Drugs / BNT162b2
BNT162b2
also known as
COMIRNATY · Tozinameran · Pfizer-Biontech · Pfizer-BioNTech COVID-19 Vaccine · Pfizer · BNT162b2 (Omi JN.1) · BNT162b2 (Omi KP.2) · BNT162b2 (Omi XBB.1.5) · +8 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | COMIRNATY | COVID-19 | 2021-10-15 | “submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 mRNA vaccine) to the European Medicines Agency (EMA)” biontech.com ↗ |
| Filed | EU (EMA) | COMIRNATY | COVID-19 | 2021-04-30 | “On April 30, 2021, BioNTech and Pfizer submitted to the EMA a variation to the European Conditional Marketing Authorization (CMA) for COMIRNATY ®” biontech.com ↗ |
| Filed | US (FDA) | — | COVID-19 | — | “This follows the completion of the rolling submission of the BLA in May 2021” biontech.com ↗ “pending FDA approval of the primary BLA submitted in May 2021” biontech.com ↗ |
Trials 63 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06831786 | Mar → May 2024 | COVID-19 | Prince of Songkla University | Completed | No outcome recorded |
| Phase 0 | NCT04936997 | Jun → Aug 2021 | COVID-19, cancer | University of Arizona | Completed | Mixed |
| Phase 11 trial | ||||||
| Phase 1 | NCT05630352 | Jan 2025 → Jul 2026 | COVID-19 | BioNTech SE | Withdrawn | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05602961 | Feb 2023 → Sep 2024 | COVID-19 | GreenLight Biosciences, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05132855 | Nov 2021 → Apr 2023 | COVID-19 | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04889209 | May 2021 → Jun 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04380701 | Apr 2020 → Jun 2021 | respiratory tract infectious disorder, viral infectious disease | BioNTech SE | Completed | No outcome recorded |
| Phase 220 trials · 1 met primary | ||||||
| Phase 2 | NCT07390968 | Dec 2026 → Sep 2028 expected | hematopoietic and lymphoid system neoplasm | Fred Hutchinson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06237049 | Jan → Sep 2024 | COVID-19, influenza | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT05886777 | Jun 2023 → Jan 2024 | — | Pfizer | Completed | Met primary |
| Phase 2 | NCT05596734 | Oct 2022 → Dec 2023 | COVID-19, influenza | BioNTech SE | Completed | No outcome recorded |
| Phase 2 | NCT05525208 | Sep 2022 → Jul 2023 | COVID-19 | PT Bio Farma | Completed | No outcome recorded |
| Phase 2 | NCT07408297 | May 2022 → Jun 2024 | COVID-19 | Victoria Biomedical Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT05289037 | Mar 2022 → Nov 2023 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05084989 | Jan → Aug 2022 | COVID-19 | Jiangsu Rec-Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04895982 | Oct 2021 → Jul 2023 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 2 | NCT05049226 | Sep 2021 → Feb 2022 | COVID-19 | Mahidol University | Completed | No outcome recorded |
| Phase 2 | NCT04977479 | Sep 2021 → Jun 2022 | hypersensitivity reaction disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05004181 | Aug 2021 → Aug 2023 | COVID-19, severe acute respiratory syndrome | BioNTech SE | Completed | No outcome recorded |
| Phase 2 | NCT05000216 | Aug 2021 → Jun 2023 | juvenile dermatomyositis, juvenile idiopathic arthritis, pediatric multiple sclerosis, pediatric systemic lupus erythematosus +3 | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04969263 | Aug 2021 → Nov 2022 | disease related to solid organ transplantation | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05016622 | Aug 2021 → Apr 2022 | cancer | Montefiore Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04949490 | Jul 2021 → Apr 2022 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 2 | NCT04992182 | Jul → Aug 2021 | COVID-19 | Universidad del Desarrollo | Unknown | No outcome recorded |
| Phase 2 | NCT04800133 | May 2021 → Mar 2025 | COVID-19 | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT04824638 | Mar → Jun 2021 | — | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT04649021 | Dec 2020 → Feb 2021 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 2/36 trials · 3 met primary | ||||||
| Phase 2/3 | NCT05997290 | Aug 2023 → Mar 2025 | COVID-19 | BioNTech SE | Completed | Met primary |
| Phase 2/3 | NCT05472038 | Jul 2022 → Mar 2024 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 2/3 | NCT05022329 | Sep 2021 → May 2022 | COVID-19, chronic kidney disease | Sunnybrook Health Sciences Centre | Terminated | Met primary |
| Phase 2/3 | NCT05279365 | Jul 2021 → Aug 2022 | COVID-19 | DHR Health Institute for Research and Development | Unknown | No outcome recorded |
| Phase 2/3 | NCT04754594 | Feb 2021 → Jul 2022 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 2/3 | NCT04368728 | Apr 2020 → Feb 2023 | COVID-19 | BioNTech SE | Completed | Met primary |
| Phase 314 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07798648 | Aug 2026 → Apr 2027 expected | — | BioNTech SE | Recruiting | No outcome recorded |
| Phase 3 | NCT07300839 | Dec 2025 → Jul 2026 overdue | COVID-19 | BioNTech SE | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07222384 | Oct 2025 → Jul 2026 overdue | COVID-19 | BioNTech SE | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07069309 | Jul 2025 → May 2026 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 3 | NCT05812586 | Mar → Jun 2023 | COVID-19 | D'Or Institute for Research and Education | Unknown | No outcome recorded |
| Phase 3 | NCT05310084 | Apr → Oct 2022 | COVID-19 | BioNTech SE | Completed | Met primary |
| Phase 3 | NCT05124171 | Dec 2021 → Dec 2022 | COVID-19 | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT05047640 | Sep 2021 → Oct 2022 | COVID-19 | Giselle Guerra | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT04955626 | Jul 2021 → May 2023 | COVID-19 | BioNTech SE | Completed | Met primary |
| Phase 3 | NCT04887948 | May → Dec 2021 | COVID-19, pneumococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT04816669 | Apr → Dec 2021 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 3 | NCT04816643 | Mar 2021 → Oct 2023 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 3 | NCT04951323 | Mar 2021 → Dec 2022 | COVID-19, hematopoietic and lymphoid cell neoplasm | University of Liege | Unknown | No outcome recorded |
| Phase 3 | NCT04713553 | Feb → Jul 2021 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT05970887 | Oct → Dec 2022 | — | Catholic Kwandong University | Completed | No outcome recorded |
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 4 | NCT05343871 | Jul 2022 → Jul 2023 | COVID-19 | Albert B. Sabin Vaccine Institute | Completed | No outcome recorded |
