Pfizer's 20-Valent Pneumococcal Conjugate Vaccine Receives FDA Priority Review for Prevention of Invasive Disease and Pneumonia in Adults

Pfizer Announces FDA Acceptance of Biologics License Application for 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) for Adults Aged 18 and OlderPfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and older. The FDA has also granted priority review to this application, with a decision expected by June of next year.

Streptococcus pneumoniae is a Gram-positive, facultative anaerobic bacterium with more than 90 serotypes. This bacterium can cause severe conditions such as pneumonia, meningitis, bloodstream infections, and sinus infections. Approximately 500,000 patients aged 70 years and older die annually from diseases associated with Streptococcus pneumoniae infection.

Conjugate vaccines chemically link polysaccharide or oligosaccharide antigens to protein carriers, thereby more effectively stimulating immune responses in both adults and children and prompting B cells to produce IgG antibodies. Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) includes the 13 serotypes contained in the already marketed Prevnar 13, plus seven additional new serotypes. These seven newly added serotypes are associated with invasive pneumococcal disease (IPD), high case-fatality rates, antibiotic resistance, and/or meningitis. Previously, the U.S. FDA granted Fast Track designation and Breakthrough Therapy designation to the 20vPnC vaccine.

This application is supported by data from three Phase 3 clinical trials. These Phase 3 trials have enrolled more than 6,000 adult subjects aged 18 years and older, including adults aged 65 years and older, as well as vaccine-naïve adults and adults previously vaccinated with pneumococcal vaccines.

References:

[1] uniQure Presents Late-Breaking Data from the HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B at the 62nd Annual Meeting of the American Society of Hematology. Retrieved December 8, 2020, from https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=3846830&lang=en-GB&companycode=nl-qure&v=

[2] First Data from the Phase 3 HOPE-B Gene Therapy Trial: Efficacy and Safety of Etranacogene Dezaparvovec (AAV5-Padua hFIX variant; AMT-061) in Adults with Severe or Moderate-Severe Hemophilia B Treated Irrespective of Pre-Existing Anti-Capsid Neutralizing Antibodies. Retrieved December 8, 2020, from http://uniqure.com/investors-newsroom/ASH%202020%20HOPE-B%20PRESENTATION_FINAL.pdf

[3] uniQure Announces Two-Year Follow-Up Data from the Phase IIb Study of Etranacogene Dezaparvovec and Long-Term Follow-Up Data for AMT-060 in Patients with Hemophilia B. https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=3846649&lang=en-GB&companycode=nl-qure&v=

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