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Pfizer's RSV vaccine to protect newborns is approved by the FDA

A MARTÍNEZ, HOST:

The Food and Drug Administration has approved a vaccine against RSV that protects newborn babies. The shot is made by Pfizer and is given during pregnancy, as NPR pharmaceuticals correspondent Sydney Lupkin reports.

SYDNEY LUPKIN, BYLINE: RSV causes mild cold-like symptoms in most people but can be dangerous in young children and older adults. Each year in the U.S., up to 80,000 children under 5 are hospitalized with RSV, and up to 300 of them die. Here's Dr. Scott Roberts from Yale School of Medicine.

SCOTT ROBERTS: RSV has plagued the infant population of not just the United States but the world for years. And there have been attempts at developing both vaccines and therapeutics against RSV that have failed for decades.

LUPKIN: He says RSV is scary because it even hits healthy infants hard, blocking their tiny airways. The vaccine will be given to expectant mothers between the 32nd and 36th weeks of pregnancy. That immunity will then get passed on to their newborns through the placenta. Pfizer studied the vaccine in more than 7,000 pregnant women across 18 countries. The vaccine was 82% effective at preventing severe disease in infants during their first three months of life and 70% effective in the first six months. Dr. Eric Simoes at Children's Hospital Colorado worked with Pfizer and has been working on RSV prevention for decades.

ERIC SIMOES: My only hope is that we can get these vaccines not only in the U.S. but also to children in developing countries that need it the most.

LUPKIN: The FDA originally approved the vaccine in May for adults over 60. It's already available for the upcoming RSV season. Pfizer says it has been manufacturing the shot ahead of approval and expects to have enough supply to meet demand. Here's Roberts again.

ROBERTS: I feel very reassured going into this winter season, when many of us are really expecting surges in RSV the way we had pre-COVID.

LUPKIN: RSV activity has already begun this year in some states. The Pfizer vaccine joins another shot given to babies up to 24 months old. It's technically not a vaccine, but it, too, prevents RSV. It's a monoclonal antibody made by AstraZeneca that was also approved in July. For Roberts, this is good news. His family is expecting a baby in December.

ROBERTS: Having a baby in the middle of RSV season with, you know, another sibling in day care, you know, that really concerns me. And when I think about this year compared to last year, where we might have these options, you know, I'm just thrilled with that.

LUPKIN: So he will eagerly await the vaccine rollout.

Sydney Lupkin, NPR News. Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Sydney Lupkin is the pharmaceuticals correspondent for NPR.