Drugs / 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | idiopathic severe pneumococcemia | 2023-01-06 | “Earlier this month, Pfizer submitted the 20vPnC biologics license application for adults 18 years of age or older to the U.S. Food and Drug Administration” pfizer.com ↗ “accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC)” pfizer.com ↗ “in January 2023, Pfizer announced that the FDA had granted priority review to a supplemental BLA for its 20vPnC candidate” pfizer.com ↗ |
| Filed | EU (EMA) | — | idiopathic severe pneumococcemia | 2021-02-26 | “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...” pfizer.com ↗ “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...” pfizer.com ↗ “today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine...” pfizer.com ↗ “EMA had previously accepted review of Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate on February 26, 2021.” pfizer.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 37 trials | ||||||
| Phase 3 | NCT05875727 | Aug → Oct 2023 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05512819 | Sep 2022 → Sep 2025 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05408429 | Jun 2022 → Jun 2023 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04530838 | Sep 2020 → Apr 2022 | pneumococcal infection | Pfizer | Completed | Mixed |
| Phase 3 | NCT04546425 | Sep 2020 → Apr 2022 | pneumococcal infection | Pfizer | Completed | Mixed |
| Phase 3 | NCT04379713 | May 2020 → Aug 2022 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04382326 | May 2020 → Sep 2022 | pneumococcal infection | Pfizer | Completed | Mixed |
| Phase 41 trial | ||||||
| Phase 4 | NCT07135427 | Sep 2025 → Mar 2027 expected | alpha 1-antitrypsin deficiency, chronic obstructive pulmonary disease, immunodeficiency disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT07086677 Comparator | Jul 2025 → Oct 2027 expected | pneumococcal infection | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06524414 Comparator | Jul 2024 → May 2027 expected | pneumococcal infection | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07794748 Comparator | Sep 2026 → Jun 2027 expected | pneumococcal infection | Pfizer | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-05-20 | Pfizer | Results Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Strong Positive Phase 2 Results pfizer.com ↗
One month after Dose 3 , geometric mean titers for serotype 3 were 8.8-fold higher with 25vPnC than with PREVNAR 20 ( 4.22 vs. 0.48 ). |
| 2024-10-23 | Pfizer | Regulatory Advisory Committee on Immunization Practices Recommends PREVNAR 20® (20-Valent Pneumococcal Conjugate Vaccine) for Adults Aged 50 and Older pfizer.com ↗
With respect to PREVNAR 20, ACIP recommended: Vaccination is recommended for all adults aged ≥50 years and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown. |
| 2024-03-13 | Pfizer | Regulatory European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease pfizer.com ↗
The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway. |
| 2023-04-27 | Pfizer | Regulatory U.S. FDA Approves PREVNAR 20®, Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus 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 ® . |
| 2023-01-06 | Pfizer | Regulatory U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine in Infants and Children pfizer.com ↗ |
| 2022-09-19 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 3 Study in 20-Valent Pneumococcal Conjugate Vaccine in Infants in the European Union pfizer.com ↗
Pfizer today announced positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) |
| 2022-08-12 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Infants pfizer.com ↗
All 20 serotypes met the co-primary objective of NI of IgG GMCs after Dose 4. |
| 2022-02-15 | Pfizer | Regulatory European Medicines Agency Approves Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease and Pneumonia in Adults pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) has approved the company’s 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name APEXXNAR. |
| 2022-01-12 | Pfizer | Results Positive Top-Line Results of Pfizer’s Phase 3 Study Exploring Coadministration of PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine in Older Adults Released pfizer.com ↗
Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). |
| 2021-12-17 | Pfizer | Regulatory CHMP Issues Positive Opinion for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Vaccine-Type Pneumococcal Pneumonia in Adults pfizer.com ↗
The CHMP’s positive opinion will now be reviewed for this indication by the European Commission (EC). |
