Valneva switches focus to bilateral discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001
Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).
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Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY®
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) 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 February 17, 2021.
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Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days.
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Valneva reports positive Phase 1/2 data for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001
Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
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Pfizer and BioNTech confirm high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose.
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BioNTech provides update on vaccine production status at Marburg manufacturing site
BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg site over the course of this week.
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NIAID statement on AstraZeneca vaccine and AstraZeneca update
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.
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Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC). 
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) 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 February 17, 2021.