Lawmakers Demand Answers From FDA on Timeline of Covid Vaccines for Kids Under 12

As millions of children in the U.S. return to schools amid a nationwide surge in coronavirus cases, 108 members of Congress sent a letter Tuesday calling on the Food and Drug Administration to urgently clarify when caregivers can expect Covid-19 vaccines to be approved for children between the ages of two and 11.

While the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine to include individuals from ages 12 to 15 in May, children under 12 remain ineligible to receive any Covid-19 vaccination.

According to the lawmakers: "No pharmaceutical company has applied for an EUA, and clinical studies are ongoing. Data from these trials was expected by September, but recent FDA requests to increase the size and scope of the studies may delay the results. The current situation is alarming for parents, including many of us, whose children ages 2-11 will be in months of school without vaccinations available."

To make matters worse, millions of vaccine-ineligible children returning to in-person instruction have been made more vulnerable to Covid-19 in Florida, Texas, and other states where Republican governors are trying to prohibit school districts from implementing mask mandates, prompting an ongoing fight over public health precautions in educational and other local settings.

"With kids going back to school and cases surging, we need to know when children under 12 will be able to get vaccinated," tweeted Rep. Katie Porter (D-Calif.), who led the letter with Rep. Ro Khanna (D-Calif.).

Although "children and adolescents who contract Covid-19 generally have milder symptoms than adults, more than four million Americans under age 18 have tested positive for the virus," the lawmakers wrote. "Children--including those without symptoms--can spread Covid-19 to others, including immunocompromised and high-risk adults."

Moreover, even if a majority of kids "are not likely to become seriously ill, the long-term health consequences are unknown--and some children are dying of Covid-19," said the lawmakers. "And as with adults, there is a much higher risk for kids with underlying conditions like type 1 diabetes or heart problems."

Pediatric cases have been rising steadily since early July. According to the American Academy of Pediatrics (AAP), 121,427 children were reported to have tested positive for Covid-19 between August 5 and August 12, compared with previous week-over-week increases of 93,824, 71,726, and 38,654. And the lawmakers pointed out that "in some states, the number of children hospitalized with Covid-19 is higher now than at any other point during the pandemic."

The lawmakers cited the AAP, which stated earlier this month in a letter (pdf) to FDA Acting Commissioner Janet Woodcock that "in our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort."

In their letter to Woodcock, the members of Congress requested, within 10 days, a briefing from the FDA to answer the following questions:

• When will the FDA begin studying the safety and efficacy data for children from 5-11 years old that is already publicly available?
• When does the FDA expect to receive data from clinical trials studying the benefits and risks of vaccines for children under age 5? Will this data include information about children as young as 2?
• How long will it take for the FDA to review the safety and efficacy data once relevant studies are complete? What, if any, barriers or competing concerns does the FDA see to the fastest scientifically possible review of the data?
• In determining the safety and efficacy of a Covid-19 vaccine for children, is the FDA applying the same standard of review as it applied to determining an EUA was warranted based on the safety and efficacy of the vaccine for adult use?
• How have the studies addressed the recommended childhood vaccination schedules for non-Covid illnesses and how might this interact with safe vaccine distribution?

"We recognize that the FDA must consider many factors for vaccine authorization, even for an EUA during a global pandemic," the lawmakers wrote. "The start of the school year, however, was a clear moment that could have been used to educate and disseminate vaccines. Now with a late summer surge, the reopening of schools seems likely to increase community spread."

"We respect the scientific process and the FDA's dedication to safety, and we applaud the swiftness with which the FDA granted an EUA for the Covid-19 vaccines for adults and adolescents," added the members of Congress. "The American people need information about the status of an EUA for a vaccine safe for children, however, and we as lawmakers need to understand the FDA's efforts to protect our youngest Americans."

As the lawmakers noted, the current escalation in Covid-19 infections--including the rapid growth in pediatric cases and hospitalizations--as well as the rise of new, potentially more dangerous variants, "is coming right as the school year begins, as temperatures drop, and as more parents are required to return to in-person work."

In light of this confluence of factors, Brown University School of Public Health Dean Dr. Ashish K. Jha told the members of Congress who sent the letter to the FDA that "we need to move quickly to protect America's children by making vaccines available as quickly as the data warrant."

That message was echoed forcefully on Wednesday in an essay written by The Week's Ryan Cooper.

Cooper called it "unacceptable" that the FDA's decision to ask Pfizer and Moderna to substantially increase the sample size of their clinical trials for children "will likely push back initial approval by months, into midwinter."

The agency "already has data on kids aged between 5-11, and should issue emergency authorization for all children under 12 as soon as possible, so long as that data shows an acceptably low risk of complications," argued Cooper. "Dithering to understand very rare side effects is simply bad risk management with the Delta variant spreading like wildfire."