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Spikevax (Moderna COVID-19 Vaccine) FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 13, 2023.

FDA Approved: Yes (First approved January 31, 2022)
Brand name: Spikevax (Moderna COVID-19 Vaccine)
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula and Moderna COVID-19 Vaccine 2023-2024 Formula are mRNA vaccines for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

  • Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula is approved for use in individuals 12 years of age and older.
  • Moderna COVID-19 Vaccine 2023-2024 Formula is authorized under an Emergency Use Authorization (EUA) in individuals 6 months through 11 years of age. The EUA for this product is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
  • Moderna COVID-19 Vaccine (Original monovalent) and Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are no longer authorized for use in the United States.
  • The COVID-19 vaccines (2023-2024 Formula) are monovalent and encode the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5. Clinical data have demonstrated robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86.
  • Spikevax and Moderna COVID-19 Vaccine are administered by intramuscular injection.
  • Warnings and precautions associated with authorized or approved mRNA COVID19 vaccines include increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For Spikevax, the observed risk is highest in males 18 years through 24 years of age.
  • Common adverse reactions for Spikevax:
    - in adults 65 years of age and older include pain at injection site, fatigue, myalgia, headache, arthralgia, chills, and axillary swelling/tenderness.
    - in adults 18 years through 64 years of age include pain at injection site, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, and nausea/vomiting.
    - in adolescents 12 years through 17 years of age include pain at the injection site, fatigue, headache, myalgia, chills, axillary swelling/tenderness, arthralgia, nausea/vomiting, and swelling at the injection site.
  • Common solicited adverse reactions for Moderna COVID-19 Vaccine:
    - in children 37 months through 11 years of age include injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, and nausea/vomiting.
    - in infants 6 months through 36 months of age include injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.

Development timeline for Spikevax (Moderna COVID-19 Vaccine)

DateArticle
Sep 11, 2023Approval Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine
Dec  8, 2022Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 6 Months Through 5 Years of Age
Nov 14, 2022Moderna's BA.4/BA.5 Targeting Bivalent Booster, mRNA-1273.222, Meets Primary Endpoint of Superiority Against Omicron Variants Compared to Booster Dose of mRNA-1273 in Phase 2/3 Clinical Trial
Oct 12, 2022Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Children and Adolescents 6 to 17 Years of Age
Aug 31, 2022Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Adults 18 Years and Older
Aug 23, 2022Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222
Jul 11, 2022Moderna's Omicron-Containing Bivalent Booster Candidate, mRNA-1273.214, Demonstrates Significantly Higher Neutralizing Antibody Response Against Omicron Subvariants BA.4/5 Compared To Currently Authorized Booster
Jun 22, 2022Moderna Announces Bivalent Booster mRNA-1273.214 Demonstrates Potent Neutralizing Antibody Response Against Omicron Subvariants BA.4 And BA.5
Jun 17, 2022Moderna Receives FDA Authorization for Emergency Use of Its COVID-19 Vaccine for Children 6 Months of Age and Older
Apr 28, 2022Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age
Mar 29, 2022Moderna Receives FDA Approval for Emergency Use Authorization of 2nd Booster Dose of Its COVID-19 Vaccine, mRNA-1273
Mar 23, 2022Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint
Mar 17, 2022Moderna Submits Amendment to the Emergency Use Authorization for an Additional Booster Dose of its COVID-19 Vaccine in the U.S.
Jan 31, 2022Approval Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax
Jan 26, 2022Moderna Announces First Participant Dosed in Phase 2 Study of Omicron-Specific Booster Candidate and Publication of Data on Booster Durability Against Omicron Variant
Dec 20, 2021Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant
Nov 26, 2021Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant
Nov 19, 2021Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older
Nov 15, 2021Health Canada Authorizes Booster Dose of Moderna’s COVID-19 Vaccine in Individuals 18 Years of Age and Older
Nov  9, 2021Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years
Oct 31, 2021Moderna Provides Update on Timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for Adolescents
Oct 25, 2021Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age
Oct 21, 2021U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine
Oct 20, 2021Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
Oct 14, 2021Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
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

See also

Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Consumer information

Further information

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