500 kids under 5 given vaccine by MD

Toronto doctor was told to stop by public health

A Toronto physician has vaccinated hundreds of children under five — some as young as six months old — against COVID-19, despite the vaccine not being authorized by Health Canada for this age group.

The Star has learned public health officials stepped in after they discovered Dr. Christopher Sun, a family doctor in Weston-Mount Dennis, was giving COVID vaccines to ineligible children.

In a conversation with the Star, Sun said he gave the vaccine to about 500 kids between the ages of six months and five years during a three-month span, a decision he said he made “to protect children.”

Sun, who believes he was “one of the only people in Ontario” vaccinating children under five, said he felt compelled to give the vaccine “off label” to this age group after some parents started to ask for the shot in late December. They told him they wanted to protect their families during the Omicron wave.

“I put my neck on the line and did what I wanted to get done, which was to protect children,” he said in an interview. Health Canada has not approved any COVID vaccines for children under five.

The parents who came to him “understood the benefits and risks,” Sun said, and he felt he “ethically had no reason to say no.” One shot quickly turned to more as word got around.

“These are worried parents in time of a health crisis and I think it’s wrong to turn away people who know what they are getting into,” he added.

In March, Toronto Public Health told him to stop vaccinating kids under five and reported him to the College of Physicians and Surgeons of Ontario, said Sun, adding he still vaccinated this age group until the end of that month.

He said the CPSO interviewed him about his actions, but dismissed the concern. Sun said he has since stopped giving any COVID vaccines off-label — for a purpose or patient group that it’s not approved for.

CPSO spokesperson Shae Greenfield said in an email that the college can’t comment on this specific matter, but considers the “unique facts” in each case “to determine how best to ensure that the public is protected.”

On average only about one per cent of concerns result in a referral to the tribunal, out of more than 3,600 last year, and the college is not aware of others about vaccines for under-fives, Greenfield said.

“Among the factors that would be considered are the nature of the concern, the physician’s willingness to correct that behaviour, and whether there is reason to believe that further intervention is necessary to ensure that patients are not subjected to unnecessary risk,” Greenfield added.

Asked multiple times to confirm details on this case, and about the scope of COVID vaccines given to kids under five in the city, a spokesperson for Toronto Public Health responded in an email that it follows Ontario Ministry of Health guidelines.

“At this time, no COVID-19 vaccine is approved in Canada for children under the age of five years old. The Ontario Ministry of Health guidance does not permit vaccination of children under age five with any publicly funded COVID-19 vaccine,” Lenore Bromley wrote in an email.

Ministry of Health spokespersons would not comment on how many kids under five have been vaccinated in the province, or how many physicians have administered vaccines to this age group.

“A report was run in March 2022 that showed some incidents of children under the age of five being vaccinated,” said W.D. Lighthall in an email.

“The information was provided to Public Health Units to review their local vaccine practices and ensure alignment with provincial guidance.”

“COVID-19 vaccinations for children under five are still pending safety and efficacy trials and do not yet have Health Canada approval,” his colleague Bill Campbell said.

Older children aged five to 11 became eligible for COVID shots six months ago; Health Canada approved Pfizer’s vaccine for that age group on Nov. 19.

It’s not clear how many other doctors were offering the vaccine to kids under five. But at Toronto Western Hospital’s family health team, some four-year-old children who would soon turn five got the shot.

This happened over a period of about four days “when the MoH had opened the dates in the system which allowed for the vaccination of children within their fifth year,” University Health Network spokesperson Gillian Howard confirmed in an email.

“When that changed — as I recall after the first weekend — (the) Family Health Team changed their approach. All of the other UHN clinics were for adults.”

Early signals from health agencies had suggested a spring approval for COVID vaccines for kids under five. But now experts suggest vaccine candidates from Pfizer and Moderna won’t be authorized until at least June, triggering a summer rollout at the earliest.

Families watching Omicron variants sweep through daycares, schools and communities, and public health restrictions drop, have had to rely on masks, distancing and a little bit of hope that their unvaccinated kids might escape infection.

Dr. Samantha Green was one parent who decided her kids couldn’t wait.

The Toronto family doctor had heard about a doctor in Weston— Mount Dennis who was giving COVID vaccines off label. At the end of January, she got Sun to vaccinate her two young children against COVID, despite them being ineligible

Her preschooler son, Jack, and toddler daughter, Florence, were both in daycare, and after reviewing Pfizer’s initial drug trial data, Green decided the benefits of the shots outweighed any risks.

“With Omicron rising, I grew more and more nervous,” said Green, a family physician at Unity Health Toronto. “I started to really worry for their health and well-being.”

She chose to give Jack — at the time, he was three-and-a-half — the 10-microgram dose meant for children five and older. For Florence, who was 18 months, Green decided to go with the three-microgram dose studied in the company’s trial for kids six months to five years.

“We felt it was the best choice for us. I absolutely don’t have any regrets at all.”

Green said it is not uncommon for physicians to prescribe vaccines and medications off label, especially for kids, and that she was comfortable with the safety and efficacy data she reviewed. She added her family, which also takes other precautions, has not gotten COVID.

Sun said most of the parents who came to him in the three-month span he gave COVID vaccines had reviewed the Pfizer drug trial data like Green. Many of the parents who contacted him were physicians, he said.

“This wasn’t like someone asking for Ivermectin and not knowing what COVID was or how vaccines work,” he said. “These are people who actually read the studies and knew what they were asking for.

“My understanding is that doctors are allowed to prescribe things off label, which we do all the time.”

Sun said he explained to parents the vaccine was not approved by Health Canada, outlined the Pfizer data that was available at that time and asked for verbal informed consent.

Pfizer tested a two-dose, three microgram vaccine for kids six months to five years this past winter, with results that fell short of what regulators wanted to see in terms of efficacy.

The company released results on a three-microgram, three-dose vaccine just this week in a press release, which said the vaccine was about 80 per cent effective in a trial of about 1,600 kids under five.

“I told them this is a decision they are making on their own accord,” said Sun. “They are doing it based on the information available at the moment.”

So far, out of the two candidates for vaccines for the youngest kids, Moderna’s version is closer to being approved in Canada.

The company submitted to Health Canada for approval of a 25-microgram, two-dose vaccine series, in April. It “cannot speculate on the timing of Health Canada’s review,” said Alanna Fox in an email.

Pfizer spokesperson Christina Antoniou said in an email that the company is in “ongoing discussions with Health Canada about the vaccine in this population but cannot comment on filing timelines in Canada.”

A Health Canada spokesperson could not provide more information on the timeline for the Moderna review, but confirmed Wednesday that Pfizer had not yet submitted its under-five COVID vaccine for approval.

This wasn’t like someone asking for Ivermectin and not knowing what COVID was or how vaccines work.

DR. CHRISTOPHER SUN TORONTO PHYSICIAN