Moderna's COVID-19 vaccine candidate was shown to be 94.5 percent effective in phase 3 trials, the drugmaker said Nov. 16.
The data includes 95 participants with confirmed COVID-19 cases. Of those, 90 cases were observed in the placebo group and five in the vaccine group. Moderna said the trial also saw 11 severe cases of COVID-19, all of which occured in the placebo group.
"This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," said Moderna CEO Stéphane Bancel.
Moderna said it will submit an application for emergency use authorization with the FDA and will also submit applications to global regulatory agencies.
The independent safety board that reviewed the trial results didn't report any significant safety concerns from the trial, which enrolled more than 30,000 people. Most adverse events were mild or moderate and included injection site pain, fatigue and headache.
Moderna said it is working with the CDC, Operation Warp Speed — the government's initiative to speed COVID-19 vaccine and drug development — and McKesson to prepare for distribution of the vaccine. It said it expects to have 20 million doses ready to ship by the end of this year and is on track to make 500 million to 1 billion doses in 2021.
The vaccine is expected to last at temperatures of 36 degrees to 46 degrees Fahrenheit — the temperature of a standard home or medical refrigerator — for up to 30 days, up from Moderna's previous estimate of seven days, the drugmaker said. It can be stored in a standard freezer for six months and last at room temperature for up to 12 hours.
The ability for the vaccine to be stored in regular refrigerators and freezers, as opposed to ultra-low temperature freezers that Pfizer's vaccine must be stored in, means that most pharmaceutical distribution companies have the ability to store and ship the products worldwide, Moderna said. It also means the vaccine could be stored at most pharmacies, hospitals or physicians offices. The vaccine also doesn't require on-site dilution or special handling, meaning it could be given at a range of settings.