” Pfizer-BioNTech Covid-19 Vaccine Is Granted Full Approval By The FDA For Use In Individuals 16-Years Or Older, & Continues Emergency Use Authorization For 12-16 Year Old.”

August 23, 2021 By Englebrook Independent News, 

WASHINGTON, NJ.- On Monday, August 23, 2021, The United States Food and Drug Administration grants full approval to the first Covid-19 Vaccine. 

     The Vaccine has been known as the Pfizer-BioNTech Covid-19 Vaccine, will now be marketed as Comirnaty for the prevention of Covid-19 Disease in individuals 16 years of age and older. The Vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

     FDA Approved Vaccines undergo The Agency’s standard process for reviewing the quality, safety, and effectiveness of medical products. For all Vaccines, The FDA evaluates data and information included in the manufacturer’s submission of Biologics License Application.

     Comirnaty contains Messenger RNA, a kind of genetic material. The Messenger RNA is used by the body to make a mimic of one of the proteins in the virus that causes Covid-19. The result of the person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes Covid-19. The Messenger RNA in Comirnaty is only present in the body for a short time and is not incorporated into, nor does it alter, an individual’s Genetic Material. The Comirnaty Vaccine has the same formulation as The Emergency Use Authorization Vaccine and is administered as a series of two doses three weeks apart.

     The FDA Approval will give some assurance to individuals that have been reluctant in getting vaccinated, but some still might question why President Biden still has not appointed a Director to The Food and Drug Administration to date.