Pfizer study suggests COVID-19 vaccine is safe, protective in younger teens
Pfizer-BioNTech vaccine currently authorized for use in people aged 16 and older
Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the novel coronavirus. Pfizer's vaccine is authorized for ages 16 and older.
In a study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 cases among those given dummy shots, Pfizer reported in a media release on Wednesday.
It's a small study, that hasn't yet been published, so another important piece of evidence is how well the shots revved up the kids' immune systems. Researchers reported "robust antibody responses," the release said.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Pediatric studies underway for other vaccines
Pfizer and its German partner BioNTech in the coming weeks plan to ask the U.S. Food and Drug Administration (FDA) and European regulators to allow emergency use of the shots starting at age 12.
"We share the urgency to expand the use of our vaccine," Pfizer CEO Albert Bourla said in a statement. He expressed "the hope of starting to vaccinate this age group before the start of the next school year" in the United States.
A spokesperson for Pfizer Canada said the company intends to file the data supporting authorization for children aged 12 to 15 with Health Canada.
Dr. Supriya Sharma, chief medical advisor for Health Canada, said in a Facebook Live event with federal public health officials on Wednesday that it will be months before the department receives Pfizer's full data on children aged six to 12.
"It's likely that Pfizer, if all the data is fine, may be the first one where we'll be able to administer those to children at a younger age," Sharma said.
Health Canada staff need to check that the company's data shows safety and effectiveness, is high quality and that the benefits outweigh the risks in different populations before any approvals, she said.
Dr. Anna Banerji, a pediatric infectious diseases specialist in Toronto, welcomed Pfizer's top line results.
She said that while children tend not to get as sick as adults, they can develop rare syndromes, and she's seen teens with long-haul symptoms.
"We've seen in places in Ontario there's been a lot of wide spread in kids," Banerji said.
Having large amounts of kids at school vaccinated is helpful, she said, because "then you don't have to constantly be opening and shutting schools. There's all that uncertainty. This has been a very difficult year for kids."
Pfizer isn't the only company seeking to lower the age limit for its vaccine. Results also are expected soon from a U.S. study of Moderna's vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as six months old.
AstraZeneca last month began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three.
While most COVID-19 vaccines being used globally were first tested in tens of thousands of adults, pediatric studies won't need to be nearly as large. Scientists have safety information from those studies and from subsequent vaccinations in millions more adults.
One key question is the dosage: Pfizer gave the 12-and-older participants the same dose adults receive, while testing different doses in younger children.
U.S. FDA timeline not clear
It's not clear how quickly the FDA would act on Pfizer's request to allow vaccination starting at age 12. Another question is when the country would have enough supply of shots — and people to get them into adolescents' arms — to let kids start getting in line.
Children represent about 13 per cent of COVID-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That's more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.
In Canada, more than 163,000 people aged 19 and younger have been infected with COVID-19.
Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University pediatrician, presented the option. He doesn't know if he received the vaccine or a placebo.
"Usually I'm just at home doing online school and there's not much I can really do to fight back against the virus," Caleb said in a recent interview. The study "was really somewhere that I could actually help out."
His father, Dr. Richard Chung, said he's proud of his son and all the other children volunteering for the needle pricks, blood tests and other tasks a study entails.
"We need kids to do these trials so that kids can get protected. Adults can't do that for them," Chung said.
With files from CBC News