When Will a COVID-19 Vaccine Be Ready for Kids Under 12, and What’s the Latest News on Clinical Trials?

UPDATE: Pfizer recently asked the FDA to authorize its COVID-19 vaccine for ages 5 to 11! Learn more.

With the highly contagious Delta variant taking hold in communities across the country, and a new school year on the horizon, parents are eager for kids of all ages to have the protection of a COVID-19 vaccine.

Right now, only children ages 12 and older can get the COVID-19 vaccine – but it could become available for younger age groups soon.

Connecticut Children’s infectious disease expert John R. Schreiber, MD, MPH, shares an update.

In the U.S., several COVID-19 vaccines are being studied in children.

Pfizer-BioNTech and Moderna are the front-runners. Both companies launched their COVID-19 vaccine trials for kids as young as 6 months old in March, and expect to share results as soon as September.

Johnson & Johnson is collecting data about their COVID-19 vaccine in ages 12 to 17, and hopes to start studying ages 2 to 11 soon.

Novavax is still wrapping up its U.S. trial for ages 18 and up (and says it will file for emergency use authorization for adults in late summer or early fall), but has also been collecting data on the safety and efficacy of its vaccine in ages 12 to 17.

> UPDATE: Pfizer recently asked the FDA to authorize its COVID-19 vaccine for ages 5 to 11! Learn more.

In particular, vaccine researchers are studying the best dosage for each age group.

In all of the clinical trials above, the vaccines are identical to the versions that adults receive, but they’re given at kid-sized doses. To determine the best dosage, clinical trials are broken into age groups for different stages of a child’s growth and development.

For example, Pfizer is running separate trials for its COVID-19 vaccine in ages 5 to 11, ages 2 to under 5, and ages 6 months to under 2 years. All age groups are receiving the same vaccine, but the size of the dose might be different. Typically, the younger the age group, the smaller the dose.

To request authorization for kids under age 12, companies need to turn in four to six months of safety results.

Clinical trials don’t just show whether a vaccine will be effective – they must also show that it will be safe. For COVID-19 vaccine trials in kids under age 12, the Food and Drug Administration (FDA) has requested four to six months worth of follow-up safety data. (By comparison, they only required two months of data for adult trials.)

Both Pfizer and Moderna expect to share their safety results in September or October, and could file for emergency use authorization after that.

> Related: Is the COVID-19 Vaccine Linked to Heart Problems in Young People?

It seems likely that the earliest we could have a COVID-19 vaccine for kids ages 5 to 11 is this fall.

Pfizer says they anticipate sharing results and seeking authorization for their vaccine in ages 5 to 11 as early as September or October. Their COVID-19 vaccine is still the only one authorized for ages 12 to 17 in the U.S.

Moderna has talked about a similar timeline. (Currently, their vaccine is only authorized for ages 18 and up, and is pending authorization for ages 12 to 17.)

Once either company shares safety results and files for emergency use authorization, it could take weeks or months for the FDA to review the information and make a decision.

> UPDATE: Pfizer recently asked the FDA to authorize its COVID-19 vaccine for ages 5 to 11! Learn more.

There could possibly be a COVID-19 vaccine for infants and toddlers this winter.

Vaccines are usually studied and approved in order of age, with healthy adults first and babies last. After a COVID-19 vaccine is authorized for the oldest clinical trial group of kids, a company will move to the next youngest group.

Pfizer has said that once they have results from their clinical trial for 5-to-11-year-olds – expected in September or October – results for the 2-to-under-5 age group and 6-months-to-under-2 age group could quickly follow. They might then begin the same process for FDA emergency authorization for these ages.

Depending on how the next few months go, it’s possible there could be a COVID-19 vaccine for children as young as 6 months old by midwinter.

> Related: Is Your Child Scared to Get Their COVID-19 Vaccine? Tips to Prevent Fear of Needles

For now, the COVID-19 vaccine is only available for ages 12 and up.

If your child is old enough, please make sure they’re fully vaccinated.

For updates about a COVID-19 vaccine for younger kids, stay in touch with your child’s pediatrician, and subscribe to Connecticut Children’s Growing Healthy blog. We’re committed to keeping you informed, and protecting your child from COVID-19.

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• What Should Parents Know About the Delta Variant, Kids and Back to School?