Title: FDA Approves Pfizer Vaccine to Protect Newborns from Respiratory Syncytial Virus
Subtitle: First vaccine designed for infant protection administered to pregnant mothers in their third trimester
Date: [Current Date]
In a groundbreaking development, the Food and Drug Administration (FDA) has granted approval to Pfizer’s single-dose vaccine, Abrysvo, aimed at preventing infections in infants. The vaccine, to be administered to pregnant mothers in their third trimester, aims to provide protection to newborns from the moment they are born.
Abrysvo, already approved for preventing respiratory syncytial virus (RSV) in older adults, has now been authorized for use between 32 through 36 weeks of pregnancy. The FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of recommending the drug in May, emphasizing the urgent need for protection against RSV in infants.
RSV is a common cause of illness in children, with infants being especially vulnerable to severe diseases that can lead to hospitalization. The approval of Abrysvo offers a critical option for healthcare providers and pregnant individuals to safeguard infants from this potentially life-threatening disease, as highlighted by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Pfizer presented compelling data to the advisory committee, demonstrating that infants whose mothers received the Abrysvo vaccine exhibited higher levels of neutralizing antibodies against RSV through 6 months of age. Infants under 6 months face an elevated risk of developing severe RSV cases, making the vaccine particularly significant for this age group.
The FDA noted that in one clinical study, Abrysvo reduced the risk of lower respiratory tract disease by approximately 82 percent in the first 90 days after birth, and about 70 percent in the first 180 days. The approval of this maternal vaccine marks a significant milestone in protecting infants at their most vulnerable stage.
Annaliesa Anderson, Pfizer Senior Vice President, expressed gratitude to the clinical trial participants, study investigator teams, and colleagues whose commitment made this vaccine a reality. Anderson emphasized the importance of delivering a maternal vaccine that can protect infants aged six months or younger from potential serious consequences of RSV.
As respiratory viruses, including RSV, typically experience a surge in the fall and peak during the winter, the approval of Abrysvo comes at a critical time. Last winter, a high number of infants and toddlers were hospitalized due to RSV, overwhelming many hospitals already occupied with COVID-19 and flu patients.
RSV is often referred to as a common “daycare disease,” and the majority of children are exposed to it before the age of 2. Experts suggest that COVID-19 quarantines may have minimized exposure to RSV, potentially contributing to a harsher RSV season. It is worth noting that RSV cases were higher than normal even before the pandemic.
Until this year, there were no effective treatments specifically targeting RSV, apart from a monoclonal antibody for extreme high-risk cases. Recently, two RSV vaccines for older adults and a preventive monoclonal antibody for infants and toddlers received FDA approval.
While Abrysvo demonstrates promising results, the FDA panel reviewing the drug did note a numerically higher rate of preterm births among the vaccine recipients. However, this difference was not deemed statistically meaningful. Additionally, preeclampsia occurred slightly more frequently in the vaccine group, and higher rates of birth weight and jaundice were observed among the vaccine recipients. The FDA has stipulated that Pfizer must conduct postmarketing studies to evaluate the potential risks of preterm birth and other conditions associated with the vaccine.
The approval of Abrysvo signifies a significant step in protecting newborns from RSV, a disease that poses substantial risks to infants. Pfizer anticipates the availability of the vaccine during the third quarter of this year, before the predicted RSV season.
In conclusion, the approval of the first vaccine designed to protect infants from RSV through maternal vaccination is a major breakthrough in pediatric care. As healthcare providers now have the option to administer Abrysvo to pregnant individuals, the opportunity to safeguard newborns from severe RSV infections is expected to contribute to improved infant health outcomes.
Note: This article contains material from Nexstar Media Inc. and is subject to copyright restrictions.