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COVID Vaccination for Children in India: A Step Towards Better Health, Wellbeing and Development

Authors:
  • Dr Varsha's Health Solutions

Abstract

As on December 2021, COVID vaccination for children is yet to commence in India, a country that has been a global leader in vaccinating the adult population. Two indigenous vaccines have already been approved for children 12 years and above by the Drug Controller General of India (DCGI), with vaccination set to commence for children aged 15 years and above in January 2022. Children are being considered as low risk and low priority for vaccination, as in them, COVID is commonly mild, and complications, rare. However, the impact of the evolving SARS-CoV-2 mutants on children cannot be fully predicted , and some children have comorbidities and immune deficiencies putting them at higher risk. Moreover, children not being vaccinated has contributed significantly to parental anxiety and reluctance in sending them to school, and also the schools continuing hybrid teaching and not being able to start physical and interactive activities that can improve children's holistic health, wellbeing and development. As globally across several countries, children are now being vaccinated, this is being expected from India too. Vaccination of children may not only enhance protection against severe COVID and unpredictable variants, but can help the children return to a more wholesome school life and childhood.
Editorial
The Indian Practitioner d Vol.74 No.12 December 2021
7
COVID Vaccination for Children in India: A Step Towards
Better Health, Wellbeing and Development
Varsha Narayanan1
Abstract
As on December 2021, COVID vaccination for children is yet to commence in India, a country that has been a global leader
in vaccinating the adult population. Two indigenous vaccines have already been approved for children 12 years and above
by the Drug Controller General of India (DCGI), with vaccination set to commence for children aged 15 years and above in
January 2022. Children are being considered as low risk and low priority for vaccination, as in them, COVID is commonly
mild, and complications, rare. However, the impact of the evolving SARS-CoV-2 mutants on children cannot be fully predict-
ed, and some children have comorbidities and immune deciencies putting them at higher risk. Moreover, children not being
vaccinated has contributed signicantly to parental anxiety and reluctance in sending them to school, and also the schools
continuing hybrid teaching and not being able to start physical and interactive activities that can improve children’s holistic
health, wellbeing and development. As globally across several countries, children are now being vaccinated, this is being
expected from India too. Vaccination of children may not only enhance protection against severe COVID and unpredictable
variants, but can help the children return to a more wholesome school life and childhood.
Keywords: vaccination, COVID, children, school, development
1
Consultant Family Medicine and Holistic Health, Dr Varsha’s Health
Solutions, Mumbai. Email: info@drvarsha.com.
Introduction
We are now at the brink of entering the third
year of the COVID pandemic. India be-
gan vaccination against COVID in January
2021for adults, starting with healthcare and frontline
workers, elderly, and those with comorbidities, and
later extended it in May 2021 to all adults (18 years or
more).[1] However, the 2nd pandemic wave struck in
March-April 2021, and took a signicant mortality toll
that also included many young unvaccinated healthy
adults.[2]
With regards to the adult population, India has
administered more than 1.3 billion vaccine doses. [1]
However, almost one year after commencement of
COVID vaccination in India, as on December 2021, the
vaccination of children has not begun.
Global Scenario
Globally the Pzer-BioNTech COVID-19 vaccine is
approved by USFDA for children 5 years and older.[3]
Sinopharm and Sinovac vaccines are now approved by
China and some other countries for children 3 years
and older, while Moderna’s vaccine has been approved
for 12 years and above by EMA. Vaccination for chil-
dren aged 12 years or more, and in some countries for
those aged 5 years (even 3 years) and more, with the ap-
propriate approved vaccines, has started in full swing
globally across almost 100 countries. These include the
USA, most European countries, UK, Australia, Middle
eastern countries, some African and South American
countries, and several countries in Asia.[4]
Indian Scenario
In India, in August 2021, the Drug Controller
General of India (DCGI) approved the Zydus Cadila
COVID-vaccine – ZyCoV-D for 12 years and above.[5]
However, vaccination has not begun with this vaccine
as on December 2021.
The Indian Practitioner d Vol.74 No.12 December 2021
Editorial
8
In October 2021, the Subject Expert Commiee
(SEC) had recommended the approval of Bharat
Biotech’s Covaxin for children between 2 and 18 years.
