The U.S. Food and Drug Administration gave full approval to the Pfizer COVID-19 vaccine on Monday, a move health officials hope will give confidence to those who have been hesitant to get vaccinated.
Pfizer is the first vaccine to be granted full FDA approval.
“This announcement reaffirms that the vaccines are both safe and effective,” said Clay Horton, director of the Green River District Health Department. “We hope this will provide confidence to some of those that have been waiting to get vaccinated. We continue to see an alarming rate of new infections in our community. Vaccines are the best tool available to protect you and those around you. I hope anyone who hasn’t gotten vaccinated yet will take this announcement as an opportunity to reconsider.”
The Pfizer-BioNTech vaccine is fully approved for individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Pfizer said their COVID-19 vaccine will be marketed in the U.S. under the brand name Comirnaty (koe-mir’-na-tee). According to Pfizer, more than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer Chairman and Chief Executive Officer Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. ”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
“EUAs 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 a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product,” according to a release from the FDA.
Acting FDA Commissioner Dr. Janet Woodcock said the approval is a milestone.
“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,” Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
According to the Associated Press, Moderna has also applied for full approval from the FDA and Johnson & Johnson hopes to do so later this year.
