Tracking an FDA advisory panel’s meeting on J&J’s Covid-19 vaccine

Now it’s Johnson & Johnson’s turn.

A panel of outside experts is meeting Friday for a third time to consider whether the Food and Drug Administration ought to give an emergency use authorization for a Covid-19 vaccine, this one from J&J. And for a third time, STAT reporters will live-blog the advisory committee’s deliberations.

The J&J vaccine could be a potential game changer, at least in some areas. Made by J&J’s vaccine division, Janssen Pharmaceuticals, it is a single-dose vaccine that does not need to be frozen when it is shipped and distributed. The vaccine is what’s known as “fridge stable,” meaning it can be shipped and stored at the temperature of a regular refrigerator. Both those characteristics will make this vaccine much easier to deploy if the FDA authorizes its use.

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The two vaccines already in use in the United States, from Moderna and the Pfizer-BioNTech partnership, are both two-dose vaccines with onerous cold-chain requirements.

It’s hard to imagine the panel meeting to assess the vaccine, known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC, won’t recommend that the FDA issue an EUA for the J&J vaccine.

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But it is conceivable that the committee might recommend the vaccine only be used in people 18 to 75, because there were too few data generated by the J&J Phase 3 study to determine if the vaccine works in people over the age of 75. Neither of the two earlier authorized vaccines had an age cap placed on their EUAs.

Regulatory authorities in Europe and Britain faced a similar dilemma when they authorized AstraZeneca’s vaccine for use. (The company’s U.S. clinical trial is still ongoing.) But in both cases, they concluded that data gathered in Phase 2 trials — which charted the immune responses of people who had been vaccinated — were sufficient to assume the vaccine would work in the elderly. The World Health Organization has comes to the same conclusion in giving an emergency use listing to AstraZeneca’s vaccine.

It will be interesting to see if assumptions based on immunological data are sufficient for the VRBPAC members to recommend J&J’s vaccine for use in the elderly — and if they do recommend it, whether the FDA accepts the recommendation. The FDA generally follows VRBPAC’s advice, but it is not required to do so.

The J&J vaccine hasn’t been tested yet in children and teens under the age of 18, so it will not be authorized for use in them.

The J&J vaccine was found to reduce cases of moderate to severe Covid infection by 66.1%, starting 28 days after the single shot. (It takes a while for the protection of the vaccine to build up.) Results released in late January suggested the vaccine worked better in some areas than others; in the U.S., the vaccine was 72% protective.

An FDA analysis of the J&J data, released on Wednesday, suggested the vaccine was a little less effective against a virus variant first spotted in South Africa, known as B.1.351. But its protection did not appear to be eroded by a variant first spotted in Brazil, known as P.2.

The United States has purchased 100 million doses of the J&J vaccine, but supplies of are expected to be scarce until at least April.

Our live coverage of the meeting is below. We’ll be posting updates and analysis throughout the day, in reverse chronological order.

VRBPAC’s agenda

Good morning, STAT readers.

Your VRBPAC live-bloggers today are Matthew Herper and me, Helen Branswell.

For starters, let’s introduce you to the committee members. The FDA has a very strict conflict of interest policy for VRBPAC members. Anyone involved in any of the Covid-19 clinical trials — even a member who works at a university that is a trial site is “conflicted out,” which means that temporary replacements who are equally stringently vetted are named to sit in their place. Most of the members of today’s panel sat when VRBPAC evaluated the earlier two Covid vaccines.

The early part of the meeting, which begins at 9 a.m. EST, is mostly housekeeping. There’s a presentation on what emergency use authorizations are, and one on what surveillance data are indicating about the safety of the two Covid vaccines currently in use. There is also a session on the various virus variants — say that three times fast! — that are circulating and raising concerns about vaccine efficacy.

At 11:10 a.m. EST, a team from J&J will present their take on the data on their vaccine and will be questioned on it by committee members. After lunch — if there is a lunch break, VRBPAC meeting sessions often run long — FDA scientists will present their review of the data. And then VRBPAC members will be asked one or several questions by the FDA and will take one or several votes.

The meeting is meant to conclude at 5:30 pm. EST. We’ll see.

Source: STAT