Next up for COVID-19 vaccine clinical trials: children as young as 6 months

Oct. 8, 2021
father kissing his daughter, who could soon get a COVID-19 vaccine since clinical trials on children begin in October in Colorado.
COVID-19 vaccine trials for children as young as 6 months will begin this month in Colorado. Photo: Getty Images.

COVID-19 vaccines will be tested on babies as young as 6 months by the end of October in Colorado as clinical trials for life-saving COVID-19 vaccines continue.

Dr. Myron Levin is leading the Colorado COVID-19 vaccine clinical trials on children for the Moderna and Novavax vaccines. The newest round of vaccinations is slated to continue within weeks at the University of Colorado Anschutz Medical Campus in Aurora.

New phase of COVID-19 vaccine clinical trials in babies and young children

  • A team of researchers at the Anschutz Medical Center will start vaccinating babies as young as 6 months within weeks.
  • Parents who want to enroll babies and toddlers from ages 6 months to 2 years may reach out to the researchers.
  • If you are interested, please leave a message at 720.777.4496 or email the team at: [email protected].

The clinical trials for babies and younger children come as Pfizer-BioNTech has sought permission from the U.S. Food and Drug Administration (FDA) to allow COVID-19 vaccines for children ages 5 to 11.

Medical advisors to the FDA and the U.S. Centers for Disease Control and Prevention (CDC) are expected to consider the safety and efficacy of vaccines for children in that age group later this month and in early November. If federal authorities give the OK, about 28 million children ages 6 to 11 could soon become eligible to get their COVID-19 vaccines.

The doses for children are smaller than the vaccine doses that adults receive.

Levin is hopeful that COVID-19 vaccines for all children in the U.S. could be authorized by the end of this year or early in 2022.

“It is amazing. We continue to see the rapid success of vaccines for all ages. These vaccines are safe, effective and critical to keeping children healthy, while also helping end the pandemic,” said Levin, a professor of pediatrics and medicine, and an infectious diseases specialist at the University of Colorado School of Medicine.

“Ultimately, every age group from six months on up will be covered by a vaccine,” Levin said.

kids clinical trials for COVID-19 vaccines. Dr. Myron Levin is running the Moderna pediatric clinical trial for COVID-19 vaccines in Colorado.
Dr. Myron Levin is overseeing COVID-19 vaccine clinical trials for children in Colorado. Photo by Cyrus McCrimmon for UCHealth.

Children, in general, have not gotten as sick as adults with COVID-19. But, many still have contracted the coronavirus, keeping them out of school or infecting adults around them. Meanwhile, about 30,000 kids were hospitalized with COVID-19 in August as the highly contagious delta variant spread. On top of the illnesses and hospitalizations, 587 children have so far died from COVID-19. By comparison, 188 children died of flu during the 2019-2020 flu season, according to the CDC.

Levin also said doctors don’t know enough yet about the degree to which children may be vulnerable to long-term effects of COVID-19. Many adults suffer from what is known as long COVID-19 and experience an array of problems from lung and breathing difficulties to brain fog months after first getting sick.

It’s far better to prevent as many COVID-19 infections as possible in both children and adults through vaccination and prevention, Levin said.

Vaccination of younger segments of the population will be vital to driving down COVID-19 illnesses and deaths.

Levin already has overseen the Colorado clinical trials for the Moderna and Novavax vaccines for older children, ages 6 to 11. And thus far, he and his team have not seen any serious adverse outcomes among the study participants.

“We haven’t seen any unusual or unexpected reactions to the vaccines. And, that’s also been true nationally,” Levin said.

Now the team is getting ready to test the vaccines on dozens of children ages 2 to 5 and ages 6-months to 2. The research on both age groups — the babies and toddlers up to age 2 and the children ages 2 to 5 — will take place simultaneously in late October and November. Levin already has many volunteers for the study on vaccines in kids ages 2 to 5. Parents who want to enroll their babies and toddlers in the clinical trials may reach out to the research team by leaving a message at 720.777.4496 or by emailing [email protected].

As with all of the COVID-19 clinical trials, researchers are eager to include participants from diverse ethnic and racial backgrounds. Study participants receive some compensation. In pediatric trials, researchers minimize the number of times a child needs to have blood drawn since some kids are afraid of needles.

Levin said the early studies on babies and children show great promise.

“They (the vaccine makers) have already done preliminary studies in both of these ages groups to show that the vaccine is safe, immunogenic and to get the right dose for kids. That is required before many more children get the vaccines,” he said.

In the clinical trials that tested COVID-19 vaccines on adults, half of the participants received vaccines, while the other half received the placebo. In the pediatric clinical trials, children who participate have a much better chance of getting the vaccine.

For the Moderna clinical trial, three babies or children out of every four enrolled in the study will receive the vaccine compared to the placebo. In the Novavax study, two children out of every three received the vaccine versus the placebo.

Levin, who has tested multiple vaccines throughout his career, is confident that the Moderna and Novavax COVID-19 vaccines will be as safe in children as they have proven to be in adults.

“Great care is taken before new vaccines are given to children. They have been studied in successively younger populations,” Levin said. “The government and everyone who oversees clinical trials in people — including a board on the Anschutz Medical Campus — have to be convinced that the testing is in the best interests of people and that this research is worth doing.”

A rare complication for mRNA vaccines, including Moderna and Pfizer, has emerged in some adolescent boys. But, government regulators and experts at CDC have determined that the dangers of suffering a severe case of COVID-19 are 100 times greater than the likelihood of suffering a serious side effect from these vaccines. CDC experts are continuing to recommend vaccines for everyone ages 12 and up.

“Relative to this complication, it’s by far better to be vaccinated,” Levin said. “COVID-19 can be a serious disease for children and the people around them don’t want to get sick.

“Everyone can get COVID-19 and we want everyone to be protected,” he said.

Pfizer is currently authorized for kids and adults ages 12 and older, while the Moderna vaccine is authorized for those ages 18 and older. Novavax has been studied in the U.S., but is not yet authorized for use here. It could become more popular in years to come since it uses more traditional vaccine technology, rather than mRNA, to fight the virus that causes COVID-19.

Levin and other vaccine experts say it’s helpful to have multiple types and brands of COVID-19 vaccines.

“It’s always good to have multiple vaccines that are different in their mechanisms and may have different effects on virus variants,” Levin said.

About the author

Katie Kerwin McCrimmon is a proud Coloradan. She attended Colorado College thanks to a merit scholarship from the Boettcher Foundation and worked as a park ranger in Rocky Mountain National Park during summers in college.

Katie is a dedicated storyteller who loves getting to know UCHealth patients and providers and sharing their inspiring stories.

Katie spent years working as an award-winning journalist at the Rocky Mountain News and at an online health policy news site before joining UCHealth in 2017.

Katie and her husband, Cyrus — a Pulitzer Prize-winning photographer — have three adult children and love spending time in the Colorado mountains and traveling around the world.