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
· AMA: Pfizer’s
COVID-19 vaccine OK’d for ages 12–15: What doctors must know
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
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