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.
- A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 (ClinicalTrials.gov)
- Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older (ClinicalTrials.gov)
- Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) (ClinicalTrials.gov)
Development Timeline for Moderna COVID-19 Vaccine
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