J&J Covid Booster Garners FDA Advisers’ Unanimous Backing (3)

Johnson & Johnson’s Covid vaccine booster gained a key recommendation from advisers to U.S. regulators that brings the additional shot a step closer to clearance.

The Food and Drug Administration’s vaccine advisory group voted unanimously Friday in favor of recommending the booster for people 18 and older who received their initial immunization at least two months earlier. The experts also indicated support for mixing and matching booster shots from different manufacturers, but didn’t vote on a recommendation.

FDA’s Vaccine and Related Biological Products Advisory Committee voted to back Moderna Inc.’s booster Thursday, and additional shots from the partnership of Pfizer Inc. and BioNTech SE were authorized in September with the panel’s support. While President Joe Biden had foreseen offering boosters to all vaccinated Americans eight months after their first dose, the panel had until now recommended them for people at least 65 years old and younger adults who risk severe illness or viral exposure at work.

J&J presented data to the 19-member committee indicating that its vaccine loses efficacy over time, and that a booster shot is safe and can help restore both efficacy and levels of protective antibodies. The panel was originally asked to consider whether a six-month interval would be more effective, but decided not to consider that question.

Shares of New Brunswick, New Jersey-based J&J rose 0.7% at to close at $161.30 in New York.

Seen as a convenient, effective alternative to two-shot messenger RNA vaccines, J&J’s single-shot immunization has seen far less use in the U.S. The vaccine has demonstrated less efficacy than Moderna and Pfizer products, and the recommendation on J&J’s booster is the broadest to date, as the panel was concerned about recipients getting sufficient protection from one dose.

The recommendation is another step toward ensuring that recipients of the company’s vaccine have the opportunity to increase their protection, said Mathai Mammen, global head of research and development for J&J’s Janssen unit.

“We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of Covid-19,” he said.

Public Health Imperative

The panel’s consideration of J&J’s vaccine represents “a public health imperative,” said Arnold Monto, a University of Michigan professor of public health and epidemiology, who serves as acting chair. “What we’re seeing is that this is a group with overall lower efficacy than we have seen with the mRNA vaccines. So there is some urgency here to do something.”

Now it’s up to the FDA to decide whether to authorize it. The agency isn’t required follow the panel’s recommendation, but it often does.

Then the baton will be passed to the Centers for Disease Control and Prevention’s vaccine advisers, who are scheduled to meet Oct. 20 and 21. The Advisory Committee on Immunization Practices could then make a recommendation on boosters from both Moderna and J&J. CDC Director Rochelle Walensky would then make a final decision on the agency’s recommendation.

Both the FDA and CDC and have been somewhat at odds with their vaccine advisers on boosters. The FDA revised and narrowed a suggested recommendation for Pfizer’s booster after its advisers voted it down. Walensky overruled her advisers who also suggested a narrower recommendation for use of the booster, drawing questions about whether she had been influenced by political pressure.

Mixing Doses

The recommendation vote was followed by a discussion of mixing and matching booster doses with different shots than those initially received by individuals. The panelists heard a presentation on a government-sponsored study showing that mixing doses resulted in immune responses at least as strong or stronger than using the same brand.

“From a public health perspective, there’s a clear need, in some situations, for individuals to receive a different vaccine,” Amanda Cohn, chief medical officer of the CDC’s National Center for Immunizations and Respiratory Diseases, said in the discussion.

For example, Cohn said, supplies of the J&J vaccine are limited possibly making it difficult for its the 15 million U.S. recipients to find a booster. U.S. health officials should consider supply challenges when deciding whether to authorize the second dose, and how to roll it out to those who are eligible, Cohn said.

However, recommendations on mixing boosters could exacerbate messaging confusion, said Jeannette Lee, a panel member and biostatistician at the University of Arkansas for Medical Sciences. Boosters have been recommended for all J&J recipients, but mRNA vaccines have only been recommended for older people and those in high-risk groups. Anyone 18 to 55 years old who received J&J’s shot could get an mRNA booster, if it’s authorized, but some in the same age group who got Pfizer or Moderna as their initial vaccine wouldn’t be able to, she said.

“This is going to be very, very messy,” Lee said.

(Updates with company comment at end of first section. A previous version of this story corrected spelling of panel member’s name in second-last paragraph.)

--With assistance from Fiona Rutherford.

To contact the reporters on this story:
Riley Griffin in New York at rgriffin42@bloomberg.net;
Jeannie Baumann in Arlington at jbaumann27@bloomberg.net;
Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story:
Timothy Annett at tannett@bloomberg.net

John Lauerman

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