Pfizer’s COVID vaccine wins FDA’s full approval

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Monday, August 23, 2021

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Pfizer’s COVID vaccine wins FDA’s full approval

Mike Scott, mscott@stph.org

(Photo by Tim San Fillippo / STHS)

The U.S. Food and Drug Administration on Monday morning gave its full approval to Pfizer|BioNTech’s two-shot COVID-19 vaccine, a regulatory move health experts hope will mark a turning point in the pandemic by encouraging the vaccine-hesitant to roll up their sleeves and get the shot.

Like the Moderna and Johnson & Johnson vaccines, the Pfizer shot has been operating under “emergency use authorization” for months. Monday’s move gives it what the Associated Press described as the FDA’s “strongest endorsement,” adding that the agency has never before had so much evidence to judge a shot’s safety.

“These vaccines have been given to over 166 million people in the United States and many more worldwide,” St. Tammany Health System infectious disease specialist Dr. Mike Hill said Monday morning just minutes after the FDA’s announcement.

He continued: “We know they are safe and effective, and hopefully the removal of the emergency use authorization will encourage more people to get the vaccine, which is the only way out of this historic public health crisis.”

The approval comes at a crucial time in the fight against COVID-19. With the highly transmissible delta variant of the virus filling hospital beds across the country, vaccination rates have largely plateaued.

Many of those who have yet to receive it have said they were waiting until it received the FDA’s full approval. Additionally, many major companies, health systems, universities and other groups have said they planned on mandating vaccination among employees and customers once it received the FDA’s imprimatur.

According to the AP, acting FDA Commissioner Janet Woodcock said Monday’s approval – which she called “a milestone” – should put any lingering fears to rest.  

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” Woodcock said. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Eighty-nine people were under COVID care at St. Tammany Health System on Monday morning. The vast majority of those patients – 87.55% since July 1 – are unvaccinated.

St. Tammany Health System continues to administer COVID-19 vaccines for free by appointment at its Express Care clinic in Covington. Appointments can be made via the free MyChart app or by calling (985) 898-4001.

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