By Health In Five
Moderna Inc will apply for US and European emergency authorization for its COVID-19 vaccine today after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said in a statement. It said that the vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.
The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate in trials. “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.
The company informed of the following details:
Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe
Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%
mRNA-1273 continues to be generally well tolerated; no serious safety concerns identified to date
Phase 3 COVE Study has exceeded 2 months of median follow-up post vaccination as required by the U.S. FDA for Emergency Use Authorization (EUA)
Moderna plans today to request EUA from the U.S. FDA, to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
FDA has told Company to expect VRBPAC meeting for mRNA-1273 likely on December 17, 2020