Moderna Inc said it would apply for US and European emergency authorisation of its COVID-19 vaccine on Monday (US time) based on full results from a late-stage study showing it was 94.1 per cent effective with no serious safety concerns.
It also reported a 100 per cent success rate in preventing severe cases. The filing sets Moderna's product up to be the second vaccine likely to receive US emergency use authorisation this year.
A trial of Moderna’s COVID-19 vaccine in New York. The company will ask for emergency authorisation use of the vaccine on Monday.Credit:AP
"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna chief medical officer Dr Tal Zaks said in a telephone interview. "We expect to be playing a major part in turning around this pandemic."
Zaks said he was emotional after seeing the 94.1 per cent result at the weekend: "It was the first time I allowed myself to cry. At this level of effectiveness, when you just do the math of what it means for the pandemic that's raging around us, it's just overwhelming."
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 per cent effective. Pfizer has applied for emergency use authorisation, putting it about a week ahead of Moderna.
In addition to filing its US 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 November 16 of 94.5 per cent effectiveness, a difference that Zaks said was 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 US 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.
Still, the past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and claimed more than 1.45 million lives worldwide.
Independent advisers to the US Food and Drug Administration are scheduled to meet on December 17 to review Moderna's trial data and make a recommendation to the FDA. They will meet on December 10 to review Pfizer's data.
Shortly after gaining emergency use authorisation, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government's Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government.
Its distribution is expected to be easier than Pfizer's because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer's vaccine.
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