FDA Announces Formal Approval for Pfizer’s Covid-19 Vaccine

FDA Announces Formal Approval for Pfizer’s Covid-19 Vaccine

Today the U.S. Food and Drug Administration (FDA) announced their approval of the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty.

Since December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under emergency use authorization (EUA) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older. On May 10, 2021, the FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age.  The FDA’s approval is for vaccine administration for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine 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.

“This is an exciting and significant moment in the fight against COVID-19,” said Brynn Carrigan, Director of Kern County Public Health. “We hope that today’s approval will instill confidence in those who were hesitant about getting vaccinated. Vaccines remain one of the most effective tools to protect ourselves against this virus.”