Moderna said its vaccine hit a 94.5% efficacy rate, topping the 90% threshold reported by Pfizer last week, and noted that it can last for up to six months when stored at standard freezer temperatures of -4 degrees Fahrenheit, compared to the -94 degree temperatures required for the Pfizer vaccine.
The drugmaker also said it expects to apply for Emergency Use Authorization with the U.S. Food and Drug Administration within the coming weeks, while the European Medicines Agency's human medicines committee launched a 'rolling review' of the vaccine Monday.
Moderna is using so-called 'messenger RNA' techniques for its vaccine candidate, and told investors in September that it had amassed more than 25,000 participants for its clinical stage trial.
Modena said it could have 20 million doses available for the U.S. market this year, as well as a total supply of between 500 million and 1 billion doses worldwide next year.
“This is a pivotal moment in the development of our OVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. 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 CEO Stéphane Bancel. “This milestone is only possible because of the hard work and sacrifices of so many."
"I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus," he added. "They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point."
Moderna shares were marked 10.2% higher in early trading following the vaccine update to change hands at $99.07 each.
Moderna said only 95 cases from its large-scale trial emerged, with only 5 of those coming from the group that was dosed with the two-stage vaccine, which is delivered over a 28 day period.
Pfizer and its German partner, BioNTech (BNTX) - Get Report, said last week that their study had dosed half of their 43,538 trial participants with a placebo, and the other half with their vaccine candidate, on two separate occasions. Of the 94 confirmed cases of COVID-19 that resulted from the blinded trial, the pair said, more than 90% came from the placebo group.
Pfizer said it saw no serious safety concerns from its ongoing trial, the only major study not linked to the U.S. government's 'Operation Warp Speed' program, and expects to have as many as 1.3 billion doses produced next year if and when the drug is ultimately approved by regulators.