COVID Vaccine Trials for Children Are Underway

COVID Vaccine Trials for Children Are Underway
Photo: fizkes (Shutterstock)

Of the COVID-19 vaccines authorized in the US, one (Pfizer) is available for people aged 16 and up, and the other two (Moderna and Johnson & Johnson) are for 18 and over. But all three companies are testing the vaccine in younger children, and if all goes well vaccines may be available for younger teenagers by this fall.

The process is going slowly because companies use each age group’s data to plan the next age group’s trial. So rather than assuming that an adult vaccine is safe for babies, the companies work their way down: a trial in 12 to 15-year-olds, for example, then one in 5 to 11-year-olds, then age 2 and up, then infants. (This is an example; the exact breakdown of age groups will vary from one company to another.)

Children are at a lower risk of complications from COVID than adults, which is why they weren’t enrolled in trials in the first place. It’s easy for the benefits of a vaccine to outweigh its risks in a high-risk group, less so for a demographic that rarely gets very sick from the virus.

But children do get the virus, and some who do have developed a serious syndrome known as MIS-C. They may also be able to spread it to others without having symptoms themselves, so immunizing children is probably going to be key to establishing herd immunity, which protects vulnerable people who can’t get the shot.

As the trials proceed, investigators will be watching for safety issues. They may also test different dosages, in case the amount of vaccine that works best for children is different from that for adults.

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The trials

Moderna recently announced that they have begun administering the vaccine to children in their KidCOVE study. Participants are between the ages of 6 months and 12 years.

The company’s president also said on the Today show that their TeenCOVE study (12 to 17-year-olds) has finished enrolling participants and that results should be available this summer. If all goes well, the company could apply for emergency use authorization (the same type of authorization as the existing adult COVID-19) shortly afterward, and teenagers could potentially be vaccinated before school starts this fall.

Pfizer announced in January that its trial for children age 12 and up was fully enrolled. Trials for younger age groups are also in the works. One of the trial’s investigators told USA Today that they also hope to have their vaccine available for children over 12 by the start of the 2021-22 school year.

Johnson & Johnson has also said that they are planning trials for children 12 and up, and for children from “birth to [under] 18.” That information was in the material the company provided to the FDA when its adult vaccine was authorized, the New York Times reported.

Availability of the vaccine for children will depend on how the trials go, so it’s too soon to predict exactly what will happen. The trial results are blinded even to the investigators while they are ongoing, so we don’t even have preliminary data yet. Still, vaccines that are safe and effective in adults are often also safe and effective in kids, so there’s reason to be hopeful.

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