|May 14, 2021
FDA Adds Adolescents Age 12 Through 15 to Pfizer-BioNTech COVID-19 Vaccine EUA
14 year-old Mainer, Henry Fisher received his first shot earlier this week from Mid Coast Hospital
On Monday, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
· Read full announcement here
· Virtual Press Conference: COVID-19 Vaccine for Adolescents
· New American Academy of Pediatrics Policy on COVID-19 Vaccines for Children
The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.
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.
The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
Emergency Use Authorization for Vaccines Explained
< Previous Article | Next Article >
[ return to top ]
ensure delivery of Maine Medicine Weekly Update,
please add 'firstname.lastname@example.org' to your email address book or Safe Sender List.
If you are still having problems receiving our communications,
see our white-listing page for more details: http://www.commpartners.com/website/white-listing.htm
For more information or to contact us directly, please visit www.mainemed.com | ©