{"id":50657,"date":"2021-07-15T10:40:52","date_gmt":"2021-07-15T09:40:52","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=50657"},"modified":"2021-07-21T12:12:53","modified_gmt":"2021-07-21T11:12:53","slug":"emergency-use-authorisation-of-covid-19-vaccines-in-children-is-appropriate-and-necessary","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2021\/07\/15\/emergency-use-authorisation-of-covid-19-vaccines-in-children-is-appropriate-and-necessary\/","title":{"rendered":"Emergency use authorisation of covid-19 vaccines in children is appropriate and necessary\u00a0"},"content":{"rendered":"

In May 2021, The U.S. Food and Drug Administration (FDA) expanded Emergency Use Authorization (EUA) for the Pfizer-BioNTech covid-19 vaccine to adolescents aged 12-17. [1] Moderna announced that clinical trials of its vaccine demonstrated immunogenicity in adolescents and the company has applied for emergency use by the FDA, a decision on which is expected imminently. [2]<\/span><\/p>\n

Some have argued that given the statistically low risk of children developing severe infection and the uncertain risks of vaccination in children based on limited data, mRNA vaccines fail to meet standards for an EUA. [3] Such arguments may increase vaccine hesitancy and affect future authorisation of covid-19 vaccines in younger children. <\/span>The CDC has reported that as of mid-April 55.5% of parents of unvaccinated adolescents ages 13-17 intended to have children receive a covid-19 vaccine, but we could not find published data about the proportion of adolescents who have received a dose of vaccine by mid-July, 2021. [4] According to the CDC, parents and adolescents wanted more information about safety and efficacy of the vaccine.<\/span><\/p>\n

EUA <\/span>standards<\/span><\/a> require determining that: 1) there are population-level risks from a \u201cserious or life-threatening disease or condition\u201d, 2) the product under consideration \u201cmay be effective\u201d, 3) there are no alternative interventions, and 4) the potential benefits \u201coutweigh known and potential risks of the product.\u201d [5] It seems clear that the second and third conditions are met in the present covid-19 pandemic. The first and last criteria relate to the risks of the disease and the vaccine in adolescents and these points are more contested.\u00a0\u00a0<\/span><\/p>\n

In assessing risks, both the severity and magnitude must be weighed. The first criterion for issuing an EUA requires determining that the population faces serious risk from the disease, including the risk of not receiving the intervention. While few children develop severe infection from SARS-CoV-2, children nevertheless account for <\/span>1.2-3.1%<\/span><\/a> of all US hospitalizations for covid-19. [6] Fourteen US states saw 376 hospitalizations for covid-19 positive adolescents age 12-17 between 1 January 2021 and 31 March 2021, with 204 of those admitted with the primary reason being related to covid-19. [7] In addition, post-infectious <\/span>Multisystem Inflammatory Syndrome in Children (MISC)<\/span><\/a>, a rare complication of covid-19, requires intensive care, causes some deaths and complications involving the <\/span>brain<\/span><\/a>, heart, and other vital systems. [8] According to the Centers for Disease Control (CDC), as of 12 July 2021, 489 children have died of covid-19 during the pandemic\u2014more deaths than caused by influenza in a typical flu season. [9] Additionally, new <\/span>variants<\/span><\/a> such as the delta variant, which may be more virulent and\/or easier to transmit, mean vaccination may become even more important for children. [10]<\/span><\/p>\n

The magnitude of harm to unvaccinated children is substantial. Not vaccinating children perpetuates ongoing harms from covid-19 that could have a lasting impact, including <\/span>mental health challenges<\/span><\/a>, learning loss through school closures, and <\/span>familial instability<\/span><\/a> (e.g. financial insecurity, caregiving burden, and confinement-related stress). Without vaccination, children may be asymptomatic carriers and spreaders of infection with continued limited access to school or other activities (e.g. sports or participation in group artistic endeavors), or isolation from at-risk adults likely to have incomplete protection from vaccines, such as adults with immunosuppression. Even children who retain access to some interactions frequently face repeated and unpleasant viral testing.\u00a0<\/span><\/p>\n

The last criterion for an EUA requires weighing the potential benefits against the risk of the vaccines. While clinical trials testing mRNA vaccines in adolescents have not had the power to reveal the exact level of risk, no serious adverse events have occurred. As of 13 July 2021 more than 321<\/span> million doses of mRNA vaccines<\/span><\/a> have been given in the US without serious adverse events. [11,12] Knowledge about the mechanism of action has not raised concerns about special risks to children. [13]<\/span><\/p>\n

Finally, delaying widespread use of vaccines for children perpetuates social inequities. Children living in economically disadvantaged communities and\/or ethnic minority communities may disproportionately experience the harms of non-vaccination described above as rates of adult vaccination in these communities may be lower and the covid-19 disease burden <\/span>higher<\/span><\/a>. Vaccinating children in these areas may help reduce spread of disease, thereby mitigating harms. If we insist on the results of large-scale vaccine trials in children before EUA or full licensure, widespread vaccination of children could be delayed a <\/span>year<\/span><\/a> or longer. [14]<\/span><\/p>\n

Our arguments address whether the FDA should authorize vaccines with sufficient data in children, but not the relative priority children should receive in vaccine allocation. Children have a lower risk of death than older adults and should only receive vaccination as supplies become available. We also acknowledge that the current distribution of vaccines worldwide raises troubling <\/span>equity<\/span><\/a> concerns, given global disease burden. While a full analysis of justice in vaccine allocation is beyond the scope of this discussion, whether vaccines are safe and beneficial enough for the FDA to authorize them for children is a separate question.\u00a0\u00a0\u00a0\u00a0<\/span><\/p>\n

