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FDA takes key action in fight against COVID-19 by issuing Emergency Use Authorization for first COVID-19 vaccine
worldpharmanews
December 14, 2020
The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 ...
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US FDA gives EUA for Pfizer/BioNTech COVID-19 vaccine
expresspharma
December 14, 2020
The US Food and Drug Administration (USFDA) granted an emergency use authorisation for Pfizer and BioNTech’s COVID-19 vaccine which was shown to be 95 per cent effective in preventing the disease in a late-stage trial.
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Health Canada authorises Pfizer and BioNTech’s Covid-19 vaccine
pharmaceutical-technology
December 10, 2020
Health Canada has authorised Pfizer and its German partner BioNTech’s Covid-19 vaccine, BNT162b2, reaching a critical milestone in its fight against the pandemic.
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MHRA issues anaphylaxis warning for Pfizer BioNTech vaccine
expresspharma
December 10, 2020
The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulator said anyone with a history of anaphylaxis to medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy ...
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UK commences roll-out of Pfizer’s COVID-19 vaccine
expresspharma
December 09, 2020
Britain approved the vaccine for emergency use less than a week ago, and is rolling it out through its National Health Service (NHS).
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Pfizer-BioNTech COVID-19 vaccine gets EUA approval from the UK
expresspharma
December 03, 2020
Care home residents, health and care staff, the elderly and people who are clinically extremely vulnerable will be first in line.
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Evaluating Pfizer vaccine for possible listing for emergency use: WHO
expresspharma
December 03, 2020
WHO is in discussions with MHRA for accessing some of information from their assessment which may expedite WHO’s emergency listing.
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Pfizer-BioNTech can use UK as test bed for cold chain distribution: GlobalData
expresspharma
December 03, 2020
The country’s small size, dense population and strong healthcare infrastructure should mean distribution of the vaccine with cold chain should go smoothly.
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Pfizer, BioNTech Submit CMA for COVID-19 Vaccine
americanpharmaceuticalreview
December 02, 2020
Pfizer and BioNTech have submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19.
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BioNTech, Fosun Pharma initiate Covid-19 vaccine candidate trial in China
pharmaceutical-technology
November 27, 2020
BioNTech and Shanghai Fosun Pharmaceutical (Fosun Pharma) have initiated Phase II clinical trial of their lead mRNA Covid-19 vaccine candidate, BNT162b2, in Taizhou and Lianshui, Jiangsu Province, China.