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RSV Vaccine Narrowly Wins Votes

March 1, 2023 • 5:04 am CST
by Tumisu P.
(Precision Vaccinations News)

Pfizer Inc. announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted during its 179th meeting that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate ABRYSVO™ (PF-06928316 or RSVpreF).

The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.

The vaccine candidate is under FDA review to prevent acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 and older.

The FDA's decision on whether or not to approve RSVpreF is expected by the Prescription Drug User Fee Act (PDUFA) goal date in May 2023.

Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, commented in a related press release on February 28, 2023, "We are encouraged by the outcome of today's VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market."

"We look forward to working with the FDA as it completes the review of our application."

Pfizer is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate for both an indication to help protect older adults, as well as a maternal indication to help protect infants through maternal immunization.

Regarding the maternal indication, earlier this month, Pfizer announced that the FDA had granted priority review to a biologics license application for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant women.

The FDA established a PDUFA action date in August 2023.

The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding. 

RSV is a contagious virus and a common cause of respiratory illness.

The virus can affect the lungs and breathing passages of an infected individual. As a result, it can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.

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