Moderna announced the results of its phase three trials on November 16, 2020 in which it reported that its COVID-19 vaccine candidate has proven to be 94.5% effective. The biotechnology company also informed that it intends to submit for an Emergency Use Authorization (EUA) with US FDA in the coming weeks.
Moderna expects the Emergency Use Authorization to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. The first interim analysis of the trials revealed that the Phase 3 study met statistical criteria with a vaccine efficacy of 94.5 percent.
We just announced that mRNA-1273, our COVID-19 vaccine candidate, has met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study.
— Moderna (@moderna_tx) November 16, 2020
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Moderna COVID vaccine effectiveness
•The independent Data Safety Monitoring Board (DSMB) informed that the phase 3 trial study of Moderna's vaccine candidate met the statistical criteria pre-specified for efficacy with a vaccine efficacy of 94.5%.
•The study known as the COVE study was based on trial results of more than 30,000 participants in the United States.
•It is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), which comes under the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), which comes under the US Department of Health and Human Services.
•The first interim analysis was based on 95 cases, which included 15 people aged above 65 years, 20 participants from diverse communities including 12 Hispanic or Latin, 4 African Americans, 3 Asian Americans and 1 multiracial.
What does the interim analysis suggest?
The interim analysis suggest consistent safety and efficacy of the vaccine candidate across all evaluated subgroups. Moderna now plans to submit the data from the full Phase 3 study to a peer-reviewed publication.
Significance |
| The positive interim analysis of Moderna's Phase 3 study has given the company the first clinical validation that their vaccine can prevent COVID-19 disease, including severe disease. This is significant in the development of their COVID-19 vaccine candidate. |
Moderna to seek emergency use authorization
Moderna intends to submit for an Emergency Use Authorization from the Food and Drug Administration in the US in the coming weeks based on the interim safety and efficacy data. The authorization is expected to be based on the final safety and efficacy data.
Moderna's COVID-19 vaccine |
| •Moderna's COVID-19 Vaccine candidate is mRNA-1273. It has been co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. •It is a vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. The first clinical batch of the vaccine was completed in February 2020, following which it underwent analytical testing. •The first participant was given a dose of the vaccine on March 16th. The phase 2 study of the vaccine began enrolling participants from May 2020. |
Background
Moderna's positive report comes days after Pfizer and BioNtech reported that their COVID vaccine candidate was found to be more than 90% effective.
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