Almost exactly a year ago, the first COVID-19 vaccines became available in the U.S. Today, they're approved or authorized for nearly every age group — except young kids. But clinical trials involving children as young as 6 months are underway now, and some may have results by the end of the year.
Right now, the Pfizer-BioNTech COVID-19 vaccine is the only one authorized in the U.S. for use in kids under the age of 18. The original emergency use authorization — and, later, full approval — from the Food and Drug Administration covered people ages 16 and up. The FDA then authorized it for 12- to 15-year-olds in May and for 5- to 11-year-olds in early November.
Status of COVID-19 vaccines for kids under 5
The most recent estimates from Pfizer CEO Albert Bourla are that we could have data on the company's vaccine in children under 5 by the end of the year, NBC News reported. And the vaccine might be available for kids in that age group in early 2022.
Moderna submitted data from clinical trials involving 12- to 17-year-olds, but in November the FDA said it needed more time to review that data. The company also released statements recently saying that its two-dose mRNA vaccine is safe and effective in 6- to 11-year-olds. And Moderna trials involving kids 6 months and up are ongoing.
When it comes to the single-dose Johnson & Johnson vaccine, the company told TODAY in a statement that it "has initiated its phase 2/3 HORIZON 2 clinical trial in healthy adolescents from 12 to 17 years with the goal of obtaining valuable insights into the safety and immune responses of our vaccine in this critical group." The company did not share information about trials in younger age groups.
As exciting as all that is, the reality is that many parents of young kids are still anxiously awaiting their turn to get their children vaccinated. Here's the latest on the status of ongoing pediatric COVID-19 vaccine trials in the U.S. and more on the careful work that goes into developing vaccines for young kids.
Finding the perfect dose
In the first phase of the pediatric Pfizer COVID-19 vaccine clinical trials, researchers were focused on finding the right dose, Dr. Simon Li, director of the division of pediatric critical care at Rutgers Robert Wood Johnson School of Medicine, told TODAY.
In that initial process, the researchers were looking for two things, said Li, who is leading the work at one of 81 sites working on a Pfizer phase 2/3 clinical trial with kids ages 6 months to 11 years old. "One is how much of the vaccine you need to get a good immune reaction. And the second thing is how many side effects you have." The right dose is one that provides satisfactory protection against COVID-19 with the fewest side effects.
During the trials for 5- to 11-year-olds, researchers tested three doses of the Pfizer vaccine: 10, 20 and 30 micrograms, with 30 being the same dose used in adults and 12- to 15-year-olds. They found that for this age group, a 10 microgram dose was enough to get a satisfactory immune response with way fewer side effects.
"We had more fevers at the 30 microgram dose and the 10 micrograms gave a really good immune response. We didn't need to go higher," Dr. Kawsar Talaat, a vaccinologist at the Johns Hopkins Bloomberg School of Public Health who is involved with Pfizer's pediatric vaccine trials, told TODAY.
Kids 5 to 11 can get vaccinated: What to knowNov. 3, 202104:58
And the same appears to be true for this younger group, Li said. Kids under 5 are getting just 3 micrograms in each dose right now in the Pfizer trials, he explained, but they're still investigating the efficacy of that dose.
For the Moderna COVID-19 vaccine, the right dose in kids under 6 appears to be just 25% of the adult dose, Dr. Bill Hartman, principal investigator for UW Health’s KidCOVE Moderna pediatric vaccine trial, told TODAY. In children ages 6 to 11, the company deemed a 50 microgram dose effective, which is half the size of the adult dose.
Hartman anticipates that Moderna will be able to begin interpreting data about its vaccine in younger kids in mid-January and the company will decide whether or not to pursue an emergency use authorization at that time. When the emergency use authorization comes through from the FDA, that's when kids who received a placebo during the trial will be able to switch to the actual vaccine or another vaccine that's authorized for their age group, he explained.
What parents need to know
While parents wait, it's important to remember that researchers are working quickly but carefully. "No corners were cut in the development of this vaccine," Talaat said. "The reason we were able to get vaccines out so very quickly is that there was a tremendous amount of resources, in terms of financial resources, but also in terms of expertise, personnel and staff."
Plus, researchers working on pediatric vaccine trials have the benefit of building on the data we already have for the millions of COVID-19 vaccine doses given to adults, Talaat explained. And that’s not usually the case for pediatric vaccines.
To keep an eye out for potential side effects, parents are asked to monitor their children for two years in the Pfizer trial and 14 months in the Moderna trial. Monitoring starts out with daily assessments through an electronic diary system in the weeks after the kids receive the vaccine and eventually slows down to weekly checks, Li explained. But there are certain checkpoints down the line that all parents and kids have to participate in, Hartman said.
Moderna children vaccine trial underway as more states expand eligibilityMarch 17, 202102:21
When it comes to providing informed consent, Talaat explained that some older kids may go through a modified process called assent. "They get a simpler form to look at, or that is read to them or explained to them," she said, noting that it's usually illustrated with lots of pictures. But for the young kids in these trials, it's the parents who provide consent — and, so far, they've been excited to do so.
"I've done a lot of vaccine trials over the last 15 years, and this has been the easiest trial to recruit for," Talaat said. Hartman agreed and added that his group had a "huge waitlist" to enroll in the trial after just one day.
"We all want our kids to get back to a more normal existence than what they've had for the past two years," Hartman said. "The best way out of this pandemic is by vaccinating people and our children are included in that. By vaccinating them, you're protecting them from any of the bad things that can happen from COVID, but you're also protecting your family and your community."