Jeff Goad, PharmD, MPH

In the few moments we have left, I want to go around to each of you and get 1 recommendation or 1 prognostication about where we’re going to be a year from now. Donald, can we start with you?

We have to make it a priority to vaccinate the unvaccinated. We also must address the inequities in vaccine distribution and manufacturing in the developing world. There will be a lot who remain unvaccinated, they need to practice CDC [Centers for Disease Control and Prevention] mitigation strategies to prevent transmission.

 Just to follow up: if pockets of unvaccinated spark outbreaks, the silver lining is that pockets of highly unvaccinated prevent outbreaks. You can do a lot in your community if we can’t get the entire globe vaccinated.

Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS: 

A plus—if there is 1—to media panic over a new variant is that we’re paying attention to the rest of the world. Hopefully that will get more focus on vaccinating Africa and other parts of the world that aren’t nearly vaccinated enough to protect us all, including them.

I can’t agree more with everything that was just said. I’d just like to reinforce the idea that global vaccine equity is altruistic, but it’s also selfish. If we don’t want to keep playing Whac-a-Mole with different variants, constantly responding to a crisis, it’s in our best interest to make sure that unvaccinated people—whether they live in a lower middle-income country or a wealthy country like the United States—have access to vaccines. It’s crucial that we do everything we can to get them vaccinated. At the population level, that’s our best protection.

From my perspective, get vaccinated. If you’re in a high-risk, high-exposure position or if you’re high risk, get the booster. Let’s move forward. The more people who are immune to this, the fewer passages through human beings this virus goes through, the fewer mutations, the less we have to worry about. I want to thank all of you for this terrific discussion. You guys are just great. I’ve never heard Whac-a-Mole used to describe vaccine research, but it makes perfect sense to me.

I want to thank you at home for watching this 

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Key opinion leaders provide some advice for the public regarding COVID-19 booster shots and look to the future of the pandemic.

COVID-19 Booster Shots and the Future

What are the roadblocks with the COVID-19 booster recommendations? What do we do about them? How do we address them? Donald, do you have any suggestions?

Yes. One roadblock is the messaging around boosters. There’s always late-breaking news on boosters and how the eligibility criteria change over time. The public has yet to be able to keep up with those changes. Vaccinators are also finding it difficult to keep up with these changes. When people come to our vaccine events, they’re confused about whether they’re eligible. They show up, but some of them don’t understand that they have to get this booster 6 months after their complete vaccination with the 2-dose regimen. Being able to find [availability for] these boosters is difficult for some underserved populations as well. We see a lot of things happening with the boosters, but boosters are out there for people who want them. One problem is that so many people don’t want them or the first or second dose as well.

Of these 2, I get the sense that the priority is to get people their first and second doses.

Are there enough boosters out there that everybody who wants a booster can get a booster? Jason?

In the United States, there’s absolutely no shortage of supply. If anything, it’s the opposite. We have a relative oversupply. To give a little perspective: I live in New Jersey, which despite popular opinion is a wonderful state, and 1 major way of getting vaccines in the first and second dose into people was through these megasites, old department stores and so forth. Those have closed down. The boosters have been shunted largely to smaller clinics, pharmacy chains, and so forth. So the logistics have changed as well. I wonder what that’s like in more vaccine-hesitant communities. Have similar problems have occurred?

What about employees and employers? There’s a lot of controversy over requiring employers to vaccinate, much less boost, their employees. There’s a lot of pushback. I saw an article in the newspaper the other day that many large retailers are reluctant to implement mandatory vaccination, even large retailers with huge employee populations. They need the employees without regard that unvaccinated employees may turn these large stores into superspreaders. Is that a fair criticism, Jason? What do you think?

I’ll throw this out there: I strongly support vaccine mandates. The only way forward is through vaccinating our public. Booster mandates aren’t something I’m willing to go down. I don’t think it’s the same degree of importance. Truthfully, I haven’t thought about it, and don’t want to think about it yet. I don’t think that’s the major goal. It’s trying to get those first and second doses into more people to protect one another: the customers and especially the patients they serve.

All right, let’s look at the future. Nobody is being asked to do anything but prognosticate, which means it’s uncertain and we’re not going to hold you to it, although we’re being recorded. People are going to be boosted. A year from now, will this influence hospitalization rates? Will the boosting influence severe disease rates? Angie, what do you think?

In vaccinated populations, in immunized populations, we see hospitalization rates decrease. One way or another, people are going to be exposed to the spike antigen from SARS [severe acute respiratory syndrome] coronavirus 2. A year from now we’re probably going to have a lot of unvaccinated people who have at least some residual immunity through exposure and infection. I wish that weren’t the case, because anybody who dies in that situation is a preventable death, but that’s the reality. We’ll see increased immunity at the population level without vaccines.

Immunity from infection can be incredibly variable; it may not be that long lasting. But we also expect this virus to become endemic, which means we’re not going to be rid of it anytime soon. In the United States, we’ll eventually move from being in constant crisis mode to a more “normal.” I hate to use that term, but for a lot of people their lives will go back to being more like they were in 2019, before we had heard about SARS coronavirus 2. In other parts of the world, that process is going to take different periods of time, and that has to do with vaccination.

The real wild card is that this is a zoonotic virus. It’s also a very generalist virus; it can infect many species. We already know that other animal reservoirs have been established, including white-tailed deer, cats, and several small carnivores such as raccoons that are susceptible to this virus. There’s a lot of opportunity to establish an animal reservoir, and we’ve seen zooanthroponotic transmission or, as some people call it, reverse zoonosis, in which people are giving the virus to animals and then they’re giving it back to people. That’s exactly what happened after the mink farm outbreaks in Denmark.

I’m concerned, and several of my colleagues have observed that omicron is so evolutionarily different. One explanation for why it wasn’t detected before it emerged in the human population is that it’s the result of transmission through a different animal species. Given that, it’s going to be very hard to predict the new variants we might be dealing with and how they might impact a vaccinated population. But the good news, as Donald pointed out at the beginning, is that the vaccines have proven to be very cross-protective against severe disease, hospitalization, and death for all the variants of concern that we’ve looked at. That’s going to be the marker that we’re always going to have to look to. In a year’s time, in the United States, Canada, and countries that have adequate access to vaccination, we’ll stop living in acute pandemic times and move into the chronic phase of endemicity.

Did I take from what you said that you’re expecting there to be some degree of herd immunity in a year or 2 in the United States?

I think so. I know we don’t have time to get into this, but this has been confusing for a lot of people who say, “I had COVID-19. Why do I have to get vaccinated?” I don’t think we’ve done a good job explaining to people that infection-acquired immunity exists, but it’s not as reliably robust and durable as vaccination-induced immunity. This has been a real problem, but it does confer some level of immunity. If unvaccinated people are exposed, especially if they’re reinfected and exposed multiple times to the virus, eventually they’ll develop memory immune responses. That may be somewhere on a protective spectrum.

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Drs Angela Rasmussen and Donald Alcendor detail the roadblocks facing COVID-19 booster shots.

COVID-19 Booster Shot Roadblocks

It’s one thing to say, we looked at the antibody levels and they’re down to 70% of where they were in the first month after you got the second dose. But I think what the public needs to hear or is asking to hear, which we don’t have an answer for is, does this make a difference? Is 70% enough? Why do I need a booster if I’m already immune? Seventy percent sounds pretty good to me. How do you message that to people who don’t have a statistical background? Does anybody have any suggestions here?

I think you must tell people that if they’ve gotten their complete vaccination regimen, that they are completely vaccinated. Of course, a booster is recommended. Again, you wouldn’t say mandatory. When I think about boosters, I think about a targeted population; people that have a situation where their immune system is more likely compromised and are more subject to waning over time because of age and condition. I think this is more appropriate for boosters because I think in the long run, what we will have is a virus that will become endemic in our population. The idea of thinking that we can chase variants with boosters is a failed effort, and I think we must realize that. Think about it this way, if we have a variant that comes along that is resistant to all the immune protection that we have already to the other viruses, are we simply going to make a new vaccine and start to vaccinate 360 million people all over again? This would be impractical. We must look at this in a practical way. This vaccine made to the same antigen, all the vaccines have the same antigen in them, from the original Wuhan strain. The idea is that they have been able to protect against 4 of the 5 variants of concern outside of the Omicron variant. I think down the road it’ll be proven that vaccination protection will also protect to some level, and I think appreciable level, this new variant.

: I think people are uncomfortable with medical recommendations. This isn’t physics, and they don’t get it. I think people make recommendations based on population data, the best data we have to date, and safety recommendations based on large population studies. It’s not always A plus B equals C; A plus B usually equals C, and it’s pretty good to within a statistical variability, but it’s not the same. It sounds to me as if some of what we’re hearing about the waffling on the messaging is not waffling at all, rather simply medicine is good as it can be and never will be much better than that. Angie, you’re shaking your head.

