FDA is unsure whether Johnson & Johnson COVID-19 vaccine recipients need a booster – and if it should be given at two months or six months

While COVID-19 vaccine boosters are beginning to roll out for recipients of the Pfizer-BioNTech and Moderna vaccines, Americans who received the Johnson & Johnson (J&J) vaccine remain in limbo.

The one-dose vaccine’s booster is set to be discussed by a U.S. Food and Drug Administration (FDA) advisory panel on Friday, but a report released on Thursday does not show optimism in the J&J shot.

The FDA did not show confidence in the need for the booster, because the data from the New Brunswick, New Jersey-based company was lacking, including limited evidence that a second shot would help against the highly contagious Delta variant.

While the advisory committee could still vote in favor of the booster on Friday, a failure to receive recommendation would be yet another of a long lists of setbacks the company has faced during its vaccine rollout.  

An FDA advisory panel will discuss whether booster shots of the Johnson & Johnson COVID-19 vaccine (pictured) are needed for recipients six months after receiving the first shot. The agency did not show confidence in data submitted by the company in a recent report

The J&J vaccine’s reputation has faltered in recent months. In April, its use was paused for two weeks after it was linked to six cases and one death of blood clotting in women. Pictured: A man in Saratoga, New York, receives a shot of the Johnson & Johnson COVID-19 vaccine on July 30

The J&J vaccine is currently the only one-shot COVID-19 vaccine available to Americans. 

The company hopes to roll out a booster shot to the more than 15 million people who received the first shot of the vaccine if the near future.  

On Tuesday, the company released data on its booster shot, pushing for the second dose to become available to all recipients six months after the first.

J&J  is also urging that the shot be made available to people with underlying conditions after only two months.

The FDA said that the data sent to the agency by J&J shows less effectiveness than the Pfizer and Moderna booster shots.

Both were approved for immunocompromised Americans in  August. 

In September, the Pfizer vaccine received authorization for booster shots in all Americans over the age of 65 or at high risk due to pre-existing conditions or their jobs.

The Moderna booster shot was discussed by the FDA advisory panel on Thursday, where the shot received unanimous recommendation to be authorized for the same groups.

The same panel will discuss the J&J vaccine on Friday.

While the J&J vaccine was highly anticipated due to it being only one shot, it quickly fell out of favor in many parts of America.

Authorization of the shots was paused for two weeks in April after six cases of blood clotting were found in women who has received the shot – with one of the women dying.

The shot’s reputation has also slowly deteriorated over time, with many seemingly losing confidence in its efficacy despite little scientific reason to.

Detroit mayor Mike Duggan turned down his city’s initial allocation of the one-shot vaccine in a move that was widely condemned by health officials. 

San Francisco began to offer people who receive the vaccine unauthorized ‘supplemental’ shots of the Pfizer or Moderna vaccine in August after many who had receive the vaccine’s one shot demanded to receive another from a different brand.

CVS, one of the nation’s largest private vaccine providers, stopped offering the shot in early August as well.

The vaccine is still deemed safe and effective by regulators, and data released by the company in July shows that it is effective against the Delta variant.

Friday’s advisory panel vote is a recommendation to FDA regulators, meaning it is not binding and agency officials can make the rare decision to make a decision opposite the panel’s recommendation.

Officials from the FDA are expected to decide on whether to authorize the J&J and Moderna COVID-19 booster shots next week.