New Covid infections among children have jumped nearly 500% in a month, according to the American Academy of Pediatrics.
Jon Cherry/Getty ImagesUrgency and caution are in high tension now as schooling resumes and infections by the Delta variant of the Covid-19 virus surge among unvaccinated Americans. That includes children.
The Food and Drug Administration put all hands on deck this summer to complete its review of Pfizer (ticker: PFE) and BioNTech ‘s (BNTX) vaccine, hoping that a complete license would inspire hesitant adults 16 years of age and older to get the shots. Now, attention turns to vaccinating the youngest. After declining in early summer, Covid cases among American children have rebounded. The latest tally by the American Academy of Pediatrics found that new infections jumped nearly fivefold in a month to 180,000 for the week ended Aug. 19. That level is comparable to winter’s Covid surge.
“There are bleak spots right now in the pandemic,” says David Kimberlin, a professor of pediatric infectious diseases with the University of Alabama at Birmingham. “Not the least of which is the momentum of infections among the unvaccinated, including children here in the Deep South where I am.”
Pfizer’s full approval on Aug. 23 might tempt doctors to give the adult shots off-label to children. They shouldn’t until results arrive from clinical trials of a lower-dose vaccine for kids, said the AAP this week. The FDA made a similar warning. Pfizer expects to have that data for children aged 5 to 12 sometime in September. Then, federal authorities will consider an emergency use authorization of the pediatric version.
Concerned parents have asked about off-label shots for their children, says Kimberlin, who is on the American Academy of Pediatrics committee on infectious diseases. He tells them it isn’t a good idea.
It isn’t as if Kimberlin and the AAP don’t want a pediatric vaccine’s speedy arrival. Pfizer’s newly licensed shot for ages 16 and up contains a 30 microgram dose of its messenger-RNA payload. The same dose has gotten an emergency use authorization for ages 12 to 15, and the AAP urges its use in that age group. “That’s a big chunk of the pediatric population,” says Kimberlin. “And we know it works.”
The dose that Pfizer is testing among 5- to 11-year-olds, however, is 10 micrograms, or one-third the adult amount. Coming along behind that study is the trial of a smaller dose of 3 micrograms in children aged 6 months to 4 years.
While doctors shouldn’t try to guess how to use the adult dose off-label in kids, the AAP and its members are eager to get the children’s versions in hand. Kimberlin’s colleagues at Children’s of Alabama hospital are leading studies of the vaccine from Pfizer and BioNTech, as well as one from Moderna (MRNA). Kimberlin says he’s optimistic the pediatric vaccines will prove safe and effective.
Pfizer spokesperson Amy Rose says that Pfizer hopes to submit to the FDA for an emergency authorization soon after September’s results from the trial among 5- to 11-year-olds. Then the FDA and the Centers for Disease Control and Prevention will carry out reviews that could take weeks or months, depending on their thinking about the vaccine’s safety.
Extremely rare cases of heart inflammation have appeared among the hundreds of million adults who’ve gotten Covid shots, and earlier this summer the FDA asked Pfizer and Moderna to double the number of participants in their pediatric trials to better discern any rare adverse effects. On Aug. 5, the AAP’s president Lee Beers wrote the FDA to suggest that the added numbers not delay the agency’s authorization of a dose for 5- to 11-year-olds. Any serious problems will have likely appeared within the studies’ two-month safety follow-up, wrote Beers.
Unvaccinated children are a growing proportion of Covid cases, warned Beers, and could be contributing to the spread among adults. “The rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children,” he wrote.
Write to Bill Alpert at william.alpert@barrons.com
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