Skip to Content

mRNA-1273 Approval Status

Reviewed by Judith Stewart BPharm. Last updated on Jul 27, 2020.

FDA Approved: No
Brand name: mRNA-1273
Generic name: SARS-CoV-2 vaccine
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19

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

  • 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.
  • To date there have been no mRNA vaccines licensed for use in humans.
  • 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.
    • Results also showed 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 is expected to begin on July 27, 2020.
More information

Development Status and FDA Approval Process for mRNA-1273

DateArticle
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

Further information

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