Respiratory Syncytial Virus: A Year of Infant Protection Breakthroughs

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) on Friday voted to recommend the first maternal respiratory syncytial virus (RSV) vaccine to protect newborns from severe RSV infection. By an 11-1 vote, the members of the ACIP recommended that pregnant women receive a single dose of Pfizer’s bivalent RSV prefusion F protein (RSVpreF) vaccine (Abrysvo™) during 32 through 36 weeks gestation to prevent lower respiratory tract disease (LRTD) caused by RSV in infants. “Today’s ACIP recommendation for maternal immunization with Abrysvo reinforces the wide-ranging impact vaccines can have, including helping protect infants immediately at birth from the potentially severe and life-threatening complications that can develop from RSV.” Read more

The US Food and Drug Administration (FDA) has approved the first vaccine for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. The agency approved Abrysvo™ (Pfizer) for use as a single intramuscular injection at 32 through 36 weeks’ gestational age. “The approval of Pfizer’s ABRYSVO is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV,” said Eric Simões, MD, clinical professor, pediatrics-infectious diseases, University of Colorado School of Medicine, Children’s Hospital Colorado, Aurora, CO. Read more

On August 3, 2023, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) considered proposed recommendations for routine use of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The ACIP voted in unanimous fashion, 10 to 0, to recommend routine use of nirsevimab-alip for newborns and infants younger than 8 months, born during or entering their first RSV season. The ACIP additionally voted 10 to 0 recommending routine nirsevimab-alip use for children aged 8 to 19 months that are at an increased risk of severe RSV disease while entering their second RSV season. Read more

The FDA has announced the approval of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in neonates and infants entering, or born during their first RSV season, according to a press release from the federal agency. Additionally, nirsevimab-alip is approved for children up to 24 months that remain vulnerable to severe RSV through their second season.Most infants will experience mild cold-like symptoms, but others can develop LRTDs like pneumonia and bronchiolitis, which can lead to emergency department visits. The highest risk for severe RSV targets premature infants and patients with chronic lung disease of prematurity or significant congenital heart disease. Read more

After an all-day meeting, the Antimicrobial Drugs Advisory Committee (AMDAC) to the US Food and Drug Administration (FDA) voted on June 8 to recommend the approval of nirsevimab (Beyfortus) for the prevention of respiratory syncytial virus (RSV) disease in infants. Nirsevimab is a long-acting antibody, in development by Sanofi and AstraZeneca, to protect all infants against RSV disease. “Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid, and direct protection against the disease." The proposed indication for nirsevimab is to prevent RSV lower respiratory tract disease in neonates and infants born during or entering into their first RSV season. Additionally, the treatment was recommended for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Read more

An advisory committee to the US Food and Drug Administration on Thursday made a positive recommendation to the agency on a first-ever maternal vaccine against respiratory syncytial virus (RSV) in infants from birth up to age 6 months. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (14 to 0) on the efficacy of Pfizer’s investigational bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF and 10 to 4 on the vaccine's safety when given to pregnant patients in the second or third trimester. Despite the 4 "no" votes from the committee on the question of whether data presented demonstrated an adequate safety profile for the vaccine, the FDA confirms a PUDFA date of August 2023. Read more

The US Food and Drug Administration will review the biologics license application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) in infants and children up to age 24 months. The  announcement, made jointly by codevelopers Sanofi and AstraZeneca (AZ), says the FDA will work to expedite its review, setting the PDUFA date in the third quarter of 2023. If approved, the long-acting monoclonal antibody will be the first single-dose preventive option for the broad infant population, including those who are born healthy, at term or preterm, or with specific health conditions, according to the companies. The FDA will consider nirsevimab protection for infants entering or during their first RSV season and for those aged up to 24 months who remain vulnerable to the infection through their second RSV season, according to the companies. Read more