Original language of petition: English
Petition to the House of Commons
- Pfizer-BioNTech’s COVID-19 vaccine is now authorized for use in Canadians 5 years or older, and Moderna’s COVID-19 vaccine for those 12 years and older;
- These mRNA vaccines enable presentation of the SARS-CoV-2 spike protein on the surface of healthy body cells to evoke inflammatory and thrombotic responses that lead to cellular damage and destruction;
- The injected vaccine nanoparticles spread throughout the body, with accumulation in endocrine and reproductive organs, raising concerns of possible infertility, autoimmune and other health issues;
- Safety studies for these mRNA vaccines in children are too brief and underpowered in terms of number of participants to rule out risks greater than 1 in 1000 for short- and long-term adverse reactions;
- The American Vaccine Adverse Events Reporting System has documented over 800,000 reports of adverse reactions and 8000 deaths linked to COVID-19 vaccines, and this registry is considered to document only about 2% of actual injuries;
- The degree of natural immunity in children and youth is unknown, but it is robust, complete, and long-lasting, and vaccinating COVID-19 recovered individuals increases their risk of vaccine-induced injury; and
- Children and adolescents are at extremely low risk of COVID-19 morbidity and mortality and for transmission of SARS-CoV-2. Compared to COVID-19, their risk of vaccine-induced injury is at least a magnitude higher, including a 1 in 5000 risk of myocarditis.
Government response tabled
Response by the Minister of Health
Signed by (Minister or Parliamentary Secretary): Adam van Koeverden
The Government of Canada is committed to helping protect, maintain and improve the health of Canadians, and vaccination is an important public health measure that prevents severe illness outcomes. Vaccination is a key part of Canada’s pandemic response, and vaccine safety is of utmost importance to the Government of Canada. Health Canada conducts rigorous scientific reviews and testing of the vaccine before approved for use in Canada, and, even after the vaccine is in use, health authorities at Health Canada (HC) and the Public Health Agency of Canada (PHAC) continue to monitor the vaccine to ensure the highest standards of safety. Furthermore, the Government is committed to transparency and openness with regards to COVID 19 vaccines.
Most COVID-19 vaccines help the body develop an immune response against the spike protein on the outside of the coronavirus. Just like with a natural infection, when the immune cells in the body are exposed to parts of the virus in a vaccine, antibodies are developed and immune cells are primed to respond to prevent infection.
The Pfizer-BioNTech and Moderna vaccines, specifically, are messenger ribonucleic acid (mRNA) vaccines. These vaccines use an mRNA molecule that provides cells with the genetic instructions for making the SARS-CoV2 spike protein. The mRNA is formulated in a small fat particle shell to protect it until it enters into human cells, where it then makes harmless copies of coronavirus proteins.
When a person is given the vaccine, their cells will read the genetic instructions and produce the harmless spike protein, priming the immune system to recognize and attack the SARS-CoV-2 virus if it later infects the body. The mRNA and fat particles are broken down and disposed of within a few hours after being used. The vaccine does not affect, interact or alter your DNA, nor do any vaccine components remain in your body. Additional information on COVID-19 mRNA vaccines can be found here: www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/type-mrna.html.
Health Canada authorized all COVID-19 vaccines after independent and thorough scientific reviews for safety, efficacy, and quality. Health Canada has reviewed safety data from people who have been monitored for several months after vaccination, and is continuously reviewing safety data that are emerging from the real world use of vaccines in millions of people in Canada and internationally. The data reviewed so far continue to show that the benefits outweigh the risks.
COVID-19 vaccines, including the Pfizer-BioNTech and Moderna vaccines, have been rigorously tested prior to use in Canada. Clinical trials showed that beginning one week after the second dose, the Pfizer-BioNTech COVID-19 vaccine was effective against symptomatic infection as follows:
- 95% efficacious for those 16 years and older
- 100% efficacious for those 12 to 15 years old
- 90.7% efficacious for those 5 to 11 years old
The Pfizer-BioNTech vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020, and subsequently authorized for children 12 to 15 years of age on May 5, 2021. The Pfizer-BioNTech Comirnaty® COVID-19 vaccine was approved for use in children 5 to 11 years of age on November 19, 2021.
