Moderna Logo (PRNewsFoto/Moderna Therapeutics)
Pfizer (NYSE:PFE) and Moderna (NYSE:MRNA) are likely to be among the first companies to commercialize COVID-19 vaccines. But while the former has announced positive results from its interim analysis of its clinical study, the status of Moderna’s Phase 3 COVE trial remains a mystery.
The company announced that it remains blinded to whether the Phase 3 trial participants received its mRNA-1273 vaccine or placebo.
The company is preparing to share data from the trial with the independent Data Safety Monitoring Board overseeing the study.
Paving the way for the interim analysis is a “significant increase” in COVID-19 infections among trial participants. The trial required 53 people to become infected out of a pool of approximately 30,000. Given the recent rise in COVID-19 infections in the U.S., the interim analysis will likely have data from more than 53 patients infected with the virus.
While Pfizer’s delay in announcing its interim analysis fueled speculation, the company changed its interim analysis requirements from 32 to 64. As of November 8, at least 94 patients in its pool of 44,000 had contracted the novel coronavirus.
Anthony Fauci, the nation’s top infectious disease expert, has said that the Moderna trial results could be ready next week.
The Moderna vaccine, which must be held at –20° C, would require less-demanding storage requirements than Pfizer’s, which must be stored at –70° C.
The company has set a threshold for success of greater than 75% efficacy. Pfizer’s efficacy rate could be approximately 90%, based on its interim analysis.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development
