FDA Approves Covid-19 Pfizer Vaccine for Kids Ages 12–15
Welcome news for teens who are ready to get back to normal
Just in time for summer, the U.S. Food and Drug Administration (FDA) announced game-changing news. The FDA expanded the emergency use authorization for the Pfizer messenger RNA Covid-19 vaccine for kids ages 12–15 years old.
The Pfizer-BioNTech Covid-19 vaccine met the FDA’s safety and efficacy criteria to expand the emergency use authorization. Until now, the Pfizer vaccine was approved for use in people 16 years and older.
Pfizer previously announced in a press release highly encouraging results from their phase 3 clinical trial. The Pfizer-BioNTech Covid-19 vaccine was 100% effective and generated a high antibody response in children ages 12–15.
The phase 3 study included 2,260 U.S. participants. The research detected only 18 cases of Covid-19, and all were in the placebo group. None were in the study participants who received the vaccine. The Pfizer vaccine was found to be 100% effective in preventing Covid-19 in this age group.
The side effect profile in children was similar to those in adults. Injection site pain, fatigue, headache, chills, muscle pain, fever, and joint pain were the most common side effects.
Until recently, infection rates in children have been low. Children are often asymptomatic carriers but can pass the infection on to parents, teachers, and grandparents. The rise of variants such as B.1.1.7 is changing the way we view Covid-19 in children.
A March outbreak linked to youth sports in Minneapolis was a public health wake-up call. Health policymakers noted how fast Covid-19 infections in children can spread to the general public.
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The FDA press release reports the CDC has confirmed 1.5 million Covid-19 cases in children ages 11–17. American Academy of Pediatrics data shows over 3.85 million children have tested positive for Covid-19 since the onset of the pandemic.