Vaccination of teenagers and children: a more than questionable benefit/risk ratio!

The European Medicines Agency (EMA) found on Friday, May 28, 2021, that the benefit/risk ratio of Pfizer/BioNTech’s covid vaccine was positive in children aged 12 to 15 years, particularly in children with conditions that increase the risk of severe covid-19. The Agency has therefore decided to extend the indication of the vaccine to this age group, as the vaccine is already authorized for use from the age of 16. It is now up to the Member States to decide whether or not to use this vaccine in adolescents(1). Moderna has also filed an application with the EMA for approval of its covid-19 vaccine in adolescents aged 12 to 17 years(2).

In Belgium, 16 and 17 year olds will already be able to be vaccinated as of June 14, 2021 with the Pfizer vaccine « without the need for parental consent, » headlines several media(3)This is not exactly what the law provides (see 11 below). These same media outlets also stated that the possibility of allowing informed youth to opt for Astra Zeneca or Janssen vaccines would be explored(4)This is surprising, to say the least, given that clinical trials in adolescents for the latter two vaccines have barely begun (see point 2 below).

However, as the following arguments show, except for specific family situations (vulnerable relatives) or particular medical cases (young people suffering from comorbidities or immune deficiencies) which should be assessed on a case-by-case basis after demonstrating that, for these youth, the risk from the vaccine would not be greater than the risk from covid-19The generalized vaccination of young people against covid-19 seems at least premature, as long as it is the individual health benefit and the best interest of the child that are taken into account.

  1. Covid-19 risks in youth: children are often asymptomatic or paucisymptomatic and have a very low mortality risk(5). Assuming that vaccination against covid-19 is risk-free (which is not the case, as discussed in point 2), generalized vaccination of minors without co-morbidities would provide little or no individual health benefit.
  2. Vaccine risks in youth:
  • The risks associated with these vaccines, which are currently being tested, are still largely unknown. In rendering its opinion on the Pfizer vaccine, the European Medicines Agency relied on a study begun in late October 2020 that involved only a limited number of young people over the age of 12 (2,260 young people aged 12 to 15)(6). According to the French National Consultative Ethics Committee (June 14, 2021)  » the number of children included in this study is insufficient to demonstrate significant efficacy on severe forms in adolescents »(7). Moderna, for its part, announced at the end of May 2021 the complete results of its clinical trials begun in December 2020 on 3,700 participants aged 12 to 17(8). AstraZeneca did not begin clinical trials in 300 children aged 6 to 17 until February 2021(9), while Janssen did not announce trials in adolescents until April 2021, trials that appear to have been halted after cases of thrombosis in young adults(10).
  • In young adults vaccinated, as well as in minors vaccinated elsewhere in the world, numerous side and post-vaccination effects(11), as well as deaths, have already been reported(12). It took some time for the link between some cases of thrombosis and the AstraZeneca vaccine and then the Janssen vaccine to be recognized as « possible. »(13) by the European Medicines Agency, with thrombosis now to be considered a very rare side effect of AstraZeneca vaccines(14) and Janssen(15). The link between cases of myocarditis and pericarditis following vaccination (including in children(16)) is now being investigated, notably by the EMA(17). Israel considers the link between some cases of myocarditis and pericarditis and the Pfizer vaccine « probable »(18).
  • We are totally lacking in experience on the long-term consequences of the administration of these vaccines, especially mRNA vaccines. For example, « we do not yet have enough experience in terms of genotoxicity [effets sur le génome] and carcinogenotoxicity [effets cancérigènes] », warns pediatrician Marie Fabre-Grenet(19).
  • According to the reinfocovid scientific team, the Pfizer/BioNtech and Moderna vaccine conditional MAs themselves indicate that vaccine mRNAs distribute to a wide variety of organs, including the reproductive organs or gonads(20).

3. Transmission of covid-19 by children: the main argument used to impose vaccination on children is that they would be a vector for the spread of the virus. However, a growing body of research shows that the role of children in the spread of covid-19 is small and suggests that children are more likely to be infected by adults than vice versa, both at school and in the home(21). The role of adolescents in transmission also appears to be weaker than that of adults(22).

