As pediatric hospitalizations for COVID-19 reach their highest level and schools across the nation are starting a new year, lawmakers and parents want to know when a vaccine will be available for kids under 12.
More than 100 members of Congress, led by Reps. Ro Khanna and Katie Porter, both D-California, signed and sent a bipartisan letter Tuesday asking the Food and Drug Administration what the timeline is for ongoing vaccine safety and efficacy studies and how a request to broaden the duration and sample size of the studies could impact the process.
Vaccines by several drug companies have been available to adults for several months under emergency use authorization, though formal FDA approval of each is expected. The vaccine produced by Pfizer has been granted authorization for those 12 to 16.
But there’s nothing yet available to children younger than 12 except in clinical trials.
“This surge and the rise of new, 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,” the letter says. “As Brown University School of Public Health Dean Dr. Ashish K. Jha said, ‘Given the unprecedented level of infections and hospitalizations we are seeing in kids, we need to move quickly to protect America’s children by making vaccines available as quickly as the data warrant.’”
The letter is addressed to acting FDA Commissioner Dr. Janet Woodcock, while Biden chief of staff Ronald Klain is copied on it. It requests a briefing within 10 days.
The signers ask several questions, including when the FDA plans to look at the study data that’s already available about vaccine safety and effectiveness for kids ages 5 to 11. They also wonder:
- When data will be available on even younger study subjects and what age range the data will cover;
- When the complete data can be assessed and what barriers are expected;
- Whether the review standard will be the same as it was for the emergency use authorization of vaccines in adults;
- And to what extent the schedule of other childhood vaccines might interfere with COVID-19 vaccine distribution. Flu season is approaching and many children are also receiving vaccinations required for school.
The FDA’s Peter Marks said recently that data on vaccines for kids 5-11 could be available to his agency “early in the fall,” but that “it will take a few weeks at least to review them,” according to The Hill.
The American Academy of Pediatrics sent a similar letter to Woodcock Aug. 5, urging her agency to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible.”
The academy said COVID-19 infections in children climbed to nearly 72,000 the last week in July, nearly double the number just the week before.
“Simply stated,” the pediatrician group wrote, “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 FDA earlier asked Moderna and Pfizer to double the number of children age 5-11 in their safety and efficacy studies. The academy said that “while we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group.”
The rising number of delta variant cases “changes the risk-benefit analysis for authorizing vaccines in children.” Instead, that letter asked the FDA to “strongly consider” using data from the initial, smaller enrolled cohort to speed up authorization, “while continuing to follow safety data from the expanded cohort in the post-market setting” as a way to roll out the vaccine to younger children faster.
The pediatricians also noted that myocarditis, which is inflammation of the heart, has been reported in some younger adults and adolescents who received the type of vaccine created by Pfizer and Moderna. But they called it “extremely rare.” That doesn’t argue for lengthening ongoing studies, they said, as the effect is reported early and would likely be found in the data already collected in the original study design.
According to The Atlantic’s Rachel Gutman, there’s more to be done before a vaccine can be authorized.
“The process is a bit of a push-and-pull between vaccine makers and the government,” Gutman wrote. “The companies have to recruit participants, perform clinical trials, collect data, and submit that information to the government, and the FDA has to tell the companies what sorts of data it’s looking for, how much, and over what timeline. Once the FDA grants an emergency-use authorization, the (Centers for Disease Control and Prevention) has to weigh in, offering recommendations to the nation’s doctors and public-health bodies about when and how the shots should be used. (The latter step took only one day after the FDA authorized each of the Pfizer, Moderna, and Johnson & Johnson vaccines for adults.)”
Pfizer said it planned to first submit an emergency use request for the 5-11 age group in late September, and for children as young as six months to 5 years “shortly thereafter.” Moderna didn’t provide an estimate but indicated its data won’t be available that soon.
Gutman points out that even if the vaccine became available for kids immediately, “they wouldn’t necessarily get one any time soon. As of two months ago, just over half of parents of 3-to-11-year-olds in one survey said their child would likely not get a shot when it becomes available. And even if every child in America did get a jab today, their immunity wouldn’t ripen until well after Labor Day. Vaccines for the under-12s simply aren’t going to eliminate the anxiety around the back-to-school season.”