Moderna sketches out 94.1% efficacy for COVID-19 vax based on more cases, with EUA plotted for today

As Moderna continues to drip-feed the latest data from its late-stage COVID-19 vaccine effort, it has updated the shot’s efficacy figure.

The company’s vaccine, known as mRNA-1273, now has data for 196 cases, which Moderna says “confirms the high efficacy observed at the first interim analysis” that came out two weeks back.

There is, however, a slight difference: In this latest update, vaccine efficacy hit 94.1% out of the so-called COVE trial. Data posted Nov. 16 showed this efficacy at a slightly higher 94.5%, although this was based on 90 cases of COVID-19.

Breaking the figures down, 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group.

Still, an extra 100-plus cases and the percentage has moved down only very slightly, and Moderna added efficacy against severe COVID-19 was 100%. This was a key secondary endpoint, which analyzed severe cases of COVID-19 and included 30 severe cases.

“All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group,” Moderna said in a release. There was one COVID-19-related death in the study, but this occurred in the placebo group. The full data are yet to be published in a peer-reviewed journal.

The Big Biotech said it was plotting an emergency use authorization in the U.S. “today” for its mRNA vaccine, with an FDA review being “likely” on Dec. 17.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, CEO of Moderna.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.

“I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273. We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”

Analyst Michael Yee at Jefferies said in a note to clients that: “The data is [sic] strong and sets a high bar for others.”

The biotech’s shares jumped 11% premarket.

This comes on the same day that Novavax, a rival to Moderna that is creating its own version of a COVID-19 vaccine using different technology, has for the second time pushed back a U.S. trial. It had revised the date for November, but it has now been pushed back until at least next month. Its U.K. late-stage trial is still ongoing and will form the basis of its attempt to get an approval.