The U.S. Food and Drug Administration’s (FDA) announcement this morning of full approval of the Pfizer vaccine for people ages 16 and older is another important milestone in the battle against COVID-19.
The vaccine has been proven to be safe and highly effective since it first became available under emergency use last December. Full FDA approval is the final step in a rigorous approval process to confirm the vaccine’s safety and effectiveness.
The FDA’s announcement should provide confidence to anyone who may have hesitated to get the vaccine while it was under emergency use. We strongly encourage you to get vaccinated and help end the pandemic. We also strongly encourage healthcare providers who haven’t offered COVID-19 vaccines at their practice before now, to take the necessary steps to enroll as vaccine providers as soon as possible.
Getting full FDA approval for any medication, including vaccines, is a highly rigorous process. Vaccine manufacturers must meet high standards for safety, effectiveness, and manufacturing quality.
As part of the approval process the FDA analyzed effectiveness data from 20,000 people who received the vaccine and 20,000 people who received a placebo. The agency also analyzed safety data from 22,000 people who received the vaccine and 22,000 people who received a placebo. As of today, more than 200 million Americans have received a dose of a COVID-19 vaccine. That includes nearly 1.8 million Utahns.
Pfizer’s COVID-19 vaccine remains available for people ages 12-15 years through FDA’s emergency use authorization. In addition, the third dose of the vaccine that has been proposed by the federal administration would likely be done through an emergency use authorization.
For more information on FDA’s approval please visit https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
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