Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in the vaccine.
Priority Review designation by the FDA reduces the standard sBLA review period by four months. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023. The FDA previously granted Pfizer's 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication for IPD.
"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., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "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 regulatory submission is supported by results from the Phase 3 and Phase 2 clinical trial programs for the pediatric indication for 20vPnC. Three core Phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of 20vPnC, including previously announced positive, top-line results of the pivotal U.S. Phase 3 study (NCT04382326). These studies collectively enrolled approximately 3,500 infants and 800 children of all ages. Further data from a Proof-of-Concept Phase 2 study (NCT03512288) in 460 U.S. infants that assessed the safety and immunogenicity of 20vPnC, with previously announced positive results, also supported the regulatory submission.
About 20vPnC
Pfizer's 20vPnC pediatric vaccine candidate includes the 13 serotypes already included in Prevnar 13® - 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in 20vPnC are global causes of IPD.1,2,3,4,5 and are associated with high case-fatality rates6,7,8,9 antibiotic resistance10,11 and or meningitis.12,13 Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.14,15,16,17,18,19,20
The supplemental Biologics License Application (sBLA) for 20vPnC includes for review indications in the following pediatric populations:
- The prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in infants and children 6 weeks through 17 years of age.
- The prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in infants and children 6 weeks through 5 years of age.
In September 2022, Pfizer announced positive top-line results from its pivotal Phase 3 study (NCT04546425) in infants in the European Union, and in November 2022, submitted the 20vPnC pediatric indication to the European Medicines Agency (EMA).
The FDA previously approved PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) on June 8, 2021, for the prevention of invasive disease and pneumonia caused by the 20 pneumococcus serotypes in the vaccine in adults ages 18 years and older.
INDICATIONS FOR PREVNAR 13®
- Prevnar 13® is approved for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 strains of S. pneumoniae in the vaccine, and for children 6 weeks through 5 years (prior to the 6th birthday) for the prevention of ear infections caused by 7 of the 13 strains in the vaccine
- Prevnar 13® is not 100% effective and will only help protect against the 13 strains in the vaccine
IMPORTANT SAFETY INFORMATION
- Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid-containing vaccine
- Children and adults with weakened immune systems (e.g., HIV infection, leukemia) may have a reduced immune response
- In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
- A temporary pause of breathing following vaccination has been observed in some infants born prematurely
- The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
- In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
- Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you or your child
INDICATIONS FOR PREVNAR 20®
- PREVNAR 20® is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
- The indication for preventing pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses. Continued approval may depend on a supportive study.
IMPORTANT SAFETY INFORMATION
- PREVNAR 20® should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20® or to diphtheria toxoid
- Adults with weakened immune systems may have a lower response to PREVNAR 20®. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20® is right for you
- In adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Additionally, injection site swelling was also common in adults 18 through 59 years of age
- Ask your healthcare provider about the risks and benefits of PREVNAR 20®. Only a healthcare provider can decide if PREVNAR 20® is right for you
