J&J recipients are a big step closer to getting booster shots, after feeling neglected by the CDC for months

• Two shots of the J&J vaccine offer 94% protection from COVID-19, the company announced last month.
• But as many Pfizer recipients started getting boosters, J&J recipients were left wondering what’s next for them.
• On Tuesday, J&J said it submitted data to the FDA to request authorization for booster shots.
• See more stories on Insider’s business page.

Johnson & Johnson’s 14.9 million recipients are a step closer to getting booster shots, after feeling ignored by public-health agencies for months.

On Tuesday, J&J said it had submitted data to the Food and Drug Administration and asked the agency to authorize booster shots for emergency use . It will be up to the Centers for Disease Control and Prevention and FDA to evaluate that request, green-light the shots, and determine who should get the boosters.

An FDA advisory committee will meet later next week to discuss both J&J and Moderna’s booster shot applications.

Prior to Tuesday’s announcement, J&Jers described feeling remorse about their one-shot status.

“I count myself among those few and now not-so-proud,” New York Magazine’s Benjamin Hart wrote last month, in a piece with the simple headline: “Johnson & Johnson & Regret.”

The shot, a convenient one-and-done single dose, suffered a kind of fall from grace during its rollout: A factory mix-up led vaccine ingredients to be improperly mixed, then the CDC issued a pause on the vaccine altogether while they examined the risk of an an extremely rare blood clot condition. Regulators later added a warning label for women under 50.

Tuesday’s news came after months of radio silence from the CDC and FDA about the possibility of a J&J booster, even though a third Pfizer dose was authorized for many groups in September, and the same is expected of Moderna soon. Boosters from both companies were previously authorized for immunocompromised people, but even that hasn’t been true for J&J.

“Despite being in real need of some direction, it has often felt as if we’ve been cast out of the pandemic narrative altogether – like we’re the Generation X of vaccine recipients,” Hart wrote.

To shed some light for J&Jers, here’s what health officials have suggested so far.

Will I need a second shot?

“For people who received the Johnson & Johnson vaccine, we anticipate vaccine boosters will likely be needed,” Dr. Vivek Murthy, the US Surgeon General, said during a White House briefing in August. “The J&J vaccine was not administered in the US until March of 2021, and we expect more data on J&J in the coming weeks.”

That information arrived in late September, when J&J released results from its clinical trial showing that two doses of its vaccine led to 94% protection against mild to severe COVID-19, up from the 74% efficacy found in the trial of its single shot.

While the data has not yet been peer reviewed, it puts a two-shot J&J vaccine on par with the mRNA vaccines offered by Pfizer and Moderna.

Can I get an mRNA booster while the CDC figures things out with J&J?

You probably shouldn’t, but check with your doctor.

So far, all vaccine recipients have been advised to stick with the same shot when they get a booster, since there isn’t yet trial data about mixing and matching.

But health officials in San Francisco went rogue in August, telling J&Jers they would give them mRNA boosters if their doctors recommended it.

“If people talk to their health care provider and say, ‘I’d really like to have an mRNA shot in addition to the Johnson & Johnson shot that I got,’ we will accommodate that,” said Dr. Grant Colfax, the director of San Francisco’s public health department, according to CBS’ San Francisco affiliate.

The CDC estimates that 1 million Americans got an unauthorized COVID-19 booster prior to the recent recommendations, ABC News reported. It’s unclear how many of those were under the recommendation of a doctor.

“We are strongly recommending that people do not do that,” Dr. Anthony Fauci said of those unauthorized booster shots in an interview with CNN in September.

“We recommend that people wait until you get to the point where you fall into the category where it’s recommended,” Fauci added.

Still, he recognized that people simply want protect themselves against COVID-19 to the greatest extent possible.

“That’s human nature. Not much you can do about that,” Fauci said.