: No. I agree with that. I think that the messaging is a problem and I think that it’s been a problem throughout the entire pandemic. We’ve had a very difficult time communicating uncertainty to the general public. We’ve had a very difficult time communicating a lot of basic things that we take for granted: how vaccines work, how viruses work, how viruses replicate, how viruses are transmitted, and what mutation means. We’ve had a really hard time really communicating these things to the general public. When a broad public health recommendation is made, when you’re trying to make those recommendations on the fly in the face [of] a lot of uncertainty, and also when there’s a whole giant peanut gallery of people criticizing the public health agencies’ every move, it becomes very challenging to get it right every time. I think that we do the best that we can, and the public health agencies do the best that they can. They sometimes get it right and sometimes they don’t. If anything, I think that one of the biggest problems has been also the politicization of basic public health practices. That has put additional barriers beyond what already existed in terms of people’s willingness to engage with these complicated topics. With most people that I’ve talked to, they just want to be safe and want this pandemic to be over. Then when there’s this whole other political element to it as well, and the misinformation and the disinformation coming at them from all sides really, I don’t blame people for being confused. I don’t entirely blame the public health agencies for making missteps sometimes. It’s just a really challenging environment to be dealing with all of these different moving parts and try to chart the correct path through all of this.

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Donald Alcendor, PhD, and Angela Rasmussen, PhD, explain how to discuss the importance of COVID-19 booster shots with patients.

Communicating the Benefit of COVID-19 Booster Shots to Patients

Now that we’re well into the public relations campaign for boosters—it started out high-risk, then it moved down in age, now it’s pretty much available across the board for adults—there’s talk about making it available for children. How do the number of individuals receiving boosters right now compare to the number of individuals who’ve already received the first 2 doses? Jeff, do you have any numbers on that?

Yes. The CDC [Centers for Disease Control and Prevention] tracks it. I haven’t looked recently, but one of the nice things about the COVID-19 dashboard is it gives you partially vaccinated, fully vaccinated, and they’ve now added boosted vaccinated. You can look every day and see how many people have gotten their booster dose.

: If you really want to do this there’s a website, it’s a CDC website, right? Not that it means anything particularly but in terms of public health it might. In other words, we got everybody except for the 40 million, small group (not) vaccinated. Now the boosters: are we looking to get 100% booster on top of 100% vaccination? Or would 100% vaccination be enough? What do you think, Jason?

Man, that’s tough. I don’t think that getting the entire population is nearly as important as getting the 40 million vaccinated. I think that’s not even comparable in terms of its overall importance.

I’ll ask this a different way because I think that you brought this up earlier, Donald. It’s one thing to look at the science. It’s one thing to look at blood levels. And it’s one thing to look at antibodies. What I want to know is clinically, and I ask this again, do we see a trend in boosted people compared to those who simply had the first 2 vaccines that are unboosted? Is there a trend in their hospitalizations, in the severity of the disease if, and when, they do get COVID? Is booster making a clinical difference right now in the community?

I don’t think we know yet. One of the shortcomings of our surveillance system is that we don’t link very well. The hospitalization, the severe disease, and even just testing positive to the vaccine, those must be done in separate studies. We don’t have a prospective system.I don’t know if we know, though it’s been out there long enough. Remember, we just changed from may to should just very recently. I think the jury is still out on that.

Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS:

 I think we’re looking towards Israel for some of this data, and their data is not perfect but it’s better than ours. They have been going with a booster campaign longer. We’ll get more information, and there’s the suggestion of severe disease declining in certain populations. However, I don’t think it’s particularly firm just yet. Pfizer has a study of 10,000 patients where they were randomized to receive a booster versus non, and the end point was infection. It wasn’t severe disease. But that I think is the most solid data to show the efficacy of the booster. It was preventing breakthrough infections, which could have been quite mild. Not looking at severe disease, which is obviously the true end point of concern.

Jeff Goad, PharmD, MPH, and Angela Rasmussen, PhD review the population trends of COVID-19 booster shots.

COVID-19 Booster Shots: Population Trends

Is there any evidence to suggest that there’s a safety and efficacy difference amongst the booster shots across various manufacturers, Donald?

