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Marks the first US Covid vaccine authorized for this age group
FDA has expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s vaccine to now include young adults 12 to 15 years of age. This is the first Covid-19 vaccine authorized in the US for use in this age group.
“Today’s expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination program and help[ing] protect adolescents before the start of the next school year,” says Albert Bourla, Pfizer’s chairman and CEO. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”
Now, the next step is for the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to meet in order to cover recommendations for use of the Pfizer-BioNTech Covid-19 vaccine in individuals 12 to 15 years of age, based on the amended EUA.
Pfizer and BioNTech, who are also in the process of applying for full FDA vaccine approval for people 16 years of age and older, plan to submit a supplemental biologics license application (BLA) to support licensure of the vaccine in this particular age group, once the mandatory data on six months after receiving the second vaccine dose are available.