FDA Approves Emergency Use of Pfizer Vaccine for Those Aged 12 to 15
Vaccination side effects comparable to those seen in trial participants ages 16 to 25 years
TUESDAY, May 11, 2021 (HealthDay News) -- In a move that should hasten the country's recovery from the pandemic, the U.S. Food and Drug Administration on Monday approved the emergency use of the Pfizer two-dose COVID-19 vaccine for 12- to 15-year-olds.
"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, M.D., said in a statement released Monday.
The FDA authorization is not the final step in bringing the Pfizer vaccine to younger children. A U.S. Centers for Disease Control and Prevention advisory panel plans to meet Wednesday and is expected to approve the vaccine's use in 12- to 15-year-olds.
The emergency use authorization follows the results of a clinical trial involving more than 2,000 participants aged 12 to 15 years who received either two doses of the vaccine or placebo shots three weeks apart. The researchers recorded 18 cases of symptomatic coronavirus infection in the placebo group and none in the vaccinated group.
Vaccination side effects were comparable to those seen in trial participants ages 16 to 25 years. Fevers were slightly more common among inoculated 12- to 15-year-olds; about 20 percent of them had fevers compared with 17 percent in the older age group.
"It's essential for children to be vaccinated against COVID-19," Lee Savio Beers, M.D., president of the American Academy of Pediatrics, said in a statement. "According to data compiled by the AAP and Children's Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic. While fewer children than adults have suffered the most severe disease, this is not a benign disease in children."