| Phase 4 | NCT05406908 | Jun 2022 → Mar 2023 | autoimmune bullous skin disease, psoriasis | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT05329064 | Mar 2022 → Dec 2023 | COVID-19 | KK Women's and Children's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05168709 | Jan → Sep 2022 | COVID-19, vaccinia | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT05231005 | Dec 2021 → Jun 2024 | COVID-19 | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05057169 | Nov 2021 → Dec 2024 | — | The University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT05057182 | Oct 2021 → Mar 2024 | — | The University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT04961229 | Oct 2021 → Feb 2022 | acute respiratory distress syndrome | dafna yahav | Unknown | No outcome recorded |
| Phase 4 | NCT04969250 | Aug 2021 → Dec 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT04952402 | Jul 2021 → Feb 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT06189040 | May → Nov 2021 | COVID-19 | University of Antwerp | Completed | No outcome recorded |
| Phase 4 | NCT04588480 | Oct 2020 → Nov 2021 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT04927936 | Jun 2021 → Sep 2022 | COVID-19 | Erasmus Medical Center | Unknown | Met primary |
| — | NCT04900467 | May → Jul 2021 | — | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT05081271 Comparator | Oct 2021 → May 2022 | multiple sclerosis | Griffin Hospital | Terminated | No outcome recorded |
| Phase 1/2 | NCT05007509 Comparator | Aug → Sep 2021 | COVID-19 | Laboratorios Hipra, S.A. | Completed | No outcome recorded |
| Phase 2 | NCT05515042 Comparator | Jul 2022 → Jun 2024 overdue | COVID-19 | The Aurum Institute NPC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05142553 Comparator | Nov 2021 → May 2023 | COVID-19 | Hipra Scientific, S.L.U | Completed | Missed primary |
| Phase 2 | NCT05324319 Comparator | Jun 2021 → Jul 2022 | COVID-19 | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT04894435 Comparator | May 2021 → Nov 2024 overdue | COVID-19 | Canadian Immunization Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05736913 Comparator | Apr 2021 → Mar 2023 | COVID-19 | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2/3 | NCT05354024 Comparator | Feb → Oct 2023 | Coronaviridae infectious disease | Butantan Institute | Completed | No outcome recorded |
| Phase 3 | NCT05686161 Comparator | Oct → Dec 2022 | — | Stemirna Therapeutics | Unknown | No outcome recorded |
| Phase 3 | NCT05517642 Comparator | Sep 2022 → May 2023 | COVID-19 | CanSino Biologics Inc. | Completed | Missed primary |
| Phase 3 | NCT05265065 Comparator | May → Sep 2022 | COVID-19 | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT05228730 Comparator | May → Jul 2022 | COVID-19 | Murdoch Childrens Research Institute | Terminated | No outcome recorded |
| Phase 3 | NCT05543356 Comparator | May → Jul 2022 | COVID-19 | Murdoch Childrens Research Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT05293665 Comparator | Mar → Nov 2022 | — | Vaxxinity, Inc. | Unknown | Met primary |
| Phase 3 | NCT05225285 Comparator | Jan → Jun 2022 | COVID-19 | Federal University of Espirito Santo | Unknown | No outcome recorded |
| Phase 3 | NCT05668065 Comparator | Nov 2021 → Jan 2022 | COVID-19 | Institut Pasteur de Tunis | Completed | No outcome recorded |
| Phase 3 | NCT04805125 Comparator | Apr 2021 → Sep 2023 | immunodeficiency disease | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT04775069 Comparator | May 2021 → Sep 2023 | liver disorder | Humanity & Health Medical Group Limited | Completed | No outcome recorded |
| — | NCT05465863 Comparator | Sep 2021 → Feb 2022 | end stage renal failure | Istanbul University - Cerrahpasa | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 201
| Date | Issuer | Release |
|---|---|---|
| 2026-08-27 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine pfizer.com ↗ |
| 2026-08-27 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine biontech.com ↗
the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant |
| 2026-07-29 | Pfizer | Regulatory European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union pfizer.com ↗ |
| 2026-07-29 | BioNTech SE | Regulatory European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union biontech.com ↗ |
| 2025-12-15 | GeoVax, Inc. | Results GeoVax Announces British Journal of Haematology Publication Highlighting Superior T-Cell Responses of GEO-CM04S1 in CLL Patients geovax.com ↗
Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. |
| 2025-09-08 | Pfizer | Results Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula pfizer.com ↗
The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. |
| 2025-09-08 | BioNTech SE | Results Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response with their LP.8.1-adapted COVID-19 Vaccine 2025-2026 Formula biontech.com ↗
The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. |
| 2025-08-27 | Pfizer | Regulatory Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19 pfizer.com ↗
today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) |
| 2025-08-27 | BioNTech SE | Regulatory Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19 biontech.com ↗ |
| 2025-07-25 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-adapted COVID-19 Vaccine in the European Union pfizer.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY ® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. |
| 2025-07-25 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union biontech.com ↗ |
| 2025-05-28 | BioNTech SE | Regulatory Pfizer and BioNTech Submit EMA Application for COVID-19 Vaccine Targeting LP.8.1 for 2025-2026 Season biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that they have submitted a regulatory application to the European Medicines Agency (EMA) for approval of COMIRNATY ® for the 2025-2026 season, targeting the LP.8.1 strain. |
| 2025-04-24 | GeoVax, Inc. | Results GeoVax Highlights Strong Clinical Results Following Presentation of Multi-Antigen COVID-19 Vaccine at the 25th Annual World Vaccine Congress geovax.com ↗
In a randomized Phase 2 trial comparing GEO-CM04S1 to the Pfizer-BioNTech (Comirnaty®) vaccine in patients with Chronic Lymphocytic Leukemia, GEO-CM04S1 demonstrated a significantly higher T cell response rate. |
| 2024-09-30 | CSL Behring | Results Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination csl.com ↗ |
