Skip to main content

Comirnaty FDA Approval History

Last updated by Melisa Puckey, BPharm on Sep 13, 2022.

FDA Approved: Yes (First approved August 23, 2021)
Brand name: Comirnaty
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Prevention of COVID-19

Comirnaty is an mRNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Indication & Authorized Use

Comirnaty® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older.
    • Comirnaty is also authorized under Emergency Use Authorization (EUA) to be administered to provide:a two-dose primary series in individuals 12 through 15 years;
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
  • Comirnaty is no longer authorized as booster doses for individuals 12 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine (monovalent) has emergency use authorization to prevent COVID-19 as a: :

  • Three-dose primary series for individuals 6 months through 4 years of age.t
  • Two-dose primary series for individuals 5 years of age and older. 
  • Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. 
  • Single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine. Pfizer-BioNTech.
  • COVID-19 Vaccine (monovalent) is no longer authorized as booster doses for individuals 12 years of age and older. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorisation for use to prevent COVID-19 in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: 

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or 
  • Have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Development History

  • The BNT162 program initially consisted of four vaccine candidates, each representing a unique combination of messenger RNA (mRNA) format and target antigen. In early studies, BNT162b1 and BNT162b2 emerged as the two strongest candidates based on assessments of safety and favorable viral antigen specific CD4+ and CD8+T cell responses.
  • BNT162b1 is a nucleoside modified RNA (modRNA) that encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, and BNT162b2 is a nucleoside modified RNA (modRNA) that encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies.
  • In Phase 1 studies, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody geometric mean titers, which were substantially elevated after the second dose, showing clear benefit of a two-dose regimen.
  • The data demonstrated a favorable overall tolerability profile for BNT162b2 when compared to BNT162b1. After Dose 1, systemic events reported by participants 65 to 85 years old who received BNT162b2 were similar to those reported by those who received placebo. After Dose 2 of 30μg BNT162b2, only 17% of participants 18 to 55 years old and 8% of participants 65 to 85 years old reported fever (≥38.0 to 38.9 °C), compared to 75% of 18 to 55 year old participants and 33% of 65 to 85 year old participants administered a second dose of 30μg of BNT162b1. Severe systemic events (fatigue, headache, chills, muscle pain, and joint pain) were reported in small numbers of younger BNT162b2 recipients and were transient and manageable. No severe systemic events were reported by older BNT162b2 recipients. There were no reports of Grade 4 systemic events by any BNT162 recipient.
  • The BNT162b2 vaccine candidate was chosen to progress into the Phase 2/3 study, at a 30 µg dose level in a two-dose regimen, based on the data from preclinical and clinical studies.
  • BNT162b2 was granted U.S. FDA Fast Track designation in July 2020.
  • The Phase 2/3 safety and efficacy study is an event-driven trial that includes up to 44,000 participants aged between 16 and 85 years of age from diverse population groups in the U.S., Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa.
  • The first results from an interim efficacy analysis of a Phase 3 study were reported by Pfizer on November 9, 2020. BNT162b2 was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. Protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule (injections of the vaccine on Day 1 and Day 21). The study is ongoing and additional data could affect these results.
  • The analysis evaluated 94 confirmed cases of COVID-19 in trial participants. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
  • Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
  • Further information on the design of the clinical trial and the study protocol can be found at pfizer.com/science/coronavirus.

