Decision on Pfizer's COVID-19 vaccine for younger kids coming within two weeks: Health Canada
Pfizer-BioNTech seeks approval to use vaccine on children aged 5 to 11 years
Canada's review of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of 5 to 11 should be completed within the next "one to two weeks," Health Canada's chief medical adviser says.
"As with all of the COVID-19 submissions, we're doing it on a priority basis and we have a dedicated team that's looking at that data and that data is not just the clinical data, but as well the formulation," Dr. Supriya Sharma told a Public Health Agency of Canada briefing in Ottawa today. "And we look at that in the Canadian context for the ... possible use in children."
Three weeks ago, Pfizer-BioNTech became the first company to seek Health Canada's approval for a pediatric COVID-19 vaccine. Other companies, including Moderna, are working on children's formulations.
While children aged 12 and older are already approved for the adult formulation, the pediatric formulation would be given in two smaller doses — 10 mcg (micrograms), instead of the 30 mcg used for those over the age of 12.
Sharma said last month that while the children's version of the vaccine is "slightly different" from the adult one, it contains the same mRNA and works the same way.
The chief medical adviser also said that while Health Canada has a "completed submission" for a vaccine from Novavax, reviews of that product will continue.
Chief Public Health Officer Dr. Theresa Tam told the briefing that, for the second week in a row, "children under 12 continue to have the highest incidence rates across all age groups."
Asked what could be done to encourage more kids in the 12 to 17 age group to get their shots, Tam said the group got access to the vaccines later than others and saw a "pretty good acceleration" in uptake at the beginning of the vaccination campaign.
"Things have been slowing down somewhat in the last weeks, so this is the last mile as well for them," she said.
Tam praised student groups and ambassadors for non-government organizations for encouraging young people and their parents to get vaccinated.
Tam said there has been an 11 per cent increase in new COVID-19 cases compared to last week, with an average of almost 2,500 new cases reported daily across Canada.
On average, more than 1,800 people with COVID-19 were hospitalized each day, with 528 treated in intensive care units and 22 deaths reported daily, she said.
Tam said that while more than 28 million people — representing 85 per cent of the eligible population over age 12 — are fully vaccinated against the virus, there are still "sizeable gaps in vaccine coverage." More than five million eligible Canadians and more than four million children under 12 have not been vaccinated.
"Where there are pockets of very low coverage, there is a higher risk of local surges in virus activity," she said.
Tam said there's been a 5.5 per cent increase in first-dose vaccine coverage since about mid-August, when the federal government and other governments announced new proof-of-vaccine requirements.
"Every day there are still more people getting vaccinated. Slowly," she said. "We do believe that we can gain several more percentage points of those eligible … who haven't already got their vaccine."
Will Johnson & Johnson vaccine reach holdouts?
To help reach the holdouts, the federal government is distributing doses of the one-shot Johnson & Johnson vaccine, also known as the Janssen vaccine, to provinces. Alberta, Saskatchewan and British Columbia asked for supplies of the Janssen vaccine to help convince the vaccine-hesitant.
The vaccines from BioNTech-Pfizer and Moderna use messenger RNA, or mRNA technology, to direct protein production in cells throughout the body to trigger an immune response and protect against infectious diseases. The Janssen vaccine uses the more conventional viral vector vaccine technology.
In late April, roughly 300,000 doses of the Janssen vaccine shipped to Canada were rejected by Health Canada because of concerns about the third-party manufacturer of these shots, a Maryland-based company called Emergent. Last week, the government confirmed the delivery of 20,000 doses from France.
Clinical trials showed that, beginning two weeks after the single dose, the Janssen vaccine is 66 per cent effective at protecting trial participants against COVID-19, according to Health Canada. Pfizer's product is 95 per cent effective for participants 16 and up, one week after the second dose. Moderna's vaccine is 94 per cent effective for participants aged 18 and up, two weeks after the second dose.
'It's better to have a vaccine in someone's arm'
Tam said it's too early to know whether there will be a significant increase in vaccinations due to the Johnson & Johnson product, adding the health agency will monitor the situation over the coming weeks.
"Based on the information and the data we have, the mRNA vaccines are performing very well and seem to perform better than the Janssen vaccine but I think it's better to have a vaccine in someone's arm than to have someone not vaccinated at all," she said.
The National Advisory Committee on Immunization has recommended booster shots for people who got the Janssen vaccine. Health Canada also has said the Janssen vaccine will include warning labels for rare but serious side effects, such as autoimmune disorders and blood clots.
Asked what she would say to those who believe the Janssen vaccine is safer than those that use mRNA technology, Tam said Canadians should be grateful that all approved vaccines have been "thoroughly reviewed" by the regulator and any serious side effects have been rare.
Sharma said it's difficult to compare one vaccine to another without a head-to-head trial. While Health Canada has recommended mRNA vaccines because of their higher level of effectiveness, that does not mean they are free of side effects, she said.
"Having a vaccine administered is better than not having a vaccination," she said.
Watch: Tam says children under 11 making up highest number of cases
With files from Nicole Ireland, David Thurton, John Paul Tasker
