Novavax COVID-19 Vaccine Candidate Wins 'Fast Track' Designation From US FDA
Novavax, a US based biotechnology company, on Monday, said that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for NVX-CoV2373, the Company’s COVID-19 vaccine. The vaccine is currently in the late-phase of clinical development.
Washington, November 9: Novavax, a US based biotechnology company, on Monday, said that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for NVX-CoV2373, the Company’s COVID-19 vaccine. The vaccine is currently in the late-phase of clinical development. The phase 3 trials of the vaccine is likely to start in end November in the USA and Mexico. It is currently conducting phase 3 trials in the UK. Novavax expects to launch the vaccine by first quarter of 2021. Pfizer Says COVID-19 Vaccine 90% Effective in Phase 3 Trial, Likely to File for Emergency Use by November-End.
Gregory M. Glenn, M.D., President of Research and Development, Novavax, said, “The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine.” He added that expedition in the process, they are committed to ensure a "data-driven and scientifically rigorous approach in demonstrating safety and efficacy. World News | Production of AstraZeneca COVID-19 Vaccine Begins in Australia.
Read the Tweet by Novavax Here:
Novavax has got funds worth $2 Billion for its global COVID-19 vaccine programme. It has been funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and the US Government. The US Food and Drug Administration's FTD is a process undertaken speed up the development and review of drugs that can be useful in treating serious medical conditions and making the drug accessible to all the patients quickly.
(The above story first appeared on LatestLY on Nov 09, 2020 09:12 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).