| 2024-09-30 | Arcturus Therapeutics, Inc. | Results Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination arcturusrx.com ↗ |
| 2024-09-20 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union pfizer.com ↗
The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. |
| 2024-08-22 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine pfizer.com ↗ |
| 2024-08-22 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine biontech.com ↗
the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older |
| 2024-06-27 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union pfizer.com ↗ |
| 2024-02-05 | Arcturus Therapeutics, Inc. | Results New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster arcturusrx.com ↗
The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence. |
| 2023-12-21 | CSL Behring | Results CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster csl.com ↗
Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. |
| 2023-12-21 | Arcturus Therapeutics, Inc. | Results CSL and Arcturus Therapeutics’ ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster arcturusrx.com ↗
ARCT-154 results were achieved with one sixth the dose of Comirnaty ® (5 μg vs 30 μg). |
| 2023-09-28 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Health Canada Authorization for XBB.1.5-Adapted Monovalent COVID-19 Vaccine biontech.com ↗
Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that Health Canada has authorized the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY ® Omicron XBB.1.5) for ages 6 months and older. |
| 2023-09-11 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine pfizer.com ↗ |
| 2023-09-11 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine biontech.com ↗
the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) |
| 2023-08-30 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union pfizer.com ↗ |
| 2023-08-30 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union biontech.com ↗ |
| 2023-06-23 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Applications to U.S. FDA for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine biontech.com ↗ |
| 2023-06-23 | BioNTech SE | Regulatory Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX “BioNTech”) today announced they have initiated the submission of a variation to the European Medicines Agency (EMA) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season. |
| 2023-03-14 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years pfizer.com ↗
The bivalent vaccine is also authorized in this age group as the third dose of a three dose-primary series; for these children, a booster (fourth) dose is not authorized at this time. |
| 2023-03-14 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years biontech.com ↗ |
| 2023-03-01 | Pfizer | Regulatory Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years pfizer.com ↗ |
| 2023-03-01 | BioNTech SE | Regulatory Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years biontech.com ↗ |
| 2023-01-20 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory COMIRNATY® Bivalent COVID-19 Vaccine is Officially Approved as Regular Imported Vaccine by the Pharmaceutical Administration Bureau of Macao SAR fosunpharma.com ↗ |
| 2022-12-23 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory BioNTech and Fosun Pharma Announce Full Regulatory Approval of their Mono- and Bivalent COVID-19 Vaccine COMIRNATY® in Individuals 12 Years and Older in Hong Kong fosunpharma.com ↗
COMIRNATY®Original/Omicron BA.4/BA.5 is the first and currently only variant-adapted vaccine available for individuals 12 years and older which was granted aBiologics License Applicationequivalent in Hong Kong |
| 2022-12-23 | BioNTech SE | Regulatory BioNTech and Fosun Pharma Announce Full Regulatory Approval of their Mono- and Bivalent COVID-19 Vaccine COMIRNATY® in Individuals 12 Years and Older in Hong Kong biontech.com ↗
Individuals 12 years and older can now receive COMIRNATY ® vaccines at medical institutions or clinics in Hong Kong with a medical prescription, in addition to vaccine access via governmental vaccination centers |
| 2022-12-09 | Sinovac Biotech Co., Ltd | Results 香港第五波疫情启示录：及时接种，守护生命 sinovac.com ↗
研究数据显示，对于60岁以上老人来说， 无论接种三剂次的新冠病毒灭活疫苗克尔来福 ® 还是一款mRNA工艺制备的疫苗，在防重症、防死亡的保护效果均超过了90% 。 |
| 2022-12-08 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years pfizer.com ↗ |
| 2022-12-08 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. |
| 2022-11-18 | Pfizer | Results Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages pfizer.com ↗
These data, posted on the preprint server bioRxiv, indicate that the companies’ bivalent vaccine elicits a greater increase in neutralizing antibody titers than the companies’ original COVID-19 vaccine against these emerging Omicron sublineages. |
| 2022-11-10 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY ® Original/Omicron BA.4/BA.5 5/5-µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. |
| 2022-11-04 | Pfizer | Results Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine pfizer.com ↗
Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies’ original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. |
| 2022-11-04 | BioNTech SE | Results Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine biontech.com ↗
Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies’ original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. |
| 2022-10-19 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union biontech.com ↗ |
| 2022-10-13 | Pfizer | Results Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older pfizer.com ↗
Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels |
| 2022-10-13 | BioNTech SE | Results Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older biontech.com ↗
Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels |
| 2022-10-12 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age pfizer.com ↗
the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. |
| 2022-10-07 | BioNTech SE | Regulatory Pfizer and BioNTech’s Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster Receives Health Canada Authorization for Individuals 12 Years of Age and Older biontech.com ↗
Pfizer Canada ULC and BioNTech SE today announced that Health Canada has authorized COMIRNATY Original & Omicron BA.4/BA.5 as a 30-μg booster dose for individuals ages 12 years and older. |
| 2022-09-28 | BioNTech SE | Regulatory Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) |
| 2022-09-26 | Pfizer | Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age pfizer.com ↗ |
