We welcome the recommendations of the Indian Academy
of Pediatrics Advisory Committee on Vaccines and Immunization Practices
(IAP-ACVIP) during the COVID-19 pandemic [1]. These recommendations are
likely to assuage the doubts of pediatricians as well as parents. The
Government of India is planning to layout the distribution of COVID-19
vaccine soon. In such times, the guidance from IAP-ACVIP regarding
immunization of children with the COVID-19 vaccine is much desirable.
Recently a few vaccines have completed phase 3 trials
and are likely to be available for the general population very shortly
(Phase 4) [2]. Though the efficacy of these vaccines is impressive in
trials among adults, there is apprehension for their safety and efficacy
in children. Recently a group of experts stated that the wait shall be
prolonged for the pediatric age group due to the lack of clinical trials
of COVID-19 vaccine in children and their vulnerable status [3].
However, explicit guidance from the Government of India on this aspect
is not yet available. It is high time that the panel considers it as an
urgent public health issue and advocates the right decision for children
that is based upon robust scientific evidence and strong ethical
aspects.
In a scientific view, the decision for vaccination
should depend upon the overall disease prevalence and associated
mortality and morbidity. For COVID-19, all these three aspects are
relatively less severe in children, though due to the unknown status of
the long-term implications, the situation remains grave. Another
scientific aspect is the efficacy and safety of the vaccine in a given
population. Unfortunately, similar to other therapeutic trials for
COVID-19, the children are ostracized from vaccine trials too. Hence,
this data is lacking at present and is unlikely to be available in the
next few months.
The ethical view advocates that the decision must be
coherent with the principles of medical ethics (non-maleficence and
beneficence, equity, justice, fairness, and transparency) [4]. All of
the principles except non-maleficence and beneficence advocate for the
equal share of children among COVID-19 vaccine recipients. In ethics,
non-maleficence and beneficence supersede others therefore; vaccinating
children cannot be advised unless it has been proven safe.
Since we have a large amount of short-term data on
the implications of COVID in children, there is a need to analyze it
properly to make an informed decision. Once, phase 4 vaccination trials
begin, and we have sufficient data about its safety and efficacy in the
general population, children should be enrolled in the ongoing vaccine
trials. The results of the phase 3 trial done in children will serve as
the best guide for further decision making.
The role of IAP has always been instrumental in all
national policies about children. Now it’s time to continue that
advocacy by giving its representation to the national steering committee
for the COVID vaccine so that the children are not ostracized again.
1. Kasi SG, Dhir SK, Verma S, et al. Immunization
During the COVID-19 Pandemic: Recommendations from Indian Academy of
Pediatrics Advisory Committee on Vaccines and Immunization. Indian
Pediatr. 2020;57:1147-52.
2. Zimmer C, Corum J, Wee S-L. Coronavirus Vaccine
Tracker. The New York Times. 2020. Accessed on December 5, 2020.
Available from: https://www.nytimes. com/interactive/2020/
science/coronavirus-vaccine-tracker.html
3. Fauci JM. COVID-19 vaccines for children must
‘strike a balance’. AAP News. 2020. Accessed as of December 5, 2020.
Available from:
https://www.aappublications.org/news/2020/10/03/nce2020fauci100320
4. Bell BP, Romero JR, Lee GM. Scientific and ethical
principles underlying recommendations from the advisory committee on
immunization practices for COVID-19 vaccination implementation. JAMA.
2020;324:2025-26.
5. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for
mortality of adult in patients with COVID-19 in Wuhan, China: A
retrospective cohort study. Lancet. 2020;395:1054-62.