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fda panel recommends approving pfizer’s covid-19 vaccine emergency use authorization

AVATAR Darrell Etherington
Darrell Etherington
Editor at Large, TechCrunch
December 10, 2020
fda panel recommends approving pfizer’s covid-19 vaccine emergency use authorization

A group of independent specialists has advised the Food and Drug Administration (FDA) to grant an official Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and BioNTech. This development signifies progress toward initiating vaccinations for individuals in specific situations – notably, healthcare professionals on the front lines who are working in medical centers operating at maximum capacity because of the continuing and escalating pandemic across the United States, which is consistently reporting new highs in daily mortality figures among those affected.

The Pfizer/BioNTech vaccine utilizes mRNA technology, delivering genetic instructions to the body’s cells to stimulate the production of antibodies that combat the SARS-CoV-2 virus, the cause of COVID-19. Trial results released by Pfizer indicate the vaccine demonstrates 95% effectiveness. Following these promising Phase 3 trial outcomes, Pfizer submitted a request for an EUA to the FDA in late November.

The Pfizer vaccine has already received authorization for use in several nations, including Canada, where the national health authority approved it earlier in the week. The FDA’s EUA evaluation includes a thorough assessment of both effectiveness and safety data, and the agency states it has “examined extensive documentation” concerning the Pfizer/BioNTech vaccine, encompassing details about its creation and production, alongside the findings from its clinical studies.

With the panel’s affirmative vote, the FDA will now reach a conclusive decision regarding the EUA, which is anticipated to occur in the coming days.

 

#Pfizer vaccine#COVID-19#FDA#emergency use authorization#vaccine approval

Darrell Etherington

A journalist specializing in the areas of space exploration, scientific advancements, and innovations in health technology. Prior experience includes reporting on the automotive industry and advancements in transportation technology. Previously held positions at both Apple and Shopify.
Darrell Etherington