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    FDA grants vaccine approval for moms-to-be to prevent RSV in newborns

a close-up of a young couple and their newborn, sitting together on a couch

The Food and Drug Administration has approved a vaccine for pregnant women to provide immediate protection against respiratory syncytial virus, or RSV, in infants.

Abrysvo, is a single-dose vaccine produced by Pfizer and is approved for use between week 32 and week 36 of pregnancy.

"This is especially exciting for us in pediatrics because vaccinating pregnant women in the second or third trimester of pregnancy can protect babies when they're most vulnerable for developing severe illness with RSV, usually in the first six to 12 months of life," says Dr. Nipunie Rajapakse, a pediatric infectious diseases physician with the Mayo Clinic Children's Center.

Watch: Dr. Nipunie Rajapakse talks about RSV drug for infants

Journalists: Broadcast-quality sound bites with Dr. Rajapakse are available in the downloads at the end of the post. Please courtesy: "Mayo Clinic News Network." Name super/CG: Nipunie Rajapakse, M.D./Pediatric Infectious Diseases/Mayo Clinic.

What is RSV?

RSV is often a seasonal illness that typically starts circulating in the fall. It is transmitted from person to person through close contact with an infected person.

"This is a relatively common virus that used to be seasonal in the fall and winter. But over the COVID-19 years, we've seen some changes in that seasonality with seasons starting earlier or ending later than usual," says Dr. Rajapakse. 

surge of RSV infection during last season resulted in many young children needing medical attention or being hospitalized. The Centers for Disease Control and Prevention says 58,000 to 80,000 infants and children are hospitalized yearly due to RSV.

RSV in young children is very common. The virus typically infects most children by their second birthday and can also affect adults. Healthy adults and older children may experience mild symptoms that mimic a cold.

Severe and potentially life-threatening infections can happen in young babies, older adults or anyone with a weakened immune system. 

Symptoms usually appear in stages rather than all at once, including:

  • Runny nose
  • Decrease in appetite
  • Coughing
  • Sneezing
  • Fever
  • Wheezing

There is no treatment for a mild or moderate RSV. In most cases, doctors recommend drinking plenty of fluids, taking over-the-counter pain or fever medication and resting. Symptoms should go away on their own in a week or two. 

Last month, the FDA approved a drug called Beyfortus that can be given to newborns and infants. Back in May, the FDA approved Abrysvo for use in people 60 and older.