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Pfizer Approval Means It’s Technically Legal For Kids. Parents Should Still Wait.

It *could* be prescribed to kids under 12 for "off-label" use, but experts ask parents to have patience and wait for authorization.

Experts are cautioning parents who may seek a Pfizer vaccination for under 12-aged kids without full FDA approval for the age group to wait until the vaccine is officially approved for kids 12 and under.

Technically, now that the Pfizer vaccine has been fully approved by the FDA, doctors could prescribe the Pfizer BioNTech COVID-19 vaccination for the population of kids under 12 for “off-label use” since it was granted full approval for people aged 16+. But even so, parents should wait until there’s more data. Here’s what parents need to know.

According to USA Today, leading pediatricians around the country released a statement urging doctors to not prescribe the COVID-19 vaccines to kids under 12, even though they are now legally able to do so.

The Vaccine is Legally Approved for “Off-Label Use”

Currently, there’s not an approved vaccine for the age group. But with the full approval of the Pfizer vaccination through the FDA, doctors could, technically, prescribe an “off-label” use for kids, which is now legal.

But even though it’s legal, and technically a possibility, experts are sounding the alarm to steer clear for now.

Parents Should Still Wait for a Vaccine to be Approved for Kids Under 12

“We don’t have the data on young children. So that really ought to be a no-no,” said Dr. Jesse Goodman, an infectious disease expert at Georgetown University. “The science is not there to support dosing yet in small children.”

Currently, Pfizer is the only vaccine available to kids 12 and up. Trials are still ongoing for the 5-11 age group, and in fact, the vaccine could be approved within months for that age group — the vaccine is on track to have its data from these trials sent to the FDA for review and the timeline seems realistic to have details by the end of September or early October.

Until then, experts are asking parents to have patience.

“We need to see the data from those studies before we give this vaccine to younger children,” Dr. Lee Savio Beers, president of the American Academy of Pediatrics (AAP) said in a statement. “The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

But Kids 12 and Up, and Everyone Else, Should Get Vaccinated ASAP

While experts are asking parents to wait for kids under 12, they are strongly urging parents with kids 12 and up to get their kids vaccinated. And as we wait for emergency use authorization of a COVID-19 vaccine for the younger kids, other mitigating efforts – like wearing a mask, avoiding crowds, and washing hands – should be front and center to keep our kids safe and healthy.

“We know parents are eager to be able to give their children the protection of this vaccine, and the American Academy of Pediatrics shares that feeling of urgency,” Beers 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.”

In other words, get vaccinated, encourage others to do so, and wait for more data to vaccinate your kid if they’re under 12.