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The FDA has approved Pfizer’s and BioNtech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures. Read More
The drug was granted conditional marketing authorization in the EU in July 2020 for treating COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen. Read More
The existing Emergency Use Authorization stipulates that the Pfizer/BioNTech vaccine must be stored in an ultra-cold freezer at temperatures between -112 to -76 Fahrenheit. Read More
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen. Read More
J&J submitted data from an ongoing global phase 3 trial, in which the vaccine showed 66 percent efficacy in preventing moderate-to-severe infection 28 days after inoculation. Read More
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program. Read More
Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures. Read More
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