Comirnaty

also known as BNT162b2 · Comirnaty bivalent vaccine · Pfizer-BioNTech

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Comirnaty	—	2020-12-21	europa.eu ↗

Trials 8

today

EU approved 2020

NCT06919796 · Ph 2 NCT05977127 · Ph 2 NCT05075538 · Ph 4 NCT04969601 · Ph 1/2 NCT05029245 · Ph 3 NCT04907331 · Ph 2 NCT04780659 · Ph 4 NCT04569383 · Ph 1

202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT04569383	Oct 2020 → Aug 2021	COVID-19	University Medical Center Hamburg-Eppendorf	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT04969601	Sep 2021 → Feb 2022	acute lymphoblastic leukemia, acute myeloid leukemia	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 23 trials · 1 met primary
Phase 2	NCT06919796	May 2025 → May 2026 overdue	Orthocoronavirinae infectious disease	PharmaJet, Inc.	Not yet recruiting	No outcome recorded
Phase 2	NCT05977127	Sep 2023 → Mar 2024	COVID-19	Radboud University Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04907331	May → Nov 2021	COVID-19	Medical University Innsbruck	Unknown	Met primary
Phase 31 trial
Phase 3	NCT05029245	Aug 2021 → Aug 2022	COVID-19	Department of Medical Services Ministry of Public Health of Thailand	Withdrawn	No outcome recorded Stop: Business
Phase 42 trials
Phase 4	NCT05075538	Dec 2021 → Jan 2024	cancer	Jules Bordet Institute	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04780659	Feb → Oct 2021	COVID-19	Karolinska University Hospital	Completed	No outcome recorded
Comparator or background therapy26 trials
Phase 0	NCT07605520 Comparator	May 2026 → May 2028 expected	—	ANRS, Emerging Infectious Diseases	Recruiting	No outcome recorded
Phase 1	NCT05394012 Comparator	Dec 2022 → Feb 2023	COVID-19	Walvax Biotechnology Co., Ltd.	Unknown	No outcome recorded
Phase 1	NCT05396573 Comparator	Jul → Aug 2022	COVID-19	Walvax Biotechnology Co., Ltd.	Unknown	No outcome recorded
Phase 1/2	NCT07280858 Comparator	Jan → Dec 2026 expected	—	SK Bioscience Co., Ltd.	Recruiting	No outcome recorded
Phase 1/2	NCT05490108 Comparator	Jun → Sep 2022	COVID-19	Shanghai Zerun Biotechnology Co.,Ltd	Unknown	No outcome recorded
Phase 2	NCT06742281 Comparator	Dec 2024 → Jun 2026	COVID-19	CyanVac LLC	Completed	No outcome recorded
Phase 2	NCT06672055 Comparator	Oct 2024 → May 2027 expected	COVID-19	Vaxart	Active not recruiting	No outcome recorded
Phase 2	NCT05930730 Comparator	Oct 2023 → Feb 2024	—	Chulalongkorn University	Unknown	Met primary
Phase 2	NCT05542693 Comparator	Jan → Mar 2023	COVID-19	Azidus Brasil	Unknown	No outcome recorded
Phase 2	NCT05329051 Comparator	Jul → Sep 2022	COVID-19	Sinocelltech Ltd.	Unknown	No outcome recorded
Phase 2	NCT05239975 Comparator	Apr → Jul 2022	COVID-19	Sinocelltech Ltd.	Withdrawn	No outcome recorded
Phase 2	NCT05239806 Comparator	Apr → Aug 2022	COVID-19	Sinocelltech Ltd.	Unknown	No outcome recorded
Phase 2	NCT05305573 Comparator	Mar → Oct 2022	COVID-19	Hipra Scientific, S.L.U	Completed	No outcome recorded
Phase 2	NCT05238454 Comparator	Mar → Jul 2022	COVID-19	Sinocelltech Ltd.	Unknown	No outcome recorded
Phase 2	NCT05238441 Comparator	Mar → Jun 2022	COVID-19	Sinocelltech Ltd.	Unknown	No outcome recorded
Phase 2	NCT05160766 Comparator	Nov 2021 → Oct 2022	—	Oliver Cornely, MD	Completed	No outcome recorded
Phase 2	NCT05378191 Comparator	Apr 2021 → Aug 2022	COVID-19	Instituto de Investigación Hospital Universitario La Paz	Unknown	No outcome recorded
Phase 3	NCT05749926 Comparator	May → Jul 2023	COVID-19	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 3	NCT05534048 Comparator	Feb → Jul 2023	COVID-19	Everest Medicines (Singapore) Pte. Ltd.	Unknown	No outcome recorded
Phase 3	NCT05329220 Comparator	Aug 2022 → Mar 2023	COVID-19	Bavarian Nordic	Completed	No outcome recorded
Phase 3	NCT05188677 Comparator	Jun 2022 → Jun 2023	COVID-19	Clover Biopharmaceuticals AUS Pty	Completed	No outcome recorded
Phase 3	NCT05405283 Comparator	Jun → Jul 2022	—	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 3	NCT05323461 Comparator	May → Oct 2022	COVID-19	Sinocelltech Ltd.	Unknown	Met primary
Phase 4	NCT06452654 Comparator	May 2024 → Oct 2027 expected	type 1 diabetes mellitus	Technical University of Munich	Recruiting	No outcome recorded
Phase 4	NCT05924685 Comparator	Aug → Dec 2023	varicella zoster infection	University Medical Center Groningen	Completed	No outcome recorded
Phase 4	NCT04760132 Comparator	Feb 2021 → Dec 2023	Orthocoronavirinae infectious disease	Jens D Lundgren, MD	Completed	No outcome recorded

