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COVID Vaccine

Food and Drug Administration Approves Pfizer COVID-19 Vaccine

(South Lake Tahoe, CA) – The Food and Drug Administration (FDA) has officially approved Pfizer-BioNTech’s two-dose COVID-19 vaccine for individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. The Pfizer vaccine will now be called Comirnaty (koe-mir’-na-tee).

“Many individuals were awaiting full FDA approval to get the vaccine. With this official approval, we are excited more people will now receive the vaccine and get us one step closer to slowing the highly-infectious Delta variant,” says Dr. Clint Purvance, Barton Health President and CEO.

The two-dose shot was first cleared in December 2020 by the FDA on an emergency use basis for people 16 years and older and the authorization was expanded to include those 12 through 15 years of age in May 2021. Regulators are still reviewing Moderna’s application for full approval for its coronavirus vaccine. Currently, both vaccines are allowed for an additional dose to be given to certain immunocompromised individuals, 12 years of age or older for Pfizer and 18 years of age and older for Moderna.

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 such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

The COVID-19 vaccines are proven to be safe and effective. Vaccination reduces the risk of COVID-19, including severe illness, among people who are fully vaccinated by 90% or more. The vaccination is 88-95% effective against hospitalization and severe illness from the Delta variant.

For information on where to find a Pfizer vaccine near you, visit Vaccines.gov. Vaccines are also available at Barton Family Medicine and Barton Community Health Center for established patients.