Moderna COVID-19 boosters to be examined by FDA panel Thursday, Johnson & Johnson set for Friday

Coronavirus

INDIANAPOLIS — Thursday is the first of two meetings for an FDA expert panel in evaluating data for Moderna and Johnson & Johnson vaccine boosters.

The panel will examine Moderna’s data on Thursday, followed by Johnson & Johnson on Friday.

We spoke with Dr. Christopher Doehring, vice president of medical affairs at Franciscan Health, about the process and how soon we could see guidance.

Doehring says the FDA panel is the first step of the process in issuing Emergency Use Authorization for these companies.

“It really is a three step process,” he said. “It has to go through a couple of different committees, including at the FDA and at the CDC. Then, in the end, once all those committees meet and weigh in with their respective input, then it’s really ultimately up to the director of the CDC to sign off on the final recommendations and the FDA will then add, or not, that new recommendation to the approval that’s in play.”

Like Pfizer’s approval just a few weeks ago, Doehring expects guidelines to be similar by prioritizing older Americans and those with underlying medical conditions or high risk of exposure.

“Assuming those companies come through with favorable recommendations, it’ll probably be another couple of weeks before the other committees meet,” Doehring said, “but once that happens, and the update is made, then it’s basically green light for folks who meet the eligibility criteria.”

One of the differences, this time around, is what’s been seen with the Johnson & Johnson vaccine.

“The single dose J&J really didn’t quite hit the same mark with that early protection. Since the first couple of months, it looks like they’ve all kind of fallen off in terms of their ability to protect against getting COVID, particularly this delta variant,” said Doehring.

“We’ve certainly seen that with the Pfizer, the Moderna has maybe held up a little bit better, but we certainly expect, with all of them, a pretty immediate benefit in additional protection from that booster,” he added.

On Tuesday, FDA scientists shared Moderna had not met all of its requirements to support a booster. They shared data showed an increase in antibodies, but the difference in levels, before and after the shot, was not wide enough.

Meanwhile, data from about a month ago, showed a second dose of Johnson & Johnson had a 94% boost in protection when given two months after the first shot. However, when discussing booster benefits, FDA scientists noted not enough data on the older population or the delta variant.

Doehring says this will be a “wait and see” process, but regardless, he says boosters are a good idea when it comes to protection against the virus and its variants.

“We obviously don’t know what future variants may hold, hopefully we won’t experience another highly contagious variant, but you know, it’s possible, maybe even likely, that we will,” he said. “So staying protected, getting that vaccine immunity, is really the best way to approach this to avoid severe illness and death.”

Following the FDA panel meetings this week, the CDC’s advisory panel is expected to meet next Wednesday and Thursday (Oct. 20 & 21). Pending recommendations and final approvals, experts say we could see guidance on these boosters by the end of the month.

Sometime soon, most likely after the next couple of weeks, Doehring says we could also hear more about cross boosting. For example, if you were originally vaccinated with Pfizer, could you get Moderna or J&J as a booster, or vice versa.

“We’re, I think, expecting to hear maybe a positive recommendation on that front as well,” Doehring said.

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