COVID-19 Vaccine Candidate Reports 94.5% Efficacy
The first interim analysis of a limited number of COVID-19 participants in a phase 3 vaccine study is reported to have met a vaccine efficacy rate of 94.5 percent.
Massachusetts based Moderna, Inc. issued a press release on November 16, 2020, stating that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the COVE study of mRNA-1273, its vaccine candidate against COVID-19, this new interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group.
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2-weeks following the second dose of the mRNA-1273 vaccine.
The COVE study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIAID, and the Biomedical Advanced Research and Development Authority (BARDA), at the U.S. Department of Health and Human Services.
The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns.
A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived.
These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis, states the company.
As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
Stéphane Bancel, Moderna’s CEO added in the press statement: “We look forward to the next milestones of submitting for authorizations to the U.S., and countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study.”
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.
By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
And, Moderna recently announced further progress towards ensuring the distribution, storage, and handling of the vaccine can be done using existing infrastructure.
BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract.
Furthermore, the U.S. government has agreed to provide up to $1.525 billion to purchase a supply of mRNA-1273 under a U.S. Department of Defense Contract.
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