 I would think not. Not in any serious way. Meaning, in terms of protection, if we think what a vaccine should do, I talked about this before: prevent severe disease, prevent hospitalizations, and prevent death in people that receive it. Between those 3 vaccines there’s no difference.

Check box number 2. What are the risks associated with the booster compared to the second shot or first shot initial vaccination? Is there a difference? Do we have to worry with our third or second, depending on how you did the first immunization, more than we worried with the first 1, Jeff?

For example, if you look at the Pfizer data, what they saw in the third dose or booster versus second dose, they’re very similar. The adverse event profile looks similar from dose number 2 to booster, which was more than dose number 1. I think that’s what we’ll see throughout the other vaccines that people anecdotally reporting and that we’ve seen in studies. There is no difference from the second dose.

Check box number 3. This comes up all the time. What are your recommendations regarding the booster shot in pregnant and breastfeeding populations? Is that a reasonable question, Jason?

That’s a wonderful question. I’m so glad it came up. I feel like it’s worth more than just the check box because this is a highly under-vaccinated population that’s at enormous risk of complications from COVID-19. Every time it comes up, I think of a specific patient. However, some of the worst outcomes I’ve seen personally have been in pregnant women and they’re heartbreaking, truthfully.

Let me be very clear. You’re saying some of the worst outcomes are COVID in pregnant patients, not from vaccines in pregnant patients?

Yes, wholly not my intention of course. I was specifically talking about COVID outcomes in unvaccinated pregnant women. Almost everyone that’s in our hospital with COVID is unvaccinated, truthfully. That is the population that just breaks my heart the most because they’re young, they’re healthy, and they’re 2 people. Their outcomes are poor. So it’s essential that they are vaccinated and boosted if they’re time-wise eligible.

So it’s safe and efficacious both in breastfeeding populations and in pregnant populations?

Yes. And this has been tracked. At first there was no reason to be worried, though obviously individual people were. There actually is data now saying that this is safe.

 I just want to remind folks that in the Moderna trial, some of the women became pregnant during the time they received the vaccination. Simply meaning that they got the vaccination and became pregnant. The idea is, they followed those women. I think it was about 36 of them. Eighteen of them were in the vaccine arm and again they followed them. There were no ill effects seen. Moderna also looked at 1000 rats looking for changes in fertility, changes in the amount of pups they had, and changes in pregnancy in these animals. They saw no ill effects. That was a bell ringer for the women that were pregnant to get this. Of course, ACOG [American College of Obstetricians and Gynecologists] and all the governmental bodies for health and wellness of women have approved that.

I just want to add too that this is something that ASIP [American Society for Investigative Pathology] periodically revisits. They look at the rates of miscarriage and stillbirth over backgrounds, and there’s absolutely no increase whatsoever in vaccinated pregnant people compared to unvaccinated.

An explanation of the risks associated with COVID-19 booster shots.

Risks of COVID-19 Booster Shots

 Let’s keep discussing safety. What does the evidence suggest about the safety and efficacy of the booster shots across the various manufacturers? Donald, is there any difference?

 When you look at the second shot or the first shot of the Johnson & Johnson, side effects that might occur are side effects that are very similar to the initial doses. They don’t see anything that’s dramatically added in terms of side effects. However, this is from person to person and can change from one individual to another. Again, a person could experience a severe adverse event with any of these vaccines.

One of the things that was clear to me is that when there wasn’t a lot of media attention on any vaccination program, the number of people who had severe side effects was calculated, documented, and we went forward. If it was more than what we thought was reasonable, things changed. Here, the instant there’s an adverse reaction anywhere, it is front-page news. People don’t have the experience of seeing vaccine rollouts before. Whether it’s clots, neurologic complications, myocarditis, they don’t necessarily have the statistical background to evaluate this is 1 in a 1,000,000, 1 in 10,000,000, 1 in a 100,000. What does this really mean? What are my chances? How do you combat that? How do you deal with that?

 You want to try to explain to them that we have been taking vaccines for decades. I talk to parents all the time. I explain to parents about their experience with vaccines, and they have quite a bit. I ask them, “Do you have a child that goes to public school?” They tell me yes. I say, “To go to public school there’s state mandated vaccinations that they have to have, and they have to be updated every year.” I ask them, “How many of your children come back after receiving a vaccine and complain of an adverse event?” I don't hear anything. The reason being is that vaccines have been safe and effective for decades. Vaccines have allowed us to live they say 30 years longer in part to vaccines than we did 100 years ago. Vaccines are the most highly scrutinized public health interventions we know. When you think about vaccines and what they go through, you’re talking about 3 phase clinical trials, a data safety monitoring board, the FDA [Food and Drug Administration] advisory committee, the FDA, then the CDC [Centers for Disease Control and Prevention] specific advisory committee, and then at a P4 level of pharmacovigilance that follows people that get vaccines for years after.

