The calls and emails started to trickle and then pour in to the University of Maryland School of Medicine in recent weeks as word got out to parents about a study of the COVID-19 vaccine in young children.
The unofficial tally of families already far exceeds the likely spots that will be available in the Baltimore medical school’s Center for Vaccine Development and Global Health, which soon will join the trial of the Moderna vaccine in kids ages 6 months to 11 years that launched nationally this week.
“We had so many families interested in having their children enrolled, we had to set up a website and get a contact list because we weren’t yet recruiting,” said Dr. James Campbell, a pediatric infectious disease specialist in the Maryland medical school and the site’s principal investigator.
“Now we’re ready,” he said. “The hope is that we will be activated at the end of this month.”
Campbell said the eagerness speaks to the faith many people have in the vaccine that was federally authorized for emergency use in December and already injected into millions of adults. But it also shows the fear that remains from the virus.
There have been more than 3 million cases in children and almost 250 deaths, according to data compiled by the American Academy of Pediatrics. It’s just a small fraction of the toll on adults, but researchers, doctors and others say it remains a serious threat and have been calling on authorities to begin trials for months.
The pediatric group wrote a letter to the White House in February urging the administration to “use every measure available to achieve authorization of COVID-19 vaccines in children as soon as can be done safely.”
There are three vaccines authorized for use in adults, including those from Moderna and Johnson & Johnson, both approved for those 18 and older. The Pfizer/BioNTech vaccine is approved for those 16 and older.
Studies already are underway in children ages 12 to 16, meaning the vaccine could be made available before the next school year begins in the fall. The younger children will have to wait longer, potentially until next year.
That could place additional hardships on children, for whom higher rates of mental health issues are being reported as they’ve been kept out of schools and activities for the past year. Further, the pediatric academy reports that disproportionate numbers, close to two-thirds, of children’s deaths from COVID-19 are in Black and Latino populations.
Pediatric health experts say even though the overall case numbers are lower in children than adults, the disease can be serious and long-term effects from COVID-19 remain unknown. Even in mild cases or those with no symptoms, children can pass the virus to others.
“Vaccines would help in both respects, keeping children from getting sick and from infecting others,” said Dr. Yvonne Maldonado, chief of the division of pediatric infectious diseases in the Stanford University School of Medicine.
She said a study that begins now could mean vaccinations for young children widely begin by year’s end, but may extend into 2022.
The Moderna study will look at safety, including side effects that could be different from adults, as well as how well children produce antibodies that protect them from the disease. The vaccine has proved safe and early data shows it’s 94% effective at preventing disease in adults.
“It is hoped that these vaccines will demonstrate similar safety profiles in children but that must be verified by careful tracking of participants,” said Maldonado, also chair of the pediatric academy’s committee on infectious disease.
The Moderna study, called KidCOVE, will include 6,750 children at multiple locations in the United States and Canada. The company is collaborating with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, both federal health agencies.
It will be split into two parts, Moderna officials said. The first will check up to three dose levels to find the optimal level with the fewest side effects. That level will be used in the second part of the study, in which participants are either injected with the vaccine or a placebo and followed for a year after they have had two doses.
Families will be seen at trial sites multiple times in person and will keep an electronic diary of side effects. Trial leaders primarily will assess the effectiveness of the vaccine by looking at the level of protective antibodies the children develop, though they also will track infections.
In a statement March 16 when the study launched, Moderna CEO Stéphane Bancel called it “humbling” that 53 million doses of the vaccine already had been used in the United States and said the newest study would help the Massachusetts biotechnology company assess the safety and effectiveness of its vaccine in this younger age group.
At the University of Maryland, the vaccine center has tested a host of pediatric vaccines, as well as COVID-19 vaccines for adults, trials that are ongoing.
Campbell said officials would begin recruiting officially for this trial as soon as the center is given approvals from the company, federal regulators and the school’s internal review board.
He said he was as eager as the parents to get underway and show whether the vaccine is as safe and effective as it’s proved to be in adults. Campbell said it’s uncommon to find severe side effects in children not seen in adults, but the trial will offer proof. It also will determine the best dose and interval of doses for the Moderna vaccine. Adults are given two doses, 28 days apart.
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“It’s not fair to children, parents or pediatricians to just assume that without testing data,” he said. “We don’t want pediatricians prescribing vaccine only tested in adults. ... That said, we have no reasons to have preconceived concerns about the vaccine in children.”
The Moderna vaccine, like the Pfizer one, uses a bit of genetic material from the coronavirus to spur an immune response in the recipient.
The children tested at Maryland will be enrolled in Baltimore or at an affiliated center in Frederick. They still will have to follow all safety guidance, including masking and distancing, throughout the trial.
Though Campbell said COVID-19 is a far more serious threat to children than the flu, he said those who are unvaccinated or in the trial still can attend schools that take proper precautions. He said there are risks but there are many benefits beyond academic, including emotional, social and physical ones.
It’s still unknown, he said, whether adults or children will end up needing an annual COVID-19 shot, as they do for the flu. There are several variants circulating, ones that are far more contagious than the original virus strain, and the vaccine makers have said they are preparing for the possibility that booster shots would be needed sooner or later.
Campbell said that shouldn’t delay a vaccine for children. They will need to be inoculated if the nation wants to move past the pandemic. Herd immunity could require up to 80% or more of the population getting vaccinated, and children are close to a quarter of that total.
“We talk about there being enough vaccine for everyone soon, but that just means adults,” Campbell said. “Children have been left out of all of this until now.”