| 2022-09-26 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age biontech.com ↗ |
| 2022-09-16 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union biontech.com ↗ |
| 2022-09-12 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union pfizer.com ↗
a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) |
| 2022-09-12 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union biontech.com ↗ |
| 2022-09-01 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union biontech.com ↗ |
| 2022-08-31 | Pfizer | Regulatory Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older pfizer.com ↗ |
| 2022-08-31 | BioNTech SE | Regulatory Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. |
| 2022-08-26 | Pfizer | Regulatory Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. |
| 2022-08-26 | BioNTech SE | Regulatory Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. |
| 2022-08-23 | Pfizer | Results Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age pfizer.com ↗
Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection. |
| 2022-08-23 | BioNTech SE | Results Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age biontech.com ↗
Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection. |
| 2022-08-22 | Pfizer | Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine pfizer.com ↗ |
| 2022-08-22 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. |
| 2022-07-19 | BioNTech SE | Regulatory Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. |
| 2022-07-08 | BioNTech SE | Regulatory Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age biontech.com ↗
COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 years and older, following emergency use authorization in May 2021 |
| 2022-06-17 | Pfizer | Regulatory Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). |
| 2022-06-17 | BioNTech SE | Regulatory Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age biontech.com ↗
Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for all individuals 6 months of age and older |
| 2022-06-15 | BioNTech SE | Regulatory Pfizer and BioNTech Provide Update on Rolling Submission to European Medicines Agency for a Potential Variant-Adapted Vaccine biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the companies’ COVID-19 vaccine. |
| 2022-05-23 | Pfizer | Results Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose pfizer.com ↗
Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. |
| 2022-05-23 | BioNTech SE | Results Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose biontech.com ↗
Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. |
| 2022-05-17 | Pfizer | Regulatory Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age pfizer.com ↗ |
| 2022-05-17 | BioNTech SE | Regulatory Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. |
| 2022-04-26 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12). |
| 2022-04-14 | Pfizer | Results Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. |
| 2022-04-14 | BioNTech SE | Results Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age biontech.com ↗
These data demonstrate an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine compared to two doses. |
| 2022-03-29 | Pfizer | Regulatory Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older pfizer.com ↗
The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. |
| 2022-03-29 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older biontech.com ↗
The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. |
| 2022-03-15 | BioNTech SE | Regulatory Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults biontech.com ↗ |
| 2022-03-11 | Joincare Pharmaceutical Group Industry Co., Ltd | Results 最新研究：第三针丽珠二价苗对Omicron中和水平具显著优势 joincare.com ↗ |
| 2022-03-04 | Shionogi | Results Shionogi Presents the Interim Report (Top-line Results) of a Phase 2/3 Additional Dose Clinical Trial for the COVID-19 Vaccine, S-268019 shionogi.com ↗
Regarding the GMT of the neutralizing antibody titer and the seroresponse rate of the SARS-CoV-2 neutralizing antibody titer on the 29th day (28 days after inoculation), the non-inferiority of the S-268019 group to the COMIRNATY group was confirmed, and this trial achieved the primary endpoint. |
| 2022-02-24 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY ® as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 years of age. |
| 2022-02-01 | Pfizer | Regulatory Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From U.S. FDA pfizer.com ↗ |
| 2022-02-01 | BioNTech SE | Regulatory Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA biontech.com ↗ |
| 2022-01-28 | CastleVax Inc. | Results The inactivated NDV-HXP-S COVID-19 vaccine induces a significantly higher ratio of neutralizing to non-neutralizing antibodies in humans as compared to mRNAvaccines castlevax.com ↗
Neutralizing activity of sera from NDV-HXP-S vaccinees was comparable to that of individuals vaccinated with BNT162b2. |
| 2022-01-24 | Pfizer | Results Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication of new results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralize the Omicron variant (B.1.1.529). |
| 2022-01-24 | BioNTech SE | Results Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant biontech.com ↗
Both data sets confirm previously announced initial study results demonstrating that serum antibodies induced by BNT162b2 neutralize the SARS-CoV-2 Omicron variant after immunization with three doses. |
| 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 to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). |
| 2022-01-06 | Janssen Research & Development, LLC | Results Real World Evidence Shows Johnson & Johnson COVID-19 Vaccine Demonstrates Durable Protection Against Breakthrough Infection, Hospitalization, and Intensive Care Unit Admission in the United States jnj.com ↗
BNT162b2 demonstrated a profile that showed an increase in hospitalizations and breakthrough infections starting in month 2, with no waning of effectiveness for ICU admissions over the study period. |
| 2022-01-03 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. |
| 2022-01-03 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older biontech.com ↗ |
| 2021-12-30 | Janssen Research & Development, LLC | Results Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant jnj.com ↗
A homologous boost with BNT162b2 generated a 17-fold increase in neutralizing antibodies by four weeks following the boost and a 1.4-fold increase in CD8+ T-cells by two weeks. |
| 2021-12-23 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA biontech.com ↗
