FDA Panel Recommends Johnson & Johnson Booster Shot—Here's What Happens Next
It's been a lingering question for months: Do people who got the Johnson & Johnson (J&J)/Janssen COVID-19 vaccine need a booster shot? Finally, a scientific panel advising the US Food and Drug Administration (FDA) has provided a bit of clarity.
On October 15, the FDA's Vaccine and Related Biological Products Advisory Committee, by a 19-0 vote, agreed that available safety and effectiveness data support emergency use of a COVID-19 booster dose for people 18 and older.
It's now up to the FDA to either accept or reject the panel's decision, setting the stage for potential second doses in the arms of some 15 million Americans who, according to the US Centers for Disease Control and Prevention, received the one-dose J&J vaccine.
Who is eligible for the J&J booster dose?
Specifically, the advisory panel recommended that the FDA grant emergency use of a J&J booster to people 18 years of age and older. Adults who received the single-shot J&J COVID-19 vaccine would be eligible for that extra jab at least two months after their first J&J shot.
It's a broad recommendation, covering anyone who got the J&J vaccine. You may recall that the FDA granted emergency use of J&J's single-dose vaccine in February 2021, making it the third COVID-19 vaccine authorized for use in the US and the only one approved as a one-dose regimen.
The advisory panel's recommendation a day earlier for a Moderna booster is much more nuanced, singling out older adults and certain at-risk individuals for a "boost." Likewise, a Pfizer booster dose is recommended for specific groups of individuals, not everyone who has had the Pfizer COVID-19 vaccine.
Why did the panel vote for a J&J booster?
During a comment period prior to the October 15 vote, several members of the advisory panel indicated that, despite limited data, providing a booster dose two months after the initial dose is not only safe but also warranted.
Archana Chatterjee, MD, PhD, an infectious disease expert who serves as a member of the panel, told her colleagues she was initially against recommending a J&J booster dose. However, after discussion and review of the available evidence—and considering that 15 million people in US received a single dose of vaccine and their immunity may be waning—she concluded that "this is still a public health imperative."
Dr. Chatterjee said she agreed with most of her colleagues that a booster "is necessary in these individuals for them to boost up that immunity into the 95% range."
When can I get my J&J booster?
The advisory panel's recommendation is the just the first step in a multi-pronged process. Next, the FDA must decide whether to accept the panel's vote and approve emergency use of a J&J booster. After that, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) will review the evidence to weigh the risks and benefits of a booster dose and make real-world decisions about how to administer these additional doses. And finally, the CDC will issue guidance.
If I had J&J, can I get a Moderna or Pfizer booster?
Well, that's another wrinkle. After the FDA advisory panel's vote, members heard from Kirsten Lyke, MD, of the University of Maryland School of Medicine. Dr. Lyke presented preliminary data from a small "mix-and-match" study, suggesting that people who got the J&J vaccine might benefit from a Moderna or Pfizer booster.
Ultimately, the panel did not take a vote on whether J&J recipients should get a booster dose of one of the mRNA vaccines. That debate continues.
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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