The US Food and Drug Administration (FDA) has granted its approval to an innovative vaccine named Abrysvo, designed to safeguard infants from birth up to 6 months old against lower respiratory tract disease (LRTD) and severe LRTD resulting from the respiratory syncytial virus (RSV), as stated in an official press release by the federal health agency.
Significantly, this vaccine marks a significant milestone as the first of its kind. It’s noteworthy that back in May, the FDA had granted approval for Abrysvo to be used in preventing LRTD caused by RSV in individuals aged 60 years and above.
Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research, remarked, “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.”
He further noted, “This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
RSV, an extremely contagious virus responsible for respiratory infections across all age groups, has a particularly strong impact on infants, rendering them highly susceptible to severe respiratory illnesses that often require hospitalization. The approval of Abrysvo presents a crucial preventive measure for pregnant women, enabling them to shield their infants from the potentially life-threatening repercussions of RSV.
Administered during the gestational period of 32 to 36 weeks, Abrysvo involves a single-dose injection into the muscle. It’s important to highlight that pregnant women with a high risk of preterm birth were largely excluded from Abrysvo’s clinical trials, as mentioned in the FDA press release.
Although Abrysvo displayed some side effects among pregnant individuals who received the vaccine, including pain at the injection site, headache, muscle pain, and nausea, there were more notable findings. Notably, a rare but significant hypertensive disorder known as pre-eclampsia occurred more frequently among those vaccinated with Abrysvo compared to the placebo group.
The FDA reported, “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.”
Within the first 90 days after birth, Abrysvo demonstrated an 81.8 percent reduction in severe LRTD risk, along with a 69.4 percent reduction within the first 180 days after birth. In the case of pregnant individuals at 32 to 36 weeks of gestational age, Abrysvo yielded a 34.7 percent reduction in LRTD risk and an impressive 91.1 percent reduction in severe LRTD risk within the initial 90 days after birth.
Considering the 180-day mark, Abrysvo showcased a 57.3 percent reduction in LRTD risk and a 76.5 percent reduction in severe LRTD risk in comparison to the placebo group.
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