(CMR) The United States Food and Drug Administration (FDA) gave full approval on Monday for the Pfizer/ BioNTech COVID-19 vaccine to be given to Americans as young as 16 years old. Experts believe the granting of this approval is expected to reverse a nationwide slowdown in the number of persons getting vaccinated as people will become more trusting of the vaccine now.
The mRNA vaccine was on the U.S. market under an Emergency Use Authorization that the FDA granted in December. Since then, more than 204 million Pfizer shots have been administered, according to the Centers for Disease Control and Prevention.
Federal health officials had reportedly been under pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May.
FDA said its scientists evaluated “hundreds of thousands of pages” of vaccine data.
Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement.
“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 added.
The vaccine continues to be available under emergency use authorization for individuals 12 to 15 years old and for the administration of a third dose in certain immunocompromised individuals.