In its latest update, the FDA has approved Pfizer-BioNTech vaccines for emergency use in adolescents from 12 to 15. Find out more in this coronavirus news update with StreamMD!
Coronavirus News Update: EUA Amendment
Issued Dec 2020, the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine only allowed administration for individuals 16 years of age and older. May 10, the FDA amends the EUA to include adolescents from the age of 12 to 15, along with the revised Fact Sheets for Healthcare Providers Administering the Vaccine and Recipients and Caregivers.
The vaccine has met the FDA’s requirements for the EUA amendment. Its known and potential benefits in people aged 12 and up outweigh the vaccine’s known and potential risks.
According to Janet Woodcock, M.D., Acting FDA Commissioner, this move to cover 12 to 15-year-old adolescents takes a significant step in the battle against the raging pandemic. Dr. Woodcock assured parents and guardians that, as of all EUA amendments, FDA conducts “a rigorous and thorough review of all available data.”
As the course of COVID-19 disease in children and teenagers is usually milder than that of adults, vaccine approval for a younger population can lift the massive burden weighing on the world in the meantime. From March 2020 to the end of April 2021, CDC confirmed around 1.5 million COVID-19 cases in adolescents aged 11 to 17.
The Pfizer-BioNTech COVID-19 Vaccine administration consists of two doses; dosage and dosing regimen remain the same as the previous EUA for 16 years of age and older.
FDA’s intervention is another effort to fight the pandemic while gradually taking the population to restore normalcy.
*Disclaimer: The EUA amendment does not imply FDA “approves” a vaccine. The EUA may be amended or revoked if the FDA decides that the EUA no longer meets its requirements or protects public health or safety.
As in previous blogs, we mentioned lowering the vaccine approval down to age 12 can make a difference in these dynamics. Now the good news is coming, and we hope for more! Let us know your opinion about this amendment from the FDA in the comment section below!
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