FDA endorsement essentially calls for Johnson & Johnson to be 2-shot vaccine

Coronavirus

NEW YORK — An FDA panel unanimously recommended a Johnson and Johnson booster vaccine on Friday afternoon.  The terms of their endorsement essentially call for the J&J vaccine to be a two-dose shot, rather than the one-dose shot for which it’s been known since it first got emergency use authorization last spring.

The panel called for a second shot to be available to people 18 and older, at least two months after the first shot.

That was in contrast to the Pfizer and Moderna booster vaccines.  FDA panels of medical experts recommended that those medications be used as boosters only for people 65 and older, or for people with an underlying medical condition, or who are in high COVID risk conditions, such as hospital or public transit workers. 

The FDA has already given approval to a Pfizer vaccine booster under the conditions its panel recommended. Approval for a Moderna booster is expected within days. 

At the FDA hearing on Friday, data was presented showing that those boosters had remarkable results when given to people whose first shot was J&J. 

“Their antibody levels were actually higher if they got a Moderna or Pfizer booster instead of another Johnson and Johnson shot,” said Dr. Shereef Elnahal, the president and CEO of University Hospital in Newark.

He was not part of Friday’s review panel, but his hospital, one of the largest in the region, serves a population that’s likely to benefit from the panel’s recommendation. 

The results of a study presented to the panel found that when patients who’d first gotten a J&J shot, and later received a J&J booster, their antibody levels increased four-fold.  

Among patients in the study who’d first gotten a J&J shot, and later received a Pfizer booster, the increase was 35-fold. Also, when patients in the study who’d first gotten a J&J shot later received a Moderna booster, their antibody increase was 76-fold.

That doesn’t mean that Johnson and Johnson is ineffective on its own.  That’s what another study presented to the panel concluded. 

The data, presented in the New England Journal of Medicine, showed that over eight months, one Johnson and Johnson dose either stays as strong or gets stronger in its immune response.

That’s in contrast to the Pfizer and Moderna vaccines, which show a slight decline in immune response after six months.

The FDA is now considering the panel’s recommendation on the J&J booster, and is expected to approve it shortly. The CDC will next consider the data presented to the FDA.  Full emergency use authorization for the booster isn’t expected until next week at the earliest.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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