4 News Now Q&A: Why hasn’t a COVID vaccine been approved for younger kids yet?

Your Questions Answered

Q: Why hasn’t a COVID vaccine been approved for younger kids yet?

There is a group of 48 million people who do not have the option of getting a COVID vaccine right now: children younger than 12. A vaccine is not authorized for these younger kids yet, and as pediatric cases climb, many families are left in a difficult position heading into this school year. 

A: For the kid’s version of the COVID vaccine, scientists use results from the adult trials and a full pediatric trial.

Having the adult research that shows vaccines are safe and effective speeds up the process.

That’s because for people as young as 12, vaccine companies did not have to enroll the 30,000 people it needed for adult trials because it could do what is called “immunobridging.”

The data showed that for this group, the immune response was the same as adults’.

Companies take a similar approach with the younger kids. But in August, the FDA asked for six months of follow-up safety data instead of the two months it asked for with adults. It also asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials.

“Early fall is when we will anticipate seeing the data, and then it will lie with the hands of the FDA,” CDC Director Dr. Rochelle Walensky said. “I’m hopeful for the end of the year.”

If the FDA signs off on it, the vaccine gets another set of expert eyes with the CDC’s advisory council. That committee also puts together a formal recommendation about the delivery, timing, distribution and administration of the vaccine. The committee’s recommendation becomes official when the CDC director approves it.

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