FDA Approves Vaccine For Pregnant Women To Prevent RSV In Newborns

The FDA approved the first vaccine for pregnant women to prevent RSV in infants. The vaccine would allow babies to be born with antibodies that protect against RSV instead of having to get immunized, the FDA said.

Wednesday, September 13th 2023, 5:31 am

By: Associated Press, Jonathan Polasek


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The FDA approved the first vaccine for pregnant women to prevent RSV in infants.

RSV is a disease that’s common in children. Severe RSV can require hospitalization, oxygen supplementation, and also lead to lower respiratory tract disease.

The vaccine would allow babies to be born with antibodies that protect against RSV instead of having to get immunized, the FDA said.

However, with this vaccine still being very new, doctors are still waiting on guidance as to how and when to administer it.

The Centers for Disease Control and Prevention must issue recommendations for using the vaccine, named Abrysvo, during pregnancy.

"I think the important thing to know, just that we are still kind of waiting on clinical guidance from some of our other medical governing bodies, the CDC and things like that, to see how it fits into our vaccination schedule, and to see exactly which women may benefit from this vaccine," said Dr. Jessica Koshy at Utica Park Clinic.

If you are interested in getting this vaccine, you're encouraged to talk to your doctor to see if you might be a good candidate.

How will the new RSV vaccination for pregnant women work?

A single injection late in pregnancy gives enough time for the mom-to-be to develop virus-fighting antibodies that pass through the placenta to the fetus — ready to work at birth.

It’s the same way pregnant women pass along protection against other infections. Pregnant women have long been urged to get a flu shot and a whooping cough vaccine — and more recently, COVID-19 vaccination.

Pfizer’s study included nearly 7,400 pregnant women plus their babies. Maternal vaccination didn’t prevent mild RSV infection — but it proved 82% effective at preventing a severe case during babies’ first three months of life. At age 6 months, it still was proving 69% effective against severe illness.

Vaccine reactions were mostly injection-site pain and fatigue. In the study, there was a slight difference in premature birth — just a few weeks early — between vaccinated moms and those given a dummy shot, something Pfizer has said was due to chance. The FDA said to avoid the possibility, the vaccine should be given only between 32 weeks and 36 weeks of pregnancy, a few weeks later than during the clinical trial.

If enough pregnant women get vaccinated, Pfizer has predicted the U.S. could prevent as many as 20,000 infant hospitalizations a year and 320,000 doctor visits.

The RSV vaccine for newborns:

The only other option to guard babies from RSV is by giving them lab-made antibodies. The FDA recently approved a new drug that’s the first one-dose version, recommended for all infants younger than 8 months before their first RSV season starts. Beyfortus, from Sanofi and AstraZeneca, is expected to be available this fall.

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