[6] The DCGI has given the nal approval for this vac-
cine in December 2021, with vaccination for those 15
years and above set to commence in January 2022.[6]
Both ZyCoV-D and Covaxin were given approval
by the subject expert commiees after the review of the
ecacy and safety data from pediatric phase II and III
trial interim results.[7] Covaxin is a killed whole virus
vaccine, and children have already undergone immu-
nization with other vaccines with this technology be-
fore.
As of now the reason available in public domain
and as recommended by the National Technical
Advisory Group on Immunization (NTAGI), for not
commencing pediatric vaccination in India is that chil-
dren constitute a low-risk population for COVID, and
that symptoms seem to be mild in them, therefore they
are not a priority group for urgent vaccination as of
now.[8] The priority is to complete double dose for all
adults with contemplation of booster doses for high-
risk adult groups. There are also challenges in ramp-
ing up production, administrative and technical issues,
and want of more ecacy and safety data in children,
as being additional reasons for delaying commence-
ment of pediatric vaccination in India.
An administrative decision considered practical and
wise by most, is to open schools in India without wait-
ing for children to be vaccinated. Children have suf-
fered an immense impact on their physical and mental
health, holistic wellbeing and education, social interac-
tion, and growth and development, by being conned
to online school, or in some sections a lack of access to
any education. It is a signicant uphill task to vaccinate
more than quarter billion eligible children of India and
that requires resources, production capacity, and plan-
ning that will take time, which is not worthy of losing
by keeping schools closed any further.
Reasons for Vaccinating Children
The advantages of COVID vaccination for children
in India are summarized below:
Children constitute a low-risk group for COVID
complications, hospitalization and mortality, and
mostly display mild symptoms. However, that does
not mean that there is no risk.[9] Some children have
suered severe symptoms, and even hospitaliza-
tion. Multi-system inammatory syndrome in chil-
dren (MIS-C), is a recognized, serious and often de-
layed complication of COVID.[10] Children who had
mild COVID can also suer impacts of long COVID.
There are many children with immunocompro-
mised conditions and comorbidities who can have
more severe COVID and therefore deserve high pri-
ority and urgency for vaccination.[11] These include
children with heart or respiratory conditions, or-
gan transplant, kidney ailments like nephrotic syn-
drome, corticosteroid therapy or cancer chemother-
apy, childhood obesity, diabetes etc.
Children can transmit infection to high-risk or el-
derly adults in the household who were vaccinat-
ed almost 8-10 months ago.[12] Therefore vaccinating
children is important for overall family health and
reducing community transmission.
Even though the administration has ordered open-
ing of schools, many parents are reluctant to send
their children to school as they are not yet vaccinat-
ed and are hoping that vaccination for children will
be starting soon.[13] This apprehension has only in-
creased due to the tremendous talk in the media of
cases of the recent Omicron variant increasing in
the country.[14]
Schools are also being extremely cautious due to the
children not being vaccinated yet. Signed parental
consent is mandatory, and since some parents are
apprehensive to send their children, aendance in
schools is unsteady. Also, many schools are calling
children in groups, and not all from a class on the
same day so that distancing can be maintained in
the classroom. For both these reasons, schools are
forced to conduct hybrid (online-oine) classes
that are not as eective as pure online classes for
those children aending from home.[15] This is im-
pacting learning and academics.
For the children coming to school, they are not al-
lowed to freely move around and interact with oth-
er children, and have to keep distancing at all times.
Co-curricular, sports/games and interactive social
and educational activities, have not begun, as chil-
dren are not vaccinated. Many schools have not re-
sumed their transport as well as meal service for
fear of spread of infection. This is creating prac-
tical diculties for parents in sending their chil-
dren to school. So many children continue with or
go back to online school from home for these rea-
sons. It is already established that lack of adequate
social interaction, physical activity (sports/games)
and personality development co-curricular activi-
ties, and living in a virtual gadget dominated world
Editorial
The Indian Practitioner d Vol.74 No.12 December 2021
9
throughout the day has impacted children’s well-
being, health and development signicantly.[16]
Most schools that have opened have done so initial-
ly for the senior classes. Therefore, the children in
junior and pre-primary classes are largely continu-
ing with online mode. Regression of social, motor
and language skills are a big concern in such chil-
dren.[17] Many children in rural areas without devel-
oped internet facilities, and available smart phones/
laptops are being left out of education all together.
