The U.S Food and Drug Administration (FDA) approved the first COVID-19 vaccine, for individuals of 16 years and up. The Vaccine, previously known as the “Pfizer-BioNTech Vaccine” will now be marketed as “Comiranty.” The Vaccine is also still available under Emergency Use Authorization (EUA) for individuals of age 12 to 15, and as a third dose for immunocompromised individuals.
The FDA’s Acting Commissioner Janet Woodcock MD stated, “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Any FDA approved vaccine must go through a long process that reviews its quality, safety, and effectiveness. Through this evaluation process, the FDA evaluates the vaccine’s submission of a Biologics License Application (BLA). Comirnaty in that case had to submit a BLA that supported the EUA, which includes pre-clinical and clinical data, details of the manufacturing process, vaccine testing results, and inspection of the labs where the vaccines are made. The FDA then does its own investigation based on which the vaccine would be approved or disapproved.
Peter Marks, M.D, Ph.D., director of FDA’s Center for Biologics Evaluation and Research stated “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and the medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA 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. “Comirnaty” has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
