Moderna has applied for US emergency authorisation for its COVID-19 vaccine after full results from a late-stage study showed it was 94.1 per cent effective with no serious safety concerns.
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The US Food and Drug Administration said an advisory committee would meet to discuss the request on December 17, making Moderna's candidate the second highly effective vaccine likely to receive US regulatory backing and a potential rollout this year.
A shot developed by Pfizer and BioNTech SE that was 95 per cent effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the emergency use authorisations after the advisers make their recommendations.
Moderna reported its vaccine's efficacy was consistent across age, race, ethnicity and gender demographics as well as having 100 per cent success in preventing severe cases of the disease that has killed nearly 1.5 million people worldwide.
"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna chief medical officer Tal Zaks said.
Moderna said it would also seek conditional approval from the European Medicines Agency and continue to talk with other regulators doing similar rolling reviews.
Moderna said it was on track to have about 20 million doses of its vaccine ready in the United States by the end of 2020, enough to inoculate 10 million people.
The vaccines developed by Moderna and Pfizer-BioNTech use a new technology called synthetic messenger RNA whereas others, such as AstraZeneca's, employ more traditional methods.
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, followed by a full dose.
Recent positive vaccine results have ignited hopes for an end to the pandemic and come as new infections and COVID-19 hospitalisations are at record levels in the United States.
Almost immediately after receiving an EUA, Moderna expects its vaccine to be shipped across the United States by the government's Operation Warp Speed program.
Distribution is expected to be less complicated than for Pfizer's vaccine. While it needs to be stored in a freezer, it does not require the ultra-cold temperature or specialised equipment needed for Pfizer's vaccine.
Australian Associated Press
