What San Diegans should know about COVID-19 vaccine boosters

This Friday, a panel of experts will advise the Food and Drug Administration on whether to approve a booster shot of Pfizer’s COVID-19 vaccine for anyone 16 and up.

It’s a question fraught with controversy and confusion. And the vote comes at a time when the fast-spreading Delta variant of the virus is fueling COVID-19 cases, hospitalizations and deaths across the U.S., mainly among the unvaccinated.

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We reached out to Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital, to clear things up. Sawyer is part of the panel that will meet Friday to advise the FDA. He’s also one of 11 experts tapped by California Gov. Gavin Newsom to review the safety and effectiveness of authorized coronavirus vaccines. In the past, he has served on a committee that helps the Centers for Disease Control and Prevention issue national vaccination recommendations.

This conversation has been edited for length and clarity.

Q. What is Friday’s vote all about?

I think the question is whether there’s enough safety and effectiveness data to support approving a booster in everybody. That’s a little different than whether everybody should get a booster. That’s not really the FDA’s job. That’s the CDC’s job to say, well, now we have an approved booster — who should get it?

Q. Where do you stand on that — are boosters safe and effective?

Speaking from prior data I’ve seen on third doses among the immunocompromised, who are already eligible for boosters, the safety in those populations looks sort of similar to what second doses look like in terms of the distribution of side effects. I’m mostly talking about fever and achy muscles and not feeling good for a day. And even in people with compromised immune systems, a fair number respond to a third dose. So I’m anticipating that effectiveness will not be a question, and I’m anticipating that the safety profile will probably be similar to what we’ve already seen.

Dr. Mark Sawyer, infectious disease expert at Rady Children's Hospital.

Dr. Mark Sawyer, infectious disease expert at Rady Children’s Hospital.

(John Gastaldo)

Q. How do boosters work?

When you’re infected or vaccinated with something, your immune system pays attention and remembers that there was a foreign material in the body. You develop both antibodies and T cells that remember that virus, and, if they ever see it again, they’re primed to turn on the immune response. That’s how vaccines work: You prime the immune system, and then, when you get exposed to the real thing, your immune system reacts before you get sick. Third doses are likely to generate a good boost because your immune system has already been primed by the first and second shots.

Q. What’s the point of a booster shot — to prevent severe disease or slow transmission and the evolution of new viral variants?

That’s a great question, and that’s where differences of opinion come up. If we’re hoping to get life as close to normal as we can, preventing transmission that leads to outbreaks, school closures and things like that with a third dose might get us there, though we don’t really know. I don’t think it’s realistic to think a third vaccine dose in the United States is going to cut down on the development of viral strains since most of the world has not been immunized. That’s not the objective. It’s either to prevent hospitalizations and deaths in people with two doses, which are rare, or to prevent transmission.

I think you have to argue that, in general, preventing death is the key goal. And then the question is, are there enough deaths happening in people with two doses that it’s worth a third dose? I haven’t come to a personal, final conclusion on that. But I don’t think that’s going to be the question the FDA answers. That’s going to be the question the CDC answers.

Q. The World Health Organization and others say rolling out boosters in wealthy countries while billions of people have yet to get their first dose takes vaccine away from places where it’s desperately needed. Do you agree?

I think there is something behind that argument, though I don’t think our committee is going to debate that part of this question. But I guess the question is whether there’s enough excess supply in the United States that not giving boosters would substantially impact the worldwide situation. I don’t know the answer to that. If we’re giving boosters to the 200 million people who’ve had a dose here in the U.S., then we’re talking 200 million booster doses compared to the several billion doses needed to immunize the world. You could argue that’s not sufficient to impact the overall picture that much.

Q. Last month, the White House announced plans to offer boosters beginning the week of Sept. 20. But the CDC and FDA have pushed back, including two senior FDA officials who reportedly resigned in protest of the White House announcement and argue that boosters aren’t currently needed. Have you been surprised to see these agencies publicly feuding?

It is surprising because, usually, the federal response is very coordinated. The normal steps are for the FDA to first rule on the safety and effectiveness, then the CDC makes recommendations on how to use the vaccine, and then we mount a public relations campaign to say go get your vaccine. This one has sort of been done the other way around, with the White House announcing many weeks ago that we’re going to have boosters before the first two steps were even carried out.

Q. How likely is it that the FDA approves boosters but the CDC makes a different recommendation?

That’s quite possible. The CDC could take a more middle-of-the-road stance and say, well, let’s give boosters to really high-risk people like seniors over 65 or over 75 but not to everybody. The CDC has a long track record of not recommending a vaccine simply because the FDA approves it, so that would not surprise me in the least. Now, once it’s FDA-approved, individual physicians can decide to give a third dose to anybody they want. But, as a policy across the country, the CDC may not say it’s the best thing for everybody.

Q. Would we be talking about boosters if not for the Delta variant?

I think the whole conversation is happening because of Delta and the hope that we can shut that down by giving out boosters. We do know that the protective levels of antibodies are not as great against Delta as they were against the original strain. Now, the protective level for death and hospitalization is still pretty close to the original strain, but more people are getting infected and we’re seeing breakthrough infections. I think the hope is by giving boosters that’s all going to go away. And it probably will for a while, but, presumably, antibody levels after the third dose will go down over time, too, and we’ll be revisiting booster number two in a while

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