Moderna announced Monday that in the first interim analysis of the phase 3 COVE study, its experimental COVID-19 vaccine mRNA-1273 demonstrated efficacy of 94.5%. The company noted that the analysis was based on 95 cases of coronavirus infection, of which 90 cases were observed in the placebo group versus five in the mRNA-1273 group.
Stéphane Bancel, CEO of Moderna, called the results a “pivotal moment,” adding that “this positive interim analysis…has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.” The drugmaker indicated that it plans to seek emergency-use authorization from the FDA in the coming weeks, with the filing set to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.
The study is testing mRNA-1273 at the 100 mcg dose level in 30,000 participants in the US, ages 18 and older, who are at risk of severe COVID-19 disease, with subjects receiving two doses 28 days apart. The trial’s primary endpoint is the prevention of symptomatic COVID-19 disease, while key secondary goals include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.
Prevents severe disease
Moderna noted that the independent data safety monitoring board informed it that the trial has met the statistical criteria pre-specified in the study protocol for efficacy. The company added that for one of the secondary goals, 11 cases of severe COVID-19 were seen at the first interim analysis, all of which occurred in the placebo group. The drugmaker added that a review of available safety data “did not report any significant…concerns.”
The data come shortly after Moderna disclosed that mRNA-1273 is stable in a normal fridge at temperatures of between 2 and 8 degrees Celsius for 30 days, and can be stored for up to 6 months at -20 degrees Celsius. In contrast, Pfizer and BioNTech’s mRNA vaccine BNT162b2, which has also produced promising early data from a phase 3 study, must be kept at ultra-low temperatures, posing a number of logistical challenges.
Ready to ship
Moderna, which is developing mRNA-1273 as part of the US government’s Operation Warp Speed program, expects to produce about 20 million doses for the country this year, with millions of these doses already manufactured. “Assuming we get an emergency-use authorization, we’ll be ready to ship through Warp Speed almost in hours,” Moderna president Stephen Hoge said, adding “so it could start being distributed instantly.”