Rushed Decisions Lead To Regret: Part 3

To date, a decision to rollout the vaccine to children aged 5 – 11 years has not been made. We question the idea that vaccine mandates are a “no-brainer” particularly for children. Specifically, we believe that for children, emerging data indicates that such a policy will lead to more harm than good. We urge a precautionary approach be taken and that any plans for the vaccination of children be delayed for three important reasons.

The risk covid presents to children is negligible: 

The second reason against vaccinating children is the very small risk that the virus poses to this group.²² There is a 1,000-fold difference in mortality risk between comparing children with frail elderly people after testing positive for covid-19. It is extraordinarily rare for a child to suffer any significant illness from covid-19 and orders of magnitude more rare for them to die from this virus.²³ 

A prominent US epidemiologist likened the risk of a person less than 65 years old dying from covid-19 as remarkably uncommon and about the same as dying during a car journey from between 21 – 162 km each day.²⁴ This comparison shows that there is little personal risk posed by covid-19 to children and thus no reason to expose them to an experimental vaccine. Other arguments for vaccinating children are related to the threat of ‘asymptomatic transmission’. Up-to-date evidence, however, shows little evidence of this phenomenon in Wuhan, after 10 million people were screened by PCR for infection, whether or not they had symptoms.²⁵

Vaccine-associated risks that need further investigation: 

To date, 18 countries including Canada, Sweden, Latvia, Germany, Italy, France, Spain, Denmark, Norway, and The Netherlands, have halted the roll-out of the AstraZeneca covid-19 vaccine due to concerns that it has caused blood clots in some recipients.⁶ There are similar concerns that the Pfizer vaccine may also cause clots. In Norway, 23 deaths of frail elderly people occurred shortly after receiving the Pfizer vaccine – with an investigation concluding that the vaccine was responsible for at least 10 of these deaths.²⁶ In Australia two middle-aged women also died after receiving the AstraZeneca vaccine, caused by rare blood clots in the brain.²⁷

Another risk from the vaccine for young people that have received the Pfizer or Moderna vaccine is myocarditis or pericarditis. In the US, more than 1,200 such cases have been identified in people younger than thirty years according to the Centres for Disease Control. A study in the United States showed that the risk of myocarditis after vaccination was 3.7 to 6.1 times higher than the risk of hospitalisation due to covid-19, even under conditions of moderate and high covid-19 incidence.²⁸     

A more recent study shows a 13.6-fold (1,260%) increase in new cases of myocarditis after the second vaccine in 16 to 19-year-old males, compared to background rates of the disease in the same demographic group between 2017 and 2019.²⁹ Other authors have questioned the use of vaccines in anyone less than the age of 65 years, since deaths attributable to the vaccine are likely to outnumber those saved by a factor of five.³⁰ For younger children, this calculation is even less favourable. These events have generally occurred within a week following receiving the second dose of the vaccine.³¹

Under-reporting into vaccine safety databases is common. In a United States study that compared augmented electronic monitoring of health records in the thirty days post-vaccination, with prompting of clinicians to report likely vaccine-related events to usual practice, the augmented system resulted in a 30-fold increase in vaccine-related incident reporting,³² compared to historical periods. This means that analyses based on such reporting systems are likely to be gross underestimates of the true burden of adverse events.

Other academics overseas have expressed concerns at the high rate of post-vaccine adverse effects reported in vaccine safety databases. In the UK ‘Yellow card’ system, for example, between 4 Jan and 26 May 2021, a total of 1,253 deaths and 888,196 adverse reactions post covid-19 vaccine were recorded, with 63 million people receiving at least one dose, and 24 million having had two doses.  This is roughly a 1/50,000 risk of death and 1/70 risk of adverse reaction after vaccination, assuming these reports are all caused by the vaccine. The author of the document, Dr Tess Lawrie, stated that based on these figures there was: “more than enough evidence … to declare the COVID-19 vaccines unsafe for use in humans”.³³

Table 1. Adverse Events for Covid-19 Pfizer vaccine verses influenza vaccine in NZ

Reviewing the latest Covid-19 vaccine safety report from Medsafe (New Zealand Medicines and Medical Devices Safety Authority) published on 9 October 2021³⁴ – a total of 27,651 Adverse Events following Vaccination (AEFI) have occurred. With 982 of these being Adverse Events of Special Interest (AESI) which are paid greater attention due to their seriousness. Most concerning is the number of deaths that have occurred following vaccination which now totals 91. When comparing the number of adverse events from the covid-19 vaccine to those reported to Medsafe for the influenza vaccine in 2019, ³⁵ we calculate that the Covid-19 vaccine adverse events rate is more than 31-fold greater. Further, the influenza vaccine has no reports of Adverse Events of Special Interest, nor death following vaccination. From these data the covid-19 vaccine exposes those who receive it to far higher rate of adverse health consequences than that for influenza.

Summary: 

The Pfizer covid-19 vaccine remains experimental and is only provisionally approved for use in New Zealand. Long-term safety and efficacy data will not be known until 2023, and children are largely unaffected by the virus. Like the swine flu vaccine, a true understanding of the long-term side-effects of the vaccine remain unknown until these trials are complete. There are several serious side effects caused by current covid-19 vaccines whose risks are not fully understood. Basic safety biodistribution studies are missing,³⁶ with data from rodent models showing high uptake of nanoparticle delivery substrate in the ovaries of these animals.³⁷ Basic safety studies, that are a routine part of vaccine development were not carried out for this vaccine.

