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.
- 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 Status and FDA Approval Process for mRNA-1273
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