The United States Food and Drug Administration (FDA) published this Monday that it approved the Pfizer-BioNTech vaccine in its entirety and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in people 16 years of age or older.
This is the first vaccine to be fully approved by the FDA, as it was previously only authorized for “emergency” use.
“The FDA approval of this vaccine is a milestone as we continue to fight the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, such as the first COVID-19 vaccine approved by the FDA, the public can be very confident that this vaccine meets the high standards. standards of safety, efficacy and manufacturing quality. FDA requires an approved product, “said Acting FDA Commissioner Janet Woodcock, MD.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, FDA approval of a vaccine can now instill additional confidence to get vaccinated. Today’s milestone brings us one step closer to altering the course of this pandemic in the US, “he said.
Since December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under the US for individuals age 16 and older, and the authorization was expanded to include those ages 12-15 on May 10, 2021. USA can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent , diagnosing or treating the disease outweighs the known and potential risks of the product.
Vaccines approved by the FDA undergo the agency’s standard process for reviewing the quality, safety, and efficacy of medical products.
With information from FDA press release