The administration has now allowed schools to re-
open even for junior classes, however it is very chal-
lenging for schools to impose strict COVID proto-
cols on the younger children. So parental reluctance
for sending younger children to school is even high-
er. Schools in low socioeconomic or rural sections
are not equipped with stringent sanitation and so-
cial distancing measures for children, and can also
not conduct hybrid classes.[18]
Children are subjected repeatedly to RT-PCR tests
as they are not vaccinated. While in most Indian
states double vaccinated people do not need RTPCR
for entry, but if travelling as a family, children over
5 years have to undertake the RT-PCR, sometimes
2-3 times in a short interval. Some schools after re-
opening are also conducting/asking for frequent
RT-PCR tests, that is causing severe inconvenience
to the children and parents. International travel as a
family is also now posing challenges as most coun-
tries are vaccinating children, and completion of
COVID vaccination is a requirement for travel to
many of the countries.[19]
In the rst wave of the pandemic in 2020, we saw
the elderly and people with comorbidities suer
more and the scientic impression was that nor-
mal healthy younger adults rarely get severe dis-
ease. However, the mutated SARS-CoV-2 variants
and the subsequent 2nd wave in 2021, saw several
of the unvaccinated young healthy adults get hos-
pitalized and even lose their life. Even though the
current variant Omicron seems to be causing mild
disease without mortality or hospitalization, it is a
variant of concern (VOC) and it is too early to pre-
dict its course, and very lile data to understand all
its features is available.[20] There is also no scientif-
ic or medical ‘guarantee’ that a 3rd or subsequent
wave, or any future COVID variant will not impact
children signicantly. Therefore, preventive steps
are always beer and it is imperative to vaccinate
children timely.
Vaccination has globally proven to be the most ef-
fective way of preventing severe COVID, hospital-
ization and death. Since in most countries, children
are now being vaccinated, and their health, educa-
tion and development is being given priority, this
would be the way ahead for India too, and is be-
ing expected and awaited by apprehensive parents
and schools. Parents in India need to be given clar-
ity and reassurance on when vaccination will begin
for their children, and meanwhile not refrain from
sending children to school. The schools also need
clarity and uniformity, on whether they can resume
normal physical classroom teaching mode with all
students or how long to continue hybrid mode, and
also if they can start sports, co-curricular, and inter-
active social-education activities, and other essen-
tial services without waiting for children to be vac-
cinated.
Conclusion
India has shown tremendous leadership in vaccina-
tion and has been a global example in vaccinating its
adult population. All the more that we set such an ex-
ample for our children as well. Commencing vaccina-
tion for children from 2022, starting with those 15 years
and above, is the rst and needed step in this direction.
There is data and approval for 2 indigenous COVID
vaccines for children.
COVID vaccination for children confers many im-
portant benets. It can reduce the risk of serious or
severe COVID and confer some protection from un-
predictable current and future COVID virus variants.
Secondly, it allays parental anxiety and will encourage
more children to aend physical school. Thirdly, it can
also impart the required conviction and condence to
the schools and administration to open sports, games
and play, as well as interactive, social and co-curricular
activities, along with school transport and meal facili-
ty for children. All this will contribute to the children’s
physical, mental, social and emotional health and de-
velopment, and bring back their normal healthy child-
hood. Vaccination can reduce the need for extra RT-
PCRs and travel/quarantine restrictions for children.
Children being immunized can also cut community
transmission of COVID.
As of now children have not been vaccinated as
they have been considered low risk. But at the same
time because of COVID risk, children are being de-
nied normal and wholesome school life with physical
and peer interactive activities that are so important for
their health, well-being and development. Thus, chil-
The Indian Practitioner d Vol.74 No.12 December 2021
Editorial
dren are being penalized from both sides, which is not
only unfair to the children but also to the future of our
country.Vaccination of children should now be made
one of the national priorities, with gearing up of re-
sources and ramping up production for successful pe-
diatric vaccination drives in 2022.
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+
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... The vaccine gives mild to moderate side effects, and most went away within one to two days. Based on efficacy and safety data from pediatric phase II and III interim trial results, the Indian government approved Covaxin (Narayan, 2021). Children constitute a low risk for COVID-19 hospitalization, mortality, and complications and mostly show mild symptoms. ...
