NEW DELHI: US-based biotech major Moderna on Monday announced that it will apply for emergency use authoriSation for its Covid-19 vaccine in the US and Europe based on final results which have confirmed that it has 94.1% efficacy and nobody vaccinated with it developed the serious disease.
This means that the company could be the second vaccine against coronavirus likely to receive US emergency use authorisation this year after Pfizer-BioNTech's vaccine candidate, which showed 95% efficacy in the final analysis.
The announcement comes after the study, called phase 3 COVE study, has exceeded 2 months of median follow-up post-vaccination as required by the US Food and Drug Administration for emergency use authorization.
Moderna’s phase 3 analysis involved 30,000 people given the jab in the US, of whom 196 became ill. Of these, 185 were in the placebo or non-vaccinated arm of the trial.
Thirty people became severely ill and one even died but all of them were in the non-vaccinated arm of the trial, said the company in a statement.
The trials also included substantial numbers of people in the most at-risk groups, with 7,000 people over 65 and more than 5,000 younger people with chronic diseases, such as diabetes, severe obesity, and cardiac disease.
It also included 11,000 people from black, Asian, and minority ethnic communities, the company said, which is 37%, the same proportion as in the US population. The company said there were no serious side-effects, and the most common ones included sore arms, headaches, and fatigue.
The full trial data has not been released, but will be published in a peer-reviewed journal in due course, the firm said.
“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease,” said Stéphane Bancel, company CEO.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations, and death,” he said.
The vaccine, mRNA-1273—which like the vaccine by Pfizer-BioNTech—uses genetic code and not inactivated or weakened virus to deliver antigen in the hosts, had met its primary efficacy endpoint in the first interim analysis of the study with a vaccine efficacy of 94.5% earlier this month.
Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the US by the government's Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the government.