NEW YORK CITY (dpa-AFX) - Pharma major, Pfizer Inc. (PFE) said on Wednesday that the US Food and Drug Administration or FDA has provided Breakthrough Therapy Designation for its maternal Respiratory Syncytial Virus or RSV vaccine candidate or RSVpreF.
RSVpreF is aimed at treating RSV-associated lower respiratory tract disease in infants of birth up to six months of age by immunizing pregnant women.
The regulator's decision follows Phase 2b proof-of-concept study of RSVpreF done in healthy pregnant women ages 18 through 49 years old.
RSV is an infectious virus that causes respiratory illness by impacting the respiratory organs. The micro organism can be potentially life-threatening for young infants, the patients with weaker immunity, and others.
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