FDA authorizes Pfizer-BioNTech vaccine in children aged 12 to 15 years
The FDA on Monday authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 12 to 15 years.
The vaccine, which was previously available for people aged 16 years or older, remains the only COVID-19 shot available for any pediatric population. The FDA amended an emergency use authorization (EUA) issued in December to include the younger age group.
Acting FDA Commissioner Janet Woodcock, MD, called the expanded EUA “a significant step in the fight against the COVID-19 pandemic.”
“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” Woodcock said in a news release. “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.”
Pfizer and BioNTech formally asked the FDA last month to expand the EUA based on phase 3 data showing that the vaccine is safe and effective in children aged 12 to 15 years.
According to the AAP, as of May 6, more than 3.8 million children have been diagnosed with COVID-19, accounting for 14% of all U.S. cases.
The expanded EUA “is a critically important step in bringing life-saving vaccines to children and adolescents,” AAP President Lee Savio Beers, MD, FAAP, said in a statement. “Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”
Last week, President Joe Biden, announced a three-point plan to get 70% of the country at least partially vaccinated by July 4 that included efforts to vaccinate children aged 12 to 15 years.
Biden said the White House would be “ready to move immediately” upon the issuance of an EUA and would make vaccines for children available in about 20,000 pharmacies, in addition to shipping doses directly to pediatricians.
The CDC’s Advisory Committee on Immunization Practices has scheduled a meeting for Wednesday to vote on recommendations for using the vaccine in the newly authorized age group.
Pfizer CEO and Chairman Albert Bourla, DVM, PhD, said last week that the company also plans to submit a request for an EUA to the FDA for vaccine use in children aged 2 to 5 years and 5 to 11 years, in September.
Perspective
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The FDA approval for younger age groups will be very important in removing any obstacles for in-person learning and will allow extracurricular activities to have less of a negative impact on schooling as children can be vaccinated. This will also decrease, to some degree, the spread of the virus. However, it is important to remember that children are spared from the severe consequences of disease and are not magnifiers of infection, and there are many high-risk individuals around the globe who are not yet vaccinated.
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FDA. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use. Accessed May 10, 2021.
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