Vaccines for COVID-19 are shot into more than 1 million arms every day in the United States, and the number is growing. Frontline health care workers, first responders, elderly and vulnerable individuals are top priorities, and tens of millions of adults anxiously await their turn.
But what about a COVID-19 vaccine for kids? So far, no vaccine has been approved for anyone younger than 16.
What’s going on?
Why trials on kids take longer
“First, children are a legally protected population. So when doing research, you usually have to take additional steps to assure safety and to make sure what you’re doing has clear benefits and not extra risk,” she said.
“The second point is that when the pandemic started, children overall were having fewer symptoms and less severe illness. It was more pressing to focus on adults, especially seniors.
“But children certainly get sick and have specific complications from exposure to the virus, and that’s why we need to keep pushing forward, because they are not risk-free.”
How clinical trials work
Getting a vaccine from the initial research phase into widespread use usually takes years. Unprecedented worldwide efforts to produce COVID-19 vaccines reduced that to months. Most of that time is consumed by clinical trials and analyzing data.
Thousands of volunteers, representative of the general population, are recruited to participate in the trials. The larger the testing pool, the more accurate the results will be. About half of the volunteers receive the vaccine. The other half are unknowingly given a placebo, such as a saline solution.
All of the volunteers are studied for allergic reactions, side effects and, of course, whether the vaccine protects them once they’ve been exposed to an infected person. They are evaluated for months to see if they produced antibodies against the virus, to see if anyone got sick in spite of the vaccine and, if so, how sick did they become? The data undergo strenuous statistical analysis.
Not every trial is successful, and some require additional trials before gaining approval.
Looking for age-related effects
Testing children requires consent from their parent or guardian, so recruiting an adequate pool of volunteers is more complex. The trial process is basically the same for children as adults, although researchers must watch for some differences.
“Kids have great livers and kidneys, so their bodies may clear the vaccine faster,” Margaret said. “This could impact their immune response to the vaccine. That’s why, if you look at how pediatric vaccines are given, they tend to get a lower dose more times. So researchers will do dose-reduced studies on children. They’ll also monitor for side effects and see if any are age-related.
“The big thing is safety. Since we have data that show the vaccine is safe for adults, we are not expecting anything different with kids. But we still need to do the study in younger kids to make sure the vaccine doesn’t have an effect we’re not expecting.”
Trials planned for young kids
Pfizer and Moderna produced the first vaccines to gain emergency use approval by the Food & Drug Administration. The Pfizer vaccine has been tested and approved to administer to people 16 years and older. The Moderna vaccine is approved for 18 and over.
Both companies are in the trial stage for children 12 and older.
“Hopefully, we’ll have that data in late summer and a vaccine for that age group before the 2021-22 school year,” Margaret said. “Pfizer has hard plans to test children age 5-11. We would hope to have that data by the end of 2021, but it’s not likely a vaccine for that group will be available until early 2022. Moderna is considering a trial down to 6 months old, but I don’t think there would be data available until early 2022.”
In addition, Johnson & Johnson, which received emergency use approval on February 27 by the FDA for its viral vector vaccine developed by Janssen Biotech, it’s vaccine manufacturer, has plans to test its vaccine in kids, infants, newborns and pregnant women. It currently is approved for use in people 18 and over.
Those plans for future trials were included on page 34 of the company’s application to the FDA. It’s not clear whether this will be for Johnson & Johnson’s one-dose vaccine that received emergency use approval or it’s two-dose vaccine that remains in clinical studies. The company hasn’t shared any timeline for these additional studies.
Keep kids safe while they wait
The American Academy of Pediatrics recommends that young people 16 and older get the COVID-19 vaccine as soon as it is available to them. The same would be expected for younger ages as a COVID-19 vaccine for kids is approved.
“We want to prevent long-term spread of the virus,” Margaret said. “We want the kids to stay healthy so they stop spreading it to vulnerable populations – grandma, grandpa or even other children who might be immunosuppressed.
“The other thing is, some children can get sick enough to get hospitalized due to COVID-19 exposure. We want to stop that from happening.”
So, while your child awaits vaccination, it’s important to stay diligent with those 3Ws – wash hands, wear a mask and watch their physical distance from others.