Moderna Inc. has said it will apply for US and European emergency authorisation of its COVID-19 vaccine on Monday based on full results from a late-stage study showing its vaccine was 100 percent effective in preventing severe cases and 94.1 percent on the regular.
The filing sets Moderna’s product up to be the second vaccine likely to receive U.S. emergency use authorization this year, according to a report monitored on Reuters.
“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Tal Zaks, Moderna Chief Medical Officer, said.
“We expect to be playing a major part in turning around this pandemic,” Zaks said.
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Moderna’s announcement follows news from Pfizer Inc and German partner BioNTech SE that their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95% effective. Pfizer has applied for emergency use authorization, putting it about a week ahead of Moderna.
In addition to filing its U.S. application, Moderna said it would apply for conditional approval from the European Medicines Agency, which has already begun a rolling review of data, and would continue to talk with other regulators conducting rolling reviews.
Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov. 16 of 94.5 per cent effectiveness, a difference that Zaks said is not statistically significant.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50 per cent benchmark set by the U.S. Food and Drug Administration.
Britain’s AstraZeneca has announced an average efficacy rate of 70 per cent for its vaccine and as much as 90 per cent for a subgroup of trial participants who got a half dose first, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90 per cent efficacy figure for the smaller group.
