Moderna Inc 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 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.
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 Nov. 16 of 94.5% 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% benchmark set by the U.S. Food and Drug Administration.
Britain’s AstraZeneca has announced an average efficacy rate of 70% for its vaccine and as much as 90% 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% 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. It comes as new infections and Covid-19 hospitalizations are at record levels across the United States.
Independent advisers to the U.S. Food and Drug Administration are scheduled to meet on Dec. 17 to review Moderna’s trial data and make a recommendation to the FDA. They will meet on Dec. 10 to review Pfizer’s data.
Shortly after gaining emergency use authorization, 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 U.S. 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.