Moderna COVID-19 Vaccine 94.5% Effective in Phase 3 Trials, Likely to Receive Emergency Use Approval From US FDA
With a nearly 95 percent success rate, Moderna in its press note sounded hopeful of receiving the emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in the coming weeks. The vaccine, for the general masses, is on the way for a roll-out in early 2021.
Washington, November 16: Moderna Inc, one of the leading vaccine manufacturers of the United States, announced on Monday that its vaccine candidate was found 94.5 percent effective in preventing coronavirus. The results were derived from the third and final phase of trials conducted by the biotechnology company. Pfizer Says COVID-19 Vaccine 90% Effective in Phase 3 Trial, Likely to File for Emergency Use by November-End.
The final lap of study was conducted in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).
With a nearly 95 percent success rate, Moderna in its press note sounded hopeful of receiving the emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in the "coming weeks". The vaccine, for the general masses, is on the way for a roll-out in early 2021.
Moderna Vaccine Found 94.5% Effective: AFP
Moderna Issues Statement to Confirm Efficacy Rate
Moderna, in the preliminary analysis of its trial data, found a broadly consistent safety and efficacy profile across all evaluated subgroups. As more cases accrue leading up to the final analysis, the company expects the point estimate for vaccine efficacy may change. The final set of data from the full phase study would be submitted to a peer-reviewed publication.
“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. 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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
"We look forward to the next milestones of submitting for an EUA 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," the Moderna CEO added.
The success of Moderna in Phase 3 trials, based on the internal study of trial data, comes days after Pfizer declared a similar effectiveness rate of its vaccine candidate being developed in coordination with Germany's BioNtech. Their candidate was found to be 90 percent effective, and is expected to receive EUA from the American regulator by November-end.
(The above story first appeared on LatestLY on Nov 16, 2020 05:50 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).