Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for the company's 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
"The EC's authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU," said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. "PREVENAR 20 builds on Pfizer’s decades-long commitment to develop vaccines to help prevent potentially life-threatening infections, and we are proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe."
Today's authorization follows the recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway. It also follows the approval of PREVNAR 20 for infants and children by the U.S. Food and Drug Administration (FDA) in April 2023, and approvals in several other countries including Canada, Australia and Brazil. Regulatory applications for PREVENAR 20 for the pediatric indication have been submitted to additional countries around the world.
The EC authorization of PREVENAR 20 is based on evidence from the Phase 3 clinical trial program comprised of four core pediatric studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079), which helped to expand the data on the safety, tolerability, and immunogenicity of the vaccine. These studies collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages.
About PREVENAR 20®
Pfizer's PREVENAR 20® includes 13 serotypes already included in PREVENAR 13® - 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in PREVENAR 20 - 8, 10A, 11A, 12F, 15B, 22F, and 33F - are global causes of invasive pneumococcal disease (IPD), and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.(9) Together, the 20 serotypes included in PREVENAR 20 are responsible for the majority of currently circulating pneumococcal disease in the EU and globally.(1,2,3,4,5,6,7,8)In February 2022, the European Commission Decision was adopted for APEXXNAR® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 S. pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Pfizer is changing the tradename of APEXXNAR to PREVENAR 20 following the expansion of its indication to include individuals from 6 weeks of age and older.
In April 2023, the United States Food and Drug Administration (FDA) approved PREVNAR 20® (20v PnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 S. pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.
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1. Active Bacterial Core (ABCs) surveillance. National Center for Immunization and Respiratory Diseases. Atlanta, GA. CDC. Published March 2020. Updated May 22, 2020. Accessed February 6, 2024. Available at: https://www.cdc.gov/abcs/reports-findings/survreports/spneu18.pdf
2. Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study [published correction appears in Lancet Infect Dis. 2018 Feb 6;:]. Lancet Infect Dis. 2018;18(4):441-451. doi:10.1016/S1473-3099(18)30052-5
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5. Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the U.S. CDC. ACIP. Published October 24, 2018. Accessed February 6, 2024. Available at: https://stacks.cdc.gov/view/cdc/61449
6. Invasive pneumococcal disease. In: ECDC. Annual epidemiological report for 2016. ECDC. Published August 8, 2018. Accessed February 6, 2024. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/AER_for_2016-invasive-pneumococcal-disease_0.pdf
7. Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015-2016. Published November 2018. Accessed February 6, 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/30524382/
8. Grant L, Suaya J, Pugh S, et. al. Coverage of the 20-Valent Conjugate Vaccine Against Invasive Pneumococcal Disease By Age Group in the United States, 2017. Abstract No. ISP20-237
9. Senders, S., et al. (2021, October 1). Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants in the United States. The Pediatric Infectious Disease Journal. Published September 13, 2021. Accessed February 6, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443440/