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Follow the FDA advisory panel meeting on the J&J Covid vaccine booster – STAT

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The booster-shot question that has been on the top of many minds for many months will be addressed today when the Food and Drug Administration’s vaccines advisory committee reconvenes to complete a two-day meeting. The question before it: Should people who got the one-dose Johnson & Johnson vaccine get a booster shot, and if so, when?

Another top-of-mind question, however, may end up not being addressed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). If the highly active discussion on Twitter is any indication, people who got the J&J vaccine want to know if they should be boosted with one of the messenger RNA vaccines from Pfizer-BioNTech or Moderna.

That option doesn’t appear to be on the table for today.

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During Thursday’s online meeting to discuss Moderna’s application for a booster shot, the question — actually questions — that will be put to the committee during today’s discussion about the J&J application was temporarily posted by mistake. Nowhere among them was a question about whether J&J vaccine recipients ought to get a heterologous boost, in other words a boost with a different vaccine.

Data will be presented today on a study of mix-and-match boosting conducted by the National Institutes of Health. But according to the meeting schedule, it will be at the end of the day, after VRBPAC votes on the J&J booster application. There’s no provision on the schedule for a vote on heterologous boosting.

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People who got the one-and-done J&J vaccine have been in booster-shot limbo as the manufacturers of the mRNA vaccines have argued that an increasing number of breakthrough cases among fully vaccinated Americans and declining antibody levels signal a need for boosters.

If protection from two doses of the mRNA vaccines is already wearing off for people who were vaccinated early in the U.S. rollout, so the thinking goes, surely people who got only one dose of the J&J vaccine are also becoming increasingly vulnerable.

But available data don’t necessarily show a decline in protection from the J&J vaccine — or, for that matter, huge gains from a J&J booster shot. The vaccine’s protection against serious illness was never as high as the protection offered by the mRNA vaccines in the early days after vaccination. But it hasn’t waned either. The vaccine’s efficacy against moderate to severe disease was nearly 73% after one dose, and about 75% after two.

J&J submitted several studies to the FDA, evaluating both a second dose after two or three months and a booster given at least six months after the first dose.

For VRBAC, voting on a J&J booster will come in stages. The committee will first be asked to vote on whether the available evidence supports the safety and effectiveness of giving a dose of the J&J vaccine as a booster for all adults 18 years of age and older at least two months after their first dose.

If the committee votes “Yes” on that question, it will be asked if the data suggest that extending the interval between the first shot and the booster to at least six months might make the booster shot more effective. If the committee votes “No” to the first question, members will be asked if the data support a booster shot given six months or more after the first shot.

The vote places no restrictions — other than being age 18 and older — on who should get a J&J booster if one is approved. But given the vaccine’s safety profile — it has been linked to a small but real risk of serious clotting problems seen mainly in women under the age of 50 — there will likely be discussion about whether a J&J booster for anyone who got the vaccine is warranted.

There might be discussion about this regardless. Both the Pfizer/BioNTech and the Moderna boosters were greenlit for specific groups of people, albeit large groups that include people over 65, people 18 to 64 with medical conditions that increase their risk from Covid, and people who live in or work in places which increase their risk from Covid.

Matthew Herper and I will be live blogging the meeting, which you can watch here, starting at 8:30 a.m. EDT. We will be posting our updates and analysis below in reverse chronological order; check back often.

— Helen Branswell

Batting clean up, the FDA makes a mess

4:40 p.m.: The panel ended the day with a wide-ranging discussion about two of the biggest issues facing vaccines in the real world: whether to allow so-called “mix-and-match” boosters, in which people get a booster different than their original vaccine, and whether the age cut-off for getting a booster to the mRNA vaccines, the ones from Moderna and Pfizer, should be lowered from age 65 to 40.

Some panelists seemed open to both ideas, but it was unclear if there was a consensus and there was no formal vote on either topic.

Kirsten Lyke from the University of Maryland School of Medicine presented data from an NIH-funded study showing that, in general, a mix-and-match booster — the technical term is heterologous — increased antibody levels at least as much as getting a booster of the same type. However, she noted, there were limitations to the study, including not only that it wasn’t big enough to yield data on whether the boosters prevented infection but also that patients had not been randomly assigned to their groups and that the researchers did not control for differences in precisely how long it had been since people received their first dose.

Still, many panelists were open to the idea. A few said they were open to making the “mix-and-match” boosters available now. Steven Pergram, of the Fred Hutchinson Cancer Research Center, suggested changing the language of the vaccines’ authorizations to allow people to get a different vaccine if they’ve had a reaction to the first. Right now, he emphasized, rules around emergency use authorization make it difficult for people to get a vaccine for an unauthorized use.

Arnold Monto of the University of Michigan, the panel’s chair, brought up a separate topic: whether the age at which people who don’t have risk factors can get a booster of the mRNA vaccines should be lowered to 40. Several panelists expressly said that they were open to the idea, but Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, which approves vaccines, said an exact vote would not be necessary.

Jesse Goodman of Georgetown University, who previously held Marks’s job, called the discussion “imprecise in its structure and outcome” on a call with reporters and said such a topic would require much more structure from the FDA and that it would require the FDA to vote. Generally, throughout the past two days, Marks has seemed to be steering the panel in ways that are unusual for an FDA official, but not unheard of.

Outside experts and advisory committee members worried about another aspect of the meeting: the fact that the FDA had not, as it normally does, fully vetted the data from J&J’s studies, point by point. That did not happen, Marks said, because there just wasn’t time.

Panelist James Hildreth, the CEO of Meharry Medical College, made a point of publicly underlining the need to conduct those analyses.

“Dr. Marks, you’ve gone on record to say that the FDA team has not fully evaluated the data presented to them, and we voted to approve this without them having done so,” Hildreth said. “So I think it would be really really important that it be clarified that they’re going to do so and that if there are challenges that arise in that analysis that appropriate actions will be taken.”

Goodman said he was concerned about the precedent that was set by holding the meeting before data could be analyzed. Norman Baylor, a former head of the FDA office that reviews vaccines, echoed that concern on the same press call, saying the meeting may have been held too soon. “It does set a bad precedent,” Baylor said.

That’s a wrap. Thanks for tuning in. We’ll see you next time.

— Matthew Herper and Helen Branswell

That’s a wrap

3:30 p.m.: This two-day VRBPAC meeting is adjourned!

Matt and I are going to huddle and come back to you with a few wrap up thoughts shortly.

— Helen Branswell

The vote

1:30 p.m.: The panel voted on the following question:

Do available data support the safety and effectiveness of Janssen COVID-19 Vaccine for use under EUA as a booster dose in individuals 18 years and older…

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