OTTAWA -- Health Canada has , giving the regulatory green light to Pfizer-BioNTech鈥檚 two-dose vaccine, meaning kids across the country will soon be able to receive additional protection against the novel coronavirus.
Children ages five- to 11-years old are now eligible to get vaccinated with a dosage that is one third the size that has been offered to those aged 12 and older.
The first shipment of these pediatric doses will arrive on Sunday, with a total of 2.9 million doses landing by the end of next week.
鈥淭hat鈥檚 enough doses to offer a first shot to all eligible children in this country,鈥 Procurement Minister Filomena Tassi said Friday.
While Health Canada has approved the doses to be given 21 days apart, the National Advisory Committee on Immunization (NACI) is recommending an interval of eight weeks or more between the first and second doses.
鈥淭his is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada's fight against COVID-19,鈥 said Canada鈥檚 regulatory agency in a statement. 鈥淎fter a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks.鈥
In an interview on 愛污传媒 Channel鈥檚 Power Play, Health Minister Jean-Yves Duclos said that these doses can start to be administered next week, but couldn鈥檛 confirm when further doses to cover second shots will be arriving, other than to say he anticipates it鈥檒l be in time to meet NACI鈥檚 eight week interval recommendation.
During a press conference discussing the long-anticipated authorization, Health Canada's chief medical adviser Dr. Supriya Sharma said that the formulation 鈥 than the version authorized for adults, but the immune responses were 鈥渃omparable.鈥
鈥淭he main adverse events reported were similar to those and in adolescents and young adults, but were less frequent, except for redness and swelling at the injection site, which were slightly higher. Other adverse events reported included fatigue, and headache. Most reactions were mild to moderate in severity, and resolved quickly on their own,鈥 Sharma said of the clinical and safety data evaluated by Health Canada.
Pfizer Canada says that steps have been taken to differentiate the pediatric formulation vials from the adult version, including putting an orange cap on the version for kids.
Health Canada had been prioritizing the review of Pfizer鈥檚 submission to use its vaccine in those ages five to 11 since Oct. 18, and a similar review is ongoing for Moderna鈥檚 two-dose mRNA vaccine for those ages six to 11.
鈥淭his is an exciting moment, and it's a day that many parents across the country have been eager to wait for and this is the opportunity for them to start to immunize their school-based children,鈥 said Pfizer Canada vaccines lead Fabien Paquette in an interview.
According to Health Canada鈥檚 authorization, clinical trials have shown that the Pfizer vaccine was 95 per cent effective in protecting trial participants from COVID-19 for those 16 years and older, 100 per cent effective for those 12 to 15 years old, and 90.7 per cent effective for those five to 11 years old.
Sharma said that in the data reviewed by Health Canada, the four reported serious adverse events were ultimately determined to be unrelated to vaccination, and there were no reports of myocarditis, pericarditis, or severe allergic reactions.
Dr. Tam said that evidence emerging from adult immunization indicates that longer intervals between doses results in a longer-lasting immune response, and may lower the risk of myocarditis and pericarditis.
NACI is recommending that, unless otherwise advised by their doctor, children have a 14-day interval between receiving any other vaccines and the COVID-19 shot, calling it a 鈥減recaution鈥 to help determine the possible cause of any side-effects that may arise.
Paquette said that NACI鈥檚 suggestion for a longer interval is based on its own analysis, and that Pfizer鈥檚 submission was based off of its studies using a 21 day wait between doses.
鈥淎 longer interval has not been studied with this age group,鈥 he said.
Should NACI鈥檚 dose interval be observed by provinces and territories, it means that those aged five to 11 will not be able to be fully vaccinated before the Christmas holiday season. Sharma suggested that if families have specific dosing concerns related to holiday or travel plans, they could discuss their situation with healthcare practitioners.
Still, Dr. Tam is viewing the authorization as a 鈥渨elcome additional prevention option,鈥 given 鈥渢he current and prevailing epidemiology of COVID-19 in Canada, where incidence rates have remained highest in children aged five to 11 years for most of the fourth wave.鈥
The Public Health Agency of Canada says there will be efforts taken to inform parents and encourage them to vaccinate their children, but in her view, Tam doesn鈥檛 think now is the time to be discussing implementing an extension of vaccine mandates to children.
鈥淲e shouldn鈥檛 include a pediatric mandate at this point鈥 There鈥檚 very little access anywhere else in the world to pediatric vaccines, we鈥檙e one of the first countries鈥 And so for the purposes of travel for example, I don鈥檛 expect that we will be requiring this,鈥 she said.
鈥淒uring this time, it is very important that we support children and their caregivers and making informed decisions about COVID-19 vaccination while respecting their choices and pace of decision making,鈥 Tam said.
Referencing potential hesitancy, Sharma said that she understands the worry about what might happen, but 鈥渘ot choosing to get the vaccine for your children is also a choice.鈥
Reacting to the news, 愛污传媒 medical specialist Dr. Marla Shapiro said that the side-effects from COVID-19 vaccines are 鈥渨ell outweighed鈥 by the risks associated with a COVID-19 infection.
鈥淢ostly, what we expect to see is sore arms, redness, maybe a little bit of flu like symptoms if some kids experience that鈥 But every parent has to ask their questions, be comfortable with their decision, and I think it's really to understand what's the downside of not getting vaccinated and then the risk of getting COVID in a child,鈥 she said on 愛污传媒 Channel.
Pfizer will be required to continue providing Canada with safety and efficacy information from ongoing studies and real-world usage, with Health Canada and the Public Health Agency of Canada pledging to 鈥渃losely monitor鈥 the usage of this vaccine, which has been given the brand name of 鈥淐omirnaty.鈥
Sharma had been signalling for a few weeks that the authorization was around the corner, and in anticipation provinces and territories have been putting plans in place to administer these doses as soon as supply is ready.
Officials have previously stated that Canada has enough syringes and other supplies necessary to administer the pediatric COVID-19 vaccines.
鈥淲e are working closely with Pfizer to firm up the exact schedule for delivery of the second doses, and we all have more information to share about that soon,鈥 Tassi said.
