Let’s assume this goes through and the FDA then licenses these mRNA vaccines. For those over 65, anyone can get it. But for those less than 65 who are otherwise healthy, the yearly vaccine can only be given to those at highest risk. So now to use it would be an off-label use. That wouldn’t have been the case if the CDC had targeted the recommendation. So you wonder whether a healthy 35-year-old who wants to get the vaccine, will insurance pay for that?

VoxPopuli: So does this just come down to whether insurance will cover the vaccine for healthy adult and kids?

Paul Offit: That’s my question.

VoxPopuli: Could people pay out of pocket for it? Would that be an option if they really wanted it?

Paul Offit: Practically, yes. Most people, me included, get their vaccines from the pharmacist. I can’t believe the pharmacist would be the gatekeeper for whether or not you have a medical indication.

VoxPopuli: The FDA is requiring additional studies to be done to verify the safety and efficacy of the covid vaccines. You developed a covid vaccine. Do you believe additional studies are warranted?

Paul Offit: No. What they’re talking about is  [looking] at the 50 to 64-year-old in a prospective saline, placebo-controlled study. Why? They say they want to do six months as a primary endpoint of symptomatic disease. That's been done. Ruth Link-Gelles published several studies that have looked at just that. How long are you protected for and in what manner — meaning all symptomatic infection or just mild to moderate disease, mild to moderate to severe disease. She’s published on that,  and you see that for the most part, you boost your antibodies. Those antibodies will protect you against mild-to-moderate disease for four to six months. I think we'll learn nothing from that that we don't already know.

Then the question becomes one of safety, which they also say they want to look at. Well, this vaccine has been given to hundreds and hundreds of millions of people, I think we have a pretty good idea of its safety profile.

 If you're trying to look for a serious side effect that hasn't been seen before, you're not going to see it in a relatively small study, meaning tens of thousands.  Look at what happened in 2020 when we looked at 40,000 people who got the Pfizer vaccine or 30,000 who got the Moderna vaccine. Myocarditis was not seen in either of those studies. It wasn't until the vaccine was given to hundreds of thousands of people that you saw this rare adverse event come up at roughly one in 50,000 people. That’s not the kind of thing you pick up in a pre-licensure trial, frankly, [or] in these post-marketing surveillance trials. That's why you have the Vaccine Safety Datalink.

VoxPopuli: Myocarditis, that’s the inflammation of the lining of the heart that occurred in males?

Offit: Primarily in males between 16 and 29 years of age, within four days of dose two.

VoxPopuli: Can we remind people about the purpose of the vaccine? I remember during the pandemic hearing pushback when people who got the vaccine still got covid, they were like, What was the point?

Paul Offit: It’s to prevent hospitalization.  I had a moderate infection six months after my third dose. I had a pretty significant cough. I was home for a couple days, pretty miserable, high fever. But I didn't go to the hospital, so the vaccine did what it was supposed to do. It kept me out of the hospital.

VoxPopuli: Is that the answer to skeptics who say the vaccine doesn’t work, you still got covid. Is the answer, Well, you weren’t in the hospital and you didn’t die?

Paul Offit:  I think we should have done a better job of explaining that early on. I think we tended to oversell the vaccine a little bit.  in 2020, when we looked at the Pfizer/ Moderna trials protection, protective efficacy was like 95 percent against all manner of symptomatic illness, including mild-to-moderate disease. But that was because those were three-month trials. Those participants had just gotten their second dose. Six months later, protection against severe disease was holding up to that 90 percent range. But protection against mild-to-moderate disease had dropped to 50 percent because antibodies started to fade. That's exactly what you would've expected. And I think people felt that they had been lied to about the vaccine. Here I got a vaccine. They made me get the vaccine. I would've been fired from my job if I didn't get the vaccine. And now I'm home for two days and sick with covid. So they lied to me.

I just think we needed to explain early on what that vaccine could and couldn't do, and we didn't do a great job.

VoxPopuli: And the reason for an annual covid vaccine is because the covid virus mutates? We get a flu vaccine every year to match the flu strain circulating. So the new covid vaccine would be adapted to the new strains of covid floating around, correct?

Paul Offit: Right. Although, if you look at protection against severe disease, if we had never gone away from the original strain, the ancestral strain, Wuhan-1, and only gave that [vaccine] you still would be relatively protected against severe disease. It’s the mild-to-moderate disease where you have better protection with the more updated [vaccine] strains. And the reason is that memory cells, immune cells, like cytotoxic T cells, killer T cells, recognize more conserved regions on the spike protein that are present on Wuhan-1 all the way through Omicron.  

VoxPopuli: This new recommendation that came out from the FDA, is it based in science or is this based in politics?

Paul Offit: I think it’s more political than anything else. I think it’s the language of We’re doing gold standard science. We’re doing robust science. We’re finally having evidence-based recommendations. We care. I’m not sure this is going to advance our understanding of the safety of this vaccine or the efficacy of this vaccine. I don’t think it’s going to affect public trust because I don’t think the public has lost trust because they don’t think the right studies are being done. I think the public has lost trust because 1) they don’t really think covid is a problem anymore and 2) they read a lot of bad information about vaccines, about vaccine safety issues. So I don’t think this is going to affect things one way or the other.

The only thing I do worry about is whether the insurability matters when you would use it as an off-label recommendation.

Obviously if they ever advance to not vaccinating children, then there will be a big price to pay. Just last year, 150 children died of covid. Eighteen hundred children died of covid throughout the whole pandemic. Children can die of covid. I’ve seen it. It happened in our hospital. We had three floors of covid when covid hit in 2020 and 2021. Three floors. We canceled elective surgeries. We were overwhelmed by that virus. Children can get sick from this virus.

VoxPopuli: Whoa. My son is 19. Should I urge him to get the covid vaccine?

Paul Offit: I think if you’ve had three doses — meaning two doses initially, then one dose at least four to six months later — you’re good. My son is 33; my daughter’s 31. They don’t get yearly doses.