COMMENT | Covid-19 vaccine risk-benefit analysis for children aged 5-11

COMMENT | This article is a follow up from our earlier article on the vaccination of children 5-11 years old with the Pfizer vaccine.

The earlier article can be found here.

Since we do not have a risk-benefit analysis for Covid-19 vaccination in children 5-11 years old, it is best to refer to the FDA studies.

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:

a. Scenario 1 (baseline Covid-19 incidence)

b. Scenario 2 (Covid-19 peak incidence)

c. Scenario 3 (lowest Covid-19 incidence)

d. Scenario 4 (higher vaccine efficacy)

e. Scenario 5 (higher Covid-19 death rate)

f. 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 two-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 hospitalisations and ICU stays due to vaccine-related myocarditis/pericarditis compared to prevented hospitalisations and ICU stays due to Covid-19.

Notwithstanding, even under this Scenario 3, considering the different implications and length of stay for Covid-19 hospitalisation (six days) versus hospitalisation for vaccine-associated myocarditis/pericarditis (one 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 a 30ug dose of Pfizer vaccine. The dose in the paediatric (age 5-11) 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 aged 12 years and older. It is anticipated that the rates of myocarditis/pericarditis after vaccination in 5-11-year-olds is most likely lower than the rates quoted in the risk-benefit analysis

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

This risk assessment neither considers potential long-term adverse effects due to Long-Covid, nor does it include secondary benefits like reducing Covid-19 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.

In summary, taking into account the six different scenarios, and considering the other benefits of reducing MIS-C, Long-Covid, disease transmission, the emergence of more virulent VOC, the utilisation 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 outweigh the harm.

Signatories:

Dr Amar-Singh HSS, Consultant Paediatrician

Dr Hung Liang Choo, Consultant Paediatrician

Dr Musa Mohd Nordin, Consultant Paediatrician

Dr Zulkifli Ismail, Consultant Paediatrician

The views expressed here are those of the author/contributor and do not necessarily represent the views of Malaysiakini.