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FDA panel recommends approving Pfizer’s COVID-19 vaccine emergency use authorization – TechCrunch

FDA panel recommends approving Pfizer’s COVID-19 vaccine emergency use authorization – TechCrunch


An independent panel of experts has recommended the Food and Drug Administration (FDA) approve an official Emergency Use Authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine. This means that it’s one step closer to beginning to be administered to people in special circumstances — including for front-line healthcare workers dealing with healthcare facilities stressed to the breaking point due to the ongoing and rising pandemic crisis in the U.S., which continues to break grim records for single-day death counts among afflicted patients.

The Pfizer/BionNTech vaccine is an mRNA vaccine, which means that it provides a set of instructions to a person’s cells to prompt them to begin creating antibodies that are effective against the SARS-CoV-2 virus that leads to COVID-19. So far, the vaccine has been shown to be 95% effective according to Pfizer’s own final trial data. Based on the strength of those Phase 3 results, Pfizer applied for an EUA from the FDA toward the end of November.

Already, Pfizer’s vaccine has been approved for use in other countries, including Canada, where the national health regulator cleared it earlier this week. The FDA’s EUA process involves reviewing key information about efficacy and safety, and the agency says that it has “reviewed thousands of pages of technical information” about the Pfizer/BioNTech vaccine, including materials related to its development and manufacturing, as well as the results of its clinical trials to date.

Now that the panel has voted in favor of approval, the FDA will make a final determination on granting the EUA, and that should come within the next few days.

 



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