Pfizer’s Abrysvo (bivalent RSV prefusion F vaccine) Receives the US FDA’s Approval for the Prevention of Respiratory Syncytial Virus in Infants
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- The US FDA has approved Abrysvo (bivalent RSV prefusion F vaccine) for the prevention of LRTD & sev. LRTD caused by RSV in infants from birth up to 6mos. by active immunization of pregnant individuals at 32 through 36wks. gestational age.
- The approval was based on the P-III trial (MATISSE) evaluating the efficacy, safety & immunogenicity of Abrysvo in 7000+ pregnant individuals in a ratio (1:1) against LRTD & sev. LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy. The trial was conducted in 18 countries over 4 RSV seasons, followed by infants for ~2yrs.
- RSVpreF vaccine administered during pregnancy was effective against sev. RSV-associated lower respiratory tract illness in infants with no safety concerns, the incidence of AEs was similar b/w active & PBO groups in mothers and infants. The results were published in The NEJM
Ref: Pfizer | Image: Pfizer
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
