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COVAX to purchase up to 40 million COVID-19 vaccine doses from Pfizer and BioNTech
Through COVAX, doses of the Pfizer-BioNTech vaccine will be provided at a not-for-profit price for 92 low- and lower-middle-income countries.
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FDA grants Emergency Use Authorization for Pfizer’s COVID-19 vaccine BNT162b2
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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Pfizer’s COVID-19 vaccine data accessed in EMA cyber-attack
Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).
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Health Canada authorises emergency use of Pfizer’s COVID-19 vaccine
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
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Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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Pfizer and BioNTech submit for EUA of COVID-19 vaccine with FDA
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
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Pfizer and BioNTech to supply the EU with 200 million doses of BNT162b2 vaccine
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
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EMA begins rolling review of BNT162b2 COVID-19 vaccine
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
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Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
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COVID-19 vaccine candidate gets green light for trial in China
The COVID-19 vaccine candidate, BNT162b1, has been approved for clinical trial registration by China's National Medical Products Administration (NMPA).
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FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.