PREVNAR 20® (APEXXNAR) Vaccine April 2023
Pfizer'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 additional serotypes that cause pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for most currently circulating pneumococcal diseases globally.
On May 14, 2020, Pfizer announced a phase 3 study that found 20vPnC's safety profile was similar to the Prevnar 13. On Dec. 8, 2020, Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20vPnC vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
On Jun. 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. In addition, the European Medicines Agency (EMA) issued its Approval for the brand name Apexxnar on Feb. 15, 2022.
Pfizer announced on Aug. 12, 2022, that pivotal top-line data demonstrate a four-dose series of 20vPnC elicited robust immune responses to all 20 serotypes meeting the statistical non-inferiority criteria for the co-primary objective after Dose 4; 20vPnC demonstrated a favorable safety and tolerability profile similar to Prevnar 13®; and Pfizer plans to submit a supplemental BLA (sBLA), subject to discussions with U.S. FDA. On Apr. 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®.
For more information, please visit New York-based pfizer.com. (NYSE: PFE)
PREVNAR 20 Indication
The U.S. CDC recommends pneumococcal vaccination for children younger than two years old and adults 65 years 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.
The PREVNAR 20 is a 20-Valent pneumococcal conjugate vaccine candidate to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults and children.
PREVNAR 20 For Children
Pfizer Inc. announced the FDA approved PREVNAR 20 for the prevention of 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. 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.
PREVNAR 20 Dosage
The 20vPnC (PF-06482077) vaccine is administered as an intramuscular injection.
PREVNAR 20 News For 2021 - 2023
April 27, 2023 - "Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
January 6, 2023 - Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, commented in a press release, "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."
August 12, 2022 - "We are encouraged by today's data which show that if approved for a pediatric indication, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine," commented Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
July 28, 2022 - Pfizer announced the Prevnar family (Prevnar 13 & 20) in the U.S. was up 41% operationally over the second quarter of 2021, driven by strong stocking and patient demand following the launch of Prevnar 20 for the adult population.
July 21, 2022 - Pfizer Canada ULC announced PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema, and bacteremia) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
February 15, 2022 - Pfizer Inc. announced that the European Medicines Agency Approved the company's 20-valent pneumococcal conjugate vaccine, which will be marketed in the European Union under the brand name APEXXNAR.
February 8, 2022 - Pfizer confirmed responses to a booster dose of the Comirnaty vaccine were also similar when given with Prevnar 20 or a placebo. The safety profile of co-administering Prevnar 20 with a booster dose of Comirnaty generally reflected that observed with a Comirnaty vaccine booster dose.
January 12, 2022 - Pfizer Inc. announced positive top-line results from a Phase 3 study describing the safety and immunogenicity of PREVNAR 20 when administered simultaneously as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with a placebo. Responses elicited by PREVNAR 20 for all 20 serotypes were similar,r whether given with a Pfizer-BioNTech COVID-19 vaccine dose (n=190) or with a placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.
September 29, 2021 - Pfizer Inc. announced positive top-line results from a Phase 3 study evaluating the safety and immunogenicity of PREVNAR 20™ in adults 65 or older administered simultaneously as the seasonal influenza vaccine Fluad Quadrivalent.
June 8, 2021 - Pfizer Inc. announced today that the U.S. Food and Drug Administration had approved PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) to prevent invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
May 24, 2021 - Pfizer Inc. announced that the first enrolled study subjects of 600 had received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company's 20-valent pneumococcal conjugate vaccine candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine. The trial's primary objective is to describe safety when both vaccines are co-administered, with follow-up six months after vaccination. The secondary objectives are to characterize immune responses produced by each vaccine.
February 26, 2021 - Pfizer Inc. announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA's Committee for Medicinal Products for Human Use begins.
December 31, 2020 - A study published by Open Forum Infectious Diseases: Conclusion - Based on the robust immune responses and comparability to licensed pneumococcal vaccines, as well as bridging to the younger age group, these data support that PCV20 will be protective against pneumococcal disease due to the 20 serotypes in adults.
December 9, 2020 - Pfizer announced that the U.S. Food and Drug Administration accepted for priority review a Biologics License Application for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. Additionally, the FDA put 20vPnC in the priority review fast lane, which means the FDA decision deadline is June 2021.
October 21, 2020 - Pfizer presents data from clinical trials for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older as well as the 20vPnC Phase 2 Infant Trial, which overall, the safety profile of four-dose schedule of 20vPnC was consistent with 13vPnC given in the same schedule. In addition, the investigational vaccine demonstrated positive safety results and immune responses to 20 S. pneumoniae serotypes in adults and infants. Pfizer also submitted its biologics license application to the FDA for adults 18 yr older and awaits acceptance for review.
June 1, 2020 - The first Global Pneumonia Forum: coronavirus recommendations.
May 14, 2020 - Pfizer Inc. announced top-line results from a second Phase 3 study, which described the safety and evaluated the consistency of immune responses elicited across three lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate. This study's 20vPnC safety profile was similar to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) control group. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. FDA and other regulatory agencies.
March 18, 2020 - Pfizer Inc. announced top-line results from a Phase 3 clinical trial, which evaluated the candidate's 20-valent pneumococcal conjugate vaccine (20vPnC). Pfizer's press release stated: The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at 11 months after vaccination were met for all serotypes in common with licensed Prevnar 13, and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23).
September 9, 2019 - Pfizer Inc. announced positive preliminary results following the administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants.
April 13, 2019 - Pfizer Inc. announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam, Netherlands.
September 20, 2018 - "As the industry leader in pneumococcal conjugate vaccination, we are proud to start the Phase 3 trials of our third generation pneumococcal vaccine, which received Breakthrough Therapy Designation by the FDA in September 2018. We look forward to continuing our dialogue with the FDA to accelerate the development program of the adult indication of Pfizer's 20-valent next-generation pneumococcal vaccine candidate," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes. We are dedicated to continuing to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate."
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).