Development timeline for Comirnaty

DateArticle
Dec  5, 2022Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
Nov 18, 2022Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages
Nov  4, 2022Pfizer 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
Oct 13, 2022Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older
Oct 12, 2022Pfizer 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
Sep 26, 2022Pfizer 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
Aug 31, 2022Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Aug 23, 2022Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age
Aug 22, 2022Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
Jul 27, 2022Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design
Jul  8, 2022Approval Pfizer and BioNTech Announce U.S. FDA Approval of Their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age
Jun 25, 2022Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron
Jun 17, 2022Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
May 23, 2022Pfizer-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
May 17, 2022Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age
Apr 26, 2022Pfizer 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
Apr 14, 2022Pfizer 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
Mar 29, 2022Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older
Feb 11, 2022Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age
Feb  1, 2022Pfizer 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
Jan 25, 2022Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age
Jan 24, 2022Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant
Jan  3, 2022Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older
Dec 17, 2021Pfizer and Biontech Provide Update on Ongoing Studies of COVID-19 Vaccine
Dec 16, 2021Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Comirnaty in Adolescents 12 Through 15 Years of Age
Dec  9, 2021Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older
Dec  8, 2021Pfizer and BioNTech Provide Update on Omicron Variant
Nov 22, 2021Follow-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
Nov 19, 2021Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older
Oct 29, 2021Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years
Oct 26, 2021FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years
Oct 21, 2021Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
Sep 28, 2021Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
Sep 22, 2021Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
Sep 20, 2021Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
Sep 17, 2021FDA Advisory Committee Votes Unanimously in Favor of Comirnaty® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
Aug 25, 2021Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
Aug 23, 2021Approval FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Aug 16, 2021Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine
Jun  1, 2021Pfizer 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
May 10, 2021FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
May  7, 2021Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
Apr  7, 2021NIH Begins Study of Allergic Reactions to Moderna, Pfizer-BioNTech COVID-19 Vaccines
Apr  1, 2021Pfizer 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
Mar 31, 2021Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
Feb 25, 2021Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants
Feb 19, 2021Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA
Feb 18, 2021Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women
Feb 17, 2021In 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
Feb 17, 2021Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY®
Feb 12, 2021Pfizer and BioNTech to Supply the United States with 100 Million Additional Doses of COVID-19 Vaccine
Feb  8, 2021Pfizer 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
Feb  1, 2021Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature
Jan 29, 2021Pfizer 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
Jan 27, 2021In 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
Jan 25, 2021BioNTech and Fosun Pharma Receive Authorization for Emergency Use in Hong Kong for COVID-19 Vaccine
Jan 22, 2021Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19
Jan 20, 2021Pfizer 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
Jan  8, 2021An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
Dec 29, 2020Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
Dec 23, 2020Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
Dec 21, 2020Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
Dec 21, 2020Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine
Dec 14, 2020Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2
Dec 12, 2020U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older
Dec 11, 2020Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19
Dec 10, 2020Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
Dec 10, 2020Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
Dec  2, 2020Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
Dec  1, 2020Pfizer and BioNTech Submitted Application for Conditional Marketing Authorization for COVID-19 Vaccine to the EMA
Nov 25, 2020BioNTech and Fosun Pharma Announce the Start of a Phase 2 Clinical Trial of Lead mRNA COVID-19 Vaccine BNT162b2 in China
Nov 20, 2020FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
Nov 20, 2020Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
Nov 18, 2020Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
Nov 16, 2020Pfizer Update On Our U.S. COVID-19 Vaccine Candidate Distribution Preparedness
Nov 11, 2020Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2 mRNA-Based Vaccine Candidate Against SARS-CoV-2
Nov  9, 2020Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study
Oct  9, 2020Pfizer Canada and BioNTech Initiate Rolling Submission to Health Canada for SARS-CoV-2 Vaccine Candidate BNT162b2
Oct  6, 2020BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2
Sep 30, 2020BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2
Sep 17, 2020BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021
Sep 15, 2020BioNTech to Receive up to €375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vaccine Program BNT162
Sep 12, 2020Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial
Sep  9, 2020Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19
Sep  9, 2020Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
Sep  7, 2020BioNTech 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
Aug 27, 2020BioNTech and Fosun Pharma to Potentially Supply 10 Million Doses of BioNTech’s BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2 to Hong Kong SAR and Macao SAR
Aug 20, 2020Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
Aug 12, 2020Pfizer and BioNTech Announce Publication of Peer-Reviewed Data from Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate, BNT162b1, Against SARS-CoV-2 in Nature
Aug  5, 2020BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China
Aug  5, 2020Pfizer and BioNTech to Supply Canada with their BNT162 mRNA-Based Vaccine Candidate
Jul 31, 2020Pfizer and BioNTech to Supply Japan with 120 Million Doses of Their BNT162 mRNA-Based Vaccine Candidate
Jul 28, 2020Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study
Jul 22, 2020Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
Jul 20, 2020Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2
Jul 20, 2020Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
Jul 13, 2020Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
Jul  1, 2020Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2
May  5, 2020Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program
Apr 29, 2020BioNTech and Pfizer Announce Completion of Dosing for First Cohort of Phase 1/2 trial of COVID-19 Vaccine Candidates in Germany
Apr 22, 2020BioNTech and Pfizer Announce Regulatory Approval from German Authority Paul-Ehrlich-Institut to Commence First Clinical Trial of COVID-19 Vaccine Candidates
Apr  9, 2020Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development
Mar 17, 2020Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine
Mar 16, 2020BioNTech and Fosun Pharma Form COVID-19 Vaccine Strategic Alliance in China
Mar 16, 2020BioNTech Reports Rapid Progress on COVID-19 Vaccine Program to Address Global Public Health Threat

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.