4. Transmission of covid-19 by vaccinees: data from Phase 4 trials are needed to assess the extent to which vaccinees remain transmitters — or not. However, to date, there have been numerous cases of vaccinated individuals testing positive for covid-19(23).

5. Benefit-risk ratio for youth: Studies must demonstrate that the benefit to the pediatric population outweighs the potential risks to this population. How a positive benefit/risk ratio for these age groups (12–15 and 16–18), when the medium- and long-term risk is undetermined to date and the individual health benefit for young people who do not suffer from pathologies that put them at risk is almost nil? The French National Consultative Ethics Committee insists, this June 14, 2021:  » In adolescents, between 12 and 16 years old, the individual benefit related to the infection is very low in the absence of comorbidity and does not seem sufficient to justify, by itself, the vaccination(24) ». On the other hand, we do not hear the National Council of Bioethics of Belgium on this question…

6. Natural immunity in youth:

— To date, a certain number of young people have antibodies and therefore an immunity that has proven to be sufficient to protect them. 

- It is likely that the natural immunity after infection is stronger to face the possible mutations of the virus, explained the pediatrician Michel Dechamps to L’Avenir(25).

- To allow the development of this natural collective immunity in young people, it is important to let them develop numerous interactions between them without restraint, thus allowing them to strengthen their immune system instead of weakening it through a sedentary lifestyle, indoors, deprived of outings, contacts, sports, pleasures and leisure activities other than screens. 

- According to the reinfocovid science team, a study published in May 2021 in the journal  » Science »(26) demonstrates that children have specific humoral protection against SARS-CoV‑2, even when they have not encountered it. Another study also reported similar observations(27). This protection would be based on the fact that children are regularly subject to mild respiratory illnesses (and common colds) in winter due to the « classical » coronaviruses with which we coexist. These mild infections cause children who have never encountered SARS-CoV‑2 to produce numerous B cells called « memory » cells, each of which produces a particular repertoire of antibodies that recognize SARS-CoV‑2. Specifically, these different memory B cell clones recognize motifs (called « epitopes ») present on the Spike proteins of different coronaviruses, including mutant forms of SARS COV 2. Adults have also been exposed to these benign coronaviruses as children. But their memory B cells targeting these coronaviruses appear to have lost much of their effectiveness over the years, thus explaining (among other age-related factors) the greater susceptibility to SARS-CoV‑2 as the years pass(28).

7. The pseudo-moral argument — Because the incidence and morbidity of covid-19 is so low in young people, their vaccination is not actually undertaken for their own protection, but for the protection of the population at risk. In other words, it is not the individual health benefit of the youth or the best interests of the child that are considered. This raises the question: should young people be made to take indeterminate risks to protect the rest of the population? Wouldn’t the opposite be in accordance with morality and even with the most natural instinct? 

- In the current state of knowledge, making the collective choice to vaccinate minors against covid-19 means that the interests of this class of individuals are considered secondary to the interests of a relatively small number of adults at risk. 

- In the same way, to make, at the present time, the collective choice of vaccinating minors against covid-19 with the aim of favouring the return to « freedom » and to the « old life » means that these objectives would be judged as having priority over the interest of the young. One might object that young people also had an interest in regaining freedom. But an act (vaccinating oneself) performed in exchange for a promise of freedom is not a free act, but a blackmail. And the « freedom » regained is not one either: such blackmail inevitably announces others. Moreover, « the members of the (French) National Ethics Committee recommend that adolescents, like the general population, be informed of the risk of being confined again, even though they have been vaccinated, in the event of a rebound in the epidemic due, for example, to the appearance of a new variant »(29).

- Vaccinating young people so as not to close down classrooms and youth meeting places is an outdated argument. Indeed, on the basis of arguments 1, 3 and 6 presented above and on the basis of many other arguments (physical and mental health, fight against school and social dropout, etc.), these places do not have to be closed anymore: facilities must be organized. 

- Currently, making an individual choice to vaccinate one’s child against covid-19 means that the interests of parents and grandparents at risk are considered to take precedence over the interests of the children: such reasoning can be defended in certain situations (very vulnerable close relative), but is difficult to generalize as a principle. But if, in addition, vaccines do not guarantee the absence of contagiousness (see point 4), the argument of an « altruistic vaccination » and of a « civic duty » (which was already not justified with regard to the individual health benefit/risk ratio for young people without co-morbidity) loses all credibility and makes the ethics of vaccinating young people all the more questionable. 

