COVID-19 vaccine testing focuses on children

The 9-year-old twins didn’t budge because they each received test doses of Pfizer’s COVID-19 vaccine – and then a sparkling bandage to cover the spot.

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

Researchers in the US and abroad are starting to test younger and younger children to make sure that COVID-19 vaccines are safe and work for any age. The first shots go to adults most at risk from the coronavirus, but children must also be vaccinated to end the pandemic.

“Children should be given the chance,” Marisol told The Associated Press this week after the sisters participated in Pfizer’s new study of children under the age of 12. “So that everything could be more normal.” She looks forward to having sleepovers with friends again.

So far, the testing of teens in the US is furthest: Pfizer and Moderna expect to soon publish results showing how two doses of their vaccines performed in audiences 12 and older. Pfizer is currently authorized for use from the age of 16; Moderna is for people 18 and older.

But younger children may need different doses than teens and adults. Moderna recently started a study similar to Pfizer’s new study, as both companies are looking for the right dosage of each shot for each age group as they work to eventually vaccinate babies as young as 6 months.

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Last month, AstraZeneca in Great Britain began a study of its vaccine in 6 to 17-year-olds. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing that the vaccine is safe for children as young as 3 years old.

Obtaining this data, for any vaccines being rolled out, is critical because countries must vaccinate children to achieve herd immunity, Duke pediatric and vaccination specialist Dr. Emmanuel “Chip” Walter, who helps lead the Pfizer study.

Most of the COVID-19 vaccines used around the world have been studied in tens of thousands of adults for the first time. Studies in children don’t have to be that big: Researchers have safety information from those studies and subsequent vaccinations of millions of adults.

And because the rates of childhood infections are so low – they make up about 13% of the COVID-19 cases documented in the US – the main focus of pediatric studies is not disease counting. Instead, researchers are measuring whether the vaccines stimulate young people’s immune systems, just like adults’ – suggesting they will provide similar protection.

Evidence that this is important because while children are much less likely than adults to become seriously ill, at least 268 have died of COVID-19 in the US alone and more than 13,500 have been hospitalized, according to a count of the American Academy of Pediatrics. That’s more than dying from the flu in an average year. In addition, a small number have developed a serious inflammatory condition related to the coronavirus.

Aside from their own health risks, there are still questions about how easily children can spread the virus, which complicates efforts to reopen schools.

Earlier this month, Dr. Anthony Fauci, America’s top infectious disease expert, told Congress that he expected high school students to get vaccinated in the fall. The elementary students, he said, may not be eligible until early 2022.

In North Carolina, Marisol and Alejandra made their own choice to volunteer after their parents explained the possibility, 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 conduct their own research projects with the girls.

In the first phase of the Pfizer study, a small number of children will receive different doses of vaccine, while in the next phase, scientists choose the best dose to test in thousands of children.

“We really trust the research process and understand that they can get a dose that doesn’t work at all, but that can have side effects,” said Naggie, describing the decision-making that parents face when registering their children.

But 9-year-olds have some understanding of the devastation of the pandemic, and “it’s fun to get involved in something that’s not just about yourself, but also about learning,” Naggie added. “They worry about others and I think this is something that really, you know, came to them.”

For Marisol, the only part that was “a little unnerving and scary” was that he had to take a blood sample first.

The vaccination itself was “very easy. If you just sit still during the recording, it just gets simple, ”she said.

The Associated Press Department of Health and Science is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.