The FDA approves the first maternal vaccine to prevent RSV, Pfizer’s single-dose Abrysvo vaccine

The Food and Drug Administration (FDA) has approved the first vaccine pregnant woman to prevent RSV in infants, the agency announced on Monday.

Abrysvo is approved as a maternal vaccine for prophylaxis disease of the lower respiratory tract (LRTD) in babies from birth to 6 months of age, the FDA news release said.

The single-dose vaccine is given by injection from the 32nd and 36th week of pregnancy.

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The news followed the FDA's May announcement of approval of Abrysvo for the prevention of LRTD in people ages 60 and older.

RSV (Respiratory Syncytial Virus) can cause infection of the lungs and respiratory tract. It is very common in children – in fact, most contract the virus before the age of 2.

The Food and Drug Administration (FDA) has approved the first vaccine for pregnant women to prevent RSV in infants, the agency announced Monday. (iStock)

High-risk groups, including babies 12 months of age and younger older adultsAccording to the Mayo Clinic website, people with heart and lung disease and those with compromised immune systems are more prone to serious illness.

According to the FDA, RSV is the leading cause of lower respiratory tract disease worldwide.

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It is the leading cause of hospitalizations for infants in the United States

“The approval of ABRYSVO as the first and only maternal vaccine to help protect newborns from RSV immediately after birth up to six months represents a significant milestone for the scientific community and public health,” said Annaliesa Anderson, PhD , senior vice president and chief scientific officer at Pfizer, in a company press release.

“The approval of ABRYSVO as the first and only maternal vaccine to help protect newborns from RSV immediately after birth up to six months represents a significant milestone for the scientific community and public health,” said Annaliesa Anderson, PhD , senior vice president and chief scientific officer at Pfizer. (REUTERS/Carlo Allegri/File Photo)

“Today, a long-awaited goal was achieved to provide a maternal vaccine that will help protect infants aged six months and younger – when they are most at risk of potentially serious consequences from RSV.”

For most adults and older, healthy childrenRSV causes only mild, cold-like symptoms that usually do not require medical attention.

“RSV is a common cause of disease in children, and infants are at highest risk for serious illnesses that can lead to hospitalization,” said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. (Getty Images)

“RSV is a common cause of disease in children, and infants are among those at highest risk for serious illnesses that can lead to hospitalization,” said Peter Marks, MD, Ph.D., director of the Center for Biologics Evaluation and the FDA Research, in the FDA press release.

“This permit provides an option for health care provider and pregnant individuals to protect infants from this potentially life-threatening disease,” he added.

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The FDA's approval follows promising clinical trials that measured the “efficacy, safety and immunogenicity of the vaccine against LRTD and severe LRTD due to RSV in infants of healthy individuals vaccinated during pregnancy,” Pfizer said in its press release .

The results of these studies were published in April 2023 in the New England Journal of Medicine.

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Of the 3,500 pregnant women who receive the vaccineCompared with the women who received placebos, their infants were more than 81% less likely to develop severe lower respiratory tract disease within the first three months after birth.

According to the FDA, RSV is the leading cause of lower respiratory tract disease worldwide and the leading cause of hospitalizations in infants in the United States (iStock)

In pregnant women who received the vaccine, the most common side effects were muscle pain, headache, nausea and pain at the injection site.

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Infants born to mothers who received Abrysvo had a slightly higher incidence of pre-eclampsia, low birth weight, preterm birth and jaundice compared to those in the placebo group.