Drugs / PCV20
PCV20
also known as
20-valent PCV · Prevnar 20 · Apexxnar · pneumococcal 20-valent conjugate vaccine · Prevenar 20
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | PREVNAR 20 | streptococcal pneumonia | 2022-01-12 | “Pfizer has recently submitted to the FDA a supplemental Biologics License Application to include data in the PREVNAR 20 prescribing information” pfizer.com ↗ “in January 2023, the U.S. FDA accepted for priority review a supplemental Biologics License Application (sBLA) for PREVNAR 20” pfizer.com ↗ |
| Filed | EU (EMA) | — | streptococcal pneumonia | 2021-02-26 | “The 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 ↗ “In November 2022, Pfizer submitted the 20-valent pneumococcal conjugate vaccine candidate pediatric indication to the European Medicines Agency (EMA).” pfizer.com ↗ “in November 2022, submitted the 20vPnC pediatric indication to the European Medicines Agency (EMA).” pfizer.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07406347 | Jan 2027 → Oct 2028 expected | bacterial pneumonia | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07406334 | May 2026 → Feb 2027 expected | bacterial pneumonia | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07428759 | Mar → Dec 2026 expected | bacterial pneumonia | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07105722 | Aug 2025 → May 2026 | bacterial pneumonia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03512288 | Apr 2018 → Feb 2020 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03313037 | Oct 2017 → Dec 2018 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05879107 | May → Dec 2023 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT07135453 | Jul 2026 → Mar 2027 expected | pneumococcal infection | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT07252791 | Jan → Dec 2026 expected | autoimmune disease | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06049134 | Oct 2023 → Dec 2026 expected | lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05767606 | Mar → Jul 2023 | COVID-19, pneumococcal infection | Medical University of Vienna | Unknown | Met primary |
| Comparator or background therapy15 trials | ||||||
| Phase 1 | NCT07300267 Comparator | Jan 2026 → Oct 2028 expected | pneumococcal infection | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT06986239 Comparator | Jul 2025 → Apr 2026 overdue | — | LiteVax BV | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05540028 Comparator | Sep 2022 → Jul 2023 | — | Inventprise Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT06151288 Comparator | Nov 2023 → Jul 2024 | — | Vaxcyte, Inc. | Completed | Met primary |
| Phase 1/2 | NCT05266456 Comparator | Feb 2022 → Jan 2023 | — | Vaxcyte, Inc. | Completed | Met primary |
| Phase 2 | NCT06720038 Comparator | Nov 2024 → Dec 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06077656 Comparator | Oct 2023 → May 2024 | — | Inventprise Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05844423 Comparator | Mar 2023 → Aug 2025 | — | Vaxcyte, Inc. | Completed | Met primary |
| Phase 3 | NCT07425392 Comparator | Feb 2026 → Mar 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07284654 Comparator | Dec 2025 → Jan 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT06806137 Background | May 2025 → Dec 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06855160 Background | Apr 2025 → Sep 2026 overdue | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06740630 Background | Jan 2025 → Dec 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06693895 Background | Nov 2024 → Nov 2026 expected | chickenpox | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05425732 Comparator | Jul 2022 → May 2023 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | 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. |
| 2023-11-28 | Merck Sharp & Dohme LLC | Results Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older merck.com ↗
In adults 50 years of age and older (Cohort 1), V116 elicited non-inferior immune responses compared to PCV20 for all 10 serotypes common to both vaccines as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. |
| 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 ↗
Pfizer Inc. (NYSE:PFE) today 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. |
| 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 ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate |
| 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 |
| 2020-05-14 | 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 safety and immunogenicity results from this study suggest that our 20vPnC candidate, which initiated Phase 3 development in adults last year, could potentially offer comprehensive coverage of additional serotypes causing pneumococcal disease globally and in the U.S. |
| 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 22 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PCV20 | “Participants were block randomised (1:1:1:1) using a web-based randomisation and trial management system to receive a dose of intramuscular low-dose, mid-dose, or high-dose...” PMID 41864214 ↗ Mar 202626“The aim of this clinical trial was to assess the safety, tolerability, and immunogenicity of three different doses of VAX-24 compared to pneumococcal 20-valent conjugate...” PMID 38061367 ↗ Dec 2023 “A 20-valent PCV (PCV20) has been developed to add coverage for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) to those in the existing 13-valent PCV (PCV13).” PMID 34525007 ↗ Oct 2021 “A 20-valent PCV (PCV20) containing capsular polysaccharide conjugates of serotypes present in the 13-valent PCV (PCV13) and 7 new serotypes” PMID 32716500 ↗ Oct 2021 “PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.” NCT07252791 ↗ “PCV20 (Prevnar 20) was the control.” PMID 41576705 ↗ Jan 2026 “Will receive PCV20” NCT07135453 ↗ |
| Known as | 20-valent PCV | “A 20-valent PCV (PCV20) has been developed to add coverage for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) to those in the existing 13-valent PCV (PCV13).” PMID 34525007 ↗ Oct 20211“A 20-valent PCV (PCV20) containing capsular polysaccharide conjugates of serotypes present in the 13-valent PCV (PCV13) and 7 new serotypes” PMID 32716500 ↗ Oct 2021 |
| Known as | Apexxnar | “PCV20 (Apexxnar®) plus placebo” NCT05767606 ↗ |
| Known as | pneumococcal 20-valent conjugate vaccine | “The aim of this clinical trial was to assess the safety, tolerability, and immunogenicity of three different doses of VAX-24 compared to pneumococcal 20-valent conjugate...” PMID 38061367 ↗ Dec 2023 |
| Known as | Prevenar 20 | “PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.” NCT07252791 ↗ |
| Known as | Prevnar 20 | “Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1” NCT07425392 ↗1“PCV20 (Prevnar 20) was the control.” PMID 41576705 ↗ Jan 2026 |
| Modality | Vaccine | “A 20-valent PCV (PCV20)” PMID 32716500 ↗ Oct 2021 |
| Route | Intramuscular | “a single intramuscular dose of multivalent pneumococcal conjugate vaccine” NCT03313037 ↗ |