The 9-year-old twins were unfazed when each received test doses of Pfizer’s COVID-19 vaccine, and then a bright bandage to cover the spot.
“The sparkles make everything better,” declared Marisol Gerardo as she jumped from an exam table at Duke University to make way for her sister Alejandra.
Researchers in the US and abroad are beginning to test increasingly young children to make sure COVID-19 vaccines are safe and work for all ages. The first vaccines go to adults who are most at risk of contracting the coronavirus, but ending the pandemic will also require vaccinating children.
“Children should get the vaccine,” Marisol told The Associated Press this week after the sisters participated in Pfizer’s new study of children under 12 years of age. “So that everything is a little more normal.” She looks forward to the time when she can have a sleepover with friends again.
So far, in the US, testing for teens is more advanced: Pfizer and Moderna hope to publish results soon that show how two doses of their vaccines performed in the 12-year-old age group or older. Pfizer is currently licensed for use ages 16 and up; Moderna is for people over 18 years old.
But younger children may need different doses than teens and adults. Moderna recently began a study similar to the new Pfizer trial, as both companies search for the correct dose of each injection for each age group as they work to eventually vaccinate babies as young as 6 months.
Last month in Britain, AstraZeneca began a study of its vaccine among children ages 6 to 17. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced that it submitted preliminary data to Chinese regulators showing that its vaccine is safe in children as young as 3 years old.
Obtaining this data, for all vaccines that are being implemented, is critical because countries must vaccinate children to achieve herd immunity, said Dr. Emmanuel “Chip” Walter, Vaccine and Pediatric Specialist at Duke, who is helping to lead the Pfizer study.
Most of the COVID-19 vaccines in use around the world were first studied in tens of thousands of adults. The studies in children won’t need to be that large – researchers have safety information from those studies and subsequent vaccines for millions of adults.
And because childhood infection rates are so low (they account for about 13% of documented COVID-19 cases in the US), the primary focus of pediatric studies is not counting the number of illnesses. Instead, researchers are measuring whether vaccines boost young people’s immune systems as adults do, suggesting they will offer similar protection.
Proving that is important because while children are far less likely than adults to become seriously ill, at least 268 have died from COVID-19 in the U.S. alone, and more than 13,500 have been hospitalized, according to a tally by 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 severe inflammatory disease related to the coronavirus.
Aside from its own health risks, there are still questions about how easily children can spread the virus, something that has complicated efforts to reopen schools.
Earlier this month, Dr. Anthony Fauci, America’s leading infectious disease expert, told Congress that he expected high school students likely to start getting vaccinated in the fall. Elementary students, he said, might not be eligible until early 2022.
In North Carolina, Marisol and Alejandra made their own decision 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 while scientists select the best dose to test on several thousand children in the next phase.
“We really trust the research process and understand that they may be given a dose that doesn’t work at all but can have side effects,” Naggie said, describing the decision-making that parents face when enrolling their children.
But 9-year-olds have a little understanding of the devastation of the pandemic and “it’s nice to be involved in something that is not just about yourself but about learning,” Naggie added. “They care about others and I think this is something that really caught their attention.”
For Marisol, the only part that was “a bit stressful and scary” was having to give a blood sample first.
The vaccination itself was “really easy. If you stay still during the shot, it will be simple, ”he said.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.