The FDA has decided to extend the Pfizer COVID vaccine’s emergency use authorization to children ages 12 and up. The vaccine appears to be as safe and effective in this age group as in young adults, according to recent studies.
The vaccine is authorized now, so theoretically a kid in that age range could get the vaccine today. But the Advisory Committee on Immunization Practices (ACIP), the CDC’s advisory panel on vaccines, plans to meet tomorrow (May 12) to formalize a recommendation on whether 12-year-olds should get the vaccine. They are expected to recommend it, which will require insurance companies to cover the cost. Vaccine clinics are expected to offer the vaccine to 12-year-olds and up after the ACIP recommendation.
If the ACIP decides not to recommend the vaccine, or if they add any caveats, we’ll update to let you know.
What did the studies say?
The extended authorization is based on a study of over 2,000 12-to-15-year-olds, where half got the vaccine and half got the placebo. There were 16 cases of COVID-19 in the placebo group and none in the vaccine group, for an efficacy of 100%. (Real world effectiveness may be lower, but this is still an excellent result.)
There was also an analysis that compared 190 people between ages 12 to 15 who got the vaccine with 170 people between ages 16 and 25. The younger people showed the same immune response as their slightly older peers.
While children are less at risk from death and severe complications of COVID, they are more at risk for a serious inflammatory syndrome called MIS-C that can be triggered by a COVID infection. They may also be susceptible to long COVID, and they are able to transmit the virus to other family members. Vaccinating children will help to protect them as well as the adults that they come in contact with. It will also make schools and activities safer; once most children are vaccinated and cases are low, mask requirements and distancing may not be necessary in schools anymore.
Is the kids’ vaccine any different from the adult version?
Nope, it’s the same vaccine at the same dose, given on the same schedule (two doses, three weeks apart). This means that a vaccine clinic doesn’t have to do anything significantly different for 12-year-olds than it would for 16-year-olds or, for that matter, 65-year-olds, so the rollout is likely to be simple.
In a press conference, FDA officials noted that state licensing boards sometimes regulate minimum ages that a given professional can work with, so just because the vaccine is authorized for a certain age group doesn’t mean that every provider can administer it. Check with your local vaccine clinic to see if they have a minimum age. But if an adult provider isn’t able to give the vaccine to your kid in your state, a pediatric provider can.
When will the vaccine be available for younger kids?
Studies are still ongoing for younger kids. The immunobridging approach, which compared the immune response of children to that of adults, is considered to be appropriate for 12-to-15-year-olds, but safety studies in younger children will need to be more involved. The most appropriate dose and schedule for young children may also end up being different from that for adults.
Pfizer is the company that is furthest ahead in its trials in children, and they recently said they expect to apply for authorization for younger children in September, and potentially for infants in November.