FDA calls for expanding COVID-19 vaccine trials in children

COVID-19 vaccine makers Pfizer-BioNTech and Moderna have agreed to expand their clinical trials in children at the urging of the Food and Drug Administration (FDA). The agency said larger studies of the vaccines in 5- to 11-year-olds are needed to reveal rare side effects, such as the heart inflammation problems seen in older young people. Expanding the trials may delay the approval of an emergency use authorization of the vaccines in this population. According to the American Academy of Pediatrics, more than 4 million U.S. children have tested positive for COVID-19. (New York Times article, 7/26/21)