April 16, 2021 -- As more and more adults are getting vaccinated against COVID-19, researchers are reaching out to families as they recruit the youngest members of the population to test how effective the vaccine will be in them. For the newest round of vaccine trials, focused on the Moderna and Pfizer vaccines, researchers need babies as young as 6 months to children under 12.
"It takes a lot of commitment to enroll," says Emmanuel "Chip" Walter, MD, chief medical officer at the Duke Human Vaccine Institute and an investigator for COVID-19 vaccine trials. "There are unknowns. We don't know if [kids will have] more fever or side effects. Parents have to go into it with that understanding. And not all parents are willing to have their children be included in the study, and that's OK. That's their choice. They have to be comfortable for their children to be included."
Reaching herd immunity in the U.S. will require that 70% to 85% of the population be vaccinated or have immunity from infection, and getting there will be difficult without vaccinating children, some experts say.
Families who have made the decision to enroll their children say they did not do so lightly, and that they discussed the decision with their kids, if they are old enough to understand. Here is how three families decided to volunteer.
The Gerardo-Naggie Family: Shop Talk Common
Family conversations at the home of Charles Gerardo, MD, and his wife, Susanna Naggie, MD, often involve shop talk. Gerardo is professor and chief of emergency medicine at the Duke University School of Medicine, while his wife is an associate professor and infectious disease specialist there. When they asked their 9-year-old twins, Alejandra and Marisol, what they thought about enrolling in a clinical trial to test the COVID-19 vaccine, they didn't have to start at square one.
"They understand the concept of clinical research," Gerardo says. "Both my wife and I do clinical research, so science is much more in their wheelhouse than when I was a kid."
The third graders had already seen their parents get the vaccine. Both frontline workers, Gerardo confessed that during the pandemic, he has often thought: "Will I get the vaccine first or will I get COVID first?" Thankfully, the answer was the vaccine.
Once they were vaccinated, he says, they moved on to deciding, as a family, on whether to enroll their girls in the clinical trials. "They are old enough to remember the 'before,'" and their lives at in-person school and other activities, Gerardo says. They were game. Even at 9, ''the pandemic has profoundly impacted their lives and the lives of all their friends," Gerardo says.
Then there was the prospect of bragging rights for the girls. They were first in the country to get vaccinated when Duke University began the phase I trial of the Pfizer vaccine involving children 12 years down to 6 months.
For Gerardo and Naggie, the decision to enroll their twin daughters was also accompanied by a change in their mindset about privacy. "Normally we wouldn’t give names, but we made a conscious decision to give their names in this case," Gerardo says.
"It's important to have racial and ethnic diversity in the clinical trials themselves," says Gerardo, who is of Mexican descent. "There is a fair amount of vaccine hesitancy in the Latino community. It is good for some of the people to see that some of the participants in this trial are Mexican-American girls."
The Palma Family: What About the Baby?
Tegan Palma, MD, an anesthesiologist in Rochester, NY, and her husband, Chris Palma, MD, a rheumatologist at the University of Rochester Medical Center, have agreed to enroll all four children in the COVID-19 vaccine trials there. They are ages 6, 4, and 3, and 7 months.
Tegan says her husband was in a clinical trial for the vaccine. Toward the end of the trial, he found out he had been in the placebo group, but was then able to get the vaccine through work. So it was natural to think about enrolling their children, she says.
"We talked about it," Tegan says. "I guess my initial though was, 'I definitely want to enroll my toddler [as well as the older children], but there is this very unscientific part of me that doesn't want to enroll my baby.'" After a little more thought, she says, she became comfortable enough to enroll all four.
Part of her comfort might originate from her childhood, she says, when her mother, a pediatric resident at the time, enrolled her in a trial for a vaccine for Hib, an infection common in children. Their decision to enroll all four children, she says, is supported by two goals. "We like to contribute to the science and to have our family protected."
The older kids have their own goals, she says. Her 6-year-old and 4-year-old ''mostly want to see their cousins and grandparents," she says. But the 3-year-old has her goals, too. "She wants to return to dance class," her mother says.
"You have to weigh your own personal risk-benefit analysis," she says. "But this is a known technology [the messenger RNA in the Moderna and Pfizer vaccines], and it has been studied extensively in other populations, and there is no good scientific reason why it should be any different in kids." The dose needed, of course, may be different, and the trial will evaluate that.
Once her kids are vaccinated, she says, her comfort level about them returning to school will be greatly increased.
The Richards Family: Teens Just Want Their Lives Back
Teens are often the most enthusiastic participants, Walter of Duke University has found. As he was enrolling participants, teens often mentioned to him that it was more their idea than their parents'.
Katherine Richards says her teen, Zachary, 15, is ''full-steam ahead, saying he's ready, what are we waiting for." Richards and her husband signed up Zachary and their younger son, Sean, 9, for University of Rochester trials. The trial has not yet begun; they are in the pre-screen phase.
Their younger son shows a bit more pause, she says, although he is game for anything that will make life normal again. He gets nosebleeds, Richards says. So he is a bit leery of a potential need to have a nasal swab done. Even so, she says, both boys ''appreciate that [the trial] is a way out of this [pandemic]."
Richards says the boys were involved in the decision, as was her husband. "You have to look at your family beliefs. We have a big belief in preventive medicine. We value [other types of] vaccination and well-child checks."
For Katherine, there is another motivation. "As a researcher who does human research studies, I do feel an obligation to be willing to participate myself." She and her husband asked about the vaccine trial when it was recruiting adults, but ended up not being eligible.
The response from families about enrolling in the pediatric trials so far has been robust, say Walter, of Duke Univeristy, and Jennifer Nayak, MD, chief of pediatric infectious diseases at the University of Rochester Medical Center and an investigator for pediatric COVID-19 vaccine trials there. When Walter was ready to enroll 100 participants at one stage of the trial, he says they received more than 800 inquiries.
Before signing up, parents should ask about the time commitment, trial leaders say, including the number of visits, the follow-up period, and other details. Parents will be expected to record detailed information, such as whether children have side effects such as fevers.
Be prepared for children to worry about things adults might not worry about, Gerardo says. His daughters were especially worried about the blood draws required. He finds that ''their concern is more immediate, like "How much will this hurt?''' and less about things like long-term side effects.
"All the drama was about the blood draw," he says of his daughters' decision-making process, but they got through it fine.
For children in a trial phase that assigns them to placebo or vaccine, parents can certainly ask at what point their child will be able to get the vaccine, Nayak says.
If a potential participant is older, Nayak advises the parents to have a conversation and let them know exactly what to expect and to see if they are truly on board.