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FDA grants Emergency Use Authorization for Pfizer’s COVID-19 vaccine BNT162b2
europeanpharmaceuticalreview
December 15, 2020
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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US begins transportation of COVID-19 vaccine to distribution points around the country
expresspharma
December 15, 2020
Cargo planes and trucks with the first US shipments of coronavirus vaccine fanned out from FedEx and UPS hubs in Tennessee and Kentucky on Sunday en route to distribution points around the country, launching an immunisation project of unprecedented ...
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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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Pfizer’s pneumococcal disease vaccine scores FDA priority review
pharmatimes
December 10, 2020
The US Food and Drug Administration (FDA) has granted Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate a priority review for the prevention of pneumococcal disease.
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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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US FDA staff back Pfizer COVID-19 vaccine data, authorisation likely soon
expresspharma
December 10, 2020
Data from the trial showed that the vaccine began conferring some protection to recipients even before they received the second shot, the FDA said.
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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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Pfizer, Sangamo announce updated results of phase 1/2 Alta study of giroctocogene fitelparvovec
pharmaceutical-business-review
December 09, 2020
Pfizer and Sangamo Therapeutics, a genomic medicines company, announced updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec (SB-525 or PF-07055480), an investigational gene therapy for patients with severe hemophilia A.
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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).