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The FDA Has Approved The Pfizer-BioNTech COVID-19 Vaccine For Adolescents Aged 12 To 15 – The Shade Room

Last week, the Biden administration announced a new goal to have 160 million Americans fully vaccinated against the COVID-19 virus by July 4th. To accomplish this goal, the administration outlined three areas of focus, including vaccinating adolescents and young adults. However, during the recent announcement, the administration was still awaiting the approval of the Food and Drug Administration (FDA). On Monday, the FDA gave their authorization to vaccinate adolescents between ages 12 and 15 using the Pfizer-BioNTech COVID-19 vaccine.

“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,” Acting FDA Commissioner Janet Woodcock said in the agency’s official press 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.”

According to The New York Times, the FDA’s authorization does not mean vaccinations can begin immediately. The next step involves a key voice in the ongoing fight against the COVID-19 pandemic: the Center for Disease Control and Prevention. An advisory committee from the agency is expected to gather and “review the data and make recommendations for the vaccine’s use” in the age group mentioned. Once this committee gives their approval, vaccinations of adolescents can begin.

Last week, President Joe Biden assured Americans that the administration would be prepared to move immediately after the FDA granted its approval. About 20,000 pharmacies are expected to be available for vaccinating this new population.

To ensure effectiveness and safety, Pfizer and BioNTech ran clinical trials on a group of 2,260 adolescents between ages 12 to 15. The group was given a saline placebo or two doses of the vaccine. There were no cases of the symptomatic coronavirus infection found in the 1,131 adolescent participants who received the vaccine.

The vaccine also proved to be safe during the trials. The side effects were similar to those found in trial participants aged 16 to 25. The most common side effects among adolescents were “pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain,” according to the FDA’s press release. Additionally, most of the adolescents reported all the symptoms, minus injection site pain, after receiving the second dose.

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