This petition is to the executive leader of Canada, Prime Minister Justin Trudeau, and to the Government of Canada, requested that they immediately suspend the authorization of use of the Pfizer-BioNTech RNA-based COVID-19 vaccine for 5-11 year olds given the inconclusive science and extremely limited data (1% of what is actually required to prove the vaccine is safer than COVID-19) from the manufacturer’s safety and efficacy trials that was used as the basis of the decision to grant this authorization. 

This petition requests that the Government of Canada immediately suspend this authorization until such time as: 

1. The manufacturer’s safety and efficacy trial is expanded from a sample size of 1,518 children to at least a sample size of 156,026 vaccinated children to show that the vaccine actually reduces the chance of severe COVID-19 for this age group, and that the vaccine itself is safer than the disease (see detailed data sources and statistical calculations below).
2. The trial protocol be updated to also include testing for actual Sars-CoV-2 infections, not just symptomatic COVID-19 cases.  The current trial data can only show efficacy in reducing COVID-19 symptoms, as the trial protocol involved a subjective evaluation of kids showing symptoms who were then PCR-tested. However, kids in the trial were not regularly tested for actual infections to show efficacy of the vaccine protecting against the virus itself (see more detailed info regarding the current trial protocol below).  

With only a 0.0020% (1 in 50,000) chance of a child aged 5-11 in Canada getting a serious case of COVID-19, there is no urgency to administer vaccines to them (kids with no comorbidities are even less likely at 1 in 100,000) - but with current data from all vaccinations in Canada shows a 1 in 33,333 (0.0030%) chance of a severe adverse reaction from the vaccine, thus it is probable that the vaccine could do more harm than the virus itself to these children if administered, thus the urgency to suspend the authorization of use immediately.  Once authorization is suspended the trial can be expanded to ensure the right decision can be made based on sound science and proper data. 

See below for all data sources and more detailed information regarding this urgent request. 

BACKGROUND:  

On November 19, 2021, the Canadian government approved the use of Comirnaty (the Pfizer-BioNTech COVID-19 vaccine) in children 5 to 11 years of age.  

This approval was based on the 24 page report by Canada’s National Advisory Committee on Immunization (NACI) and their analysis of the Pfizer-funded and Pfizer-conducted trial on the efficacy of their own product/vaccine.  

The Pfizer Phase 2/3 trial was conducted with a sample size of only 1,518 kids living in 4 countries (USA, Finland, Poland and Spain) - spread across 2 continents, multiple climates and cultures, many different ethnicities, and it was only conclusive based on this sample size at showing that the vaccine provided a reduction in “symptomatic COVID-19” (see further details below).

Data from Public Health Ontario, the NACI Recommendation Report, and studies published in the Canadian Medical Association Journal, shows that kids in Canada aged 5-11 have a 0.0041% chance of getting COVID-19 and then getting hospitalized (1 in 25,000) and a 0.0020% chance of getting a serious case of COVID-19 (1 in 50,000.  Note: kids with no comorbidities are 50% less likely to have a serious case of COVID-19, thus have a 0.0010% chance, 1 in 100,000). See calculations and links to all data from government studies and sources here.

In order for the trial to statistically prove with a 95% confidence rate that the vaccine can reduce the chance of a severe case of COVID-19 in kids aged 5-11 (and thus be better than status quo), the sample size for a trial proving the product’s efficacy would need to be: 156,026.  (See calculations for this sample size in above referenced document)

The long term cohort from the Phase 2/3 trial conducted by Pfizer only used a sample size of 1,518 vaccinated children, which is only 1% of the required sample size to show efficacy at reducing severe outcomes.  As quoted on page 8, paragraph 4 of NACI’s recommendation to the government: “the [trial] data did not include estimates of vaccine efficacy against severe outcomes such as hospitalization, MIS-C or death.”

The trial must also show that the vaccine is safer than getting a severe case of COVID-19 (again a 1 in 50,000 chance, 0.0020%). Data published by the Ontario Government show Pfizer’s vaccine has a 1 in 33,333 (0.003%) chance of a severe adverse event (SAE) from over 16M doses (link).  Also a study published in the New England Medical Journal of all Israel’s shots show the rate of myocarditis alone has a 1 in 47,000 likelihood (0.0021%, with an even greater likelihood in the younger population).  Thus this real world data already suggests the likelihood of a severe outcome from the vaccine is greater than the likelihood of severe outcome from SARS-CoV-2.  However, more evidence is required to prove this. Thus the trial would need a vaccinated sample size of 156,026 and track all severe adverse reactions of the trial participants to show that it is safer than SARS-CoV-2 itself for children aged 5-11.  

Thus as stated above, this petition is to the Canadian government requesting that they suspend the authorization of use of the Pfizer-BioNTech COVID-19 vaccine until such time that:

1. The trial is expanded to a sample size of 156,026 vaccinated kids to show with a 95% confidence rate that Comirnaty reduces the chance of this population getting a severe case of COVID-19, and that the vaccine itself is safer than SARS-CoV-2. 
2. The trial include testing for SARS-CoV-2 infections in both the vaccine and placebo cohorts in order to show the efficacy of the vaccine at reducing infections of SARS-CoV-2 in kids aged 5-11.  The current Pfizer Phase 2/3 trial only PCR-tested kids whose parents subjectively determined their kids were symptomatic, thus why the trial can only conclude a 90.7% reduction in “symptomatic covid” but cannot conclude if the vaccine reduces actual infections (refer to Phase 2/3 trial protocol pg. 57; as well as page 8 of the NACI recommendation, paragraph 2, on efficacy).  Currently this can only prove that the vaccine suppresses symptoms, and without further data and evidence the effects of the vaccine may be analogous to how acetaminophen or ibuprofen suppresses a fever, but does not protect the individual from the underlying disease or infection, its severity, nor reduce the spreading of it.  

REFERENCES:

• NACI Recommendation Report:  https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/pfizer-biontech-10-mcg-children-5-11-years-age/pfizer-biontech-10-mcg-children-5-11-years-age.pdf   
• Ontario Public Health data and Study:  https://www.publichealthontario.ca/-/media/documents/ncov/epi/2020/05/covid-19-epi-infection-children.pdf?la=en
• Detailed Study published in Canadian Medical Association Journal of all children admitted to hospital with acute SARS-CoV-2 infection in Canada in 2020: https://www.cmaj.ca/content/193/38/E1483
• Pfizer’s Phase 2/3 Trial Protocol: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2116298/suppl_file/nejmoa2116298_protocol.pdf
• Ontario Government’s report on all adverse events resulting from vaccinations:  https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid-19-aefi-report.pdf?sc_lang=en
• Study published in the New England Medical Journal of all adverse events resulting from vaccinations in Israel:  https://www.nejm.org/doi/full/10.1056/NEJMoa2110737