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Moderna COVID-19 Vaccine FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 12, 2021.

FDA Approved: No (Emergency Use Authorization)
Brand name: Moderna COVID-19 Vaccine
Generic name: SARS-CoV-2 vaccine
Previous Name: mRNA-1273
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19

The Moderna COVID-19 Vaccine (mRNA-1273) is an investigational mRNA vaccine against SARS-CoV-2 in development for the prevention of COVID-19.

  • The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Moderna COVID-19 Vaccine (mRNA-1273) to prevent COVID-19 in individuals 18 years of age and older on December 18, 2020.
  • mRNA-1273 is an mRNA vaccine that works by using snippets of a virus’s genetic material (rather than an inactivated or weakened form of the virus itself) to build the proteins that trigger the body’s protective immune response.
  • The first patient in a Phase 1 study was dosed on March 16, 2020, with positive interim Phase 1 data reported by Moderna, Inc. on May 18, 2020.
  • Results from the Phase 1 study were published in The New England Journal of Medicine on July 14, 2020.
    • This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57. Three participants did not receive the second vaccination, one of which had urticaria on both legs thought to be related to the first vaccination, and two who missed the second vaccination window owing to isolation for suspected COVID-19 (test results were negative).
    • Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints showed that mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.
    • The company reported that mRNA-1273 was generally safe and well-tolerated.
      • The most notable adverse events were seen at the 250 µg dose level, with three of those 14 participants (21%) reporting one or more severe events.
      • Solicited systemic adverse events were common after the first vaccination, and occurred in five of 15 participants (33%) in the 25-μg group, 10 of 15 (67%) in the 100-μg group, and 8 of 15 (53%) in the 250-μg group. None of the participants had fever after the first vaccination.
      • Solicited systemic adverse events were more common after the second vaccination and occurred in seven of 13 (54%) participants in the 25 µg group, all 15 (100%) participants in the 100 µg group and all 14 (100%) participants in the 250 µg group. After the second vaccination, fever was reported in none (0%) of the participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group. One of the fever events (maximum temperature 39.6°C) in the 250-μg group was graded severe.
      • The most commonly reported systemic adverse events following second vaccination at the 100 µg dose were fatigue (80%), chills (80%), headache (60%) and myalgia (53%), all of which were transient and mild or moderate in severity.
      • The most common solicited local adverse event at the 100 µg dose was pain at the injection site (100%), which was also transient and mild or moderate in severity.
  • The Phase 3 study of 30,000 participants commenced July 27, 2020 with interim results published in November 2020. 
    Moderna Vaccine Shows 94.5% Effectiveness Against COVID November 16, 2020
  • The FDA granted Emergency Use Authorization for the Moderna COVID-19 Vaccine in the U.S. for use in persons 18 years and over on December 18, 2020.
  • Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine were published in the the New England Journal of Medicine on December 31, 2020.
  • It was announced that the TeenCOVE Study of the Moderna COVID-19 Vaccine in adolescents met its primary endpoint on May 25, 2021.
  • A rolling submission of the Biologics License Application (BLA) for the Moderna COVID-19 Vaccine was initiated on June 1, 2021 and the submission completed on August 25, 2021.

