FDA APPROVES COVID-19 VACCINES FOR KIDS AGES 12-15 ON EMERGENCY BASIS

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East County News Service

May 10, 2021 (Washington d.C.) -- Today, the U.S. Food and Drug Administration expanded the emergency use authorization for Pfizer’s COVID-19 vaccine to include adolescents ages 12 through 15, Previously, the Pfizer vaccine was approved only for people age 16 and up.

Acting FDA Commissioner Janet Woodcock, M.D., says the action is “a significant step in the fight against the COVID-19 pandemic,” adding, “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. 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.”

Around 1.5 million cases of COVID-19 have been reported in the U.S.in kids ages 11 to 17 from March 1, 202 through April 30, 2021, according to the U.S. Centers for Disease Control and Prevention (CDC).  Although youths generally have milder cases then adults, fatalities and long-term serious complications of the disease have occurred in some children.  Children and teens can also transit the disease to others who may be at higher risk of death or long-term disability from COVID-19.

Approval of the vaccines for adolescents a;sp brings a level of relief to parents wary of kids returning to in-person learning at schools reopening across the nation.

As with adults, the Pfizer vaccine will be given in two shots, three weeks apart, at the same dosage as for adults.

The vaccine was tested on 2,260 participates ages 12-15 in an ongoing randomized, placebo-controlled study in the U.S.that followed participants for two months after they received the vaccine.

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, as with adults who received the vaccine.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

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.