NEWS

FDA Panel Endorses Johnson & Johnson COVID-19 Booster Shot

Johnson & Johnson booster vial with cape

Jessica Olah / Verywell

UPDATE

On October 20, the FDA authorized a single booster of the Johnson & Johnson COVID-19 vaccine at least 2 months after initial vaccination in adults 18 and up. The FDA also said COVID booster shots do not have to match a recipient's initial vaccine series. In other words, vaccines can be "mixed and matched."

Key Takeaways

  • An FDA advisory panel today voted to recommend authorizing Johnson & Johnson boosters to people two months after their first shot.
  • Panelists said that the Jassen vaccine should have been a two-dose regimen.
  • Compared to Moderna and Pfizer, Johnson & Johnson's vaccine is less effective at preventing COVID-19 hospitalizations.

An advisory panel to the Food and Drug Administration (FDA) on Friday, October 15, voted unanimously in favor of authorizing Johnson & Johnson boosters to people two months after their initial vaccination.

If authorized, after the application for emergency use authorization at the beginning of October, the Johnson & Johnson booster would be available to people aged 18 and above who received the single-dose vaccine.

“There is a public health imperative here, because what we're seeing is that this is a group with overall lower efficacy than we have seen with the mRNA vaccine,” said Arnold S. Monto, MD, an epidemiology and public health professor at the University of Michigan School of Public Health. 

The same FDA panel voted yesterday to recommend Moderna boosters for people aged 65 and older, adults with underlying medical conditions, and those who work in high-risk settings—the same guidelines for Pfizer’s boosters.

Both decisions will need to be backed up by an official FDA authorization before people can receive those boosters.

At Friday’s meeting, Johnson & Johnson representatives presented data that showed a second dose of the Jassen vaccine would strongly boost immune response. A booster dose administered two months after the initial shot would increase protection against COVID-19 from 70% to 94%, according to the company’s data.

Leana Wen, MD, a public health professor at George Washington University who received the Johnson & Johnson vaccine, says that an extra shot should be considered not just as a booster, but as part of an initial series.

“This is not even a question of waning immunity and needing a booster. It’s a question of whether people with the J&J vaccine should get an additional dose to increase the protection,” Wen tells Verywell.

The panelists stressed an “urgency” for the booster due to the single-dose vaccine’s limited protection compared to that of the mRNA vaccines.

“If the vaccine isn't adequate, then it should be boosted in everybody,” said FDA panelist Daniel Rubin, PhD.

While Moderna is 93% effective and Pfizer is 88% effective at preventing hospitalizations, the Jassen vaccine fares the worst at 71% effectiveness against COVID-19 hospitalizations, according to a recent study by the Centers for Disease Control and Prevention.

FDA official Peter Marks, MD, PhD added that a Johnson & Johnson booster could better serve minorities, some of whom received the single shot through outreach campaigns.

Some experts have argued that boosters are not yet necessary because the initial vaccine series remain largely effective at preventing hospitalizations and deaths. But Wen says the optimism shouldn’t take away the importance of protecting people from getting infected by the virus.

“I do not think that our federal health officials should be in the business of telling people what they should care about when it comes to their health,” Wen says. “There are a lot of people who don't want to get COVID at all, don’t want to have the potential of long haul symptoms, don't want to transmit it to their loved ones.”

The FDA is expected to present a decision following the panel’s recommendation in the following days. 

“It’s very clear cut that the protection for the J&J vaccine just is not to the same level as Pfizer and Moderna,” Wen says.

What This Means For You

A Johnson & Johnson booster may be authorized soon for people 18 and older who initially received that vaccine. If the FDA authorizes the booster, people could be eligible for it as soon as two months after their first shot.

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  1. Self WH, Tenforde MW, Rhoads JP, et al. Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021. MMWR Morb Mortal Wkly Rep 2021;70:1337–1343. doi:10.15585/mmwr.mm7038e1