ROCHESTER, Minn. — In a sign that the delta variant has raised the stakes in the eyes of the nation's pediatricians, the American Academy for Pediatrics appealed last week to the Food and Drug Administration to delay no further in deciding on COVID-19 vaccines for children ages 5-11.
It's a position endorsed by Mayo Clinic pediatric infectious disease specialist Dr. Nipunie Rajapakse.
"As pediatricians, we've seen really concerning trends among children occurring in this country," said Rajapakse.
"The FDA had set out quite stringent criteria approval criteria for a vaccine (in this population)... I think the intent of the letter was to get across where we are in the pandemic, what is going on, the urgency we see in trying to get the kids in the pediatric population protected from this infection as quickly but as safely as possible."
The letter of which she speaks was released on Wednesday, August 5, and it urged federal regulators "to continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible."
The AAP represents 67,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists. Its letter came on the heels of reports from earlier that week suggesting the FDA had pushed back its timeline for getting COVID-19 shots in children's arms.
To better understand the possibility of rare adverse events, the FDA asked manufacturers to double the size of their trials of COVID-19 vaccine in patients age 5-11, while extending the period of follow-up safety review from two to six months, effectively pushing back approval of COVID-19 vaccine for young children into the winter at the earliest.
"While we appreciate this prudent step to gather more safety data," the AAP letter read, "we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group."
To underscore their point, the doctors pointed to the troubling news that the number of children testing positive for COVID-19 nationally has almost doubled, from 38,000 to 72,000 in a week's time.
"I don't think one number tells us the full story" said Rajapakse, "but the rapidity of increase in number of cases among kids ...that is the most concerning trend were seeing."
The AAP letter argued that two months was sufficient time to understand the safety profile of a new vaccine, and that the nation's previous experience with 340 million doses given of the vaccines indicates "there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration."
"They are not advocating for skipping any usual steps or going outside the realm of prior trials," said Rajapakse. "They are trying to get across (the lack of necessity) of gathering an additional four months of data, when we know we have not seen in adults and adolescents serious adverse events in that 2-6 months post-vaccination period."
"It's a unique circumstance that we're in with this pandemic," she adds. "If we had the luxury of time, obviously I think we would all love to see as large numbers and as long follow-up data for these vaccines in kids as possible. But we have to kind of balance that with the risk of the numbers of kids we are seeing getting infected, based on how transmissible this virus is."
Currently Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines have all been granted an Emergency Use Authorization for adults, with the Pfizer vaccine having been given the same clearance for children 12-17. Having submitted results for a trial of 3,700 younger teen participants, Moderna currently awaits an FDA decision on its application for use in children age 12-17.
Although children with COVID-19 end up in the hospital far less often than do adults or the elderly, Rajapakse says, "there's still many unknowns... We don't know long-term impacts... We can't look at an individual child and say, 'this child isn't at risk from getting this infection.'"
And children can get long COVID, she adds.
"We also know that kids who are mildly symptomatic, or asymptomatic, are capable of spreading the infection to others."
Finally, each new case is another opportunity for the virus to mutate.
"That's another reason we want to drive down the new infections as quickly as possible," she says. "It's difficult to do when you have a large segment of your population that's not yet eligible for vaccination."