Father to a two-year-old toddler, Raywat Deonandan was delighted when advisers to America’s drug regulator gave their unanimous blessing to COVID-19 vaccines for children down to six-month-olds.
“What’s that I hear emanating from the clouds on high,” the University of Ottawa epidemiologist and COVID commentator tweeted. “The dulcet tone of angels singing?”
While it’s true that children are less likely to be symptomatic and much less likely to be hospitalized with COVID than adults, “the threat to children is real,” Deonandan said. “In the U.S., the rate of hospitalization for kids under five was four times during the Omicron wave as it was during Delta.”
The Food and Drug Administration concurred with its advisers and Friday authorized Pfizer and Moderna “kiddie” shots. On Saturday, the Centers for Disease Control and Prevention, the final arbiter in how vaccines should be used, expanded eligibility for Pfizer and Moderna jabs to nearly 20 million children ages six months through five. Vaccines will start going into little bodies Tuesday. U.S. President Joe Biden greeted the news as a “monumental step” in the fight against the virus.
Health Canada, meanwhile, has announced no timeline at all. The department is expediting its review of Moderna’s submission with a dedicated scientific team (Pfizer hasn’t yet applied to have its vaccine for babies and toddlers approved here) “and will only issue a decision following a through scientific review of the vaccine’s safety and efficacy,” the agency said in an email late Thursday.
“It’s not possible to predict when a regulatory decision will be made.”
Roughly 1.8 million children under five reside in Canada, a “largish” contingent of the population that has not yet had the opportunity to be vaccinated against COVID, Deonandan said. Parents, he said, should be given the option.
However, some argue that, as mask and vaccine mandates evaporate and the mantra is all about “living with COVID,” the case for vaccinating the very young at this juncture in the pandemic may have become smaller.
“There are two different reasons for vaccinating anybody: One is to protect themselves, the other is to protect other people,” said Dr. Dominic Wilkinson, a medical ethics expert at Oxford University and a physician who specializes in newborn intensive care.
There are obvious direct benefits to children, he said, in terms of reducing the chance of them getting unwell with COVID, “and children can become unwell with COVID.” As of June 10, 33 COVID-related deaths had been reported in Canada in children aged 11 and younger. Indirect benefits include fewer disruptions in daycare and school.
But many children have already had COVID. “For many families, the question will be, ‘How much is this going to help my child who has already had a dose of COVID and recovered,’” Wilkinson said.
An argument can be made that there is still a strong public health reason to vaccinate young children to reduce spread to vulnerable family members and the wider community. But many adults themselves have been both vaccinated and exposed to the virus, “so the additional benefits of vaccinating children to protect adults again becomes smaller,” Wilkinson said.
It’s not totally clear whether there’s a huge gain in terms of controlling the spread of the virus at this point in vaccinating childrenDr. Dominic Wilkinson
The variants today are less severe but also more contagious. We’re seeing more “vaccine escape” and more repeat infections. “It’s not totally clear whether there’s a huge gain in terms of controlling the spread of the virus at this point in vaccinating children,” Wilkinson said.
He hasn’t seen in detail Moderna’s trial data in the younger age group, but the data he has seen in older children have been reassuring. “The complications from the vaccine are lower than the complications from the virus, which continue to evolve and spawn new subvariants.”
Individual parents should be free to make an informed decision whether to vaccinate their children against COVID or not, Wilkinson said. “The important thing to emphasize is that whatever their decision, whatever their uncertainties, there are a whole lot of other very effective and safe vaccines that we know children benefit from receiving,” he said, including vaccines to prevent measles, pertussis, and meningococcus. “That should be their first priority, making sure their kids get those.”
The Moderna vaccine for little kids contains one quarter the adult dose and requires two shots, one month apart. Pfizer’s would require three shots.
Moderna’s efficacy was based on a concept known as immuno-bridging. The level of neutralizing antibodies seen in the younger children were compared to levels that have been protective in older children and young adults.
Among the six- to 23-month-olds, the shots were deemed 51 per cent effective in preventing symptomatic COVID-19 from Omicron. That dropped to 37 per cent for the two through five-year-olds. The most common side effects were pain at the site of injection, fever and underarm or groin swelling. There were no deaths, and no cases of heart inflammation — myocarditis or pericarditis — in the first week, a known risk associated with Moderna, particularly in males 18 to 24.
Some are worried about the limited data. The trial also excluded babies and young kids who had already had COVID. Johns Hopkins University surgeon and Fox News contributor Marty Makary dismissed the immuno-bridging analysis as “statistical acrobatics.” One FDA adviser compared the risk of kids dying from COVID to the risk of being struck by lightning; another said the true rate of hospitalizations is “vanishingly small.”
Others challenged the “kids aren’t at risk of COVID” narrative. Some children, including infants, have developed a rare post-COVID complication known as MIS-C, or multi-system inflammatory syndrome. One U.K. study found brain and nerve complications among four per cent of children admitted to hospital with COVID.
Even then, it’s not clear how many parents will make a beeline for the shots. Uptake among the five- to 11-year-olds has lagged public health hopes. As of May 22, 56 per cent of kids in Canada in that age bracket had received at least one dose, and 42 per cent were fully vaccinated.
“I suspect there are two competing things here,” Deonandan said. “One is the narrative that kids don’t get sick, which is wrong of course. And that, I think, is driving a lot of parental hesitation.
“Two: the other age groups over five probably saw a lot of infection over the course of the past couple of years, and a lot of parents say, ‘Hey, my kid didn’t get really, really sick, so what’s the point?’
“For those of us with toddlers and babies, I think there is more fear,” Deonandan said. “Your child hasn’t been exposed to a lot of things yet. I can’t say for sure, but I suspect that you are probably going to find a more nervous set of parents. Nervous about COVID, not necessarily nervous about the vaccines.”
Even if a child has already had COVID a strong case for not opting out of vaccination can be made, he and others said. According to a study published last week in the journal Science, an Omicron infection is a poor natural booster against re-infection.
Immuno-bridging has its challenges, Deonandan said. “Is this valid? Does it represent the real world, yes or no? We don’t know for sure. It does seem reasonable though that if we are seeing large amounts of neutralizing antibodies produced in these children, that can’t be a bad thing.”
Vaccine effectiveness increases the higher up the hierarchy you go, he said. “You probably have a small protection against infection but probably fairly robust protection against hospitalization and death. That’s what I care the most about here.”