Pfizer and BioNTech have also submitted these data to the U.S. Food and Drug Administration (FDA). |
| 2021-12-17 | BioNTech SE | Regulatory Pfizer And BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY ® (COVID-19 Vaccine, mRNA) to include individuals aged 12 through 15 years. |
| 2021-12-17 | BioNTech SE | Results Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine biontech.com ↗
Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. |
| 2021-12-09 | Pfizer | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older. |
| 2021-12-09 | BioNTech SE | Regulatory Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 16 years of age and older. |
| 2021-12-08 | Pfizer | Results Pfizer and BioNTech Provide Update on Omicron Variant pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. |
| 2021-12-08 | BioNTech SE | Results Pfizer and BioNTech Provide Update on Omicron Variant biontech.com ↗ |
| 2021-12-05 | Janssen Research & Development, LLC | Results Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses jnj.com ↗
These results demonstrate the potential benefits of heterologous boosting (mix-and-match). |
| 2021-12-05 | Janssen Research & Development, LLC | Results Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses jnj.com ↗ |
| 2021-11-25 | Pfizer | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union pfizer.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. |
| 2021-11-25 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY ® in children 5 to under 12 years of age. |
| 2021-11-22 | Pfizer | Results Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age pfizer.com ↗
The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose. |
| 2021-11-22 | BioNTech SE | Results Follow-Up Data from Phase 3 Trial Of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age biontech.com ↗
The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose. |
| 2021-11-19 | Pfizer | Regulatory Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. |
| 2021-11-19 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. |
| 2021-11-09 | Pfizer | Regulatory Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a request to amend the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a booster dose of their COVID-19 vaccine to include all individuals 18 years of age and older. |
| 2021-11-09 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older biontech.com ↗ |
| 2021-10-29 | Pfizer | Regulatory Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years pfizer.com ↗
This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age. |
| 2021-10-29 | BioNTech SE | Regulatory Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years biontech.com ↗
This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age. |
| 2021-10-26 | Pfizer | Regulatory FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years pfizer.com ↗ |
| 2021-10-26 | BioNTech SE | Regulatory FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to <12 Years biontech.com ↗ |
| 2021-10-21 | Pfizer | Results Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine pfizer.com ↗
First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against disease during a period when Delta was the prevalent strain |
| 2021-10-21 | BioNTech SE | Results Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine biontech.com ↗
First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against disease during a period when Delta was the prevalent strain |
| 2021-10-18 | Pfizer | Regulatory New Formulation of COMIRNATY® Receives Positive Opinion from CHMP pfizer.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive opinion for a new formulation of COMIRNATY® (COVID-19 vaccine, mRNA). |
| 2021-10-18 | BioNTech SE | Regulatory New Formulation of COMIRNATY® Receives Positive Opinion from CHMP biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the European Medicines Agency‘s (EMA) Committee for Human Medicinal Products (CHMP) issued a positive opinion for a new formulation of COMIRNATY ® (COVID-19 vaccine, mRNA). |
| 2021-10-15 | Pfizer | Regulatory Pfizer and BioNTech Submit Data to EMA for the Vaccination of Children 5 to <12 Years of Age with COMIRNATY® pfizer.com ↗
The variation request includes data from a Phase 2/3 study, which is enrolling children 6 months to <12 years of age. |
| 2021-10-15 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Data to EMA for the Vaccination of Children 5 to <12 Years of Age with COMIRNATY® biontech.com ↗
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that they submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 mRNA vaccine) to the European Medicines Agency (EMA) for a variation of the Conditional Marketing Authorization (CMA) in the European Union (EU). |
| 2021-10-04 | BioNTech SE | Regulatory Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union biontech.com ↗
The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. |
| 2021-09-23 | BioNTech SE | Regulatory Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster biontech.com ↗
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine |
| 2021-09-20 | Pfizer | Results Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years pfizer.com ↗
In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses |
| 2021-09-20 | BioNTech SE | Results Pfizer and BioNTech Announce Positive Topline Results from Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years biontech.com ↗
In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses |
| 2021-09-18 | BioNTech SE | Regulatory FDA Advisory Committee Votes Unanimously in Favor of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-Risk Populations biontech.com ↗ |
| 2021-09-17 | Pfizer | Regulatory FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations pfizer.com ↗
The committee recommended that the additional dose be administered at least six months after the two-dose series. |
| 2021-09-06 | BioNTech SE | Regulatory Pfizer and BioNTech Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY® biontech.com ↗
they submitted a variation to the European Medicines Agency (EMA) |
| 2021-08-25 | Pfizer | Regulatory Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older pfizer.com ↗ |
| 2021-08-25 | BioNTech SE | Regulatory Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older biontech.com ↗ |
| 2021-08-23 | Pfizer | Regulatory Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY ® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. |
| 2021-08-23 | BioNTech SE | Regulatory Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY ® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. |
