It’s almost here: What you need to know about Canada’s first approved COVID vaccine,
Health Canada provides answers to our frequently asked medical questions
Canada has become the third country in the world to sign off on a COVID-19 vaccine made by Pfizer Inc. and BioNTech SE, setting the stage for vaccination to begin here. The dose is already approved for emergency use in the U.K. and Bahrain.
In announcing Wednesday morning that it had given the dose the green light, Health Canada also released a significant amount of information about why the decision had been made, as well as more details on who should take the vaccine and how.
The efficacy of Pfizer’s dose was demonstrated in a trial that involved more than 43,000 people in six countries, Health Canada noted.
No major safety problems or deaths have been identified, it said.
The decision flagged the lack of long-term information available, but also noted the riskmanagement plan submitted by Pfizer — which includes monthly “safety summary reports” that will be provided to Health Canada — as well as commitments to monitor people who get the vaccine.
A summary of the decision said a vaccine has the potential to curb the spread of a pandemic that has had a “significant impact on public health” and to “reduce its social and economic consequences.”
In sum: “The benefit to risk assessment for Pfizer-BioNTech COVID-19 Vaccine is considered favourable.”
Here are the highlights of the rest of the information provided by Health Canada.
Who can take it?
Canada has approved the vaccine for use in people 16 and older. Safety and effectiveness in kids has not yet been established.
How is it given?
The vaccine is injected into the muscle of the arm. One dose is
0.3 millilitres. Each person should get two doses, spaced 21 days apart.
It’s important that recipients get the second dose or it may not work as well.
What does it actually do?
The vaccine is used to prevent the disease called COVID-19, which is caused by the SARSCoV-2 virus.
As with any vaccine, it may not fully protect everyone who takes it.
Experts say we don’t know yet if the vaccine will prevent transmission, which is why you’ll still have to wear a mask and follow other public health guidelines after you’re vaccinated.
How was it tested?
The vaccine was tested in more than 43,000 volunteers around the world. Those studies found that the vaccine was 95 per cent effective in preventing COVID-19.
When does immunity kick in?
About one week after the second dose.
How does this vaccine work?
The Pfizer vaccine relies on a
new technology that uses what’s called mRNA.
RNA, meaning ribonucleic acid, is the instructions for making proteins.
These vaccines include the instructions for making the coronavirus’s distinctive “spike protein.”
Recipients’ cells will make spike proteins, their bodies will recognize them as strange, and will start building an immune response that will help it fight off the real coronavirus later.
Possible side effects?
Health Canada identified no major safety concerns in the data it looked at.
More than one in 10 people may experience mild or moderate side effects, including pain at the injection site, headache, muscle pain, chills and feeling tired and feverish.
As many as one in 100 people may experience enlarged lymph nodes.
All vaccines have the risk of a serious side effect, though Health Canada says it’s rare. A serious side effect would include an allergic reaction.
Symptoms of an allergic reaction include hives, or itchy bumps on the skin, swelling of the face, tongue or throat, or
difficulty breathing.
Each country makes its own decisions for how the vaccine is used within its own borders.
The British regulator is now recommending that people with a history of significant allergic reactions do not get the vaccine, after two health care workers with allergies who got the jab Tuesday had an adverse reaction.
What to do if you have side effects?
You can report side effects to your health care professional, who can also give you information on the management of those symptoms.
Your health care provider should inform the public health department of any serious side effects.
If you experience a serious allergic reaction, call 911 or go to the hospital.
What are the interactions with other drugs?
There is no information about how this vaccine interacts with other vaccines.
Tell your health care professional about all other drugs, vitamins and supplements you take.
Interaction with other conditions
Make sure to tell a health care provider about other health conditions or problems you have, including a weakened immune system, bleeding problems, or if you are pregnant or are breast feeding.
Safety monitoring after vaccination
Health Canada says it will continue to monitor the safety of the Pfizer vaccine after people start getting it.
Once it’s on the market, Pfizer and BioNTech are legally required to tell Health Canada about any adverse events.
They’re also planning to follow all of the trial volunteers for two years to study the effect of the vaccine during that time.
Who should not take it?
If you are allergic to any of the ingredients, or if you have COVID-19 symptoms. If you are unsure, ask a health care professional.