DENVER — On Thursday, a U.S. Food and Drug Administration Advisory Committee unanimously voted to recommend a half-dose booster of Moderna's COVID-19 vaccine for certain groups.
But the vote didn't come without some concerns, including that the sample sizes in the data presented weren't big enough or explained well enough.
"I just want to explain why I voted yes on it is more gut feeling rather than based on really, truly, serious data," Dr. Patrick Moore said following Thursday's vote.
Moore is on the advisory committee. He said he felt the data wasn't explained well enough.
"But the data itself is not strong, but it is certainly going in a direction that is supportive of this vote," Moore said.
Dr. Stanley Perlman, who is also on the committee, said because Pfizer was approved, he wouldn't see why Moderna's vaccine wouldn't be either.
"I think, from a pragmatic point of view, even with what I just said, in some ways we, I, support this EUA because we've already approved it for Pfizer, and I don't see how we can possibly not approve it for Moderna and not have most U.S. folks be completely confused," he said. "I know that's not really part of what we're supposed to think about, but I think it's a pragmatic issue."
Locally, Dr. Michael Roshon, emergency physician and head of research operations for Centura Health, believes the recommendation was the right call.
"We have to make a few assumptions and frankly, weigh the risk of acting in the face of imperfect data with the risk of not acting when the data does--is fairly convincing that it is helpful," he said. "You can tell their level of discomfort with not having perfect data. And that's what I would expect from good scientists, to sort of agonize a little bit over the decision."
Roshon said he believes the vaccines have already been proven to be safe and effective, and because the recommendation is limited to certain groups, it makes the case to recommend a booster, stronger.
"We really want to limit it to the people who are going to get a clear benefit from it. And that's people over age 64 and people who have some underlying condition that might make them where they didn't make a good enough immune response to the initial doses of the vaccine," he said. "So I think that was the right decision. Actually, we would not want to give it to people who are already fully protected."
On Friday, the panel is expected to vote on a recommendation for Johnson & Johnson's COVID-19 vaccine booster shot, and discuss mixing and matching vaccine brands. Roshon said he's had patients already mix vaccine doses.
"I've heard from several folks that got J&J for the first one. They said that the booster dose of either the Pfizer or the Moderna did cause a little bit more reaction," he said. "A little bit more of, sort of, a few hours of flu-like feeling and maybe even a low-grade fever. And it just tells you the immune system is primed to react against that. And it does. And that reaction tells you that the immune system is getting fired up and ready to fight COVID, which is what we want."
Overall, Roshon has a message about the COVID-19 vaccine.
"We are seeing a lot of people who could have been protected by vaccine who aren't. So if you haven't been vaccinated, don't worry about the booster. Get that first dose. That's what we need, right? And do everything you can to stop the spread. You do not want a breakthrough infection. You do not want to end up in the hospital with this," he said.
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