| 2021-08-16 | Pfizer | Regulatory Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine pfizer.com ↗ |
| 2021-08-16 | BioNTech SE | Results Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine biontech.com ↗
Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses |
| 2021-07-16 | BioNTech SE | Regulatory U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine biontech.com ↗ |
| 2021-07-08 | BioNTech SE | Results Pfizer and BioNTech Provide Update on Booster Program in Light of the Delta-Variant biontech.com ↗
Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile |
| 2021-05-28 | Pfizer | Regulatory Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents pfizer.com ↗
Pfizer Inc .(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. |
| 2021-05-28 | BioNTech SE | Regulatory Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. |
| 2021-05-11 | BioNTech SE | Regulatory Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. |
| 2021-05-10 | Pfizer | Regulatory Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. |
| 2021-05-07 | Pfizer | Regulatory Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. |
| 2021-05-07 | BioNTech SE | Regulatory Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine biontech.com ↗ |
| 2021-05-05 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Health Canada Authorization of COVID-19 Vaccine in Adolescents biontech.com ↗
Pfizer Canada ULC and BioNTech SE today announced that Health Canada has expanded the Interim Order authorization for their COVID-19 vaccine to include individuals 12 to 15 years of age. |
| 2021-04-30 | BioNTech SE | Regulatory Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY® in the EU to Adolescents biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY ® (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. |
| 2021-04-09 | BioNTech SE | Regulatory Pfizer and BioNTech Request Regulatory Agencies Expand Emergency Use of Their COVID-19 Vaccine to Adolescents biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. |
| 2021-04-01 | Pfizer | Results Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study pfizer.com ↗
The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA). |
| 2021-03-31 | Pfizer | Results Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents pfizer.com ↗
In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated |
| 2021-03-31 | BioNTech SE | Results Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents biontech.com ↗
In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated |
| 2021-03-26 | Pfizer | Regulatory EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers. |
| 2021-03-26 | BioNTech SE | Regulatory EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union biontech.com ↗
With this approval, the COMIRNATY vials can be stored in all 27 European Union (EU) member states at these updated temperatures for a total of two weeks alternatively to the storage at ultra-low temperatures. |
| 2021-03-26 | BioNTech SE | Regulatory BioNTech provides Update on Vaccine Production Status at Marburg Manufacturing Site biontech.com ↗
BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. |
| 2021-03-11 | Pfizer | Results Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared pfizer.com ↗
The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. |
| 2021-03-11 | BioNTech SE | Results Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared biontech.com ↗
The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. |
| 2021-02-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory BioNTech and Fosun Pharma Receive Special Import Authorization in Macau for COVID-19 mRNA Vaccine fosunpharma.com ↗
the COVID-19 mRNA vaccine COMIRNATY® (also known as BNT162b2, Chinese product name: 復必泰TM) has received Special Import Authorization granted by the Health Bureau of Macau Special Administrative Region of the PRC (“Macau”) |
| 2021-02-25 | BioNTech SE | Regulatory BioNTech and Fosun Pharma Receive Special Import Authorization in Macau for COVID-19 Vaccine biontech.com ↗
“With the support from the Macau SAR government, we reached another important milestone in Greater China for the COVID-19 vaccine co-developed by BioNTech and Fosun Pharma.” |
| 2021-02-19 | Pfizer | Regulatory Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. |
| 2021-02-19 | BioNTech SE | Regulatory Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA biontech.com ↗ |
| 2021-02-17 | BioNTech SE | Results In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer-BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations biontech.com ↗
Although the results indicated a reduction in neutralization of virus with all the South African variant spike glycoprotein mutations, all the sera neutralized all the viruses tested. |
| 2021-02-08 | BioNTech SE | Results Pfizer and BioNTech Publish Data from In Vitro Studies in Nature Medicine Demonstrating COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants biontech.com ↗ |
| 2021-02-01 | BioNTech SE | Results Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature biontech.com ↗
The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. |
| 2021-01-29 | BioNTech SE | Results Pfizer and BioNTech Publish Data on COVID-19 Vaccine-Induced Antibodies’ Ability to Neutralize SARS-CoV-2 U.K. Strain Pseudovirus in Cell Culture in Science biontech.com ↗
The study published today includes a larger number of sera from vaccinated individuals and confirms the initial study results that the B.1.1.7 lineage is unlikely to escape BNT162b2-mediated protection. |
| 2021-01-27 | BioNTech SE | Results In Vitro Studies Demonstrate Pfizer and BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants biontech.com ↗
The sera neutralized SARS-CoV-2 with key mutations present in the United Kingdom (U.K.) and South Africa variants, as measured by studies conducted by Pfizer and the University of Texas Medical Branch (UTMB). |
| 2021-01-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory BioNTech and Fosun Pharma Receive Authorization for Emergency Use in Hong Kong for COVID-19 Vaccine fosunpharma.com ↗
We are excited and encouraged that COMIRNATY® has been authorized to emergency use in Hong Kong. |
| 2021-01-25 | BioNTech SE | Regulatory BioNTech and Fosun Pharma Receive Authorization for Emergency Use in Hong Kong for COVID-19 Vaccine biontech.com ↗ |
| 2021-01-20 | BioNTech SE | Results Pfizer and BioNTech Publish Results of Study Showing COVID-19 Vaccine Elicits Antibodies that Neutralize Pseudovirus Bearing the SARS-CoV-2 U.K. Strain Spike Protein in Cell Culture biontech.com ↗
Sera of participants from the previously reported German Phase 1/2 trial inhibited pseudovirus bearing the U.K. strain SARS-CoV-2 spike in a neutralization range that is regarded as biologically equivalent to the unmutated Wuhan SARS-CoV-2 spike. |
| 2021-01-08 | BioNTech SE | Results An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission biontech.com ↗
The sera of 20 participants from the previously reported Phase 3 trial neutralized the virus with the mutation as well as they neutralized virus without the mutation. |
| 2020-12-21 | Pfizer | Regulatory Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine pfizer.com ↗
Positive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of scientific evidence, including Phase 3 efficacy and safety data |
| 2020-12-21 | Pfizer | Regulatory Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine pfizer.com ↗
The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. |
| 2020-12-21 | BioNTech SE | Regulatory Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine biontech.com ↗ |
| 2020-12-21 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY ® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. |
| 2020-12-19 | BioNTech SE | Regulatory Pfizer and BioNTech Receive Conditional Marketing Authorization by Swissmedic for COVID-19 Vaccine biontech.com ↗
Pfizer AG and BioNTech SE today announced that Swissmedic in Switzerland has granted a Conditional Marketing Authorization for their COVID-19 mRNA vaccine COMIRNATY ® (BNT162b2). |
| 2020-12-14 | Pfizer | Results Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2 pfizer.com ↗
The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. |
| 2020-12-14 | BioNTech SE | Results Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2 biontech.com ↗
The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. |
| 2020-12-12 | Pfizer | Regulatory U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older pfizer.com ↗ |
| 2020-12-12 | BioNTech SE | Regulatory U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older biontech.com ↗ |
| 2020-12-11 | Pfizer | Regulatory Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. |
| 2020-12-11 | BioNTech SE | Regulatory Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 biontech.com ↗ |
| 2020-12-10 | Pfizer | Regulatory Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S. pfizer.com ↗ |
| 2020-12-10 | Pfizer | Results Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. |
| 2020-12-10 | BioNTech SE | Regulatory Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S. biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted (17 to 4) in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). |
| 2020-12-10 | BioNTech SE | Results Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. |
| 2020-12-09 | BioNTech SE | Regulatory Pfizer and BioNTech Achieve Health Canada Authorization for Their Vaccine to Combat COVID-19 biontech.com ↗
Pfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). |
| 2020-12-02 | BioNTech SE | Regulatory Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19 biontech.com ↗
This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. |
| 2020-11-20 | Pfizer | Regulatory Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine pfizer.com ↗ |
| 2020-11-20 | BioNTech SE | Regulatory Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine biontech.com ↗ |
| 2020-11-18 | Pfizer | Results Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. |
| 2020-11-18 | BioNTech SE | Results Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints biontech.com ↗
Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 28 days after the first dose, 7 days after the second dose. |
| 2020-11-16 | BioNTech SE | Regulatory BioNTech and Fosun Pharma receive approval to commence COVID-19 Vaccine Candidate BNT162b2 trial in China biontech.com ↗
I would like to thank the National Medical Products Administration for their great support and for their approval of the clinical trial and we will continue our close collaboration with BioNTech. |
| 2020-11-13 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma and BioNTech receive approval to commence COVID-19 Vaccine Candidate BNT162b2 trial in China fosunpharma.com ↗
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK) and BioNTech SE (“BioNTech”; Nasdaq: BNTX,) today announced that the China National Medical Products Administration (hereinafter referred to as the "National Medical Products Administration") has approved the clinical trial in Mainland China for their mRNA vaccine candidate, BNT162b2. |
| 2020-11-09 | Pfizer | Results Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study pfizer.com ↗
The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19, |
| 2020-11-09 | BioNTech SE | Results Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study biontech.com ↗
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. |
| 2020-10-14 | BioNTech SE | Results Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 biontech.com ↗
The publication describes key safety and immunogenicity data from the Phase 1 portion of the U.S. trial for the BNT162b2 and BNT162b1 vaccine candidates. |
| 2020-10-09 | BioNTech SE | Regulatory Pfizer Canada and BioNTech Initiate Rolling Submission to Health Canada for SARS-CoV-2 Vaccine Candidate BNT162b2 biontech.com ↗
The rolling submission has been accepted under the Minister of Health’s Interim Order allowing companies to submit safety and efficacy data and information as they become available. |
| 2020-10-06 | BioNTech SE | Regulatory BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2 biontech.com ↗
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. |
| 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 ↗
As part of a two-day virtual Investor Day, Pfizer Inc. (NYSE: PFE) provided an extensive overview of pipeline advances and shared updates on the Company’s efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. |
| 2020-09-09 | Pfizer | Results Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19 pfizer.com ↗
In a non-human primate preclinical study, immunization with the BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, protected rhesus macaques against SARS-CoV-2 infection. |
| 2020-09-09 | BioNTech SE | Results Pfizer and BioNTech Announce Data From Preclinical Studies of mRNA-Based Vaccine Candidate Against COVID-19 biontech.com ↗
