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Advisers to the FDA support approval of an RSV vaccine to protect infants

LEILA FADEL, HOST:

Next winter could be just a little less miserable for many new parents. That's because doctors are one crucial step closer to getting the first RSV vaccine for newborns. Advisers to the Food and Drug Administration endorsed the vaccine late yesterday. NPR health correspondent Rob Stein joins us now to discuss. Hi, Rob.

ROB STEIN, BYLINE: Hey, Leila.

FADEL: So what do we know about this vaccine?

STEIN: It's a twist on the vaccines people typically get to protect themselves against diseases like the flu, COVID and measles. This is a vaccine that pregnant people would get, not to protect themselves against RSV, but to protect their newborn babies. Here's how it works. The pregnant person gets the vaccine when they're four to six months pregnant to stimulate their immune systems to produce antibodies against RSV. Those antibodies then make their way to the fetus in their womb to protect them for at least the first six months after birth.

FADEL: Oh, wow. So how effective and how safe is it?

STEIN: A big study conducted by Pfizer, which developed the vaccine, found that the shot was almost 82% effective at protecting newborns against severe RSV through their first three months of life and 69% effective at protecting them against severe disease in their first six months. And you know, Leila, the question of safety is obviously a big deal and was the focus of a lot of discussion yesterday when the FDA convened an all-day meeting of the agency's outside advisers to review the vaccine. One concern was the vaccine might interfere with other vaccines, but the biggest worry was that there was a hint in the company study that women who get the vaccine are more likely to give birth prematurely. Here's Dr. Paul Offit from the University of Pennsylvania, one of the FDA advisers.

PAUL OFFIT: I worry that if preterm births are in any way a consequence of this vaccine, that would be tragic.

STEIN: But other committee members say they were convinced by the vaccine's effectiveness. Here's Dr. Jay Portnoy from Children's Mercy Hospital in Kansas City.

JAY PORTNOY: If the vaccine actually lives up to the data that we've seen today, I can guarantee that many infants and their parents will breathe easier in the coming years.

STEIN: And in the end, the FDA advisers voted unanimously that the vaccine is effective and 10 to 4 that it's safe.

FADEL: Now, how big of a problem, how dangerous is RSV to kids and babies?

STEIN: You know, RSV is a huge problem each fall and winter. Most kids will catch RSV in their first year of life. For most, the RSV just causes, you know, like a cold. But a small but significant percentage will be hospitalized for RSV, making it the leading cause of hospitalization for very young babies. As many as 80,000 babies end up in the hospital each year because of RSV, and between 100 and 300 die, according to the CDC.

FADEL: How soon will this vaccine be available for infants?

STEIN: The FDA will now consider those votes and make a final decision by the end of August. So this vaccine could be available to protect newborns against RSV next winter. You know, I should mention there may be another option too - the FDA is also considering what's called a monoclonal antibody shot babies could get to protect them. And the agency's already approved a vaccine to protect older people against RSV who are also at high risk for severe complications. And another vaccine for older folks from Pfizer could be approved this summer. So, you know, after decades of frustration, there are finally some weapons to fight RSV in the pipeline.

FADEL: NPR health correspondent Rob Stein, thanks a lot.

STEIN: You bet. Transcript provided by NPR, Copyright NPR.

Leila Fadel is a national correspondent for NPR based in Los Angeles, covering issues of culture, diversity, and race.
Rob Stein is a correspondent and senior editor on NPR's science desk.