Drugs / 20vPnC
20vPnC
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic severe pneumococcemia 2 milestones | |||||
| 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 ↗ “FDA 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 | “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 ↗ “in November 2022, submitted the 20vPnC pediatric indication to the European Medicines Agency (EMA).” pfizer.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | PREVNAR 20 | — | 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 ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07019909 | Jul 2025 → Jan 2026 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT07023081 | Jun 2025 → May 2027 expected | pneumococcal infection | Pfizer | Active not recruiting | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT04875533 | Jun 2021 → May 2022 | pneumococcal infection | Pfizer | Completed | Mixed |
| Phase 3 | NCT04887948 | May → Dec 2021 | COVID-19, pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04642079 | Dec 2020 → Apr 2022 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03828617 | Feb → Oct 2019 | pneumococcal infection | Pfizer | Completed | Met primary |
| Phase 3 | NCT03835975 | Feb 2019 → Feb 2020 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03760146 | Dec 2018 → Dec 2019 | pneumococcal infection | Pfizer | Completed | Mixed |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT06531538 Comparator | Jul 2024 → Feb 2026 | pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT07629440 Comparator | May 2026 → Jun 2029 expected | pneumococcal infection | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07573462 Comparator | May 2026 → Dec 2028 expected | pneumococcal infection | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT04526574 Comparator | Sep 2020 → Jun 2021 | pneumococcal infection | Pfizer | 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. |
| 2023-04-27 | 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 ↗
Pfizer Inc. (NYSE:PFE) today announced the full analysis from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. |
| 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 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 20vPnC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06531538 ↗ |
| Known as | 20-valent PCV | “The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13.” PMID 34315611 ↗ Jul 2021 |
| Known as | 20-valent pneumococcal conjugate vaccine | “A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease.” PMID 34839993 ↗ Nov 20213“Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)” NCT04526574 ↗ “20-valent pneumococcal conjugate vaccine (20vPnC)” NCT07629440 ↗ “20-valent pneumococcal conjugate vaccine (20vPnC)” NCT06531538 ↗ |
| Known as | PCV20 | “This study evaluated the safety and immunogenicity of coadministration of the 20-valent pneumococcal conjugate vaccine (PCV20) and a booster (third dose) of BNT162b2 COVID-19 vaccine.” PMID 37244809 ↗ May 20235“This study evaluated coadministration of 20-valent pneumococcal conjugate vaccine (PCV20) and an adjuvanted quadrivalent inactivated influenza vaccine (QIV).” PMID 36828719 ↗ Feb 2023 “A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease.” PMID 34839993 ↗ Nov 2021 “The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend protection beyond earlier pneumococcal vaccines.” PMID 38267330 ↗ Jan 2024 “The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13.” PMID 34315611 ↗ Jul 2021 “a 20-valent PCV (PCV20) were evaluated” PMID 34940806 ↗ Aug 2022 |
| Modality | Vaccine | “20-valent pneumococcal conjugate vaccine” NCT03760146 ↗ |
| Route | Intramuscular | “into the left thigh muscle” NCT07573462 ↗ |