Currently too, to follow up what you’re saying, is that when you talk about statistics people’s eyes glaze over. Where are they really getting their information? Facebook? Instagram? I think one of the things we must do is when you have your patients who took their 5-year-old, 6-year-old, they didn’t say anything. Their arm didn’t even hurt. That needs to go on social media. Because guess what’s showing up there? “My arm hurt. I got some weird reaction that people associate with vaccine.” That’s all they’re seeing. Therefore, we must encourage our patients post this stuff on social media: “My kid got vaccinated, it was fine.”

Let me give you a personal story, it also discloses a bit of how old I am. Back in the 1950s, I remember my parents saying you can’t go to a public swimming pool in the summer. You can’t do it. Polio, the scourge of this country, is everywhere. Then along came Jonas Salk. People brought their kids in. I got one of the first waves of polio vaccine. I got jabbed in the arm in the gym in my public school. My parents praised the name of Jonas Salk, and he was a secular god in this country. There were side effects of the polio vaccine, and there were side effects to the Sabin vaccine. Today is different. What’s so different now? Why aren’t people saying, “God bless this vaccine?” What has changed?

I think if you want to compare it to the polio vaccine, and I talked to my mom about her experience because I think she may be around your age, Peter.

Thanks a lot, Angie. Let’s just let one go.

I took my polio vaccine for granted. I’m old enough that I did get an oral polio vaccine when it was still used in the U.S. I actually remember it even though I was only 2 because I just remember getting a ton of shots and then I got a sugar cube. I asked my mom, “Did you get a shot or a sugar cube?” and she said, “Yes. I got a sugar cube.” My parents couldn’t wait to get me in there. But if you go back even further, my mom told me something else: she said it was way better than the smallpox vaccine, and talk about a vaccine with a bad profile in terms of adverse events. At the same time, nobody talks about the smallpox vaccine as if it were unnecessary. In fact, thanks to that vaccine, we don’t have to get smallpox which has a mortality rate of upwards of 30%.

It’s terrible. We had smallpox come back for some reason; it was a lab leak. I would not hesitate to get a vaccine myself. I think that it’s all relative. When you don’t grow up seeing your friends paralyzed, seeing your friends in an iron lung; when you don’t grow up seeing children all over the place getting sick and sometimes dying from a preventable illness, then I think you do start to get a little complacent. I think as a society we have gotten complacent about some of these viruses. We hear this in anti-vaccine propaganda all the time. Measles; it’s a childhood disease. It’s natural. It’s not a problem. It doesn’t kill that many kids. But back in that day when measles was rampant, people did not think twice about a vaccine that would prevent it.

I want to put a cap on this, which is you say that we’re not seeing people get sick from measles or mumps or smallpox. However, this pandemic is killing hundreds of thousands in the U.S., and across the globe millions of people. The message, the takeaway, is different here than it was with polio. Why?

 I think we must go back and just understand the extent of coronaviruses as we know it. That is there are 7 different coronaviruses that infect humans. Many of them are nonpathogenic. The last 3 are very important because they can produce a mortality rate for SARS COVID-1 10%, COVID-2 about 3%-5% percent. However, the MERS [Middle East respiratory syndrome] virus, which is a very dangerous coronavirus, has a fatality rate of 35%. When we think about it, we have never seen any variants that have developed from the common circulating coronaviruses in children. We were simply surprised by this. Our bodies have never seen this virus. Remember, this is a zone not a transmission. The idea is a zoonotic virus, and again its primary host more than likely is the bat. The secondary intermediate zoological host is currently unknown to this day; we just haven’t seen this. The way we can track this in the same way in history, is we look at the Spanish flu where young people had not seen that virus and had a tremendous amount of mortality in younger folks and not in younger folks that had seen that virus prior. It has to do with your immune recognition of something. If your immune symptom has something to go on, then it’s going to be better equipped to fight it. We had nothing to go on with this the SARS coronavirus.

Dr Peter Salgo leads a discussion on the safety and efficacy of COVID-19 booster shots with a comparison to historical vaccine rollouts.

Jeff Goad, PharmD, MPH

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