In part II of our vaccine series, Pharmacist Anita Rasoda delves into the specifics about the COVID vaccine process. She covers questions we've all thought of - how did we get a vaccine so fast? What exactly is in the approved vaccine, and what are the side effects.
Again, at Bloom & Elix, we are not endorsing whether you do or don't take the vaccine, we are simply giving you accurate and real information so that you can make a truly informed decision for your health and wellness.
Anita: As a pharmacist with a background in sciences I have faith that all the things I believe including health, wellness, science, data, and technology have enabled our current world to develop a vaccine that is safe and effective for most members in our communities.
The first 4,000 or doses of Pfizer’s vaccine that BC is has received will go to workers in long-term care homes and other health care workers who are on the front lines of treating COVID-19 patients.
For me, I am in favor of taking the the vaccine, because in doing so I will hopefully be able to protect those around me. I am willing to take a risk and bet on science that taking this vaccine will be more beneficial to myself than the risk of the perceived harm.
Which Vaccine will work against COVID?
COVID has seen the collaboration of global health authorities and vaccine developers whom are currently partnering to support the technology needed to produce vaccines. Some approaches have been used before to create vaccines, but some are still quite new.
There are currently more than 300 COVID-19 vaccine candidates However, the majority of these are at the pre-clinical phase of development, with around 50 in clinical trials.
Only phase III trials can determine if the vaccine protects against COVID-19. Many phase III vaccine studies fail because the dose chosen does not best balance safety and efficacy, and because they are large enough to reveal evidence of relatively rare side effects that might be missed in earlier, smaller-scale studies.
So how did we get a vaccine for COVID in less than a year?
Because of the seriousness of the COVID-19 pandemic, vaccine regulators fast-tracked some of these steps. Health Canada received Pfizer's submission for its vaccine on October 9, 2020 and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department's stringent safety, efficacy and quality requirements for use in Canada.
COVID is the first pandemic our generation has faced, and from it we have witnessed the advancements in science and technology that have collectively come together to create a vaccine in less than a year.
What do we know so far?
On 2 December 2020, the Pfizer/BioNTech mRNA vaccine became the first COVID-19 vaccine to be approved for widespread use in Canada. The vaccine is approved for people who are 16 years of age and older. Its safety and effectiveness in people younger than 16 years of age has not yet been established.
The Pfizer-BioNTech COVID-19 vaccine is manufactured by Pfizer Canada ULC and BioNTech Manufacturing GmbH.
Health Canada authorized this vaccine with conditions on December 9, 2020, under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
What is the Interim Order?
The Interim Order introduces expedited authorization pathways for the importation, sale and advertising of drugs used in relation to COVID-19.
An interim order is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.
This interim order facilitates timely access for Canadians to drugs and vaccines that have demonstrated the ability to diagnose, prevent, treat or cure COVID-19. The interim order introduces temporary regulations to expedite the authorization for importing, selling and advertising COVID-19-related drugs without compromising patient safety.
The Interim Order allow the Minister of Health to:
· authorize a drug that is not yet licensed in Canada or elsewhere with a modified set of requirements
· enable applicants to submit an application for one of these drugs with fewer application requirements, based on the authorization of a trusted foreign regulatory authority
· expand the use of an already authorized drug to include a COVID-19 indication based on known evidence with or without an application from the market authorization holder
Types of COVID Vaccines
Currently, there are three main types of COVID-19 vaccines that are or soon will be undergoing large-scale (Phase 3) clinical trials in Canada. Below is a description of how each type of vaccine prompts our bodies to recognize and protect us from the virus that causes COVID-19. None of these vaccines can give you COVID-19.
mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
Protein subunit vaccines include harmless pieces (proteins) of the virus that cause COVID-19 instead of the entire germ. Once vaccinated, our immune system recognizes that the proteins don’t belong in the body and begins making T-lymphocytes and antibodies. If we are ever infected in the future, memory cells will recognize and fight the virus.
Vector vaccines contain a weakened version of a live virus—a different virus than the one that causes COVID-19—that has genetic material from the virus that causes COVID-19 inserted in it (this is called a viral vector). Once the viral vector is inside our cells, the genetic material gives cells instructions to make a protein that is unique to the virus that causes COVID-19. Using these instructions, our cells make copies of the protein. This prompts our bodies to build T-lymphocytes and B-lymphocytes that will remember how to fight that virus if we are infected in the future.
How dose Tozinameran work?
Tozinameran is a mRNA vaccine that teach our cells how to make a protein that will trigger an immune response without using the live virus that causes COVID-19. Once triggered, our body then makes antibodies. These antibodies protect us from being infected if the real virus does enter our body in the future.
‘RNA’ stands for ribonucleic acid, which is a molecule that provides cells with instructions for making proteins. Messenger RNA (mRNA) vaccines contain the genetic instructions for making the SARS-CoV-2 spike protein. This protein is found on the surface of the virus that causes COVID-19.
When a person is given the vaccine, their cells will read the genetic instructions like a recipe and produce the spike protein. After the protein piece is made, the cell breaks down the instructions and gets rid of them.
The cell then displays the protein piece on its surface. Our immune system recognizes that the protein doesn’t belong there and begins building an immune response and making antibodies.
How is it given?
The vaccine is given by an injection (0.3 mL) into the muscle of the arm. For the vaccine to work best, you need to get 2 doses: a single dose and then a second dose 21 days later. The first shot starts building protection. A second shot a few weeks later is needed to get the most protection the vaccine has to offer.
What are the ingredients in Tozinameran:
· ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
· ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
· dibasic sodium phosphate dihydrate
· monobasic potassium phosphate
· potassium chloride
· sodium chloride
· water for injection
How effective is it?
Based on studies in about 44,000 participants, the Pfizer-BioNTech COVID-19 vaccine was 95% effective in preventing SARS-CoV2 infection beginning 1 week after the second dose. This means that people may not be protected against COVID-19 disease until at least 7 days after the second dose.
What are the side-effects?
Like all vaccines, Pfizer-BioNTech COVID-19 Vaccine can cause side effects.
Side effects may occur at the following frequencies:
Very common: may affect more than 1 in 10 people · pain at injection site · tiredness · headache · muscle pain · chills · joint pain · fever
Uncommon: may affect up to 1 in 100 people · enlarged lymph nodes
These are not all the possible side effects you may have when taking Pfizer-BioNTech COVID19 Vaccine. If you experience any side effects not listed here, tell your healthcare professional.
Should you develop any serious symptoms or symptoms that could be an allergic reaction, seek medical attention right away.
Symptoms of an allergic reaction include:
· hives (bumps on the skin that are often very itchy)
· swelling of the face, tongue or throat
· difficulty breathing
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
What are the Terms and Conditions for Health Canada Approval?
Pfizer Canada ULC and BioNTech Manufacturing GmbH will submit to Health Canada:
· monthly post-market safety monitoring reports, including information about serious and non-serious adverse drug reactions in Canada and abroad
· any further data on the long-term safety and effectiveness of the drug, including final data from ongoing clinical trials
· further quality data confirming that the manufacturing processes and controls will continue to consistently produce a product of suitable quality for the intended use
Will I take the vaccine?
Health Canada states that:
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. 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.”