Moderna Pharmaceuticals has confirmed that it will apply for emergency authorization from the U.S. and Europe for its coronavirus vaccine this Monday, based on the complete results of a late-stage study showing that its vaccine is 94.1% effective. Moderna has also reported a 100% success rate in preventing serious cases.
The presentation states that Moderna’s vaccine will be the second vaccine likely to receive U.S. emergency use authorization this year. “We believe we have a vaccine that is very effective. Now we have the data to prove it,” said Dr. Tal Zaks, Moderna’s medical director, in a telephone interview. “We hope that we are playing an important role in reversing this pandemic,” he said.
Zaks acknowledged that he was excited after seeing the 94.1 percent result over the weekend: “It was the first time I allowed myself to cry. At this level of effectiveness, when you do the math of what it means for the pandemic that is raging around us, it is ‘just overwhelming.
Moderna’s announcement follows news from Pfizer Inca and German partner BioNTech SE that their coronavirus vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95% effective. Pfizer has applied for emergency use authorization, placing it approximately one week earlier than Moderna’s.
In addition to filing its application in the United States, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun an ongoing review of the data, and will continue to talk to other regulators who conduct ongoing reviews.
Moderna’s latest efficacy result is slightly lower than an interim analysis published on November 16 of 94.5% effectiveness, a difference that, according to Zaks, is not statistically significant.