As for Moderna, clinical trials showed that beginning two weeks after the second dose, the Moderna Spikevax®COVID vaccine was:
- 94.1% efficacious in protecting trial participants aged 18 and above against COVID-19
- 100% efficacious in trial participants 12 to 17 years old
The Moderna COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, Moderna Spikevax® transitioned to an authorization under the Food and Drug Regulations.
Health Canada follows international guidelines with respect to the analysis of efficacy, immunogenicity and safety data supporting authorization of vaccines in the pediatric population. The pediatric clinical trial included 4,600 participants aged 5 through less than 12 years of age. In the initial safety group, 2,268 children 5 to < 12 years of age (1,518 in the vaccine group and 750 in the placebo group) were enrolled in the study. Of these, 2,171 participants (95.7%) (1456 in the vaccine group and 715 in the placebo group) have been followed for at least 3 months after the second dose of the vaccine. The clinical trial is ongoing for the safety and efficacy follow up.
The pediatric formulation of the Pfizer-BioNTech Comirnaty® vaccine was approved based on comparability of the formulation to the currently registered formulation for individuals 12 years of age and older. These clinical trials compared the immune response, safety, and efficacy of the vaccine to a placebo. In these studies, no safety issues were detected, and the vaccine was shown to provide very good protection against COVID-19 in the two months after vaccination.
Health Canada’s independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective, and the benefits must also outweigh any risks. Evidence shows that the vaccines used in Canada are very effective at preventing severe illness, hospitalization, and death from COVID-19. If infected, unvaccinated individuals are 4 times more likely to be hospitalized and 5 times more likely to die as a result of their illness than fully vaccinated individuals.
After a vaccine is authorized for use in Canada, continuous post-market surveillance is conducted to monitor and understand how vaccines behave in the entire population and their real-world impact. Vaccine safety surveillance is critical for rapidly detecting and responding to safety issues and ensuring that the benefits of the vaccine continue to outweigh the risks.
Canada’s vaccine safety monitoring system will help to detect any possible rare side effects that did not appear in the clinical trials. Canada has a well-established vaccine safety surveillance system that is a collaboration between federal, provincial and territorial (F/P/T) implementers of immunization programs, PHAC, HC, and vaccine manufacturers. Vaccine manufacturers will continue collecting information about safety from clinical trial participants, and are required to report serious adverse events to Health Canada as the national regulatory authority, as well as submit regular summaries of global safety information. HC has been actively and continuously monitoring and reviewing safety data submitted, including foreign data from international partners.
In addition, PHAC receives and reviews reports of adverse events following immunization from F/P/T immunization program implementers through the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). Adverse event reports are transmitted to CAEFISS weekly, and reviewed to confirm the authorized vaccines remain safe to use. Health Canada and PHAC work collaboratively to review available data and take action as appropriate to their respective mandates. Although adverse events may occur after being vaccinated with a COVID-19 vaccine, they are not necessarily related to the vaccine. Health Canada and PHAC review the reports to determine whether the vaccine may have played a role.
All serious events undergo medical review to see if there are any safety issues requiring further action. These processes include meeting regularly to review the data with provincial and territorial partners, the regulator, research networks, and medical advisors. Any unexpected safety concerns are detected quickly and acted upon immediately. HC takes appropriate regulatory actions should new safety issues be identified. PHAC provides information to decision-makers such as provincial and territorial health authorities and the National Advisory Committee on Immunization (NACI), to inform policy recommendations and decisions regarding the use of vaccines in Canada.
Although there have been rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart lining) following vaccination with COVID-19 mRNA vaccines, the majority of cases have been mild and resolved quickly. Analyses of surveillance data in Canada suggest a higher rate of myocarditis/pericarditis cases reported after vaccination with Moderna SpikeVax compared to Pfizer-BioNTech Comirnaty vaccine especially among young males following a second dose of vaccine (Abraham et al., 2021). To mitigate this rare risk, NACI released updated guidance. The use of the Pfizer-BioNTech vaccine is preferred to the Moderna Spikevax vaccine in individuals 12 to 17 years of age because of a lower reported rate of myocarditis/pericarditis following the Pfizer-BioNTech compared to the Moderna Spikevax vaccine. Additionally, a longer interval between doses is associated with higher vaccine effectiveness and potentially lower risk of myocarditis/pericarditis.
Regarding women and fertility, there have been anecdotal reports of menstrual irregularities following COVID-19 vaccination.? Some studies (Trogstad L et al., 2022; Edelman A et al., 2022) have shown evidence of an association between vaccination and heavier bleeding, shorter intervals between periods, and increased pain during periods. However, additional research is underway to understand if and how these disturbances may be related to vaccination; menstrual irregularities can be caused by a variety of factors, including pregnancy, hormonal imbalances, infections, diseases, trauma, and certain medications.
Notably, professional and public health organizations (Society of Obstetricians and Gynecologists of Canada, Ontario Medical Association, Ontario Ministry of Health, American College of Obstetricians and Gynecologists, American Society for Reproductive Medicine, Society for Maternal-Fetal Medicine) agree that alleged links between COVID-19 vaccines and infertility are unfounded and recommend vaccination for pregnant people and those intending to become pregnant. Some supporting studies can be found here: Mohr-Sasson et al., 2021; Lu-Culligan et al., 2021; Lifshitz et al., 2021; Safrai et al., 2021; Bentov et al., 2021; Morris et al., 2021; Orveito et al., 2021; Wesselink et al., 2022; Collins et al., 2022; Donders et al., 2021; Best et al., 2021; Setti et al., 2021.
There is no reason to suspect long-term impacts on fertility following COVID-19 vaccination, given the existing evidence. In studies looking at pregnancies conceived with assisted reproductive technologies such as in vitro fertilization (IVF), there were no differences in pregnancy rates between vaccinated and unvaccinated individuals; additionally, there were no differences in other measured outcomes, such as rates of ectopic pregnancies and spontaneous miscarriages. Many other large studies have examined vaccine safety during pregnancy and found no increased rates of pregnancy losses in any trimester (EMA, 2022; CDC, 2021; Lipkind et al., 2021; Shimabukuro et al., 2021).
Meanwhile, it has been observed that infection with SARS-CoV-2 may reduce fertility in males, either temporarily or longer-term. Additionally, both Canadian and US data show an increased risk of preterm birth associated with SARS-CoV-2 infection in pregnancy; preterm birth is linked to an increased incidence of diseases and long-term health complications. Similar conclusions can be found in these studies: Orvieto R et al, Bentov Y, et al.
Vaccination continues to be very important, even for individuals who have already recovered from SARS-CoV-2, as they may remain at risk of Omicron infection. Numerous reports have documented the risk of reinfection with Omicron is higher than risk of reinfection with previous variants (1, 2, 3, 4, 5). Current evidence prior to Omicron suggests protection is more robust and longer lasting with vaccination in previously infected individuals compared to immunity from SARS-CoV-2 infection alone.
Health Canada is committed to transparency and openness to strengthen trust in our regulatory decisions. For each vaccine that has been authorized, detailed information, including about the data assessed during the course of the scientific review, is available on the Vaccines and Treatment portal: COVID-19 vaccines and treatments portal (canada.ca). Clinical information is also released proactively following the completion of HC’s regulatory review. This information can be found on the public release of clinical information (PRCI) website. Additional details about mRNA vaccines are located on Health Canada’s COVID-19 mRNA vaccines page.
Information on reports of adverse events following immunization (AEFIs) following COVID-19 vaccination is published on the Government of Canada website and is currently updated on a weekly basis (https://health-infobase.canada.ca/covid-19/vaccine-safety/). These reports do not necessarily imply that a causal relationship between the event and the vaccine has been established. Health Canada and PHAC continue to monitor all reports submitted to our surveillance system. If any new safety issues are confirmed, Health Canada will take appropriate action, which could include communicating any new risks to Canadians and healthcare providers, or changing the recommended use of the product.
More information about COVID-19 infections can also be found at Government of Canada’s COVID-19 daily epidemiology update webpage and the weekly epidemiological report. Please note that data should be interpreted with caution, due to the rapid increase in cases starting December 2021, delays in data entry, and changes in COVID-19 testing policies in many jurisdictions.
- Open for signature
- December 7, 2021, at 11:47 a.m. (EDT)
- Closed for signature
- January 6, 2022, at 11:47 a.m. (EDT)
- Presented to the House of Commons
March 2, 2022 (Petition No. 441-00203)
- Government response tabled
- April 25, 2022
Only validated signatures are counted towards the total number of signatures.
|Province / Territory
|Newfoundland and Labrador
|Prince Edward Island