On November 16, 2020, the biotechnology company, Moderna, Inc., pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients have announced that its Vaccine Candidate, mRNA-1273, for coronavirus in its phase 3 study met statistical criteria with a vaccine efficacy of 94.5%.
“Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.”
Furthermore, the first interim of the analysis included 95 participants with confirmed cases of coronavirus. And, in the coming weeks, Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.
According to Chief Executive Officer of Moderna Stéphane Bancel, this is a pivotal moment in the development of their vaccine candidate and Phase 3 study’s positive interim analysis has given them the first clinical validation that their vaccine can prevent the coronavirus which also includes severe disease.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”
-Stéphane Bancel, Chief Executive Officer of Moderna
mRNA-1273 is an mRNA vaccine candidate against the virus that was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.
Phase 3 COVE Study
In the Phase 3 COVE Study trial, more than 30,0000 participants from the United States (U.S.) ages 18 and older were enrolled. In addition, the primary endpoint is the prevention of symptomatic coronavirus disease and the key secondary endpoints include prevention of severe coronavirus disease and prevention of infection by SARS-CoV-2.
Furthermore, the trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted and the final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis.