Priority Review Begins for 20-Valent Pneumococcal Conjugate Vaccine in Infants and Children

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children six weeks through 17 years of age.

And for preventing otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes in the vaccine.

The Prescription Drug User Fee Act goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023. 

“Today’s regulatory milestone further advances Pfizer’s commitment to the more than 20-year legacy of helping protect infants and children from invasive pneumococcal disease through conjugate vaccination,” said Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on January 6, 2023.

“By offering the broadest serotype coverage by a pneumococcal conjugate vaccine against important serotypes causing pneumococcal disease in U.S. infants and children, 20vPnc, if approved, can help expand the protection for this vulnerable pediatric population.”

The FDA previously approved PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) on June 8, 2021, to prevent invasive disease and pneumonia caused by the 20 pneumococcus serotypes in the vaccine in adults ages 18 years and older.