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August 24, 2023

FDA approves Pfizer vaccine during pregnancy to prevent RSV in infants


The Food and Drug Administration has approved a Pfizer vaccine for pregnant women aimed at preventing Respiratory Syncytial Virus, or RSV, in infants.

RSV typically causes symptoms such as coughing, sneezing, fever and wheezing, but it can lead to more serious complications like pneumonia, according to the U.S. Centers for Disease Control and Prevention. 

The disease is a leading cause of hospitalization in children under the age of 1, according to Pfizer, which is based in New York and has a research facility in Groton.

The company’s vaccine, called Abrysvo, is now the first and only U.S.-approved maternal vaccine to help protect infants at birth through the age of 6 months from lower respiratory tract disease (LRTD) caused by RSV, according to Pfizer. 

The vaccine is designed to be given to pregnant women who are at 32 to 36 weeks’ gestation. 

The approval follows a Phase 3 clinical trial which included more than 7,000 pregnant women and their infants, according to Pfizer.

Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer, vaccine research and development, said the approval “marks a significant milestone” for public health and the scientific community.

“Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants 6 months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved,” Anderson said, in an announcement this week.

Dr. Eric A.F. Simões of Children’s Hospital Colorado, who specializes in pediatric infectious diseases, said newborns and young infants’ immune systems are still developing, and often aren’t strong enough yet to defend against infections.

Maternal immunization via the new vaccine is expected to provide protection from birth, according to Pfizer.

In May, the FDA approved the vaccine for preventing lower respiratory tract disease caused by RSV in people aged 60 and older.

Pfizer has started clinical trials to evaluate Abrysvo for preventing RSV in children under age 2, and for high risk adults, such as those with asthma, between the ages of 18 and 60.

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