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Parents urged to hold off on ‘off-label’ COVID-19 vaccinations for children under 12

More data needed, medical experts say

Doses of the Pfizer-BioNTech COVID-19 vaccine.
Doses of the Pfizer-BioNTech COVID-19 vaccine await recipients at the Central Davis Senior Activity Center in Kaysville on Tuesday, July 6, 2021.
Spenser Heaps, Deseret News

Now that one of the COVID-19 vaccines is fully approved by the Food and Drug Administration, should shots be sought out for children younger than 12?

Not yet, experts say, even though federally approved medicines — like the Pfizer vaccine that’s available to anyone 12 and older — can be prescribed “off-label” for different age groups, conditions or other indications than spelled out by authorities.

“We just don’t have data yet. We should have that within a matter of weeks,” said Dr. Andrew Pavia, chief of the pediatric infectious diseases division at University of Utah Health and director of hospital epidemiology at Intermountain Primary Children’s Hospital in Salt Lake City.

With COVID-19 cases surging in Utah and around the country due to the highly contagious delta variant as children are headed back to school, there are reports of parents throughout the United States trying with mixed success to schedule appointments for their children to get their shots.

Pavia told reporters during a virtual news conference about Monday’s announcement that the Pfizer vaccine now has full approval from the federal government for those 16 and older, and that he understands why parents are concerned.

“I think parents are the ones who really are very understandably anxious to get their kids vaccinated,” the doctor said. “I’m totally sympathetic. I want kids of all ages to be vaccinated as soon as possible. But we really need to wait.”

There are still questions about the appropriate dosage for younger children, Pavia said, the same issue raised by the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics in offering similar advice.

“We are really discouraging people from prescribing it off-label,” he said. Pfizer is expected to submit data to the FDA as soon as next month as part of the process to be permitted to provide the shots to those 6 to 11 years old, Pavia said, but additional safety information also needs to be collected.

“No one — not anyone at the companies, not anyone at the FDA and certainly not I — can really predict exactly when they’ll be available. We hope that will be in the middle of the fall. It could shift to a little bit later,” the doctor said.

The Pfizer vaccine continues to be under an emergency use authorization for those 12 to 15 years old but full approval for that age group is likely in the coming months, he said. It is the only vaccine approved for use by those under 18 years old.

The other two-dose COVID-19 vaccine available in the United States, from Moderna, could be approved for use by younger Americans soon, Pavia said, adding he was not sure about a timeline for the single-dose Johnson & Johnson vaccine.

The FDA’s decision should counter what Pavia termed “misinformation” that’s being maliciously spread about the vaccine. That includes the idea that COVID-19 isn’t that serious, he said, citing the more than 600,000 Americans who have died from the virus.

“Another myth that we have to combat is that it’s not a big deal for children. That myth comes about because if you compare kids to people over 65, the death rate is dramatically less for kids,” Pavia said. “But how many children should be allowed to die? What’s an acceptable number of pediatric deaths?”

One child has died in Utah from COVID-19, a Salt Lake County boy between 1 and 14 years old, according to the Utah Department of Health, As of Tuesday, 432 children in the state 14 years old and younger have been hospitalized with the virus, while COVID-19 had killed a total of 2,593 Utahns and hospitalized nearly 20,000.

Acting FDA Commissioner Dr. Janet Woodcock on Monday recommended against giving COVID-19 shots to children under 12 for now, saying, according to CNN, “that would be a great concern that people would vaccinate children because we don’t have the proper dose and we don’t have the safety data, nor do we have all the efficacy data, as well.”

Woodcock said children ”are not just small adults.”

The American Academy of Pediatrics also discouraged vaccinating children under 12 against COVID-19 at this time, noting in a news release that more than 180,000 new pediatric cases of the virus were reported nationwide during the week ending Aug. 19, nearly 50% more than the prior week.

“The Delta variant has led to significant increases in the number of children and adults infected with the virus,” Dr. Lee Savio Beers, the academy’s president, said. “While we wait for a vaccine to be authorized for younger children, it’s important that everyone who is eligible now get the vaccine. That will help reduce the spread of the virus and protect those who are too young to be vaccinated.”

Just 39.4% of Utahns 12 to 18 years old are fully vaccinated against COVID-19, meaning it’s been two weeks or more since their final dose. That’s compared to 59.9% of Utahns 12 and older who are fully vaccinated, although when the state’s entire population is included, that number drops to 48.4%.