KAWARTHA LAKES-Today, Health Canada authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine in children 5 to 11 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.
Health Canada received an application from Pfizer-BioNTech to expand the indication of Comirnaty on October 18, 2021. The 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 Department says it has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks. Health Canada has authorized a two-dose regimen of 10 micrograms to be administered three weeks apart, which is a lower dose than the 30 micrograms two-dose regimen authorized for people 12 years of age and older.
17 children (0-19 yrs) across Canada have died from COVID-19 since the pandemic began. There are 9 million kids in that age group in Canada. According to the CBC youth in Canada make up 20% of cases in the pandemic but less than 2% of hospitalizations.
The vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, sucrose, and sodium chloride.
Here’s a link to the fact sheet for parents provided by the FDA: https://www.fda.gov/media/153717/download
Officials at Health Canada say the clinical trial showed that the immune response in children 5 to 11 years of age was comparable to the immune response in people 16 to 25 years of age. The relative risk reduction of the vaccine was 90.7% effective at preventing COVID-19 in children 5 to 11 years of age and no serious side effects were identified according to the Canadian Government.
The Absolute Risk Reduction is .84%. According to the National Centre For Biotechnology Information, Absolute risk reduction (ARR) – also called risk difference (RD) – is the most useful way of presenting research results to help your decision-making. They provide this example: If the ARR is 8 per cent (20 per cent – 12 per cent = 8 per cent). This means that, if 100 children were treated, 8 would be prevented from developing bad outcomes. Another way of expressing this is the number needed to treat (NNT). If 8 children out of 100 benefit from treatment, the NNT for one child to benefit is about 13 (100 ÷ 8 = 12.5). Read more here:https://www.ncbi.nlm.nih.gov/books/NBK63647/
Information provided to Kawartha 411 by the FDA found that one participant, a 6-year-old female in the vaccine group, reported Henoch-Schönlein purpura (HSP) which was diagnosed 21 days after Dose 1. As of the data cut-off, Dose 2 had not been administered.
According to the Mayo Clinic Henoch-Schonlein purpura (also known as IgA vasculitis) is a disorder that causes the small blood vessels in your skin, joints, intestines and kidneys to become inflamed and bleed. The most striking feature of this form of vasculitis is a purplish rash, typically on the lower legs and buttocks. Henoch-Schonlein purpura can also cause abdominal pain and aching joints. Rarely, serious kidney damage can occur.
One other participant in the vaccine group was withdrawn after developing a fever two days after the first dose and experiencing worsening neutropenia. Neutropenia occurs when you have too few neutrophils, a type of white blood cells. While all white blood cells help your body fight infections, neutrophils are important for fighting certain infections, especially those caused by bacteria.
Read more here:https://www.fda.gov/media/153510/download
While no cases of Myocarditis were found in this small study, Public Health Ontario reports there have been 202 ER visits for myocarditis/pericarditis with 142 requiring hospitalization. 32 were in kids 12-17 years of age. Ontario reports the risk after Pfizer second dose is in 12-17-year-old males is 66% higher than for 18-24 year old males. (PHO Ontario August 25th)
The study for kids aged 5-11 included only 2268 children.
Up to November 5, 2021 there have been 1075 cases of Myocarditis/pericarditis linked to COVID vaccination in Canada. 334 cases of pulmonary embolism, 228 cases of thrombosis, 225 cases of deep vein thrombosis, 625 Bells Palsy, 157 strokes, 558 anaphylaxis. Read more here: https://health-infobase.canada.ca/covid-19/vaccine-safety/
The information provided by the FDA states “Asymptomatic disease and transmission were not assessed”.
Health Canada says it has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals in any age group.
Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine, and will take action if any safety concerns are identified other than those already identified in the study.