While some US teens have been vaccinated for so long that they’re now eligible for Covid-19 boosters, those under the age of 5 still haven’t gotten their first shots.
The Pfizer vaccine has been authorized for children 5 and older since late October, and teens 16 and up have been eligible for boosters since December 9.
As coronavirus cases in children surge again, vaccine approval for kids under 5 can’t come soon enough for many parents. But it looks likely that the youngest children won’t get protection from Covid-19 until well into 2022.
In another setback, Pfizer announced last week that it was amending the clinical trial of its vaccine in children 6 months to 5 years old.
The company said two doses didn’t elicit the same kind of robust immune response in 2- to 5-year-olds as with adults. A third dose will be added to the trials for children under 6.
A vaccine timeline
Pfizer said in an earnings call last week that it was targeting the first half of 2022 to submit data from its trials to regulators, and that the news of a third dose should not affect this timeline. But many had hoped that approval would come sooner than that.
“It won’t be likely until the second quarter of 2022, and we were hoping it would be in the first quarter. But at least from what Pfizer is saying, by the time they get all of the necessary data and go through all of the procedure of getting an emergency use authorization, unfortunately, it’s not going to be until the second quarter,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Erica Hill last week.
Dr. Simon Li, who is working on the Pfizer/BioNTech Covid-19 vaccine trial at the Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, said the trial there is going well. His lab will follow the young subjects for two years.
Moderna is also gathering data on vaccines in younger children. Johnson & Johnson says it has not started trials of its Covid-19 vaccine for children younger than 12.
Dr. Bill Hartman, who runs the Moderna Covid-19 vaccine trial for kids 6 months to 5 years at the University of Wisconsin-Madison, thinks a vaccine for this age group could be available as early as the “first month or two” of 2022.
Even that isn’t fast enough for some parents, but having worked on several trials during the pandemic, Hartman has been impressed with how quickly things can move when there are dedicated volunteers.
“I feel lucky to live in a city that has a population of people that really want to help us get answers so we can end this pandemic,” he said. “I tell the volunteers all the time that someday in the future, they will be able to tell a story about how they helped save the world.”
A chance to make a difference
At first, Li thought it would be difficult to recruit children for the Pfizer/BioNTech trial. Parents can be protective, he said, especially when it comes to vaccines, and it can take a while to recruit volunteers.
Not so with the Covid-19 vaccine trial, which started enrolling children in May. Rutgers enrolled the younger ages starting in late June.
“We sent out a request, and literally, in 36 hours, we had at least a thousand people who were interested, and then in another 24 hours, it was a few hundred more,” said Li, a principal investigator in the Rutgers trial and an associate professor of pediatric critical care. “In the end, we had more than 1,500 people who wanted to volunteer their children for our trial.”
The center initially needed to recruit about 150 children ages 6 months to 11 years. In August, the US Food and Drug Administration asked Pfizer to enroll more to verify that there were no safety issues. Even though there were only a handful of available spots, another thousand people asked to be part of the Rutgers trial.
“A lot of parents are really interested in making a difference and being a part of this trial,” Li said. “That’s really cool to see.”
For the Moderna trial, Hartman said the researchers saw so much interest, they had to shut down the recruitment line after only one day.
Hartman said that enthusiasm carries through even to the vaccination itself. He was touched when a little girl came in for a recent appointment wearing an “I heart science” t-shirt, he said. The kids are even “brave troopers” when they see that they have to get a shot in their thigh.
“It just makes you feel good about how people want to help,” Hartman said. And there’s another strong motive: “You know, as polarizing as vaccines are in this country, people want to keep their families safe.”
Cases rising among children
At this point in the pandemic, kids under 5 make up only a tiny fraction of the number of people who’ve been sick.
This age group accounts for 2.7% of total Covid-19 cases, according to the US Centers for Disease Control and Prevention, but 6% of the overall US population.
Kids are also far less likely to be hospitalized or die from Covid-19 than adults, but the virus is still a threat to them. They make up 1.2% of the hospitalizations and 0.02% of the deaths, according to the CDC.
But cases have been rising for children.
Dr. Claudia Hoyen, director of pediatric infection control at UH Rainbow Babies and Children’s Hospital in Cleveland, said that in the past week, they had the highest number of Covid patients in the hospital that they’ve ever had during the pandemic. “It’s like the world has exploded,” Hoyen said.
Little kids need to get vaccinated when they become eligible for a number of reasons, and “one is for their own safety,” Hoyen said. “We can’t predict which kids are not going to do well with Covid, and we’ve certainly had our share of otherwise normal, healthy children who end up with very serious complications.”
The people who are having the most severe illness, she said, are the unvaccinated. “We have this entire reservoir of small people who don’t all get to stay home,” Hoyen said. “We need to have the fewest number of people to get Covid, not only for their own health but also for the health of our health care system.”
Plus, the more people the virus can infect, the more chance that it will change and become more infectious, like what happened with the Delta variant.
“As the virus evolves and we get these different variant forms out there, it will prey on people who don’t have a built-in antibody response like you can get with a vaccine, so these kids are the ones who will suffer the brunt of that,” Hartman said. “It’s important to not only keep them safe, because even in this age group, it’s a top 10 reason kids have died in the last two years. Kids aren’t supposed to die.”
Hartman said that as much as parents might want, it’s impossible to insulate these kids from the virus.
“The chances that they get Covid and will pass it along are high, and so we have to vaccinate them to not only protect them but to protect their families and communities,” Hartman said.
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