Moderna's Coronavirus Vaccine is 94.5% Effective, Says Early Data

Monday morning, Moderna announced that early data for the Phase 3 study of mRNA-1273—the company’s vaccine candidate against COVID-19—shows it is 94.5% effective. The biotechnology company also said it has made significant progress in the distribution, storage and handling of the vaccine using existing infrastructure.

This is the second COVID-19 vaccine that has shown high efficacy in early tests, with Pfizer’s BNT162b2 candidate demonstrating a 90% effective rate in data released last Monday. Both Moderna and Pfizer’s candidates are mRNA vaccines. If they are both ultimately given the green light by the FDA, they will become the first mRNA-based vaccines to be approved in the United States.

Moderna’s randomized, double-blind Phase 3 trial, called COVE, tested mRNA-1273 at the 100 µg dose level in 30,000 adult participants in the U.S. Two weeks after receiving a second dose of the vaccine, 95 cases of COVID-19 were observed—90 in the placebo group versus 5 in the vaccine group. According to Moderna, the 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities. Additionally, there were no reports of significant safety concerns.

The biotechnology company says it plans to submit for Emergency Use Authorization (EUA) in the coming weeks, assuming the final safety and efficacy data stay on point. Last month, the FDA posted new guidance for manufacturers that said they need to provide at least two months of follow-up safety data after vaccinating volunteers before asking the federal health agency to consider an EUA. Moderna will reach the two-month safety milestone at the end of November/beginning of December.

A secondary endpoint of COVE analyzed the vaccine’s effect on severe cases of COVID-19. Trial data recorded 11 cases of severe COVID-19—all occurring in the placebo group.

The encouraging news did not stop there, though. Modern also announced today that mRNA-1273 remains stable at 2° to 8°C for 30 days. That temperature range is the same as an everyday refrigerator, making the vaccine easy—and familiar—to distribute and maintain.

During shipping and long-term storage up to 6 months, the vaccine needs to be kept at -20°C—a freezer temperature common in doctor’s offices and pharmacies. This is in contrast to Pfizer’s candidate, which needs to be kept at -70°C during shipping and storage, only lasting 5 days in a refrigerator. As the first and thus far only vaccine requiring that low of a temperature, Pfizer designed temperature-controlled shipping packages that use dry ice to keep vaccine vials at -75˚C for 10 days.

Free of special requirements, Moderna is working with the CDC, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the government, to ensure successful delivery if mRNA-1273 receives an EUA. By the end of 2020, Moderna said it expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The biotechnology company expects to manufacture 500 million to 1 billion doses globally in 2021.

Pfizer’s numbers are similar but stronger—the pharmaceutical giant expects to produce up to 50 million vaccine doses worldwide in 2020 and up to 1.3 billion doses in 2021.

Excluding Moderna and Pfizer’s vaccine candidates, there are 9 more in late-stage testing around the world, four of them centered in the United States.