Moderna claims that its COVID-19 vaccine candidate, mRNA-1273 has met the primary endpoint of the Phase 3 COVE study with a staggering efficacy of almost 95%, surpassing the bar set by Pfizer and BioNTech’s vaccine (BNT162b2) that showed 90% efficacy, last week. If this trend continues in the subsequent analyses, Moderna’s mRNA vaccine will have a compelling advantage over its Pfizer and BioNTech counterpart in terms of long term storage and distribution. The improved stability of Moderna’s mRNA-1273 enables it to withstand temperatures of 2°C to 8°C for 30 days in contrast to the -70°C and -80°C freezing requirements for BNT162b2.
The Data Safety Monitoring Board (DSMB) appointed by the NIH performed the first interim analysis based on 95 COVID-19 cases, of which 90 were in the placebo group and the remaining 5 in the vaccinated group. It reported that the study met the statistical criteria with a vaccine efficacy of 94.5% (p <0.0001). Additionally, 11 severe cases of COVID-19 were analyzed for secondary endpoint analysis, but all were from the placebo group and none from the vaccinated group.
The interim analysis is performed after confirming COVID-19 cases in both vaccine and placebo arms two weeks following the second dose administration. Based on the available data, the DSMB did not report any significant safety issues. Out of 95 COVID-19 cases, 20 participants in the Moderna vaccine trial were from diverse communities, including 12 Hispanic, four African Americans, three Asian Americans, and one multiracial. Following the news, Moderna’s shares climbed by more than 11% in premarket trading.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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”.
In the coming weeks, Moderna plans to pursue Emergency Use Authorization (EUA) for its vaccine and submit applications to the USFDA and other global regulatory agencies.
By Rajaneesh K. Gopinath, Ph.D.
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