Press releases naming this drug 59 releases

Date	Issuer	Release
2025-08-27	Pfizer	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 ↗
2025-08-27	BioNTech SE	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 ↗
2023-01-20	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	COMIRNATY® Bivalent COVID-19 Vaccine is Officially Approved as Regular Imported Vaccine by the Pharmaceutical Administration Bureau of Macao SAR fosunpharma.com ↗
2023-01-06	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Self-Paid Vaccination Service for Bivalent COVID-19 Vaccine COMIRNATY® is Officially Provided in Hong Kong, Offering More Vaccine Options for People in Need fosunpharma.com ↗
2022-12-23	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	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 ↗
2022-12-23	BioNTech SE	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 ↗
2022-11-28	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Comirnaty Bivalent Vaccine Arrives in Hong Kong SAR and Macau SAR and Will Soon Be Available to the Local Residents fosunpharma.com ↗
2022-10-19	BioNTech SE	Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union biontech.com ↗
2022-09-16	BioNTech SE	Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union biontech.com ↗
2022-07-08	BioNTech SE	Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age biontech.com ↗
2022-06-17	Pfizer	Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age pfizer.com ↗
2022-06-17	BioNTech SE	Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age biontech.com ↗
2022-05-23	Pfizer	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 ↗
2022-05-23	BioNTech SE	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 ↗
2022-01-12	Pfizer	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 ↗
2021-12-23	BioNTech SE	Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA biontech.com ↗
2021-12-20	BioNTech SE	Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply biontech.com ↗
2021-12-17	BioNTech SE	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 ↗
2021-11-25	Pfizer	Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union pfizer.com ↗
2021-11-25	BioNTech SE	Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union biontech.com ↗
2021-11-22	Pfizer	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 ↗
2021-11-22	BioNTech SE	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 ↗
2021-10-26	Pfizer	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	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 ↗
2021-10-18	Pfizer	New Formulation of COMIRNATY® Receives Positive Opinion from CHMP pfizer.com ↗
2021-10-18	BioNTech SE	New Formulation of COMIRNATY® Receives Positive Opinion from CHMP biontech.com ↗
2021-10-15	Pfizer	Pfizer and BioNTech Submit Data to EMA for the Vaccination of Children 5 to <12 Years of Age with COMIRNATY® pfizer.com ↗
2021-10-15	BioNTech SE	Pfizer and BioNTech Submit Data to EMA for the Vaccination of Children 5 to <12 Years of Age with COMIRNATY® biontech.com ↗
2021-10-12	Enlivex Therapeutics Ltd.	Enlivex CSO Prof. Dror Mevorach Publishes Foundational Paper on the Pfizer-BioNTech COVID-19 Vaccine in The New England Journal of Medicine enlivex.com ↗
2021-09-18	BioNTech SE	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	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 ↗
2021-09-06	BioNTech SE	Pfizer and BioNTech Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY® biontech.com ↗
2021-08-25	Pfizer	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	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	Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older pfizer.com ↗
2021-08-23	BioNTech SE	Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older biontech.com ↗
2021-07-16	BioNTech SE	U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine biontech.com ↗
2021-05-24	Pfizer	Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of the Pfizer-BioNTech COVID-19 Vaccine in Older Adults pfizer.com ↗
2021-05-20	Pfizer	Pfizer and BioNTech to Supply the European Union With up to 1.8 Billion Additional Doses of COMIRNATY® pfizer.com ↗
2021-05-20	BioNTech SE	Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY® biontech.com ↗
2021-05-17	BioNTech SE	Update on Stability of COMIRNATY®: Longer Storage Possible biontech.com ↗
2021-04-30	BioNTech SE	Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY® in the EU to Adolescents biontech.com ↗
2021-04-19	Pfizer	Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® pfizer.com ↗
2021-04-19	BioNTech SE	Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® biontech.com ↗
2021-03-31	Pfizer	Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents pfizer.com ↗
2021-03-31	BioNTech SE	Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents biontech.com ↗
2021-03-26	Pfizer	EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union pfizer.com ↗
2021-03-26	BioNTech SE	EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union biontech.com ↗
2021-03-11	Pfizer	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 ↗
2021-03-11	BioNTech SE	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 ↗
2021-03-03	BioNTech SE	Pfizer-BioNTech’s COVID-19 Vaccine Arrives in Rwanda biontech.com ↗
2021-02-17	Pfizer	Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY® pfizer.com ↗
2021-02-17	BioNTech SE	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 ↗
2021-02-17	BioNTech SE	Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY® biontech.com ↗
2021-01-08	BioNTech SE	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 ↗
2020-12-29	Pfizer	Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® pfizer.com ↗
2020-12-29	BioNTech SE	Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® biontech.com ↗
2020-12-14	Pfizer	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 ↗
2020-12-14	BioNTech SE	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 ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

