The Food and Drug Administration (FDA) announced its approval of Pfizer’s Abrysvo (Respiratory Syncytial Virus (RSV) Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease and severe lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in infants from birth through six months of age. FDA says Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. The approval follows a clinical study that confirmed Abrysvo’s effectiveness to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy.
The safety and effectiveness of Abrysvo for immunization of pregnant individuals to prevent LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age was evaluated in ongoing, randomized, placebo-controlled international clinical studies.
A clinical study evaluated the effectiveness of Abrysvo to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy. Among approximately 3,500 pregnant individuals who received Abrysvo, compared to approximately 3,500 pregnant individuals who received placebo, Abrysvo reduced the risk of severe LRTD by 81.8% within 90 days after birth, and 69.4% within 180 days after birth. In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, of whom approximately 1,500 received Abrysvo and 1,500 received placebo, Abrysvo reduced the risk of LRTD by 34.7%, and reduced the risk of severe LRTD by 91.1% within 90 days after birth when compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3% and by 76.5% for severe LRTD, when compared to placebo.
The safety of Abrysvo was evaluated in two studies. In one study, approximately 3,600 pregnant individuals received a single dose of Abrysvo and approximately 3,600 pregnant individuals received a placebo. In the second study, approximately 100 pregnant individuals received Abrysvo and approximately 100 pregnant individuals received placebo.
The most commonly reported side effects by pregnant individuals who received Abrysvo were pain at the injection site, headache, muscle pain and nausea.
In addition, although not commonly reported, a dangerous hypertensive disorder, known as pre-eclampsia, occurred in 1.8% of pregnant individuals who received Abrysvo compared to 1.4% of pregnant individuals who received placebo. In the safety studies, low birth weight and jaundice in infants occurred at a higher rate in the pregnant Abrysvo recipients compared to pregnant placebo recipients.
The Prescribing Information for Abrysvo includes a warning to inform that a numerical imbalance in preterm births in Abrysvo recipients (5.7%) occurred compared to those who received placebo (4.7%). The available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo. Specifically, the warning informs healthcare providers that to avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age. Pregnant individuals who were at increased risk of preterm birth were generally excluded from clinical studies of Abrysvo.
To read the full FDA News Release on Abrysvo, click here.
