The vaccine aims to shield infants through the active immunization of pregnant individuals.

United States: On Thursday, August 23, 2023, Pfizer Inc.'s vaccine for respiratory syncytial virus (RSV) was sanctioned by the US Food and Drug Administration (FDA).

The FDA's ruling permits the administration of Abrysvo to those in their 32nd to 36th week of pregnancy. This is done to stave off lower respiratory tract disease (LRTD) and to mitigate the likelihood of severe LRTD in infants from birth until they reach six months of age.

Pfizer's Senior Vice President and Chief Scientific Officer for vaccine research and development, Annaliesa Anderson, remarked, "The approval of Abrysvo as the primary maternal immunization to safeguard newborns from RSV, right from birth up to six months, is a momentous achievement for the scientific community and public health."

The FDA's determination was reinforced by affirmative outcomes from the phase 3 MATISSE trial. This trial exhibited an 81.8% efficacy of the vaccine in preventing severe medically attended lower respiratory tract illnesses in infants within the initial 90 days after birth. The efficacy rate remained at 69.4% within 180 days.

RSV is a prevalent contagious virus that manifests through mild, cold-like symptoms. Though most individuals recuperate within one to two weeks, the virus can provoke severe maladies in young babies.

In the US, around 500,000 to 600,000 infants experience RSV-induced LRTD annually. Furthermore, it is estimated that 58,000 to 80,000 children under the age of five are hospitalized due to RSV infection.

Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, affirmed, "This endorsement furnishes healthcare providers and expectant individuals with an avenue to shield infants from this potentially life-threatening malady."