- Vaccinating young people against covid-19 (except in family situations or special medical cases) in the current context is therefore tantamount to instrumentalizing them, i.e. considering them as means for carrying out a vaccination strategy based on questionable premises and models(30). This choice can be considered as a sacrifice of the interests of young people, a sacrifice which also leads to a whole series of measures adopted since March 2020: wearing the mask 8 hours a day at school, education, cultural, artistic and sports activities sacrificed, although the latter are essential to maintain and strengthen the immune system and not to create young people carrying co-morbidities.

8. The economic argument From a strictly economic point of view, reminds L’Avenir, two doses of Pfizer cost 31 euros which should be multiplied by the number of minors to be vaccinated. While natural immunity is free and has been proven in miners(31).

9. The opinion of Belgian scientists Even Y. Van Laethem (a supporter of vaccination of 16–18 year olds) admits « . Personally — but I am not a pediatrician — I am very circumspect. And when it is the presidents of pharmaceutical companies who say that children must be vaccinated, it irritates me deeply. It smells a little bad…(32) « . For Olga Chatzis, a pediatric infectious disease specialist at Cliniques Universitaires Saint-Luc in Brussels and member of the pediatric group at the Conseil Supérieur de la Santé, the benefit/risk balance is rather negative. Yves Coppieters, Professor of Public Health at the ULB, agrees: « It is not the question of the circulation of the virus at the moment that is important, it is more the decrease in the number of severe forms, and the decrease in the number of hospitalizations »(33).

10. Medical and Policy Alternatives to Widespread Vaccination Rather than putting our non-at-risk children and teens at an unspecified and potentially life-threatening risk, wouldn’t it make more sense to look for other solutions to the current crisis? Why is the scientific debate in Belgium and Europe on natural immunity enhancement, preventive treatments and identified early treatments hampered? Why devalue natural herd immunity in favor of vaccine immunity, which is less effective and whose implementation is uncertain, if not for economic reasons benefiting pharmaceutical companies? And what about Belgian investments in the hospital sector since March 2020, since the primary motivation for the measures adopted and for vaccination is to avoid hospital saturation?

Why devalue natural herd immunity in favor of vaccine immunity, which is less effective and whose implementation is uncertain, if not for economic reasons benefiting pharmaceutical companies?

11. Little arrangements with the law? Finally, vaccinating 16–17 year olds « without parental consent », as several media headlines state, is not exactly in line with the 2002 law on patients’ rights(34). In fact, according to this law, the minor’s agreement is required for everyday health care, but beyond this more or less explicit agreement of the minor, it is the holders of parental authority who make the final decision. There are, however, areas where the minor can clearly exercise his or her right to care. For example, if it turns out that the parents’ choice is not in the best interest of the minor(35).

However, one may fear that in these times of vaccine frenzy and censorship of the scientific debate, the decisions of possible judicial arbitrations in case of disagreements will tend to lean in favor of vaccination, which we have just shown that, except in particular situations to be discussed on a case by case basis, it does not meet the individual health interest of the young person, and which one may even doubt, in view of the arguments 2 to 8, that it meets the collective interest.

Recommended articles on the subject:

« Vaccinating minors against COVID? The Advisory Committee on Ethics is reserved »: https://francais.medscape.com/voirarticle/3607262 (June 14, 2021)

Interview with pediatrician Marie Fabre-Grenet: https://www.youtube.com/watch?v=3upEtrz7xWU (June 7, 2021)

https://reinfocovid.fr/science/covid-19-vacciner-les-enfants-est-ce-bien-ethique/ (June 2, 2021)

https://www.francesoir.fr/politique-france/devons-nous-vacciner-nos-enfants-contre-le-covid-19 (June 2, 2021)

« Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer-BioNTech COVID- 19 Vaccination »: peds.2021–052478.full.pdf (aappublications.org) (June 2, 2021)

https://www.lavenir.net/cnt/dmf20210528_01584327/vacciner-les-enfants-quel-interet (29 mai 2021)

https://reinfocovid.fr/science/les-enfants-de-5-a-17-ans-face-a-la-covid-19/ (May 25, 2021)

https://reinfocovid.fr/science/les-enfants-ne-doivent-pas-etre-vaccines-contre-la-covid-19 (May 24, 2021)

https://collectifdesantepediatrique.fr/les-enfants-prochainement-vaccines-il-faut-etre-prudent-tout-est-une-histoire-de-rapport-benefices-risques/ (May 10, 2021)

https://presse.inserm.fr/vacciner-les-enfants-pour-lutter-contre-la-pandemie-de-covid-19-vraiment/42468/ (March 23, 2021)

https://www.revmed.ch/revue-medicale-suisse/2021/revue-medicale-suisse-726/faudra-t-il-vacciner-les-enfants-contre-le-covid-19 (February 17, 2021)

« Assessing the age specificity of infection fatality rates for COVID-19: systematic review, meta-analysis, and public policy implications »: https://pubmed.ncbi.nlm.nih.gov/33289900/ (December 8, 2020)