Supporting an EUA for covid-19 vaccines in children permits parents, in conjunction with trusted healthcare providers, public health authorities, and other community leaders (e.g. school administrators) to make informed assessments about the benefits and risks of <\/span>vaccination<\/span><\/a>. [15] The EUA does not require vaccination for children; it permits access to the benefits of vaccination during the pandemic for those determining that the benefits outweigh the risks. Vaccine authorisation plays a critical role in allowing countries to emerge from this devastating pandemic and children should not be left behind. When vaccines have strong evidence of safety and immunogenicity in pediatric populations, EUA for children is not only appropriate, it is also necessary.<\/span><\/p>\n

Joel Frader<\/strong> is professor of Pediatrics (Palliative Care) and professor of Bioethics and Medical Humanities in the Feinberg School of Medicine (FSM). He directs the Lurie Children\u2019s Hospital bioethics program.<\/span><\/em><\/p>\n

Erin Paquette<\/strong> is assistant professor of Pediatrics (Critical Care Medicine) at FSM and chairs the Lurie Children\u2019s Ethics Advisory Board.\u00a0<\/span><\/em><\/p>\n

Angira Patel<\/strong> is associate professor of Pediatrics (Cardiology) at FSM and a member of the Lurie Ethics Advisory Board.<\/span><\/em><\/p>\n

Kelly Michelson<\/strong> is professor of Pediatrics (Critical Care Medicine) at FSM, a member of the Lurie Ethics Advisory Board, and Director of the Feinberg Center for Bioethics and Medical Humanities.<\/span><\/em><\/p>\n

Seema Shah<\/strong> is associate professor of Pediatrics (Advance General Pediatrics) at FSM and a member of the Lurie Ethics Advisory Board.<\/span><\/em><\/p>\n

Competing interests<\/strong>: none declared.\u00a0<\/em><\/p>\n

References<\/strong>:<\/span><\/p>\n

    \n
  1. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. (May 10, 2021). Available at: https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use (Accessed 5\/25\/2021).<\/span><\/li>\n
  2. Miller SG, Edwards E. Moderna Vaccine Highly Safe and Effective in Children, Company Says. Available at: https:\/\/www.nbcnews.com\/health\/health-news\/moderna-vaccine-safe-highly-effective-kids-ages-12-17-company-n1268430 (Accessed 5\/25\/2021).<\/span><\/li>\n
  3. https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccination-demographic.<\/span><\/li>\n
  4. Scherer AM, Gedlinske AM, Parker AM, Gidelngil CA, et al. Acceptability of adolescent COVID-19 vaccination among adolescents and parents of adolescents\u2014United States, April 15-23,2021. MMWR. 2021 July;70 (Early Release Accessed 7\/13\/2021)<\/span><\/li>\n
  5. \u00a0<\/span>https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/emergency-use-authorization-medical-products-and-related-authorities#criteria.(Accessed<\/span><\/a> 5\/14\/2021).<\/span><\/li>\n
  6. COVID-19 Hospitalizations (cdc.gov)<\/span><\/a> (Accessed 5\/14\/2021).\u00a0<\/span><\/li>\n
  7. Havers FP, Whitaker M, Self JL, Chai SJ, Kirley PD, et al. Hospitalization of adolescents aged 12-17 years with laboratory-confirmed covid-19\u2014COVID NET, 14 States, March 1, 2020-April 24, 2021. MMWR. 2021;70(23): 851-857.<\/span><\/li>\n
  8. Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States \u200b | CDC<\/span><\/a> (Accessed 5\/14\/2021).<\/span><\/li>\n
  9. CDC COVID Data Tracker<\/span><\/a>\/#demographics<\/span> (Accessed 5\/14\/2021)<\/span><\/li>\n
  10. Kumar A, Prasoon P, Kumari C, Pareek V, Faiq MA, Narayan RK, Kulandhasamy M, Kant K. SARS-CoV-2-specific virulence factors in COVID-19. J Med Virol. 2021 Mar;93(3):1343-1350. doi: 10.1002\/jmv.26615. Epub 2020 Nov 1. PMID: 33085084.<\/span><\/li>\n
  11. Centers for Disease Control, COVID Data Tracker, available at: https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations.<\/span><\/li>\n
  12. Reactions and Adverse Events of the Pfizer-BioNTech COVID-19 Vaccine | CDC<\/span><\/a> (Accessed 5\/14\/2021).<\/span><\/li>\n
  13. https:\/\/abc7.com\/kids-covid-vaccine-children-covid-19-vaccination-side-effects-myths\/10583875\/<\/span><\/a> (Accessed 5\/14\/2021).<\/span><\/li>\n
  14. Mintz, Jardas E, Shah S, Grady C, Danis M, Wendler D. Enrolling Minors in Covid-19 vaccine trials. Pediatrics. 147(3):e2020-040717. Epub 2020 Dec 17.<\/span><\/li>\n
  15. Patel A, Feltman DM, Paquette ET. Integrating public health ethics into shared decision making for children during the novel coronavirus disease-19 pandemic. J Pediatr. 2021;231:259-264. doi:10.1016\/j.jpeds.2020.11.061<\/span><\/li>\n<\/ol>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    In May 2021, The U.S. Food and Drug Administration (FDA) expanded Emergency Use Authorization (EUA) for the Pfizer-BioNTech covid-19 vaccine to adolescents aged 12-17. [1] Moderna announced that clinical trials […]<\/p>\n

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