After showing 94.1% efficacy in final trials, American pharma giant Moderna said it will request Emergency Use Authorisation( EUA) for its COVID-19 vaccine from the regulators in the United States and European Union.
The company has said that the new analysis of trial shows promising results. Full results from a late- stage study showed that the Moderna covid vaccine offered strong protection against novel coronavirus infection with no safety concerns. It also reported 100% success rate in preventing severe cases.
“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 to Reuters. “We expect to be playing a major part in turning around this pandemic.”
In a statement, Modern said it plans to request EUA today from both the US Food and Drug Administration (FDA) and also “apply for a conditional marketing authorization with the European Medicines Agency (EMA)”.
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA. Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
— Moderna (@moderna_tx) November 30, 2020
Moderna’s COVID-19 vaccine is one of the five-leading candidates in the trial against novel coronavirus infection. Pfizer-BioNTech and Oxford-AstraZeneca are other two private and independent covid-19 vaccine developers who are also moving to stage to request EUA.
Other two covid-19 vaccine candidates are Russia’s Sputnik V and China’s vaccine.
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 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.
Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year. The pharma company is also planning another trial in younger volunteers early in 2021 hoping to have the vaccine available for adolescents by September of next year.
Moderan said it plans to produce about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.