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When will the COVID vaccine be approved for kids under 12?

“They basically had to start from scratch with phase one trials to figure out what the appropriate dose was in younger children,” said Dr. Sandy Arnold.

MEMPHIS, Tenn. — As the number of COVID cases in kids go up, so is the anticipation for a vaccine. Physicians and Pfizer weigh in about when we can expect a vaccine for children under 12-years-old. It is as though you can see the finish line, but we are not quite there.

“The one thing we should definitely be cured of right now is over confidence,” said Dr. Steve Threlkeld, Baptist Memorial Hospital Infectious Disease.

We turned to Dr. Threlkeld  and Dr. Sandy Arnold at Methodist Le Bonheur Healthcare to ask why a vaccine for kids under 12 is taking so long.

“The companies are doing their due diligence. They need to get this right,” said Dr. Arnold.

“We have to approve that it is both safe and effective,” said Dr. Threlkeld.

When it comes to getting children under 12 approved for the vaccine it is taking time.

“They basically had to start from scratch with phase one trials to figure out what the appropriate dose was in younger children,” said Dr. Arnold.

“Children are not little adults,” said Dr. Threlkeld. “They do things differently biologically. They’re immune systems are very active. It may not take as much of a shot.”

During the middle of those trials, health scientists noticed a side effect.

“We started seeing cases of myocardial inflammation or myocarditis in teenage and young adult males,” said Dr. Arnold.

That is heart inflammation which turned out to be rare in cases.

“Because of that, they actually increased the number of children that they were enrolling in the pediatric trials. In order to pick up rare adverse events, you need to study a lot of people,” said Dr. Arnold.

“One case of some side effect has to be fully examined and looked at,” said Dr. Threlkeld.

Luckily, that had no major impact on the trials.

“There was a huge waiting list for these trials. A lot of parents wanted their kids in these trials to get them vaccinated. There was not a big delay in that,” said Dr. Threlkeld.

In fact, Pfizer said their timing has not changed. In a statement, the company said, “We anticipate a potential pivotal readout for children between the ages of 5 and 11 later this month and, pending the data demonstrating safety and immunogenicity and in agreement with regulators, we could potentially submit for a US Emergency Use Authorization (EUA) shortly after that. Data for kids 2 and under 5 could arrive soon after that. For children between 6 months and 2 years, we could potentially have a safety and immunogenicity readout that would provide the data to understand the sometime in October/November, followed by a potential submission to the US FDA for an EUA once agreed upon with regulators shortly thereafter.”

“Then the FDA has to conduct their own analyses and that could take a couple of months,” said Dr. Arnold.

While kids wait, there are still steps that can be taken now.

“The most effective thing parents can do right now is to get vaccinated themselves,” said Dr. Threlkeld.

“Just make sure that you teach them to wear their masks properly and also have as many people who are around be vaccinated,” said Dr. Arnold.

It is the strategy to take as we inch closer to a safe finish.