FDA unsure whether recipients of Johnson & Johnson COVID-19 vaccine need a booster — and whether to give it after two months or six months
- The FDA released a report Thursday showing little confidence in data submitted by J&J in hopes of getting the booster shot for the COVID-19 vaccine approved.
- An FDA advisory panel will meet Friday to discuss whether the boosters are needed
- J&J’s vaccine is the only one-time COVID-19 vaccine available in the US and has been administered to more than 15 million people
- Public confidence in the injection has declined in recent months, despite little change in the science of the vaccine
- In San Francisco, recipients of the injection are eligible for an ‘additional’ injection of the Pfizer or Moderna vaccine, and CVS no longer offers the injection
As COVID-19 vaccine boosters begin to roll out to recipients of the Pfizer-BioNTech and Moderna vaccines, Americans who have received the Johnson & Johnson (J&J) vaccine remain in the dark.
The single-dose vaccine booster will be discussed Friday by a U.S. Food and Drug Administration (FDA) advisory panel, but a report released Thursday shows no optimism in the J&J shot.
The FDA showed no confidence in the booster’s need, as data from the New Brunswick, New Jersey-based company was lacking, including limited evidence that a second injection would help against the highly contagious Delta strain.
While the advisory committee could still vote in favor of the booster Friday, failing to receive a recommendation would be just one of the many 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 injection. The agency showed no confidence in data submitted by the company in a recent report
The reputation of the J&J vaccine has wavered in recent months. In April, its use was put on hold for two weeks after it was linked to six cases and one death from clotting in women. Pictured: A man in Saratoga, New York, receives an injection of the Johnson & Johnson COVID-19 vaccine on July 30
The J&J vaccine is currently the only one-time COVID-19 vaccine available to Americans.
The company hopes to roll out a booster injection in the near future for the more than 15 million people who received the first injection of the vaccine.
On Tuesday, the company released data on its booster injection, urging that the second dose would become available to all recipients six months after the first.
J&J also insists that the injection be made available to people with underlying conditions as early as two months.
The FDA said the data sent to the agency by J&J is less effective than Pfizer’s and Moderna’s booster shots.
Both were approved in August for immunocompromised Americans.
In September, the Pfizer vaccine was approved for booster shots in all Americans over age 65 or at high risk due to pre-existing conditions or their job.
The Moderna booster injection was discussed Thursday by the FDA advisory panel, where the injection was unanimously recommended to be authorized for the same groups.
The same panel will discuss the J&J vaccine on Friday.
While the J&J vaccine was long anticipated because it was only one shot, it quickly fell out of favor in many parts of America.
The authorization of the injections was put on hold for two weeks in April after six cases of blood clotting were found in women who had received the injection – with one of the women dying.
The shot’s reputation has also slowly deteriorated over time, with many seemingly losing faith in its effectiveness despite few scientific reasons for doing so.
Detroit Mayor Mike Duggan turned down his city’s initial allotment of the one-time vaccine in a move widely condemned by health officials.
San Francisco began offering unauthorized “additional” injections of the Pfizer or Moderna vaccine to people who had received the vaccine in August, after many who had received the vaccine asked to be given another vaccine from a different brand. to get.
CVS, one of the country’s largest private vaccine providers, also stopped offering the injection in early August.
The vaccine is still considered safe and effective by regulators, and data the company released in July shows it to be effective against the Delta variant.
Friday’s advisory panel vote is a recommendation to FDA regulators, meaning it’s non-binding and agency officials can make the rare decision to make a decision that conflicts with the panel’s recommendation.
FDA officials are expected to decide next week whether to approve the J&J and Moderna COVID-19 booster shots.