San Antonio Express-News

Getting shots in little arms

Scientists are starting to test young to ensure vaccines are safe for them

- By Lauran Neergaard

The 9-year-old twins didn’t flinch as each got test doses of Pfizer’s COVID-19 vaccine — and a sparkly bandage to cover the spot.

“Sparkles make everything better,” declared Marisol Gerardo as she hopped off an exam table at Duke University to make way for her sister Alejandra.

Researcher­s in the U.S. and abroad 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 as well.

“Kids should get the shot,” Marisol said this week after the sisters participat­ed in Pfizer’s new study of children under age 12. “So that everything might be a bit more normal.”

She said she’s looking forward to when she can have sleepovers with friends again.

So far in the U.S., teen testing is furthest along: Pfizer and Moderna expect to release results soon showing how two doses of their vaccines performed in the 12-and-older crowd. Pfizer is authorized for use starting at age 16; Moderna is for people 18 and older.

But younger children may need different doses than teens and adults. Moderna recently began a study similar to Pfizer’s new trial, as both companies hunt for the right dosage for each age group as they work toward eventually vaccinatin­g babies as young as 6 months.

Last month in Britain, Astrazenec­a began a study of its vaccine among 6- to 17-year-olds. Johnson & Johnson is planning its own pediatric studies. And 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 this data is critical because countries must vaccinate children to achieve herd immunity, said Duke pediatric and vaccine specialist Dr. Emmanuel “Chip” Walter, who’s helping lead the Pfizer study.

Most COVID-19 vaccines being used around the world were first studied in tens of thousands of adults. Studies in children won’t need to be nearly as large: Researcher­s have safety informatio­n from the earlier studies and subsequent vaccinatio­ns of millions of adults.

And because children’s infection rates are so low — they make up about 13 percent of COVID-19 cases documented in the U.S. — the main focus of pediatric studies isn’t counting numbers of illnesses. Instead, researcher­s are measuring whether the vaccines rev up youngsters’ immune systems much like they do adults’.

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 in the U.S. and more than 13,500 have been hospitaliz­ed, according to the American Academy of Pediatrics. That’s more than die from the flu in an average year.

A small number also 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.

This month, Dr. Anthony Fauci, the top U.S. infectious disease expert, told Congress he expected that high school students likely would begin getting vaccinated in the fall. Elementary students, he said, might not be eligible until early next year. In North Carolina, Marisol and Alejandra made their own choice to volunteer after their parents explained the opportunit­y, said their mother, Dr. Susanna Naggie, 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 receive different doses of vaccine as scientists winnow out the best dosage to test in 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 that 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 added. “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. The vaccinatio­n itself was “really easy. If you just sit still during the shot, it’s just going to be simple,” she said.

 ?? Shawn Rocco / Associated Press ?? Alejandra Gerardo looks at her mom, Dr. Susanna Naggie, as she gets a COVID shot in a clinical trial for children in Durham, N.C.
Shawn Rocco / Associated Press Alejandra Gerardo looks at her mom, Dr. Susanna Naggie, as she gets a COVID shot in a clinical trial for children in Durham, N.C.

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