The Pfizer BioNTech COVID-19 vaccine this week received full approval from the U.S. Food and Drug Administration for individuals 16 and older.
“Today’s announcement is great news as we continue to fight COVID-19 and its variants,” said Gov. Tom Wolf. “Full approval by the FDA solidifies the overall safety and efficacy of the Pfizer BioNTech COVID-19 vaccine. We hope this encourages people to get vaccinated who may have been hesitant while it was classified as emergency use to not only protect themselves, but their loved ones and everyone else around them.”
Since Dec. 11, 2020, the Pfizer vaccine has been available under an Emergency Use Authorization for individuals 16 and older. 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.
The EUA remains in effect for children 12-15 years of age.
