The American Academy of Pediatrics (AAP) is urging the FDA to work aggressively to authorize a safe and effective COVID-19 vaccine for children younger than 12 years of age as soon as possible.

“Pediatricians and the families they care for have been anxiously awaiting a vaccine that can be used in children 11 years of age and younger, and especially so now given the rise of the hyperinfectious delta variant,” AAP wrote in the Aug. 15 letter.1 “The delta variant is surging at extremely alarming rates in every region of America. This surge is seriously impacting all populations, including children.”

The AAP and the Children’s Hospital Association have been tracking COVID-19 cases in children since the start of the pandemic. “Last week saw the largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic,” AAP noted. “The data show 71,726 COVID cases in children reported last week, almost double the 38,654 reported in the previous week. Simply stated, the delta variant has created a new and pressing risk to children and adolescents across this country.”

Since the pandemic began, children have represented 14.3% of total cumulated cases. However, for the week ending July 29, children represented 19% of reported weekly cases.

“The higher proportion of cases in this population means this age group could be contributing in driving continued spread of COVID-19,” AAP wrote. “Sadly, over 350 children have died of COVID since the start of pandemic and millions of children have been negatively impacted by missed schooling, social isolation, and in too many cases, the death of parents and other caregivers.”

The FDA has worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials. However, AAP noted, things have changed and children are in immediate danger.

“In our view, the rise of the delta variant changes the risk-benefit analysis for authorizing vaccines in children,” AAP stated. “FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort [of those younger] in the post-market setting.”

The FDA also is continuing to evaluate clinical trial requirements for children younger than 5 years of age.

“We similarly urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group,” AAP stated. “Based on scientific data currently available on COVID-19 vaccines, as well as on 70 years of vaccinology knowledge in the pediatric population, the academy believes that clinical trials in these children can be safely conducted with a two-month safety follow-up for participants. Assuming that the two-month safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group.”


  1. American Academy of Pediatrics. Letter to the FDA. Aug. 5, 2021.