COVID-19 Vaccine Approved for 12 and Older

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NATIONWIDE – On Monday, May 10, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand eligibility to adolescents aged 12 years and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”

In the run up to the authorization, the FDA conducted a random, placebo-controlled study of 2,260 participants between the ages of 12 and 15 to determine both the effectiveness and safety of the vaccine. The study showed that the vaccine was 100 percent effective in preventing COVID-19, but there was not sufficient data to determine if the vaccine prevented the transmission of the disease.

Side effects for trial participants were in line with those experienced by those aged 16 years and older. In general, the most common side effects were injection site pain, tiredness, headaches, chills, fever, as well as muscle and joint pain. Also similar to the results in adults, the second dose of the vaccine resulted in more reported side effects than the first injection.

“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.”

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