| 2021-10-20 | Pfizer | Regulatory Advisory Committee on Immunization Practices Votes to Recommend Routine Use of Pfizer’s PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in Adults pfizer.com ↗ |
| 2021-09-29 | Pfizer | Results Positive Top-line Results of Pfizer’s Phase 3 Study Exploring Coadministration of Prevnar 20™ With Seasonal Flu Vaccine in Older Adults Released pfizer.com ↗
Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study’s primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. |
| 2021-06-08 | Pfizer | Regulatory U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older pfizer.com ↗ |
| 2021-02-26 | Pfizer | Regulatory European Medicines Agency Accepts Pfizer’s Marketing Authorization Application for Its Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age or Older pfizer.com ↗
Today’s acceptance of the 20vPnC application in the European Union is a significant step forward in our continuing efforts to potentially provide adults with robust and meaningful protection against more pneumococcal disease-causing serotypes. |
| 2020-12-08 | Pfizer | Regulatory U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older pfizer.com ↗ |
| 2020-10-21 | Pfizer | Results Data From Pfizer’s Adult and Pediatric Clinical Trial Programs for 20-Valent Pneumococcal Conjugate Vaccine Presented at IDWeek 2020 pfizer.com ↗
Investigational vaccine demonstrated positive safety results and immune responses to 20 S. pneumoniae serotypes in adults and infants |
| 2020-09-15 | Pfizer | Results Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas pfizer.com ↗
20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine[Diphtheria CRM197 Protein]. |
| 2020-05-14 | Pfizer | Results Pfizer Announces Positive Top-Line Results From Phase 3 Lot Consistency Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 Through 49 Years of Age pfizer.com ↗
Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study. |
| 2020-03-18 | Pfizer | Results Pfizer Announces Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults Aged 18 Years or Older pfizer.com ↗
The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines. |
| 2019-09-09 | Pfizer | Results Pfizer Announces Positive Preliminary Results from a Proof-of-Concept Phase 2 Study (B7471003) of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Otitis Media in Healthy Infants pfizer.com ↗
The initial three doses of 20vPnC in this Phase 2 trial provide preliminary evidence that the vaccine candidate in infants has an overall safety profile that is similar to Prevnar 13. |
| 2019-04-13 | Pfizer | Results Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older pfizer.com ↗
The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands. |
| 2018-09-20 | Pfizer | Regulatory Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. |
All press releases naming this drug 25 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 20-valent pneumococcal conjugate vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05512819 ↗ |
| Known as | 20-valent PCV | “This phase 3, single-arm study evaluated the safety and immunogenicity of 20-valent PCV (PCV20) in adults ≥18 y of age in India.” PMID 41504209 ↗ Jan 2026 |
| Known as | 20vPnC | “The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.” NCT05408429 ↗4“The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers.” NCT05512819 ↗ “Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1” NCT05875727 ↗ “20-valent pneumococcal conjugate vaccine (20vPnC)” NCT06524414 ↗ “20 Valent Pneumococcal Conjugate Vaccine (20vPnC)” NCT07794748 ↗ |
| Known as | PCV20 | “This phase 3, randomized, partially double-blind study investigated the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine (PCV20) in healthy...” PMID 40081152 ↗ Mar 20255“This phase 3, double-blind study randomized healthy Japanese infants to receive 4 doses (3 infant doses, 1 toddler dose) of PCV20 by subcutaneous (SC) or intramuscular (IM)...” PMID 38242195 ↗ Jan 2024 “The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend pneumococcal disease protection beyond 13-valent PCV (PCV13).” PMID 38535409 ↗ Mar 2024 “This phase 3, single-arm study evaluated the safety and immunogenicity of 20-valent PCV (PCV20) in adults ≥18 y of age in India.” PMID 41504209 ↗ Jan 2026 “Here, we describe the safety and immunogenicity of routinely recommended pediatric vaccines given with 20-valent-PCV (PCV20).” PMID 41187484 ↗ Nov 2025 “the 20-valent pneumococcal conjugate vaccine (PCV20, Pfizer)” NCT07135427 ↗ |
| Modality | Vaccine | “20-valent pneumococcal conjugate vaccine” NCT04379713 ↗ |
| Route | Intramuscular | “20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)” NCT04530838 ↗ |
| Route | Subcutaneous | “20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)” NCT04530838 ↗ |