Stage (next event)
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting
December 17, 2020
Catalyst Info & Data Links
TITLE: mRNA-1273 COVID-19 Vaccine Phase 3 interim data
Phase 1 - ClinicalTrial.gov (NCT04283461): Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)
Phase 2 - ClinicalTrial.gov (NCT04405076): Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older
Phase 3 - ClinicalTrial.gov (NCT04470427): A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
WHAT IS THE NEXT CATALYST EVENT?
1. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting
2. BLA Approval
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
05-2020: Business Updates and First Quarter 2020 Financial Results (slides 15-19)
2019: mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine, 37(25), 3326-3334.
2020: An mRNA Vaccine against SARS-CoV-2 — Preliminary Report. New England Journal of Medicine
2020: Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. New England Journal of Medicine
MECHANISM OF ACTION / RATIONALE
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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