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Commentary on study:
OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents, The OpenSAFELY Collaborative, William J Hulme medRxiv 2024.05.20.24306810; doi: doi.org/10.1101/2024.05…. Link to preprint: doi.org/10.1101/2024.05…
This is an observational study (not an RCT) meaning they are looking through the database of…
Commentary on study:
OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents, The OpenSAFELY Collaborative, William J Hulme medRxiv 2024.05.20.24306810; doi: https://doi.org/10.1101/2024.05.20.24306810. Link to preprint: https://www.medrxiv.org/content/10.1101/2024.05.20.24306810v1
This is an observational study (not an RCT) meaning they are looking through the database of the National Health Service of England (each part of the UK has their own health service) and compiling records of hospital visits, emergency room visits, critical care (ICU) admissions and deaths. There are two main study groups, children (aged 5-11) and adolescents (aged 12-15) including several hundred thousand minors total.
The results are interesting, but very much in line with what one would expect based on other data on COVID-19. The study authors have calculated that the vaccinated adolescents (12-15) had a slightly less incidence of visits to Accident & Emergency (A&E) but there were very few visits total. For children (5-11) there were so few COVID-19 related events that they couldn't draw any conclusions at all. For adolescents there were only 72 visits to A&E, 90 hospital admissions, 3 ICY admissions and no deaths - so not a lot of events total. For the younger children there were no A&E admissions, 6 hospitalizations and no deaths. Since this is an observational study the authors also mention that confounding factors may have impacted the results (for example, parents who get their kids vaccinated also take other health measures). In the end there are so few events listed in the health system database that one wonders what they're all so worked up about.
The only cases of myocarditis/pericarditis occurred in the vaccinated group, with incident rates of 27 per million for the first dose and 10 per million for the second dose. The myocarditis/pericarditis numbers are similar to what the CDC has been claiming, which is 30-40 cases per million vaccinated children. The Director of the CDC posted the following on Twitter:
“To put this into perspective, if we vaccinate 1 million 12-17 year olds, we could see 30-40 MILD cases of myocarditis. In this same 1 million, through vaccination we AVOID: 8,000 cases of COVID-19, 200 hospitalizations, 50 ICU stays & 1 death. The benefits far outweigh the risks.” (Twitter post by Dr. Rochelle Walensky, https://archive.ph/kejp7)
The CDC Director is, of course, completely wrong about the risk/benefit analysis. The biggest takeaway from the England study is the lack of COVID-19 risk in children. Whether someone thinks the vaccine works or not isn't really relevant if children don't get COVID-19, or don't suffer any significant symptoms when they do.
The original clinical trial for the vaccine used in the trial (BNT162b2, from Pfizer) showed no difference in all cause mortality between the vaccine group and the control group:
Thomas et al.; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15. PMID: 34525277; PMCID: PMC8461570. https://pubmed.ncbi.nlm.nih.gov/34525277/
The other interesting thing about the Pfizer study is there were only 162 cases of SARS-CoV-2 infection in the control group of 21,726 people, for an infection rate of only 0.75%. The study reported the relative risk reduction, which looked great (95%) but didn't mention the absolute risk reduction, which was from 0.75% to 0.04%, so the absolute reduction in risk to the average person would only be 0.71%. This means they need to vaccinate well over 100 people to stop a single infection, and only a tiny fraction of infections lead to death.
Infection fatality rates were reported by Axfors and Ioannidis:
Axfors C, Ioannidis JPA. Infection fatality rate of COVID-19 in community-dwelling elderly populations. Eur J Epidemiol. 2022 Mar;37(3):235-249. doi: 10.1007/s10654-022-00853-w. Epub 2022 Mar 20. PMID: 35306604; PMCID: PMC8934243. https://pubmed.ncbi.nlm.nih.gov/35306604/
For the 0-19 age group, the IFR was only 0.001% (1 in 100,000) and of course not everyone gets an infection so crude mortality rate for children is one in hundreds of thousands or possibly millions. It's not surprising that the England study didn't see any deaths from COVID-19, because children don't die from it.
A previous study from Ioannidis had estimated the IFR for everyone less than 70 years old at 0.05%.
Ioannidis JPA. Infection fatality rate of COVID-19 inferred from seroprevalence data. Bull World Health Organ. 2021 Jan 1;99(1):19-33F. doi: 10.2471/BLT.20.265892. Epub 2020 Oct 14. PMID: 33716331; PMCID: PMC7947934. https://pubmed.ncbi.nlm.nih.gov/33716331/
Note that in the quote from the CDC Director the implication is that the fatality rate among children is something like one in a million, and this appears justified based on the IFR estimates from Axfors and Ioannidis (two of the most respected epidemiologists in the world, by the way). So in the end they're vaccinating children for something less deadly than seasonal flu, but using an experimental drug for which the long term effects are completely unknown because this technology has never been used in an FDA approved vaccine before, so we have no long term data to work with. The rate of myocarditis looks very low, but the vaccine itself appears completely unnecessary so this, plus the other unknown risks, makes the use of this drug on children very questionable ethically.