time intervals that are hard and fast. We know that there are some there in the US and abroad, Australia, the UK, that have definitive timetables that you must adhere to. However, a lot of it is resource dependent. What we’ve seen in terms of this concerted effort is a lot more resources that will go in and be included in the Operation Warp Speed program poured into the effort to develop these vaccines. And so instead of having a slow, gradual ramp up, from a resource standpoint, it accelerated because of the increased attention and increased dumping of resources into these programs. The key though is: Were these studies robust enough? Did they have a high enough number of participants to really understand what are the potential untoward effects of these vaccines? And the answer to that is “yes.” To the extent that we have done so, and comparatively with a longer process, we can still say that the side effects are few and that vaccines are safe. To the other point of the question … well go ahead and reiterate the second part of the question.

ICT®: Is it 80% or 90% for herd immunity?

Harris: That number is dependent on what’s called the reproductive rate of the virus—the R-naught. The reproductive rate just means how many people are infected on average by one person with COVID. The reproductive rate right now nationwide is between 1.2 to 1.5, meaning 1.2 to 1.5 people are infected by one person with COVID. If we look at some states, in some cities, that R-naught number is as high as 5, in some studies. Meaning five people are infected by one person on average. And that means a greater number of people need to be vaccinated or have immunity to reach that herd immunity. If the number is 1.2, herd immunity happens around 40%. If the number is more realistically around 2.5, then the number jumps up to 60% need to be vaccinated. Again—and the data are showing—we are woefully underestimating the true burden of COVID in the US, because we just don’t have enough testing going on. And what that means is that we’re probably sitting closer to an R-naught of 4 to 5 meaning that 80% of people need to be vaccinated. We’ll see where we land at the end of the day after these new strains and new levels of infectiousness are fully understood. But I would anticipate—as most experts are—60%, 65% is the minimum we need to reach. But it may be as high as 80%.

ICT®: Do these new strains concern you? Are you worried about them?

Harris: No. From a clinical standpoint, in terms of severity of illness, the UK strain, as you mentioned, B.1.1.7, has not been shown to have people develop more severe illness. It may be more infectious in terms of how quickly it can be communicated. As we’ve seen before with the L strain of the virus back in Wuhan, China. In terms of overall concern that we’re going to see a shift in regard to how we have been experiencing COVID-19: No, I’m not very concerned. Because we’ve seen this before. We have a myriad of … I believe there’s over 11 different clades or families of mutations that have occurred thus far. Some literature says 18 times the spike protein has already mutated. It’s not alarming that it’s happening. So far, it’s not alarming because it hasn’t caused any more severeness of illness. And to the contrary, it actually may cause less severe illness, even though it’s more transmissible, if you would. We’ll see how this plays out in terms of a safety standpoint. The same precautions to protect us from this strain and other strains with the social distancing the wearing the masks, that’s key,

ICT®: What role so you think infection preventionists will play in the vaccine rollout?

Harris: They’ll be on the frontlines administering the vaccines. They’ll continue to be on the frontlines, obviously caring for patients that are being on the intake side of things into the clinical care. But also, I think, as we see programs developed around keeping the general public safe, the workforce safe, they’re going to be frontlines again, drawing blood and looking at antibodies toward the end of this year, beginning of next year, confirming that our vaccination efforts are working. And we’re trying to understand how long people are indeed immune to COVID once they received the vaccine, once they recovered from an infection of COVID. There are a number of ways that [infection preventionists] are going to continue to be on the frontlines helping us fully understand the impact of COVID-19 and get to the other side of it.

This interview has been edited for clarity and length.