US-based biotechnology giant Moderna has said it will request an emergency use authorization from the US FDA and conditional approval from the European Medicines Agency after its coronavirus vaccine showed 94.1 per cent effective rate in the trials. A couple of weeks ago, Moderna said that its COVID-19 vaccine showed to be 94.5 per cent effective in preventing the deadly disease, bringing a glimmer of hope to a world ravaged by the pandemic.
Cambridge, Massachusetts-based Moderna’s announcement had come just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters,” said Stephane Bancel, CEO of Moderna.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” Bancel said as the pandemic has killed more than 1.3 million people worldwide, more than 245,000 of them in the US.
“The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.
5 per cent,” Moderna said in a statement.
This study, known as the COVE study, enrolled more than 30,000 participants in the US, it added.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data. Moderna also plans to submit applications for authorisations to global regulatory agencies.
Bancel said the company is looking forward to the “next milestones” of submitting for an emergency use authorisation in the US, and regulatory filings in countries around the world, “while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
The announcements about the vaccines and their potential availability for use among the general population in the coming weeks and months has offered hope to millions around the world in a year that has seen the COVID-19 pandemic devastate lives and economies and still showing no signs of abating.
(With inputs from IANS)