In a non-human primate preclinical study, immunization with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, protected rhesus macaques against SARS-CoV-2 infection. |
| 2020-09-07 | BioNTech SE | Regulatory BioNTech and Pfizer Receive Regulatory Approval From Paul-Ehrlich-Institut to Commence German Part of Global Phase 2/3 Trial for COVID-19 Vaccine Candidate BNT162b2 biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Pfizer Inc. (NYSE: PFE) today announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate. |
| 2020-08-20 | Pfizer | Results Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 pfizer.com ↗
Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants |
| 2020-08-20 | BioNTech SE | Results Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 biontech.com ↗
Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. |
| 2020-07-13 | Pfizer | Regulatory Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2 pfizer.com ↗ |
| 2020-07-13 | BioNTech SE | Regulatory Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2 biontech.com ↗ |
| 2020-04-22 | Pfizer | Regulatory BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates pfizer.com ↗ |
| 2020-04-22 | BioNTech SE | Regulatory BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE), have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection. |
All press releases naming this drug 222 releases
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Evidence & citations 19 cited values
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| Field | Value | Cited text |
|---|---|---|
| Known as | BNT162b2 | “In this study, we compared immune responses to the BNT162b2 mRNA Coronavirus Disease 2019 vaccine in patients with solid tumors (n = 53) who were on active cytotoxic...” PMID 34594036 ↗ Sep 202174“BACKGROUND: Allergic reactions to the coronavirus 2019 disease (COVID-19) mRNA vaccine (BNT162b2) were originally reported at higher rates than expected, contributing to...” PMID 40497015 ↗ May 2025 “A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19...” NCT04816669 ↗ “30 young healthy adults were enrolled and received two intramuscular doses, 21 days apart of PHH-1V vaccine formulations [10 µg (n = 5), 20 µg (n = 10), 40 µg (n = 10)] or...” PMID 37775521 ↗ Sep 2023 “The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of...” NCT05525208 ↗ “Pfizer-BioNTech COVID-19 vaccine, BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA...” NCT07408297 ↗ “Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna).” PMID 37847518 ↗ Oct 2023 “randomized 2:1:1 to receive either recombinant protein (SCB-2019, Clover), adenovirus-vector (ChAdOx1-S, AstraZeneca/Fiocruz), or mRNA (BNT162b2, Pfizer/Wyeth).” PMID 38762360 ↗ May 2024 “The participants were assigned to receive no booster, an Ad26.COV2.S booster, an mRNA-1273 booster, or a BNT162b2 booster.” PMID 35045226 ↗ Jan 2022 “same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )” NCT05324319 ↗ “This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa” NCT05081271 ↗ |
| Known as | BNT162b2 (Omi JN.1) | “BNT162b2 (Omi JN.1)” NCT05997290 ↗ |
| Known as | BNT162b2 (Omi KP.2) | “BNT162b2 (Omi KP.2)” NCT05997290 ↗ |
| Known as | BNT162b2 (Omi XBB.1.5) | “BNT162b2 (Omi XBB.1.5)” NCT05997290 ↗ |
| Known as | BNT162b2 monovalent (Omicron JN.1) | “BNT162b2 monovalent (Omicron JN.1)” NCT05997290 ↗ |
| Known as | BNT162b2 monovalent (Omicron KP.2) | “BNT162b2 monovalent (Omicron KP.2)” NCT05997290 ↗ |
| Known as | BNT162b2 monovalent (Omicron XBB.1.5) | “BNT162b2 monovalent (Omicron XBB.1.5)” NCT05997290 ↗ |
| Known as | BNT162b2 mRNA COVID-19 Vaccine | “BNT162b2 mRNA COVID-19 Vaccine” NCT05022329 ↗ |
| Known as | COMIRNATY | “This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus disease 2019 (COVID-19) mRNA-based vaccine BNT162b2...” PMID 39197299 ↗ Aug 20248“Participants within the group 1 will receive BNT162b2 (Comirnaty®) intramuscularly as a 2-dose series spaced 28 days apart at a dose of 30 µg each, then a booster dose (30µg) at M8.” NCT04824638 ↗ “a first dose of Coronovac (Sinovac, Beijing, China) followed by a booster shot with the mRNA-based BNT162b2 SARS-CoV-2 vaccine (Comirnaty, Pfizer-BioNTech).” NCT05668065 ↗ “Participants will receive the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®).” NCT04951323 ↗ “BNT162b2 (Pfizer-BioNTech/Comirnaty®) vaccine is a mRNA vaccine” NCT05329064 ↗ “Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)” NCT04805125 ↗ “BNT162b2 (Comirnaty®), Pfizer/BioNTech, mARN vaccine,” NCT04900467 ↗ “30 ug of BNT162b2/COMIRNATY®, active control” NCT05602961 ↗ “BNT162b2 (Pfizer) (Comirnaty)” NCT05515042 ↗ |
| Known as | Pfizer | “A single 30μg dose mRNA vaccine Pfizer(BNT162b2)” NCT05686161 ↗1“BNT162b2 (Pfizer) (Comirnaty)” NCT05515042 ↗ |
| Known as | Pfizer-Biontech | “BACKGROUND: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2...” PMID 35320659 ↗ Mar 20224“Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna).” PMID 37847518 ↗ Oct 2023 “study participant will receive either 30ug in 0.3 ml of Pfizer/BioNTech (BNT162b2) or 0.25 ml of Moderna vaccine administered intramuscularly.” NCT05279365 ↗ “The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).” NCT04775069 ↗ “SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)” NCT05465863 ↗ |
| Known as | Pfizer-BioNTech BNT162b2 | “For dose 1 and 2, the currently available mRNA vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) are two dose vaccines which were studied in schedules of either 0 and...” NCT04894435 ↗ |
| Known as | Pfizer-BioNTech BNT162b2 COVID-19 Vaccine | “Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine” NCT04952402 ↗ |
| Known as | Pfizer-BioNTech COVID-19 Vaccine | “This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus disease 2019 (COVID-19) mRNA-based vaccine BNT162b2...” PMID 39197299 ↗ Aug 20242“Pfizer-BioNTech COVID-19 vaccine, BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA...” NCT07408297 ↗ “Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)” NCT04805125 ↗ |
| Known as | Pfizer-COVID-19 Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05170399 ↗ |
| Known as | The Pfizer-BioNTech COVID-19 vaccine | “The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of...” NCT05525208 ↗ |
| Known as | Tozinameran | “Antigen: nucleoside-modified messenger RNA (mRNA) encoding the viral Spike (S) glycoprotein of SARS-CoV-2, called tozinameran.” NCT05084989 ↗ |
| Modality | Messenger RNA (mRNA) | “BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2...” PMID 34525277 ↗ Sep 2021 |
| Route | Intramuscular | “Intramuscular injection” NCT04368728 ↗ |