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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.