Notes et références
  1. https://francais.medscape.com/voirarticle/3607202
  2. https://www.legeneraliste.fr/actu-medicale/sante-publique/vaccin-anti-covid-moderna-depose-une-demande-damm-europeenne-pour-ladolescent
  3. https://www.rtbf.be/info/societe/detail_la-vaccination-contre-le-coronavirus-etendue-aux-16–17-ans-sur-base-volontaire-et-sans-consentement-des-parents?id=10776638
  4. https://www.rtbf.be/info/societe/detail_la-vaccination-contre-le-coronavirus-etendue-aux-16–17-ans-sur-base-volontaire-et-sans-consentement-des-parents?id=10776638
  5. Voir par ex. https://pubmed.ncbi.nlm.nih.gov/33289900/ : selon cette étude, « The estimated age-specific IFR is very low for children and younger adults (e.g., 0.002% at age 10 and 0.01% at age 25) ». Voir également https://www.nature.com/articles/s41586-020‑2918‑0 et https://pubmed.ncbi.nlm.nih.gov/32537961/. Selon la BBC, une étude menée dans sept pays, publiée dans le Lancet, a estimé que moins de deux enfants sur un million sont morts du covid-19 pendant la pandémie : https://www.bbc.com/afrique/region-54712169. Selon le Figaro, on estime plus précisément ce risque à 1,7 décès par million de moins de 18 ans : https://www.lefigaro.fr/sciences/covid-19-pour-ou-contre-la-vaccination-des-enfants-20210528. Les données les plus récentes de l’Académie américaine de pédiatrie montrent que les enfants représentaient 0,00 % à 0,19 % de tous les décès dus au covid-19: https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Des formes inflammatoires post-infectieuses ressemblant à la maladie de Kawasaki ont été relevées, mais il s’agit d’une pathologie rare et pour laquelle il existe des traitements efficaces : https://presse.inserm.fr/vacciner-les-enfants-pour-lutter-contre-la-pandemie-de-covid-19-vraiment/42468/.
  6. https://francais.medscape.com/voirarticle/3607202. Des essais cliniques pour le vaccin Pfizer ont été lancés fin mars 2021 sur des enfants de 6 mois à 11 ans. Voir aussi https://pharmaceutiques.com/actualites/politique-de-sante/covid-19-lema-recommande-la-vaccination-des-adolescents/
  7. https://francais.medscape.com/voirarticle/3607262
  8. Des essais cliniques pour le vaccin Moderna ont été lancés mi-mars 2021 sur 6700 enfants de 6 mois à 11 ans : https://pharmaceutiques.com/actualites/politique-de-sante/covid-19-lema-recommande-la-vaccination-des-adolescents/
  9. https://francais.medscape.com/voirarticle/3607009
  10. https://www.francetvinfo.fr/replay-radio/le-billet-vert/covid-19-bientot-la-vaccination-pour-les-adolescents-et-les-enfants_4382873.html
  11. Voir par exemple https://pediatrics.aappublications.org/content/pediatrics/early/2021/06/02/peds.2021–052478.full.pdf
  12. https://www.medpagetoday.com/special-reports/exclusives/93040. Certains disposent d’éléments permettant de penser que seul un faible pourcentage des effets secondaires remontent, une question qui mérite d’être approfondie: voir, sur cette question, cette interview de la pédiatre Marie Fabre-Grenet du collectif de santé pédiatrique : https://www.youtube.com/watch?v=3upEtrz7xWU
  13. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood
  14. https://www.mesvaccins.net/web/vaccines/650-covid-19-vaccine-astrazeneca et https://www.afmps.be/fr/usage_humain/medicaments/medicaments/covid_19/vaccins/pharmacovigilance_pour_les_vaccins_contre_la
  15. https://www.mesvaccins.net/web/vaccines/666-janssen-covid-19-vaccine
  16. https://www.ema.europa.eu/en/news/first-covid-19-vaccine-approved-children-aged-12–15-eu
  17. https://www.ema.europa.eu/en/news/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis
  18. https://www.lecho.be/dossiers/coronavirus/lien-probable-entre-le-vaccin-pfizer-et-la-myocardite-dit-israel/10310696.html
  19. https://collectifdesantepediatrique.fr/les-enfants-prochainement-vaccines-il-faut-etre-prudent-tout-est-une-histoire-de-rapport-benefices-risques/ Voir aussi l’interview au cours de laquelle elle développe ce point : https://www.youtube.com/watch?v=3upEtrz7xWU
  20. https://reinfocovid.fr/science/les-arnm-vaccinaux-atteignent-les-organes-reproducteurs/ Ces informations se trouvent dans les autorisations de mise sur le marché des vaccins Pfizer/BioNtech et Moderna : voir https:/www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, p. 54 (paragraphe biodistribution) et https:/www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf, p. 47 (dernier paragraphe) et p. 52 (paragraphe biodistribution).
  21. Voir par exemple https://www.ecdc.europa.eu/en/publications-data/children-and-school-settings-covid-19-transmission, https://francais.medscape.com/voirarticle/3606880, de même que les études citées en bibliographie de ces articles : https://reinfocovid.fr/science/les-enfants-de-5-a-17-ans-face-a-la-covid-19/ et https://reinfocovid.fr/science/les-enfants-ne-doivent-pas-etre-vaccines-contre-la-covid-19/
  22. https://francais.medscape.com/voirarticle/3607219
  23. Par exemple https://www.lesoir.be/369544/article/2021–04-30/coronavirus-28-residents-vaccines-dun-home-erquelinnes-positifs-mais ou https://www.rtbf.be/info/dossier/ec-nivelles/detail_nivelles-la-moitie-des-pensionnaires-de-la-residence-nos-tayons-testes-positifs-mais-la-situation-est-sous-controle?id=10772780
  24. https://francais.medscape.com/voirarticle/3607262
  25. https://www.lavenir.net/cnt/dmf20210528_01584327/vacciner-les-enfants-quel-interet
  26. https://science.sciencemag.org/content/372/6543/738
  27. https://pubmed.ncbi.nlm.nih.gov/33159009/
  28. https://reinfocovid.fr/science/les-enfants-de-5-a-17-ans-face-a-la-covid-19/
  29. https://francais.medscape.com/voirarticle/3607262
  30. Voir la discussion approfondie de cette question dans cet article : https://reinfocovid.fr/science/covid-19-vacciner-les-enfants-est-ce-bien-ethique/.
  31. https://www.lavenir.net/cnt/dmf20210528_01584327/vacciner-les-enfants-quel-interet
  32. https://lameuse.sudinfo.be/782235/article/2021–05-04/faut-il-vacciner-nos-enfants-contre-le-coronavirus-yves-van-laethem-donne-son
  33. https://www.rtbf.be/info/societe/detail_en-belgique-va-t-on-vacciner-massivement-les-adolescents-de-12-a-17-ans?id=10771691
  34. https://www.erasme.ulb.ac.be/fr/enseignement-recherche/comite-d-ethique/legislation-belge-et-etudes-cliniques/droits-du-patient
  35. https://www.lacode.be/IMG/pdf/Analyse_CODE_mineur-corps_VERSION_DEF.pdf
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