Pfizer FDA APPROVAL COVID-19

#COVID19 #Pfizer #Comirnaty

Pfizer FDA APPROVAL COVID-19

The FDA has granted full approval for the Pfizer vaccine. The name of the vaccine is Comirnaty. If you have been on the fence, now is the time to get vaccinated! The life you save could be your own or the life of a loved one.

Comirnaty…represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible,” said Pfizer in announcing EU authorization last year. The name, which you might guess if you say it out loud, is meant to evoke community
The approval applies to individuals ages 16 and older. The vaccine is still available for emergency use for those ages 12 through 15.
This vaccine can save your life and the life of loved ones.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said the agency had not dragged its feet.
Marks noted that his team had reviewed tens of thousands of pages of clinical trial data — down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.
"People worked day and night."

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

Rigorous Review
In granting the approval, the agency reviewed a record amount of data from more than 40,000 clinical trial participants. About 12,000 recipients have been followed for at least 6 months, the agency said.
The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.
Based on the results from the clinical trial, the vaccine was 91% effective at preventing COVID-19 disease. That estimate was derived from data collected before the Delta variant became widespread, however.
The most commonly reported side effects in the clinical trial were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

References

Goodman, B. (2021). FDA Fully Approves Pfizer's COVID Vaccine, Paves Way for Mandates. https://www.medscape.com/viewarticle/957036?src=mkm_covid_update_210823_MSCPEDIT&uac=180486SK&impID=3588905&faf=1
Morris, C. (2021). Pfizer wants you to call its COVID vaccine Comirnaty. How the name came about. https://fortune.com/2021/08/23/pfizer-covid-vaccine-comirnaty-how-it-got-its-name/

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