FDA could boost ‘boostering’ this week

Advisory committees to discuss Moderna, J&J bids, plus mixing vaccines

BOSTON — Donna Caron is 65-years-old and got her initial COVID-19 shot at least six months ago. And she meets two other criteria for a booster shot:

“I’m taking care of my sick mom and I live in an elderly building,” she said.

There’s just one problem: Caron got the Johnson & Johnson vaccine and the only one FDA-approved as a booster at the moment is Pfizer/BioNTech’s Comirnaty. But the business of ‘boostering’ all could change by later this week. In the next several days, FDA advisory committees will be meeting to discuss not only approving the vaccines from Moderna and Johnson & Johnson as boosters but also to look into the safety and efficacy of mixing vaccine brands.

“There doesn’t seem to be much danger in mixing these vaccines, far as we know,” said Dr. Paul Sax, the clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital, Boston. “I don’t think we’re going to have definitive information about this yet for some time, but I strongly believe that the mRNA vaccines following the J&J vaccine will lead to excellent responses and a very high level of protection.”

In fact, while Sax doesn’t advocate patients resort to subterfuge to get boosters, he said it would be reasonable for those, like Caron, who got the J&J vaccine to begin with, to now get a second shot.

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“We now have enough evidence that it’s less effective than the other two vaccines and that a second shot would be more useful than having just one shot,” Sax said. “So from a medical perspective, I can understand it. I don’t ever advise patients to lie.”

But at least one recent report suggests some ARE lying to get booster shots because they don’t meet the current criteria for getting one set forth by the FDA and CDC: 65 years or older with 6 or more months having elapsed since the initial course of vaccination, or anyone 18+ years with an underlying medical condition or who works or lives in a high-risk setting.

Sax said it’s not necessary for those who got either the Pfizer or Moderna vaccines to begin with and who are outside those categories to seek out a booster shot at this time because evidence shows those products continue to protect against severe illness and hospitalizations. But, down the line, he does see a time when two shots won’t be enough for anyone.

“What I think we’ll see, perhaps the optimal, initial approach to a COVID-19 vaccine, is actually three doses, not two,” Sax said. “And then we’ll have to decide on when to give a booster. It may be as infrequently as once every decade, like the tetanus vaccines, which would be great. Or it might be more frequent than that.”

One thing that also may change with future vaccinations against COVID-19 is the intervals between shots.

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“We definitely have been seeing more breakthrough infections as the time since vaccination has elapsed,” Sax said. “One of the current thoughts is that the three-to-four week period between the two first vaccinations wasn’t sufficient for us to really prime our immune system and allow a full response to them. If that’s the case, the third dose should do the trick.”

Overall, Sax feels optimistic about the course of the pandemic, at least in the northeast.

“We’re in a much better place than we were a year ago,” he said. “Our hospitals are not overwhelmed with COVID-19 cases. Our ability to prevent severe disease and hospitalization is really much, much stronger than it was.”

But there remains one more immediate shoe to potentially drop:

“What we’re all kind of waiting for is what happens in the wintertime,” Sax said. “Cold weather comes, people are indoors more, more viral transmission takes place. Will we be able to prevent what happened last winter, which was actually a surge of cases that was actually quite massive?”

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