Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

4 years ago
Anonymous $RGO3jP_V_c

https://techcrunch.com/2020/11/20/pfizer-and-biontech-to-submit-request-for-emergency-use-approval-of-their-covid-19-vaccine-today/

Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U.K., and says that could pave the way for use of the vaccine to begin in “high-risk populations” by the end of next month.

The FDA’s EUA program allows therapeutics companies to seek early approval when mitigating circumstances are met, as is the case with the current global pandemic. EUA’s still require that supporting information and safety data are provided, but they are fast-tracked relative to the full, formal and more permanent approval process typically used for new drugs and treatments that come before they’re able to actually be administered broadly.

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Nov 20, 2020, 1:16pm UTC
https://techcrunch.com/2020/11/20/pfizer-and-biontech-to-submit-request-for-emergency-use-approval-of-their-covid-19-vaccine-today/ > Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U.K., and says that could pave the way for use of the vaccine to begin in “high-risk populations” by the end of next month. > The FDA’s EUA program allows therapeutics companies to seek early approval when mitigating circumstances are met, as is the case with the current global pandemic. EUA’s still require that supporting information and safety data are provided, but they are fast-tracked relative to the full, formal and more permanent approval process typically used for new drugs and treatments that come before they’re able to actually be administered broadly.