Photo By Jacqueline Marshall/Wyoming National Guard: On Monday, the FDA granted full approval for Pfizer-BioNTech’s COVID-19 vaccine for those 16 and older.
By Jon Johnson
WASHINGTON D.C. – On Monday, the Food and Drug Administration (FDA) granted full approval for Pfizer-BioNTech’s COVID-19 vaccine for those 16 and older. The vaccine remains in emergency-use authorization (EUA) for those 12 – 15.
An application for full approval for the Moderna vaccine is still under review and could take several weeks. The one-shot Johnson & Johnson vaccine is expected to apply for full approval soon.
The Pfizer COVID-19 vaccine has been available under EUA for individuals 16 and older since Dec. 11, 2020, and was expanded to include those 12 through 15 years of age on May 10, 2021. The Pfizer vaccine is available in both Graham and Greenlee counties.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
According to the FDA, any vaccine it fully approves undergoes the agency’s standard process for reviewing medical products’ quality, safety, and effectiveness. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA) for all vaccines. A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results ensure vaccine quality and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
The Pfizer COVID-19 vaccine was initially issued EUA after safety and effectiveness data from a study involving about 22,000 people who received the vaccine and 22,000 people who received a placebo. The results of the trial showed the vaccine had a 91% efficacy rate in preventing COVID-19 disease.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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.”
The approval will likely assist in the movement by many to require vaccination as a part of employment or to attend events.
According to recent numbers, slightly more than half of the nation has already been vaccinated. Booster shots for those with immunocompromised systems have been approved, and the general population may require a booster shot for the Pfizer and Moderna vaccines this winter.
