PREVNAR 20® Vaccine Clinical Trials, Dosage, News, Side Effects, Usage
Pfizer Inc.'s PREVNAR 20® (20vPnC, APEXXNAR, PF-06482077) is a 20-valent pneumococcal conjugate vaccine that protects adults from a substantial invasive pneumococcal disease and pneumonia burden. PREVNAR 20 includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). PREVNAR 20 also contains capsular polysaccharide conjugates for seven other serotypes that cause pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. The 20 serotypes in 20vPnC are responsible for most currently circulating pneumococcal diseases globally.
On June 8, 2021, Pfizer confirmed the U.S. FDA Approved PREVNAR 20 for preventing invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults. The FDA previously granted Pfizer's 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication of IPD. In addition, the European Medicines Agency (EMA) issued its Approval for the brand name Apexxnar on February 15, 2022. On April 27, 2023, the FDA approved PREVNAR 20 for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae 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®.
On June 22, 2023, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend PREVNAR 20 for routine use to help protect infants and children from IPD caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine 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.
Pfizer announced on March 13, 2024, that the European Commission (EC) had granted marketing authorization for the company to market the vaccine in the European Union under the brand name PREVENAR 20®. This EC authorization is valid in all 27 EU member states, including Iceland, Lichtenstein, and Norway. It follows the recent positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use.
For more information, please visit New York-based pfizer.com. (NYSE: PFE). On January 30, 2024, Pfizer announced Prevnar 13 & 20 revenues were down 7% operationally, driven primarily by the pediatric indication in emerging markets due to lower demand and unfavorable timing of customer orders.
PREVNAR 20 Indication
The U.S. CDC recommends pneumococcal vaccination for children and adults 65 or older. In addition, older children and other adults should also get pneumococcal vaccines in certain situations. Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes annually in adults 70 and older. The CDC says the 20 serotypes included in 20vPnC are responsible for the most currently circulating pneumococcal disease in the U.S. and globally. In addition, the seven new serotypes included in 20vPnC cause IPD and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
PREVNAR 20 Dosage
The 20vPnC (PF-06482077) vaccine is administered as an intramuscular injection.
PREVNAR 20 News
March 13, 2024 - Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. PREVENAR 20 builds on Pfizer's decades-long commitment to developing 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."
January 26, 2024 - Pfizer Inc. announced that the EMA's CHMP adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate for active immunization to prevent 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.
June 22, 2023 - "We are thrilled with today's ACIP decision as it recognizes the increased level of protection that PREVNAR 20 will provide to millions of infants and children against pneumococcal disease," said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. This decision represents a significant step in improving public health. It allows pediatricians and other clinicians to offer the broadest serotype pneumococcal conjugate vaccine available to help protect infants and their families from life-threatening infections caused by the 20 serotypes covered by the vaccine".
April 27, 2023 - The U.S. FDA approved PREVNAR 20® for Infants and Children.
July 21, 2022 - Pfizer Canada ULC announced that the PREVNAR 20 vaccine is now available in Canada.
Prevnar 20 (Apexxnar) Pneumococcal Vaccine Clinical Trials
Pfizer continues to test Prevnar 20 in various clinical trials.
In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication of 20vPnC. Four core Phase 3 pediatric studies will help expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies collectively enrolled approximately 4,700 infants and 800 toddlers and children of all ages, including:
A Phase 3 study describing the tolerability and safety and comparing the immunogenicity of 20vPnC to Prevnar 13® in infants vaccinated at 2, 4, 6, and 12-15 months of age in the U.S. (NCT04382326)
A Phase 3 study described the tolerability and safety of 20vPnC, with Prevnar 13® serving as the control in infants vaccinated at 2, 4, 6, and 12-15 months of age in multiple countries. (NCT04379713)
A Phase 3 study describing the tolerability and safety and comparing the immunogenicity of 20vPnC to Prevnar 13® in infant vaccination at approximately 2, 4, and 11-12 months of age in Europe and Australia (NCT04546425)
A Phase 3 study in children 15 months through <18 years of age receiving a single dose of 20vPnC in the U.S. (NCT04642079).
