Earlier this month, the U.S. broke its record for the most children hospitalized with COVID in one day since the beginning of the COVID-19 pandemic, with more than 1,900 kids in the hospital on August 15. This surge in severe cases lines up with the back-to-school season, but many school districts aren’t requiring masks and aren’t offering online options. And as parents know well, the COVID vaccine isn’t yet available for kids under 12. Yes, the Pfizer vaccine is technically legal now — but it’s definitely not safe to give to kids “off-label.” So you can beg your child to keep their mask on at school, but what else can you do? Here’s one idea: Enroll your kid in a COVID vaccine trial.
Although participating in a trial is more work than getting a shot at your local pediatrician’s office, it could potentially give your kid protection against COVID that they otherwise wouldn’t have, says Bill Muller, MD, PhD, a pediatric infectious disease specialist at Northwestern Feinberg School of Medicine who is working on a pediatric COVID vaccine trial.
Pfizer says that it expects to file for emergency use authorization for its vaccine in kids aged 5 to 11 in September. It could take several weeks after that before authorization is granted and those kids can get the vaccine. The company expects to file for kids aged 2 to 5 shortly after, and for those aged 6 months to 2 years in October or November. Moderna is on a slower timeline. In the interim, a trial is your only shot at getting your young child vaccinated against COVID.
So how do you get your kid involved in a COVID vaccine trial? Researchers all across the country are looking for kids to join their studies, but that doesn’t mean it’s easy to get in. This is how you do it.
How Pediatric COVID Vaccine Trials Work
The Food and Drug Administration can’t yet authorize the COVID vaccines for use in kids under 12 because researchers haven’t finished studying that age group. Kids need a different dose than adults., and it’s possible that the vaccines could work differently in younger people with smaller bodies. Experts need to finish testing for both safety and efficacy before the Food and Drug Administration and Centers for Disease Control and Prevention give their seal of approval and younger kids can start getting vaccinated en masse.
Moderna and Pfizer are currently testing their vaccines in kids under age 12 in the U.S. Johnson and Johnson is testing its vaccine in adolescents aged 12 to 17 in Spain and the UK, but it will eventually also enroll kids in the U.S.
In early trials, only a small number of kids get the vaccine. Experts study side effects and immune reactions in these kids to determine dosages. Next, they expand the trial to more kids, and that’s where you’re likely to come in. The researchers randomly give some of the enrolled kids the vaccine, and they give a smaller amount a placebo. You won’t know which one your child receives until much later down the line. The researchers then track side effects, which kids get sick with COVID, and who is hospitalized.
What’s It Like to Be in a COVID Vaccine Trial?
Each vaccine trial is slightly different depending on the research site. But in general, they start with a screening process to make sure that the children who have volunteered are eligible. The exact requirements are lengthy and differ slightly between Moderna and Pfizer, but the one that is relevant to most children is that they must be in good health. Chronic conditions such as diabetes or asthma must be under control.
Parents usually take an eligibility survey for their child when they express interest in a trial. If their child is selected, they will have to travel to the research site to receive their first and second doses. They will also make additional in-person and telehealth visits. For months or even years after the study, the researchers will ask them to check in and potentially visit the site in person for follow-up. During the study, they may also be asked to keep a daily diary of any side effects they experience.
“We would also ask them to continue to be followed for potential adverse effects afterwards, which would not be the case for somebody who was going to their regular physician to get the vaccine,” Muller says.
Participation in any stage of the study is voluntary, and families can drop out at any time. (But for the sake of the science, you should continue participating as long as you’re asked, barring unforeseen circumstances.)
Not every child in a COVID vaccine trial will actually receive the vaccine. Some will get a placebo. How many children get the vaccine versus the placebo may depend on the site, but it appears that many studies give three kids a vaccine for every one that gets a placebo. Because of this, it’s important to keep using other precautions to prevent COVID infection.
Priya Banerjee, MD, a forensic pathologist in Rhode Island, is trying to get her daughter enrolled in a study. If she is able to, she doesn’t plan on acting any differently after her daughter gets her shot in case it’s a placebo. “I’m not reducing my precautions even if she gets into a study,” she says. “We’re still going to follow the utmost protocol.”
When the vaccine is authorized for your child’s age group, you will have the option to reveal whether your kid received the placebo. If they did, you will be first in line to get a vaccine. “We can promise them that they would have earlier access to the vaccine if one were to become authorized prior to the end of the study,” Muller says.
Is It Safe to Enroll Your Kid in a COVID Vaccine Trial?
“The main objective for every clinical trial is safety,” Muller says. “Even in those trials that are in relatively late stages, such as the COVID vaccine trials, the most important assessment that we make is that patients are staying safe.”
This is why the researchers closely evaluate and track participants for adverse effects. There are many rules in place that would make the researchers pause the study if they found too many complications. Besides, studies have already found that the vaccines are safe in adults, and many kids have already been tested in the trials, so there is little chance that the vaccines would harm a child participant.
If you have any particular questions, don’t be afraid to ask the experts running the trial that you’re applying to. And remember, putting your child’s name on an interest list doesn’t commit them to a study. So sign up, and if you’re selected, you can get your answers straight from the mouths of the experts themselves before you and your child decide whether to participate.
How to Get Your Kid in a COVID Vaccine Trial
The basics are simple: Find a trial and put your name on the list. However, finding trials that are recruiting participants is more difficult than it sounds. Banerjee has been trying for months, but to no avail. “It’s very luck of the draw,” she says. One site, for example, had a 2,000-person waiting list.
Luckily, research sites may be recruiting more kids now. In early August, the FDA urged Pfizer and Moderna to increase enrollment for their trials for kids aged 5 to 11. With more participants, researchers have a greater chance of catching potential rare but serious side effects.
Online resources can help you find sites that are recruiting. Start by looking at the websites for the Moderna and Pfizer trials:
- Search for a pediatric Pfizer COVID vaccine trial here
- Check your eligibility and find a nearby pediatric Pfizer COVID vaccine here
- Check your eligibility and find a nearby pediatric Moderna COVID vaccine trial here
You can also look into individual trial sites near you to check if they’re recruiting, then reach out to them directly. You can find at least some of the site locations for the Moderna and Pfizer trials under the “Locations” tab at their respective clinicaltrials.gov web pages.
For many trials, there isn’t a location requirement. So if the only one you get into is on the other side of the country, you can technically do it. But remember, you’ll have to visit in person, so it may be best to stay local. Nisha Gandhi, MD, an ICU doctor in New Jersey, had her daughter accepted into a study in Idaho. But she ultimately decided that the site was too far for the number of trips they would need to take. Luckily, she was able to enroll her daughter in a study closer to home.
Don’t be afraid to network with local parents to discover new trial sites. And keep an eye on local news publications, which may announce when a nearby research site needs more volunteers.
Getting into a pediatric COVID vaccine difficult is difficult, and a lot of it is luck. But it’s also about dedication. The family that applies to eight sites is going to be more likely to get in than the family that applies to two. If you’re game to apply, don’t hesitate. Because sites are filling up fast, and there’s only so many shots to go around.