Moderna Vaccine Found '100% Effective in Preventing Severe COVID-19 Cases', Emergency Use Authorisation Sought From FDA
“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. 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, hospitalizations and death,” said Moderna CEO.
Washington, November 30: Massachusetts-headquartered biotechnology firm Moderna Inc, which is developing an mRNA-based vaccine against coronavirus, said its final set of trial data showed "100 percent effectiveness" in preventing severe cases of COVID-19. Earlier, the company had reported an overall efficacy rate of 94.1 percent.
“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. 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, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna. Pfizer COVID-19 Vaccine Found 95% Effective in Final Analysis, Says Company in Joint Statement With BionTech.
“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273," Bancel added.
Seeks Emergency Use Authorisation From US FDA
With this overwhelming success rate, Moderna has submitted its request before the US Food and Drug Administrator (FDA), seeking emergency use authorisation (EUA) at the earliest. The grant of emergency use permit would be the first step before the roll-out of vaccine for the general populace.
"We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe," the Moderna CEO said.
Apart from applying for emergency use permit in the US, Moderna has already sought a rolling review of its vaccine candidate from the drug regulators in Europe, Canada, the United Kingdom, Israel and Singapore. The company intends to seek the Emergency Use Listing (EUL) with the World Health Organization (WHO).
(The above story first appeared on LatestLY on Nov 30, 2020 05:54 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).