Saturday, September 18, 2021

FDA authorizes emergency use of Pfizer’s vaccine

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The US Food and Drug Administration late Friday authorized emergency use of a Covid-19 vaccine produced by Pfizer-BioNTech, the Associated Press reports.

Shots are expected to be available for priority US residents as early as Monday, marking what is hoped to be the beginning of the end of the pandemic that has killed nearly 300,000 Americans, laid waste to more than a million small businesses, and thrown wrenches into school plans in almost every school district in America.

On Thursday, the administration’s vaccine advisory panel, made up of independent scientific experts, infectious disease doctors, and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. After that blessing, it was simply a matter of dotting the I’s and crossing the T’s to make sure all the data were in place.

Pfizer had submitted its application for emergency use authorization on November 20. That filing launched efforts by more than 100 FDA scientists, who worked nearly round the clock to review the application. This work—combing through thousands of pages of clinical trials and manufacturing data—would normally take months. But the approval of this particular vaccine was urgent, not only for the US but for the rest of the world, with the US agency serving much as a role model.

“Among all global regulators, we are the ones that actually don’t just look at the company’s tables,” the New York Times quoted Peter Marks, the top vaccine regulator at the FDA, as saying. “We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera.”

President Donald Trump characterized the development of the vaccine as “a medical miracle” and “one of the greatest scientific accomplishments in history.”

Paul Katulahttps://news.schoolsdo.org
Paul Katula is the executive editor of the Voxitatis Research Foundation, which publishes this blog. For more information, see the About page.

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