Reasons to Carefully Consider Children’s Involvement in Emergency Use of COVID-19 Vaccine
Dear Editor
A recent paper presenting a specific research funded by Pfizer/Biontech has presented evidence concerning the safety and efficacy of COVID-19 vaccination based on mRNA in adolescents and children.(1) While a powerful media campaign pushes in that direction and critical voices are repressed or sanctioned, some concerns about the opportunity for this “widening” of potential COVID-19 vaccine recipients have already been raised, including the Italian manifesto signed by more than 1300 health professionals.(2-4)
Along with the pre-condition of arguable absence of effective pharmacological treatments, the emergency use of COVID-19 vaccines authorized by regulatory agencies in the institutional framework adopted by WHO (5) (namely, their use without having completed the experimental phase over the usual timeline) also implies a lack of information concerning their possible mid/long-term effects (if any). Given a high efficacy and favourable risk/benefit profile of the current COVID-19 vaccines, a total of 490.000 wide ranging of potential short-term adverse events (AEs) have already been reported to the European surveillance system (Eudravigilance) (6), although in most cases a direct cause-effect relationship is impossible to demonstrate. As shown by data available at Italian level, these vaccine-related AEs are remarkably more common in people younger than 39 or <29 years old (7), whereby only a very small proportion of subjects aged <20 years old are affected by COVID-19 and related complications.(8)
Children are also thought to be more rarely involved in the infection transmission.(9) Moreover, as herd immunity can arguably be reached through vaccination in a globalized and severely unequal world, the emergency use of COVID-19 vaccines should not expose children to potential vaccine-related adverse events or unknown long-term effects (if any). Besides, as recently highlighted by the World Health Organization, clear priority should be given to vaccinating higher risk age groups in all the parts of the world, so that doses in excess in the high income countries should be redistributed to low income countries, as today almost 70% of vaccines have been administered only in 10 nations.
Finally, healthcare systems should improve disease control measure at local level, as there was no need for a massive vaccination campaign involving the youngest population age groups in those countries where properly actions of testing and tracing were implemented, with rapid isolation of cases and their direct contacts. Of course, while children’s involvement in the emergency use of COVID-19 vaccines should not be actively proposed as general rule, individually-tailored risk/benefits assessments can be made case by case to detect frail children where COVID-19 vaccination might be appropriate.
Global Health Expert, Bocconi University, Via Roberto Sarfatti, 25, 20100 Milan, Italy
Prisco Piscitelli (UNESCO Chair on Health education and sustainable development, Federico II University of Naples, Italy), Luigi Cataldi (Professor of Pediatrics (retired), Catholic University of Sacred Heart, Policlinico Agostino Gemelli, Rome, Italy), Maria Triassi and Annamaria Colao (UNESCO Chair on Health education and sustainable development, Federico II University of Naples, Italy)
Rapid Response:
Reasons to Carefully Consider Children’s Involvement in Emergency Use of COVID-19 Vaccine
Dear Editor
A recent paper presenting a specific research funded by Pfizer/Biontech has presented evidence concerning the safety and efficacy of COVID-19 vaccination based on mRNA in adolescents and children.(1) While a powerful media campaign pushes in that direction and critical voices are repressed or sanctioned, some concerns about the opportunity for this “widening” of potential COVID-19 vaccine recipients have already been raised, including the Italian manifesto signed by more than 1300 health professionals.(2-4)
Along with the pre-condition of arguable absence of effective pharmacological treatments, the emergency use of COVID-19 vaccines authorized by regulatory agencies in the institutional framework adopted by WHO (5) (namely, their use without having completed the experimental phase over the usual timeline) also implies a lack of information concerning their possible mid/long-term effects (if any). Given a high efficacy and favourable risk/benefit profile of the current COVID-19 vaccines, a total of 490.000 wide ranging of potential short-term adverse events (AEs) have already been reported to the European surveillance system (Eudravigilance) (6), although in most cases a direct cause-effect relationship is impossible to demonstrate. As shown by data available at Italian level, these vaccine-related AEs are remarkably more common in people younger than 39 or <29 years old (7), whereby only a very small proportion of subjects aged <20 years old are affected by COVID-19 and related complications.(8)
Children are also thought to be more rarely involved in the infection transmission.(9) Moreover, as herd immunity can arguably be reached through vaccination in a globalized and severely unequal world, the emergency use of COVID-19 vaccines should not expose children to potential vaccine-related adverse events or unknown long-term effects (if any). Besides, as recently highlighted by the World Health Organization, clear priority should be given to vaccinating higher risk age groups in all the parts of the world, so that doses in excess in the high income countries should be redistributed to low income countries, as today almost 70% of vaccines have been administered only in 10 nations.
Finally, healthcare systems should improve disease control measure at local level, as there was no need for a massive vaccination campaign involving the youngest population age groups in those countries where properly actions of testing and tracing were implemented, with rapid isolation of cases and their direct contacts. Of course, while children’s involvement in the emergency use of COVID-19 vaccines should not be actively proposed as general rule, individually-tailored risk/benefits assessments can be made case by case to detect frail children where COVID-19 vaccination might be appropriate.
1. Frenck R.W. et al., Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents, New England Journal of Medicine, 27 May 2021
2. Lavine J S et al, Vaccinating children against SARS-CoV-2, BMJ 2021
3. Mintz K, Jardas E, Shah S, Grady C, Danis M, Wendler D. Enrolling minors in COVID-19 vaccine trials. Pediatrics. 2021 Mar 1;147(3).
4. Manifesto about critical issues on the administration of COVID-19 vaccines to children, available at: https://www.sostenibilitaesalute.org/rete-sostenibilita-e-salute-vaccino...
5. The World Health Organization, “WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access”, available at: https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-...
6. Eudravigilance, European database of suspected adverse drug reactions report, available at https://www.adrreports.eu/en/index.html
7. Report of the Italian Pharmaceutical Agency (AIFA), available at https://www.aifa.gov.it/documents/20142/1315190/Rapporto_sorveglianza_va...
8. Italian Institute of Public Health (ISS), Covid-19 cumulative data, available at https://www.epicentro.iss.it/en/coronavirus/sars-cov-2-dashboard
9. Norwegian Institute of Public Health. The role of Children in the transmission of SARS-COV2 infection. Available at: https://neumoped.org/wp-content/uploads/2020/05/The-role-of-children-in-...
Competing interests: No competing interests