COVID-19 vaccine trial was not a tribulation for Trumbull family
TRUMBULL — Ashley Balestriere wants her children to have a normal childhood. But for that to happen, she decided to sign them up for an unusual activity.
Earlier this year, Balestriere registered her son and daughter in a Moderna trial study for children at a Yale New Haven Health research facility. The trial is nearing its end and, should the vaccine be granted emergency use authorization, Balestriere is eager to vaccinate them.
Although the family goes about its normal daily activities, she still worries. When she shops at the supermarket with her children, she said she wonders if unmasked children nearby could have been exposed to COVID-19 from adults and put her children at risk.
“The kids want to go out to restaurants and they want to do certain things. So they want to get vaccinated in hopes getting some normalcy back to their lives,” Balestriere said.
To try to make that happen, Balestriere signed her children up to participate in the trials. At first, she
seriously considering taking her children all the way to Rochester, N.Y., since Pfizer was conducting a study there. But she found out that Moderna was also conducting trials much closer to home in New Haven.
Yale New Haven Health researchers were not available to comment on the study.
Her children, she said, were eager to participate in the trials, so they applied and were taken off the waiting list in early August to participate after some other children dropped out.
She had long taught them about vaccines as a nurse, so her children were unfazed. But some members of her husband’s family weren’t totally on board.
“Everybody can’t wait to get vaccinated on my side of the family. My husband’s side of the family, there’s a mixture of opinions,” she said.
Yet her husband deferred to her expertise. The safety guidelines laid out the process. Both her 7-year-old daughter, Amy Ruth, and 10-year-old so,n Jimmy, were subjected to a physical exam and checked for any preexisting conditions that would put them at risk. Once they were cleared, they participated in what is known as a doubleblind trial, where neither the participant nor researcher knows if they received the vaccine or a placebo.
Despite having to draw blood from her children, she said they were in good spirits.
“The research team made it a very pleasant experience for the kids. They gave them teddy bears, they gave them stickers, they gave them candy,” she said.
She was advised to monitor her children’s physical condition afterward and look for any reactions to the vaccine. At first, she was convinced her children had both received a placebo. Neither experienced any fatigue or muscle aches. She remembered feeling knocked out when she received her vaccine earlier in the year.
But once she did some percentage calculations, she realized one of her kids probably had received the vaccine.
“When I did the math, the likelihood that they both somehow got the placebo is only 6 percent. So there is a 94 percent chance that at least one of my children got vaccinated and has no side effects whatsoever,” she said.
She arrived at that answer because 75 percent of the study’s participants received the vaccine. She calculated there was a 53 percent chance both children would be vaccinated. The likelihood of both children getting a placebo was low.
Her children got their second dose on Sept. 14. Fears of any potential adverse reactions proved to be unfounded.
“My kids have just been running, bouncing off the walls, no fever,” she said.
She’s not completely sure, however, and speculated that the lack of side effects may also have to do with potentially getting a lower dosage. In any case, her family is at peace with the decision to participate. But a few people in the community have been critical.
When she wrote about the experience on a Trumbull Facebook group, a few people claimed she was risking the health of her children.
Balestriere stood her ground.
“I was taught how to critically examine research and look at the hierarchies of legitimate research and know what a primary source is versus a secondary source or thirdhand or hearsay information,” she said.
She still doesn’t know for sure if one of her children received a placebo, but she’s sure of one thing: If and when the Moderna vaccine gets an emergency use authorization for children younger than 12, she will not hesitate.
“If one of my kids got the placebo, I will take them right in to get vaccinated as soon as I can,” she said.