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Health Canada has approved the Pfizer-BioNTech vaccine for use in the country, after the manufacturer’s Oct. 9 submission.
“This is a critical milestone in our fight against COVID-19 and in our efforts to provide every Canadian with access to a vaccine,” Dr. Supriya Sharma, Health Canada’s chief medical adviser, said at a press conference on Wednesday.
Canadian company Acuitas Therapeutics is behind a core component of the vaccine, developing lipid nanoparticles (LNP) that protect the messenger RNA (mRNA) vaccine after it is injected.
“It is, we hope, the beginning of the end of this pandemic,” a statement from Acuitas Therapeutics president & CEO Dr. Thomas Madden reads. “It gives us light at the end of what has been – on a global level – a very dark tunnel.”
“The quality of the data from BioNTech/Pfizer’s large trial speaks to the efficacy and safety of this vaccine and that is important for people to know. What we need now are for people to get vaccinated so that we can eradicate COVID-19, a horrific virus that has taken more than 1.5 million lives worldwide and has devastated families and communities in every corner of the globe.”
Pfizer will continue providing information to Health Canada on the safety, efficacy and quality.
“Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified,” a statement from Health Canada reads. “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place.”
The initial indication of the Pfizer-BioNTech vaccine is for people 16 years of age or older but additional clinical trials are being run on children of all age groups.
What are the risks with the vaccine?
For any Canadians who are still apprehensive about getting the COVID-19 vaccine, Dr. Sharma stressed that the there are potential risks, even if they are rare, but everyone should “absolutely” feel comfortable getting the vaccine when it is their turn, while ongoing monitoring continues.
She also spoke about the recent guidance from the U.K. that individuals should not receive the Pfizer-BioNTech vaccine if they have had a significant allergic reaction to a vaccine, medicine or food. Dr. Sharma said Canada is working closely with U.K. counterparts to get additional information and confirmed that officials are currently in the phase of assessing whether the reaction was in fact related to the vaccine.
“We know that those were allergic reactions that happened quite close to after somebody got the vaccine, and that the individuals were treated appropriately and have recovered,” she confirmed. “Out of the close to 44,000 people in the clinical trials, there were two cases of allergic reactions that were on the severe side, one was in the group that got the vaccine, one was in the group that did not get the vaccine.”
“It wasn’t a significant finding in the trials, however, we know that with all vaccines there’s a risk of allergic reactions and that’s why when people receive vaccines we ask that they remain in the area that they get the vaccine for a period of time, usually 15 to 20 minutes, to be monitored.”
Who should avoid the COVID-19 vaccine?
According to the details released by Health Canada, anyone who is allergic any of the ingredients listed should not be immunized with this specific COVID-19 vaccine. Anyone who has possible COVID-19 symptoms should also not be immunized without speaking with a health professional about the symptoms and getting tested.
In terms of reactions to the Pfizer vaccine in general, the most common reaction was some discomfort at the injection site itself. The next most common was fatigue and then headache. The reactions were the same after the second vaccination but people felt a bit more fatigued.
When asked about immunity and what is known about how long people who get vaccinated with the Pfizer-BioNTech vaccine will be protected from COVID-19, Dr. Sharma indicated answers to questions about immunity will become clearer as patients are followed, including whether revaccination will be required at some point.
“So far form the data, it does look like that immunity is continuing and certainly from some of the earlier animal data in the pre-clinal trials, it looks like it is conferring longer range immunity,” she said.
When can you get your COVID-19 vaccine?
In Ontario, the initial doses will be administered to residents and staff in congregate living settings for seniors, health care workers, adults in Indigenous communities and adult recipients of chronic home health care. The province also plans to issue proof of vaccination cards to those who get immunized.
The first doses of COVID-19 vaccine that arrive in Quebec will be distributed to long-term care facilities.
Saskatchewan is set to begin with a pilot phase, beginning on Dec. 15, which will involve vaccinating 1,950 individuals who work at the Regina General Hospital.