The battle against COVID-19 took a step forward after the U.S. Food and Drug Administration officially approved the Pfizer-BioNtech vaccine. This is the first vaccine to receive federal approval.
The Pfizer-BioNtech vaccine was authorized for emergency use authorization (EUA) in December 2020 for those over the age of 16. Eligible recipients expanded to individuals at least 12-years-old in May 2021.
“While this and other vaccines have met the FDA’s rigorous, scientific standards…the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality …” said Acting FDA Commissioner Janet Woodcock, M.D.
The vaccine, now being marketed as Comirnaty, will still be readily available to individuals between the ages of 12 and 15 under EUA. The EUA will also be in place for the administration of a third “booster” shot for certain immunocompromised individuals.
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
— U.S. FDA (@US_FDA) August 23, 2021
A press release put out by the FDA details the specifics that went into approving the vaccine as well as how the mRNA genetic material defends against the virus.
How the Vaccine Works
The body uses the mRNA in Comirnaty to create a mimic of a protein that causes the COVID-19 virus. The mimic’s introduction simulates the presence of the virus in the body. This leads to their immune system reacting defensively to the actual virus. The vaccine’s mRNA is present in the body for only a short period of time.
The announcement comes off the heels of another rise in COVID-19 cases throughout the country. This impact is felt strongest among the unvaccinated.
A study conducted by the Wisconsin Department of Health Services revealed the contrast among hospitalizations and deaths within the state’s respective residents. Approximately four in five hospitalizations in the state are from unvaccinated patients.
The FDA and Center for Disease Control and Prevention are requiring Pfizer-BioNtech to conduct post-marketing studies to monitor the long-term effects of Comirnaty. Additionally, the company will conduct a pregnancy registry to monitor pregnancy and infant outcomes post-vaccination.
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