Risk Benefit Analysis of the COVID-19 Vaccine in Children 5-11  years old

Dr Musa Mohd Nordin, Dr Hung Liang Choo, Dr Amar Singh HSS,  Dr Zulkifli Ismail 

27 Nov 2021 

This article is a follow up from our earlier article on the vaccination of children 5- 11 years old with the Pfizer vaccine. (1,2).

Since we do not have risk benefit analysis for COVID-19 vaccination in children  5-11 years old, it is best to refer to the FDA studies (3)

This was unanimously passed by the FDA panel, without opposition or  abstentions. Similarly, it was evaluated by the Advisory Committee on  Immunization Practices (ACIP) and unanimously recommended by all in the  panel without exception.

They studied the risk benefit according to 6 different scenarios:

  1. Scenario 1 (Baseline COVID-19 Incidence)
  2. Scenario 2 (COVID-19 Peak Incidence)
  3. Scenario 3 (Lowest COVID-19 Incidence)
  4. Scenario 4 (Higher Vaccine Efficacy)
  5. Scenario 5 (Higher COVID-19 Death Rate)
  6. Scenario 6 (Lower Excess Myocarditis Rate)

Except for scenario 3, the model predicts that the benefits of the Pfizer COVID 19 vaccine given as a 2-dose primary series clearly outweigh the risks for  children ages 5-11 years. (see Diagram 1 and 2)

For scenario 3 (Lowest COVID-19 Incidence), the model predicts more excess  hospitalizations and ICU stays due to vaccine-related myocarditis/pericarditis  compared to prevented hospitalizations and ICU stays due to COVID-19.

Notwithstanding, even under this scenario 3, considering the different

implications and length of stay for COVID-19 hospitalization (6 days) versus  hospitalization for vaccine-associated myocarditis/pericarditis (1 day), and the  benefits accrued from the prevention of cases of COVID-19 with significant  morbidity, the overall benefits of the vaccine may still outweigh the risks.

The rates of myocarditis are based on data from adolescents and adults  receiving 30ug dose of Pfizer vaccine. The dose in pediatric (5–11-year-old)  age group is 1/3 i.e. 10ug dose. No cases of myocarditis occurred during the  clinical trials with 5–11-year-olds.

The underlying epidemiology of viral myocarditis is substantially lower in younger  children compared to children 12 years old and older. It is anticipated that the  rates of myocarditis/pericarditis after vaccination in 5–11-year-old is most likely  lower than the rates quoted in the risk benefit analysis

The benefit of reducing COVID related multisystem inflammatory syndrome in  children (MIS-C) may not be fully captured by preventable hospitalizations, ICU  stays and deaths due to COVID-19.

This risk assessment does not consider potential long-term adverse effects due  to Long COVID.

This risk assessment does not include secondary benefits like reducing COVID 19 disease transmission.

It also does not include the benefits of preventing the emergence of more  transmissible and virulent Variants Of Concern (VOC)

The CDC also compared the vaccination of children against other vaccine  preventable diseases with the vaccination of children against COVID-19. It is  obvious from Diagram 3, that we are vaccinating against vaccine preventable  diseases (VPD) which have much lower mortality rates than that caused by  COVID-19 in children. (4)

In summary, taking into account the 6 different scenarios, and considering the  other benefits of reducing MIS-C, Long COVID, disease transmission, emergence  of virulent VOC, the utilization of a much smaller dose of the vaccine, and safer  return to school and social interactions, and the higher COVID-19 mortality rates  versus other VPD, the benefits of the vaccine far outweighs the harm.

References:

  1. https://codeblue.galencentre.org/2021/11/25/covid-19-can-we-afford to-delay-vaccinating-children-aged-5-11-dr-amar-singh-hss-dr-hung liang-choo-dr-musa-mohd-nordin-dr-zulkifli-ismail/
  2. https://www.malaysiakini.com/columns/600694
  3. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11- 2-3/08-COVID-Oliver-508.pdf
  4. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11- 2-3/08-COVID-Oliver-508.pdf

 

Diagram 1:

 

Diagram 2:

 

Diagram 3:

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