Some parents, politicians and public health groups are calling on the FDA to speed up its authorization of COVID-19 vaccines in children under 12 years old amid a record number of infections in the age group as schools reopen, Politico reported Sept. 7.
Pfizer's COVID-19 vaccine was authorized for use in people as young as 12 in May. Moderna's vaccine has not received approval for use in adolescents, but a clinical trial showed its shot was 100 percent effective in the age group.
Health experts have predicted FDA authorization for COVID-19 shots in kids younger than 12 won't come for several more months. Francis Collins, MD, PhD, director of the NIH, said he doesn't "see approval for kids 5 to 11 coming much before the end of 2021," Politico reported.
Pfizer is expected to release clinical trial results from its shot in 5- to 11-year-olds this month, and Peter Marks, MD, PhD, head of the FDA's vaccine center, told Politico it would take at least a few weeks to analyze the results. Moderna said it expects to seek emergency authorization for use of its shot in ages 6 to 12 by the end of the year, and for use in kids as young as 6 months early next year, The Wall Street Journal reported Sept. 6.
Hospitalizations among children and teens quadrupled in August in states with low vaccination rates, according to a CDC report cited by Politico. Hospitalizations for unvaccinated adolescents and kids ages 4 and under have each risen tenfold since mid-June, when the delta variant began circulating widely in the US.
Last month, the American Academy of Pediatrics sent a letter to acting FDA commissioner Janet Woodcock, MD, urging the FDA to speed up authorization of COVID-19 vaccines in younger populations, saying "the delta variant changes the risk-benefit analysis for authorizing vaccines in children," Politico reported.
The FDA in July asked drugmakers to increase the size of their pediatric clinical trials to boost the chances of detecting any rare side effects of the vaccines. But enrolling kids takes much longer than enrolling adults because it requires parental consent, and some young clinical trial volunteers don't work out because some are afraid of needles, the Journal reported.
Children also require smaller doses of the vaccines, and a Pfizer spokesperson told the Journal that preparing lower doses requires more requirements to ensure the vaccine is properly assembled by pharmacists.