[Originally published: March 31, 2021. Updated: May 13, 2021]
On May 10, the Food and Drug Administration (FDA) authorized the use of Pfizer-BioNTech’s COVID-19 vaccine for adolescents between ages 12 and 15. The clearance is an amendment to the existing emergency use authorization for the Pfizer vaccine for ages 16 and up. Later that week, the Centers for Disease Control and Prevention (CDC) recommended its use in 12- to 15-year olds, clearing the way for vaccination in that age group to begin.
With schools soon wrapping up for the summer and vacations on the horizon, the news is welcome to many pandemic-weary families.
The ability to vaccinate children is also a major milestone, says Onyema Ogbuagu, MBBCh, a Yale Medicine infectious diseases specialist. “Kids make up nearly 30% of the population. If we can vaccinate them, that puts us on an easier path toward herd immunity,” he says. “This also has huge implications for school reopenings and what kids can do in the future.”
Dr. Ogbuagu was a principal investigator in the Phase 3 Pfizer-BioNTech study on adolescents completed at Yale. In late March, the drug makers announced, through a press release, that the vaccine demonstrated "100% efficacy and robust antibody responses," higher than those recorded earlier in ages 16 to 25. Side effects were also similar to those in that age group.
“We were happy to see that the safety profile was the same in kids as it was for adults. They did just fine, and their experience with side effects was no different than what we saw in the adult population,” Dr. Ogbuagu says.
Among the 2,260 trials participants, there were no symptomatic COVID-19 cases in those who received the vaccine, compared to 18 symptomatic cases in the placebo group. The study enrolled participants in January and went on for about two months after vaccine completion, he says.
Children still make up a minority of COVID-19 cases nationwide, but vaccinating them is key to slowing down spread of the disease, experts say. As of the end of April, approximately 3.78 million children have tested positive for the coronavirus since the pandemic began. This makes up 13.8% of all cases. After increases in new reported cases in children in March and April, those numbers have started to decrease, according to data from the American Academy of Pediatrics and the Children Hospital Association.
Pfizer also filed for full FDA approval for its vaccine for ages 16 to 85 in early May. If granted, it would be the first COVID-19 vaccine to have this status. The company plans to apply for emergency use authorization for children ages 2 to 11 in September.
Meanwhile, Yale is one of 90 sites across the U.S. and Canada participating in a clinical trial of the Moderna vaccine for ages 6 months to 12 years. Moderna is also expected to release results from a trial in adolescents ages 12 to 17 soon.