Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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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.
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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).
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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.
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
The COVID-19 vaccine candidate, BNT162b1, has been approved for clinical trial registration by China's National Medical Products Administration (NMPA).
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.