A COVID-19 vaccine for children under age 12 is not yet authorized for emergency use in the United States, but Pfizer-BioNTech announced on Sept. 20 that it is getting close to submitting its vaccine trial data to the U.S. Food and Drug Administration (FDA) for children between the ages of 5 and 11.
Usually, when an adult wants to participate in a COVID-19 vaccine trial, they can give legal consent, but what about minors participating in vaccine trials? Some TikTok users are claiming that kids don’t have a say because they’re underage.
Do children have the ability to opt out of a COVID-19 vaccine trial?
Yes, children who are mature enough have the ability to opt-out of a COVID-19 vaccine trial through something called the assent process. For children who are not mature enough, such as babies or very young children, their parents or guardians have the authority to grant permission.
WHAT WE FOUND
Dr. James Campbell, a pediatric infectious disease specialist at the University of Maryland Medical System, says only adults can give legal consent to participate in all forms of clinical research, like the COVID-19 vaccine trials. But Campbell, who also works on Moderna and Novavax’s COVID-19 vaccine trials for children, told VERIFY that children can assent, which is “kind of like a child version of consent.”
According to the National Institutes of Health (NIH), in order to take part in the assent process, a child must be mature enough to understand the trial and what they are required to do. NIH says assent means that a child agrees to participate. Children may also dissent, which means they do not agree to participate.
“For the older children, like teenagers, they have a written assent form that has the same content, the same general themes as what the parent permission form has, but it's written in simpler language and it's shorter,” said Campbell.
Meanwhile, for most children between the ages of 6 and 12, Campbell says doctors typically go through a verbal assent process.
“It's the same process, but since we're worried that, you know, having them sign something or reading documents might be difficult for some of them in that age, we read it to them,” said Campbell. “Then we ask them, with their parents there, ‘are you willing to be in the study? Is this something you want to do?’ And if they say yes, then depending on the child, sometimes they can sign or we can sign.”
For children who are not mature enough to assent or dissent, such as babies or very young children, their parents or guardians have the authority to grant permission, according to Campbell.
“When you're talking about a 6-month-old, obviously, there's no way that they can consent, assent or give any kind of permission, so for that, we just have to be very careful that we discussed with the parents all of the information, and then they give permission for their child to join,” said Campbell.
According to NIH, both parents need to give permission in order for their child to take part in a clinical trial unless one parent has died, is unknown, is incompetent, is not reasonably available or only one parent has sole legal custody of the child.
A Pfizer spokesperson told VERIFY children who want to participate in its COVID-19 vaccine trials are asked to provide verbal or written assent before any study-specific activity is performed. The child’s parents or guardians are also capable of giving signed informed consent.
“All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand,” said Pfizer.
In May, Moderna announced that its COVID-19 vaccine was highly effective at preventing COVID-19 in adolescents between the ages of 12 and 17. The company submitted its results to the FDA in early June and requested emergency use authorization at that time.
Campbell told VERIFY a clinical trial is currently underway at Moderna for children under the age of 12 that is separated into three age groups — 6 to 11 years old, 2 to 5 years old, and 6 months to 23 months. He said for the 6 to 11-year-old group, which includes around 4,000 children in the U.S. and Canada, half of the adult dose has been chosen for them at this point in the study, however, they are set to get their second dose of the vaccine within the next few days.
“By the end of this week, or maybe into next week, all of those children will have gotten their second dose, and then we're going to need at least a month after that, maybe two months after that, to look at their immune responses and their safety,” said Campbell.
Novavax is planning on sharing its COVID-19 vaccine trial data for individuals aged 12 and older with the FDA soon, according to Campbell, but he says no children under the age of 12 have been enrolled in any Novavax study.
While assent is not always required by law, NIH says Institutional Review Boards (IRBs) may require it. IRBs consist of a group of scientists, doctors, clergy and patient advocates that review and approve the detailed plan for a clinical trial.
“IRBs are meant to protect the people who take part in a clinical trial. They check to see that the trial is well designed, legal, ethical, does not involve unneeded risks, and includes a safety plan for patients,” said NIH. “Even if assent is not required, your child will still benefit from going through the assent process. Doing so can help them feel more in control and engaged in the trial. It shows that they have a say in what happens to them and that their questions and input are valued.”