This Monday, the Food and Drug Administration (FDA) extended the emergency use authorization of the Pfizer vaccine for adolescents aged 12 to 15 years. The FDA amended the drug’s emergency use document originally issued on December 11, 2020 for administration to persons 16 years of age and older.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said FDA Acting Commissioner Janet Woodcock.
She argued that it is another step in the quest to return to normalcy. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.”
Use of the Pfizer vaccine in teenagers
Similarly, she said that all the necessary studies and monitoring were conducted to approve the authorization. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The FDA further stated that it has determined that the Pfizer vaccine has met the statutory criteria for amending the action, and that the known and potential benefits of this vaccine in persons 12 years of age and older outweigh the known risks.
The agency stated that ” The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.”