DURHAM, N.C. — The 9-year-old twins didn’t flinch as each received test doses of Pfizer’s COVID-19 vaccine — and then a sparkly bandage to cover the spot.
“Sparkles make everything better,” Marisol Gerardo said as she hopped off an exam table at Duke University in North Carolina to make way for her sister Alejandra.
Researchers are beginning to test younger and younger kids to make sure COVID-19 vaccines are safe and work for each age. The first shots have been going to adults — who are most at risk from the coronavirus — but ending the pandemic will require vaccinating children, too.
“Kids should get the shot,” Marisol said after the sisters participated in Pfizer’s new study of children under 12 years old. “So that everything might be a bit more normal.”
She’s looking forward to when she can have sleepovers with friends again.
In the United States, testing among teenagers is the furthest along. Pfizer and Moderna expect to release results soon showing how two doses of their vaccines performed among kids 12 and older. Pfizer’s vaccines so far is authorized for use starting at 16. Moderna’s is for people 18 and older.
But younger kids might need different doses than teenagers and adults.
Moderna recently began a study similar to Pfizer’s new trial, as both companies seek the right dosage of each shot for each age group as they work toward eventually vaccinating babies as young as 6 months old.
In Britain in February, AstraZeneca began a study of its vaccine among 6- to 17-year-olds. Johnson & Johnson is planning its own pediatric studies. In China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.
Getting such data for all of the vaccines being rolled out is critical because children need to be vaccinated to achieve herd immunity, said Dr. Emmanuel “Chip” Walter, a pediatric and vaccine specialist at Duke who is helping to lead the Pfizer study.
Most COVID-19 vaccines now in use worldwide were first studied in tens of thousands of adults. Studies in children won’t need to be nearly as large, though. Researchers have safety information from the earlier studies and as a result of the subsequent vaccinations of millions of adults.
And because children’s infection rates are so low — they make up about 13% of COVID-19 cases documented in the United States — the main focus of pediatric studies isn’t counting numbers of illnesses. Instead, researchers are measuring whether the vaccines rev up youngsters’ immune systems as they do for adults — which would suggest that they’ll offer similar protection against the coronavirus.
Proving that is important because, while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 nationwide, and more than 13,500 have been hospitalized, according to a tally by the Itasca-bAmerican Academy of Pediatrics. That’s more than die from the flu in an average year.
A small number of children have developed a serious inflammatory condition linked to the coronavirus.
Apart from their own health risks, there still are questions about how easily children can spread the virus — something that has complicated efforts to reopen schools.
Dr. Anthony Fauci, the top U.S. infectious disease expert, has told Congress he expected that high school students likely would begin getting vaccinated in the fall. But elementary-age kids might not be eligible until early next year, according to Fauci.
In North Carolina, Marisol and Alejandra made their own choice to volunteer after their parents explained the opportunity, according to their mother, Dr. Susanna Naggie, who is an infectious disease specialist at Duke. Long before the pandemic, she and her husband, emergency physician Dr. Charles Gerardo, regularly discussed their own research projects with the girls.
In the first phase of the Pfizer study, a small number of children are getting different doses of vaccine to help scientists determine the best dosage to test among several thousand kids in the next phase.
“We really trust the research process and understand that they may get a dose that doesn’t work at all but may have side effects,” said Naggie, describing the decision-making parents face in signing up their children.
But 9-year-olds have some understanding of the pandemic’s devastation, and “it’s nice to participate in something where it’s not just about yourself, but it’s about learning,” Naggie said. “They do worry about others. And I think this is something that really, you know, struck home for them.”
For Marisol, the only part that was “a bit nerve-wracking and scary” was having to give a blood sample first.
But she says the vaccination itself was “really easy. If you just sit still during the shot, it’s just going to be simple.”