More information

Development Timeline for Moderna COVID-19 Vaccine

DateArticle
Sep 15, 2021Moderna Highlights New Clinical Data on its COVID-19 Vaccine
Sep  1, 2021Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster
Aug 25, 2021Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
Aug 13, 2021Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals
Aug 12, 2021Moderna Announces New Study Showing Its COVID-19 Vaccine Maintains Antibodies Against Variants of Concern and Interest to 6 Months
Aug  9, 2021Australian Therapeutic Goods Administration Grants Provisional Registration for Moderna’s COVID-19 Vaccine
Jun 10, 2021Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States
Jun  1, 2021Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine
May 25, 2021Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June
May 12, 2021Moderna Announces New Supply Agreement with Australia for 25 Million Doses of its COVID-19 Vaccine
May  5, 2021Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern
Apr 30, 2021Moderna Announces Emergency Use Listing Granted by the World Health Organization for its COVID-19 Vaccine
Apr  7, 2021NIH Begins Study of Allergic Reactions to Moderna, Pfizer-BioNTech COVID-19 Vaccines
Apr  7, 2021Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine
Feb 24, 2021Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study
Feb 17, 2021European Commission Purchases Additional 150 Million Doses of COVID-19 Vaccine Moderna
Feb 16, 2021Moderna Provides U.S. COVID-19 Vaccine Supply Update
Feb 12, 2021Canada Purchases Additional 4 Million Doses of Moderna’s COVID-19 Vaccine
Feb 11, 2021Qatar Ministry of Public Health Issues Emergency Use Authorization for COVID-19 Vaccine Moderna
Feb 11, 2021U.S. Government Purchases Additional 100 Million Doses of Moderna’s COVID-19 Vaccine
Feb  3, 2021Singapore Health Sciences Authority (HSA) Approves Interim Authorization of COVID-19 Vaccine Moderna For Use
Jan 26, 2021Moderna Provides U.S. COVID-19 Vaccine Supply Update
Jan 25, 2021Moderna COVID-19 Vaccine Retains Neutralizing Activity Against Emerging Variants First Identified in the U.K. and the Republic of South Africa
Jan 12, 2021Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland
Jan  8, 2021United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
Jan  6, 2021European Commission Authorizes COVID-19 Vaccine Moderna in Europe
Jan  4, 2021Moderna Provides COVID-19 Vaccine Supply Update
Jan  4, 2021Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel
Dec 31, 2020Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in The New England Journal of Medicine
Dec 31, 2020Moderna Confirms 40 Million COVID-19 Vaccine Dose Supply Agreement with the Government of the Republic of Korea
Dec 23, 2020Health Canada Authorizes Moderna COVID-19 Vaccine in Canada
Dec 19, 2020U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older
Dec 18, 2020Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
Dec 17, 2020Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States
Dec 14, 2020Moderna Confirms Supply Agreement with the Ministry of Health to Supply Singapore with mRNA Vaccine Against COVID-19 (mRNA-1273)
Dec 11, 2020U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate
Dec 10, 2020Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
Dec  8, 2020Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Dec  8, 2020Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Dec  7, 2020Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
Dec  7, 2020Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
Dec  4, 2020Moderna Announces Amendment to Supply Agreement with the Ministry of Health of Israel to Supply Additional Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Dec  3, 2020Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate
Nov 30, 2020Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
Nov 30, 2020Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
Nov 29, 2020Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Nov 25, 2020Moderna Announces the European Commission’s Approval of Advance Purchase Agreement for Initial 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Nov 17, 2020European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
Nov 17, 2020Moderna Announces Supply Agreement with United Kingdom Government to Supply mRNA Vaccine Against COVID-19 (mRNA-1273) if Approved for Use
Nov 16, 2020Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
Nov 16, 2020Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
Nov 16, 2020Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures
Nov 13, 2020Swissmedic Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
Nov 11, 2020Moderna Has Completed Case Accrual for First Planned Interim Analysis of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Oct 27, 2020UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
Oct 26, 2020Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)
Oct 22, 2020Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
Oct 14, 2020Moderna Receives Confirmation of Eligibility for Submission of Marketing Authorization Application to the European Medicines Agency for mRNA Vaccine Against COVID-19 (mRNA-1273)
Oct 13, 2020Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
Sep 29, 2020Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Older Adult Age Cohorts in Phase 1 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Aug 11, 2020Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Jul 28, 2020Experimental COVID-19 Vaccine Protects Upper and Lower Airways in Nonhuman Primates
Jul 27, 2020Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
Jul 27, 2020Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins
Jul 26, 2020Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19
Jul 14, 2020Experimental COVID-19 Vaccine Safe, Generates Immune Response
Jul 14, 2020Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)
Jul  9, 2020Moderna and ROVI Announce Collaboration for OUS Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Jul  8, 2020Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Jun 25, 2020Moderna and Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Jun 11, 2020Moderna Advances Late-Stage Development of its Vaccine (mRNA-1273) Against COVID-19
May 29, 2020Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 18, 2020Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 12, 2020Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May  1, 2020Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus
Apr 27, 2020Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
Mar 27, 2020Atlanta Site Added to NIH Clinical Trial of a Vaccine for COVID-19
Mar 16, 2020NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins in Seattle
Feb 24, 2020Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study
Jan 23, 2020Moderna Announces Funding Award from CEPI to Accelerate Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus

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