Field	Value	Cited text
Known as	Comirnaty	“This study evaluated the safety and immunogenicity of Comvigen, a bivalent SARS-CoV-2 vaccine, in comparison to the Comirnaty bivalent vaccine (Comirnaty).” PMID 40895389 ↗ Aug 2025 34 “The version of the Comirnaty® vaccine and the dose will be the one adapted to the variant circulating at the start of trial and authorised by EMA.” NCT07605520 ↗ “monovalent Omicron XBB.1.5 COVID-19 mRNA vaccine (Comirnaty, I.M.)” NCT05924685 ↗ NCT04569383 ↗ NCT05749926 ↗ NCT05378191 ↗ NCT05542693 ↗ NCT05188677 ↗ NCT05394012 ↗ NCT05238454 ↗ NCT05329220 ↗ Show 24 more sources
Known as	BNT162b2	“BACKGROUND: To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of...” PMID 34181880 ↗ Jun 2021 4 “The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment...” PMID 36209129 ↗ Oct 2022 “The messenger ribonucleic acid (mRNA) vaccine COMIRNATY® (BNT162b2) is already approved by health authorities for individuals older than 12.” NCT04969601 ↗ “Comparison of Heterologous Vaccination With an Vaxzevria (ChAdOx1-S) Prime and a Comirnaty (BNT162b2) Boost to Homolog Vaccination” NCT04907331 ↗ “Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)” NCT05749926 ↗
Known as	Comirnaty bivalent vaccine	“Comirnaty bivalent vaccine (Comirnaty)” PMID 40895389 ↗ Aug 2025
Known as	Pfizer-BioNTech	“In participants previously vaccinated with 3 doses of mRNA vaccine, he/she will receive one dose of Comirnaty® (Pfizer-BioNTech) vaccine as a second booster” NCT05405283 ↗
Modality	Vaccine	“Vaccination with Comirnaty (21 day interval)” NCT04569383 ↗
Route	Other	“intradermal injection or intramuscular injection” NCT05029245 ↗