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BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents 1 (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide. ....
Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY® News Provided By Share This Article ®, bringing total doses to 600 million for 27 EU member states All doses expected to be delivered in 2021 BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY ®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on 1. This brings the total number of doses to be delivered to the EU to 600 million. ....
3 Min Read LONDON (Reuters) - Britain has formally asked its medical regulator, the MHRA, to assess the Pfizer-BioNTech COVID-19 vaccine for its suitability, the first step in making the shot available outside of the United States. Slideshow ( 2 images ) Britain has ordered 40 million doses of the vaccine, which has been found to be 95% effective in preventing the spread of a virus that has killed more than 1.3 million worldwide and crippled the global economy. Britain’s health minister, Matt Hancock, said the government had taken the step after the two companies applied for emergency use authorisation in the United States. “That has given us the confidence . formally to start the process here,” he told a news conference. ....