More good news emerged from the COVID-19 vaccine front, with Moderna Inc. reporting that its candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy in an interim analysis, with efficacy of 94.5%. The product is an mRNA vaccine encoding for a prefusion stabilized form of the Spike protein.

Shares of Cambridge, Mass.-based Moderna (NASDAQ:MRNA) were trading premarket at $104.30, up $14.91, or 16%, as Wall Street reacted to word from the NIH-appointed data safety monitoring board (DSMB) about the Cove phase III. The analysis, Cove’s first, included 95 people with confirmed cases of the virus.

Moderna plans to submit for an emergency use authorization (EUA) from the FDA in the weeks ahead, and expects the application will be based on the final analysis of 151 cases with a median follow-up of more than two months. The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority.

The primary endpoint is based on the analysis of cases confirmed and adjudicated starting two weeks following the second dose of the vaccine. Of the 95 cases, 90 were observed in the placebo group and five in the mRNA-1273 segment, which led to the point estimate of vaccine efficacy of 94.5% (p <0.0001). A secondary endpoint analyzed severe cases of COVID-19 and included 11 of those as defined by the study protocol, all in the placebo group and none in the mRNA-1273 vaccinated group.

In the 95 cases were 15 older adults (ages 65 and up) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, four Black or African Americans, three Asian Americans and one multiracial.

The interim analysts included a concurrent review of the available safety data by the DSMB, which did not report any significant safety concerns, and a review of solicited adverse events (AEs) showed the vaccine generally well tolerated. Most AEs were described as mild or moderate. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). So far, the safety and efficacy profile looks consistent across all groups.

Moderna said the vaccine remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days, an extension from the earlier estimate of about a week, and stays that way at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days, and at room temperature for up to 12 hours.

Moderna is working with the CDC, Operation Warp Speed and McKesson Corp., of Irving, Texas, as well as global stakeholders to gear up for distribution of mRNA-1273, if the EUA and similar, global go-aheads come through. By the end of this year, the company aims to have about 20 million doses of mRNA-1273 ready to ship in the U.S., and is still on track to make 500 million to 1 billion doses globally in 2021.