When considering whether to vaccinate children against covid-19, one must weigh the therapeutic benefits against the risks. With such little to gain, all children can possibly experience are the risks of the product, such as myocarditis. True estimates of risks from the vaccine are now not fully understood, although there are already several identified now including blood clots, myocarditis, and death. ^{38, 39, 34}

On balance, we believe that the known and unknown risks from the vaccine outweigh any benefits for children. Historical examples should lead us to pause and make a sober assessment of the risks, given the lack of benefit to children. We believe that it is best to wait at least two years for the long-term safety and efficacy results to enable a more informed decision to be made about whether to vaccinate children against SARS-CoV-2. Whatever else can be said about the decision to vaccinate children, it cannot and must not be considered a “no brainer”. No sober analysis would come to that conclusion.

This research did not receive any specific funding.

The authors declare no conflicts of interest.

References

22. Bhopal SS, Bagaria J, Olabi B, Bhopal R. Children and young people remain at low risk of COVID-19 mortality. Lancet Child Adolesc Health. 2021 May;5(5):e12-e13. doi: 10.1016/S2352-4642(21)00066-3. Epub 2021 Mar 11. Erratum in: Lancet Child Adolesc Health. 2021 Mar 24;: PMID: 33713603; PMCID: PMC7946566.

23. Battacharya J. Opinion: Jay Bhattacharya: A compassionate covid strategy. [Internet] NWA Online. 15 November 2020. [cited 9 July 2021] Available from: https://www.nwaonline.com/news/2020/nov/15/compassionate-covid-strategy/

24. Ioannidis JPA, Axfors C, Contopoulos-Ioannidis DG. Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicenters. Environ Res. 2020 Sep;188:109890. doi: 10.1016/j.envres.2020.109890. Epub 2020 Jul 1. PMID: 32846654; PMCID: PMC7327471.

25. Cao, S., Gan, Y., Wang, C. et al. Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China. Nat Commun 11, 5917 (2020). https://doi.org/10.1038/s41467-020-19802-w

26. Torjesen I. Covid-19: Pfiver-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds BMJ 2021; 373 :n1372 doi10.1136/bmj.n1372

27. Davey M. ‘Extremely rare’: Australia records second death ‘likely linked’ to AstraZeneca vaccine blood clots. [Internet] The Guardian. 10 June 2021. [cited 9 July 2021] Available from: https://www.theguardian.com/australia-news/2021/jun/10/extremely-rare-australia-records-second-death-likely-linked-to-astrazeneca-vaccine-blood-clots

28. Hoeg T, Krug A, Stevenson J, Mandrola J. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. medRxiv preprint posted 8 September 2021. https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.full.pdf

29. Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Oct 6:NEJMoa2109730. doi: 10.1056/NEJMoa2109730. Epub ahead of print. PMID: 34614328; PMCID: PMC8531987.

30. Kostoff RN, Calina D, Kanduc D, Briggs MB, Vlachoyiannopoulos P, Svistunov AA, Tsatsakis A. Why are we vaccinating children against COVID-19? Toxicol Rep. 2021;8:1665-1684. doi: 10.1016/j.toxrep.2021.08.010. Epub 2021 Sep 14. Erratum in: Toxicol Rep. 2021 Oct 7;: PMID: 34540594; PMCID: PMC8437699. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8437699/pdf/main.pdf

31. Lovelace B. CDC safety group says there’s a likely link between rare heart inflammation in young people after Covid shot. [Internet] CNBC. 23 June 2021. [cited 9 July 2021] Available from: https://www.cnbc.com/2021/06/23/cdc-reports-more-than-1200-cases-of-rare-heart-inflammation-after-covid-vaccine-shots.html

32. Meghan A. Baker, David C. Kaelber, David S. Bar-Shain, Pedro L. Moro, Bob Zambarano, Megan Mazza, Crystal Garcia, Adam Henry, Richard Platt, Michael Klompas, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, Clinical Infectious Diseases, Volume 61, Issue 6, 15 September 2015, Pages 864–870, https://doi.org/10.1093/cid/civ430

33. Trialsite staff. Look into UK Yellow Card System Reveals Large Numbers of Adverse Events and Deaths Associated with COVID-19 Vaccine. [Internet] Trial Site News. 10 June 2021. [cited 9 July 2021] Available from:

34. https://trialsitenews.com/wp-content/uploads/2021/06/Yellow-Card-Letter.pdf

35. Medsafe. Adverse events following immunization with COVID-19 vaccines: Safety Report #32 – 9 October 2021. Published  9 October 2021. Accessed 31 October, 2020.  https://www.medsafe.govt.nz/COVID-19/safety-report-32.asp

36. Medsafe. Spontaneous reports: Seasonal influenza vaccination 2020. Revised1 April 2021. Accessed 4 October, 2020. https://www.medsafe.govt.nz/safety/reports-and-promotion/Spontaneous-Reports-Influenza-Vaccination-2020.asp#More

37. Doshi P. Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ 2021; 373 :n1244 doi: 10. 1136/bmj.n1244 Available from: https://www.bmj.com/content/373/bmj.n1244

38. Joan-Ramon Laporte, Ermengol Coma, Francesc Fina, Luís García-Eroles, Xavier Vidal, Manuel Medina.  Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study. MedRxiv preprint; this version posted September 5, 2021. Date accessed: 4 October 2021. doi: https://doi.org/10.1101/2021.07.23.21261036

39. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID- 19 vaccination. Pediatrics. 2021; doi: 10.1542/peds.2021-052478

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