The American Academy of Pediatrics said the highly contagious delta variant of the coronavirus has created "a new and pressing risk" to children amid its ongoing spread, underscoring the need for vaccines to be authorized for this age group.
The organization wrote a letter Thursday to the U.S. Food and Drug Administration, urging the agency to work "aggressively" toward authorizing a safe and effective COVID-19 vaccine for children under age 12 as soon as possible.
The U.S. saw "the largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic," the group wrote in the letter addressed to Dr. Janet Woodcok, the acting FDA commissioner.
A total of 71,726 COVID cases in children were reported the last week of July, which was "almost double the 38,654 reported in the previous week," according to the AAP. The nonprofit professional organization has been tracking such information since the start of the pandemic with the Children’s Hospital Association.
"Simply stated, the delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults," the letter states.
FILE - A woman and child visit Waterwall park on Aug. 3, 2021, in Houston, Texas. (Photo by Brandon Bell/Getty Images)
The letter comes amid a resurgence of COVID-19 cases and hospitalizations nationwide and as schools prepare to welcome students back to classrooms. At the same time, regulators continue to review cases of a rare type of heart inflammation called myocarditis that has been reported in a small number of teenagers who got the Moderna or Pfizer shots.
To date, only the Pfizer-BioNTech COVID-19 vaccine has been authorized for those 12 and up. The FDA is currently considering whether to extend the use of the Moderna vaccine to the same age group.
Meanwhile, Pfizer is testing its two-dose vaccine in up to 4,500 children in the United States and Europe. The company has previously said it expects data on children ages 5 to 11 from its ongoing pediatric trials to be available in September and the younger age group shortly after.
Moderna has said it expects to have enough data to apply for FDA authorization in younger kids by late this year or early 2022.
In the letter, the AAP said the spread of the delta variant has fueled the urgency of authorization for the 5 to 11 age group of such "critically needed vaccines."
"The 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 in the post-market setting," the letter states.
It continues: "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 2-month safety follow-up for participants."
More than 4.1 million children and adolescents have tested positive for COVID-19 since the onset of the pandemic, according to the AAP. At least 358 have died — or 0.01% of all child virus cases.
Dr. Anthony Fauci, the nation’s top infectious disease specialist, said while most children who contract the virus don’t require hospitalization — there is still a risk that parents should be aware of.
"The likelihood of a child getting serious disease compared to an elderly person or someone with an underlying condition is absolutely less, but less doesn't mean zero," Fauci said Sunday on NBC's "Meet the Press." "All you need to do is do a survey of the pediatric hospitals throughout the country, and you're seeing a considerable number of young people who are not only infected but who are seriously ill. Again, the numbers compared to the elderly are less, but that's a false comparison."
"These kids are getting sick. We've really got to make sure we protect them," Fauci added.
The push for vaccine approval in younger children comes as many are set to return to the classroom for the 2021-2022 school year.
Last month, the AAP recommended universal masking in schools, even for those who are vaccinated. The Centers for Disease Control and Prevention last month recommended mask-wearing indoors only for students and staff who are not fully vaccinated.
The recommendations weren’t embraced by some state leaders, who responded by banning face coverings altogether in the classroom come fall.
Arkansas, Arizona, Florida, Iowa, Oklahoma, South Carolina, Texas and Utah have banned mask requirements in public schools.
At the other end of the spectrum, California, Louisiana, New Jersey, Oregon and Washington state intend to require masks for all students and teachers regardless of vaccination status.
This story was reported from Cincinnati.