With many kids back in the classroom, the VERIFY team has been getting a lot of questions about the status of COVID-19 vaccines for children.
Some parents say they want their kids vaccinated, but are hesitant to use an mRNA vaccine, like Pfizer or Moderna. Recently, VERIFY viewer Kathleen asked about the status of the Johnson & Johnson vaccine for teens.
Is Johnson & Johnson planning to make its COVID-19 vaccine available for teens and young children?
- Johnson & Johnson
- U.S. Food and Drug Administration (FDA)
- Dr. Maureen Ferran, associate professor in the Thomas H. Gosnell School of Life Sciences at the Rochester Institute of Technology
- Dr. James Campbell, pediatric infectious diseases expert at University of Maryland Medical System who worked on the Moderna and Novavax COVID-19 trials in children
Yes, Johnson & Johnson is planning to make its COVID-19 vaccine available for teens and young children.
WHAT WE FOUND
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Johnson & Johnson’s single-dose COVID-19 vaccine for individuals over the age of 18 on Feb. 27, 2021. It was authorized a couple of months after Pfizer and Moderna received EUAs for their mRNA vaccines in December 2020.
A Johnson & Johnson spokesperson told VERIFY the company has completed Phase 1 and 2 studies and planned four Phase 3 studies in pediatric populations, however, they did not provide a timeline on when the data will be released to the public or when they would submit the vaccine for FDA authorization for children.
“We are committed to facilitating global equitable access to our COVID-19 vaccine and recognize the unmet needs of children. To keep children safe, and ultimately to achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups,” said Johnson & Johnson.
Dr. Maureen Ferran, an associate professor of science at the Rochester Institute of Technology, said the company’s EUA delay, along with numerous rollout issues, put Johnson & Johnson at a slight disadvantage in comparison to the mRNA vaccine manufacturers.
“Right now, we really do not have approval for use of the J&J vaccine for children under the age of 18. They have yet to complete their studies, and at this point, it's really looking like that approval wouldn't be until sometime in 2022,” said Ferran.
Meanwhile, in May, the FDA expanded the EUA for the Pfizer COVID-19 vaccine to include children between the ages of 12 and 15. A few months later on Sept. 26, Pfizer CEO Albert Bourla said during an interview that the company plans to ask for authorization for a COVID-19 vaccine for children between the ages of 5 and 11 very soon.
Moderna announced that its COVID-19 vaccine was highly effective at preventing COVID-19 in adolescents between the ages of 12 and 17 in May. The company submitted its results to the FDA in early June and requested emergency use authorization at that time.
Dr. James Campbell, a pediatric infectious diseases expert who has worked on the Moderna and Novavax COVID-19 vaccine trials for children, told VERIFY Moderna is currently in clinical trials separated into three age groups for children under the age of 12 — 6 to 11 years old, 2 to 5 years old, and 6 months to 23 months.
According to Campbell, half of the adult dose has been chosen for the 6 to 11-year-old group, which includes around 4,000 children in the U.S. and Canada. At this point in the study, Campbell said the children were set to get their second dose of Moderna’s vaccine sometime within the last week.
“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.
On Sept. 21, Johnson & Johnson announced new data that reinforced the “strong and long-lasting protection” of its COVID-19 vaccine in adults over the age of 18. The company said its new data also showed protection against COVID-19 increases after a person receives a booster shot of the Johnson & Johnson vaccine. The company did not release children’s clinical trial data with their announcement.