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FDA panel recommends second Johnston & Johnson COVID shot for adults

SCOTT SIMON, HOST:

More shots for more arms - the U.S. Food and Drug Administration's vaccine advisory committee says the agency should authorize booster shots for people who got the Johnson & Johnson COVID vaccine. If the FDA agrees with this recommendation, and that seems likely, millions of Americans could soon roll up their sleeves for another dose. NPR health reporter Pien Huang joins us. Pien, thanks so much for being with us.

PIEN HUANG, BYLINE: Thanks for having me.

SIMON: What is this panel? What does their decision mean?

HUANG: So the booster recommendation came from the FDA's vaccine advisory committee. This is a group with 19 voting members. They're doctors, immunologists, infectious disease experts. And their job is to help determine whether vaccines and treatments are safe and effective. FDA official Peter Marks reminded the panel that the goal for COVID vaccines is to save lives.

(SOUNDBITE OF ARCHIVED RECORDING)

PETER MARKS: Vaccination is most important for preventing severe outcomes from SARS-CoV-2 infections, such as hospitalization and death.

HUANG: In the U.S., the panel heard that the Johnson & Johnson vaccine might be just 68% effective at keeping people from getting hospitalized with COVID. And that's not as good as the Moderna or Pfizer vaccines. But the data they reviewed shows that giving an additional J&J shot could really improve protection.

Now, there was some discussion of giving a Pfizer or Moderna booster to people who got J&J, but the data was preliminary, and no action was taken on that. Instead, the panel supported FDA authorization for a second J&J shot at least two months after the first shot. And this is for anyone who's already received it and would apply to around 15 million people in the U.S.

SIMON: Second Johnson & Johnson shot for people who got that vaccine. What about those who got the two-dose Moderna vaccine?

HUANG: Well, the Moderna booster recommendation, which the panel considered on Thursday, was a bit more nuanced. So here the panel voted that only specific groups of people - those 65 and up or people at high risk of getting COVID - should get a third shot. This is the same recommendation they made for the Pfizer booster, which the FDA authorized in September for these same groups. And the reason for the difference is that the Moderna vaccine is holding up well. It's still more than 90% effective at keeping people from landing in the hospital with COVID. But people are still getting breakthrough infections.

Here's Peter Marks again.

(SOUNDBITE OF ARCHIVED RECORDING)

MARKS: However, in considering the value of vaccination, one may also need to consider the potential for morbidity from mild to moderate infection, such as blood clots and long COVID-19.

HUANG: Marks also said data from Israel made him worried that the vaccine's protection could slide to dangerous lows over time, so he wants to give out boosters before that happens.

SIMON: Pien, when do we expect this recommendation to become more than just a recommendation?

HUANG: Well, the FDA will likely accept the panel's advice and authorize Moderna and J&J boosters next week, and then the discussion moves to the CDC. Their advisory committee meets on Thursday to review the booster data and to make further recommendations on how these shots should be used.

And Ofer Levy, an FDA panelist who's also a Harvard Medical School professor, says the committee might also consider expanding booster access for the Moderna and Pfizer vaccines. It's currently available for those 65 and older, but he thinks that could change.

(SOUNDBITE OF ARCHIVED RECORDING)

OFER LEVY: This is a dynamic pandemic. We don't know what the winter will bring, what the dynamic of spread will be, what variants may emerge and also what new research will come forward in terms of the impact of the pandemic on those younger age groups.

HUANG: But it's important to note this week that the World Health Organization pleaded with countries not to give boosters because the global supply of vaccines is so limited and there are some places that still have not had access to any vaccines.

SIMON: NPR health reporter Pien Huang, thanks so much for being with us.

HUANG: Thanks for having me. Transcript provided by NPR, Copyright NPR.