FDA Approves Pfizer's Abrysvo For Pregnant Individuals To Prevent RSV In Infants

(RTTNews) - The U.S. Food and Drug Administration announced the approval of Pfizer Inc.'s Abrysvo (Respiratory Syncytial Virus Vaccine) for use in pregnant individuals to prevent respiratory syncytial virus or RSV in infants.

It is the first vaccine approval for use in pregnant individuals to prevent lower respiratory tract disease or LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

RSV is a highly contagious virus that causes respiratory infections in individuals of all age groups, and the most frequent cause of lower respiratory tract illness in infants worldwide. RSV most often causes cold-like symptoms in infants and young children, but it can also lead to serious LRTD such as pneumonia and bronchiolitis.

According to the Centers for Disease Control and Prevention, RSV is the major cause of infant hospitalization in the U.S.

Abrysvo, which is now approved for use at 32 through 36 weeks gestational age of pregnancy, is administered as a single dose injection into the muscle.

The application was earlier granted Priority Review status and Fast Track and Breakthrough Therapy designations.

Earlier in May, the agency had approved Abrysvo for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

The latest approval was based on a clinical study that evaluated the effectiveness of Abrysvo to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy.

In the trial with pregnant individuals, Abrysvo reduced the risk of severe LRTD by 81.8 percent within 90 days after birth, and 69.4 percent within 180 days after birth. In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, Abrysvo reduced the risk of LRTD by 34.7 percent, and reduced the risk of severe LRTD by 91.1 percent within 90 days after birth when compared to placebo.

Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3 percent and by 76.5 percent for severe LRTD, when compared to placebo.

The FDA noted that Abrysvo's safety and effectiveness for use in pregnant individuals to prevent RSV in infants from birth through 6 months of age was evaluated in ongoing, randomized, placebo-controlled international clinical studies.

In the trials, the most commonly reported side effects by pregnant individuals who received Abrysvo were pain at the injection site, headache, muscle pain and nausea.

Meanwhile, a dangerous hypertensive disorder, known as pre-eclampsia, was also reported in 1.8 percent of pregnant individuals who received Abrysvo compared to 1.4 percent of pregnant individuals who received placebo. In addition, low birth weight and jaundice in infants occurred at a higher rate in the pregnant Abrysvo recipients in safety trials, compared to pregnant placebo recipients.

The company has been asked to conduct postmarketing studies to assess the signal of serious risk of preterm birth and to assess hypertensive disorders of pregnancy, including pre-eclampsia.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said, "RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization. This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."

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