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he recent COVID-19 pandemic has reshaped the perceptions of vaccines worldwide. Presently, vaccines are the most efficacious resource that holds the strength to reduce the risk of the disease. In contrast, public health authorities are concerned about vaccine apprehension among the general public. The distribution and consumption of these vaccines began by segregating the age groups. The eligibility of Covaxin vaccines manufactured by Bharat Biotech for children over 12 years of age makes it critical to investigate its credibility among the parents and public views regarding children receiving these vaccines. Moreover, limited information on public acceptability and trustable opinions contribute to vaccine hesitancy among parents. Consequently, the major deciding factors are getting accurate data about the Covaxin’s clinical trial by Bharat Biotech, the persistence and nature of the child's immune response, and reassurance from society. This research study aims to learn more about parents' perspectives and societal attitudes towards immunity building in children by the Covaxin vaccines. The methodology adopted here leads to a precise understanding if there is any ambiguity or acceptance towards Covaxin for children in the minds of the general public. Keywords Bharat Biotech, Children, Clinical Trial, Covaxin, COVID-19, Immunity, Perception.
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Background: ZyCoV-D is a DNA vaccine candidate, which comprises a plasmid DNA carrying spike-S gene of SARS-CoV-2 virus along with gene coding for signal peptide. The spike(S) region includes the receptor-binding domain (RBD), which binds to the human angiotensin converting Enzyme (ACE)-2 receptor and mediates the entry of virus inside the cell. Methods: We conducted a single-center, open-label, non-randomized, Phase 1 trial in India between July 2020 and October 2020. Healthy adults aged between 18 and 55 years were sequentially enrolled and allocated to one of four treatment arms in a dose escalation manner. Three doses of vaccine were administered 28 days apart and each subject was followed up for 28 days post third dose to evaluate safety and immunogenicity. Findings: Out of 126 individuals screened for eligibility. Forty-eight subjects (mean age 34·9 years) were enrolled and vaccinated in the Phase 1 study Overall, 12/48 (25%) subjects reported at least one AE (i.e. combined solicited and unsolicited) during the study. There were no deaths or serious adverse events reported in Phase 1 of the study. The proportion of subjects who seroconverted based on IgG titers on day 84 was 4/11 (36·36%), 4/12 (33·33%), 10/10 (100·00%) and 8/10 (80·00%) in the treatment Arm 1 (1 mg: Needle), Arm 2 (1 mg: NFIS), Arm 3 (2 mg: Needle) and Arm 4 (2 mg: NFIS), respectively. Interpretation: ZyCoV-D vaccine is found to be safe, well-tolerated and immunogenic in the Phase 1 trial. Our findings suggest that the DNA vaccine warrants further investigation.
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An association between a novel pediatric hyperinflammatory condition and SARS-CoV-2 was recently published and termed pediatric inflammatory multisystem syndrome, temporally associated with SARS-CoV-2 (PIMS-TS) or multisystem inflammatory syndrome (in children) (MIS(-C)). We performed a systematic review and describe the epidemiological, clinical, and prognostic characteristics of 953 PIMS-TS/MIS(-C) cases in 68 records. Additionally, we studied the sensitivity of different case definitions that are currently applied. PIMS-TS/MIS(-C) presents at a median age of 8 years. Epidemiological enrichment for males (58.9%) and ethnic minorities (37.0% Black) is present. Apart from obesity (25.3%), comorbidities are rare. PIMS-TS/MIS(-C) is characterized by fever (99.4%), gastrointestinal (85.6%) and cardiocirculatory manifestations (79.3%), and increased inflammatory biomarkers. Nevertheless, 50.3% present respiratory symptoms as well. Over half of patients (56.3%) present with shock. The majority of the patients (73.3%) need intensive care treatment, including extracorporal membrane oxygenation (ECMO) in 3.8%. Despite severe disease, mortality is rather low (1.9%). Of the currently used case definitions, the WHO definition is preferred, as it is more precise, while encompassing most cases. Conclusion: PIMS-TS/MIS(-C) is a severe, heterogeneous disease with epidemiological enrichment for males, adolescents, and racial and ethnic minorities. However, mortality rate is low and short-term outcome favorable. Long-term follow-up of chronic complications and additional clinical research to elucidate the underlying pathogenesis is crucial.What is Known: • A novel pediatric inflammatory syndrome with multisystem involvement has been described in association with SARS-CoV-2. • To date, the scattered reporting of cases and use of different case definitions provides insufficient insight in the full clinical spectrum, epidemiological and immunological features, and prognosis. What is New: • This systematic review illustrates the heterogeneous spectrum of PIMS-TS/MIS(-C) and its epidemiological enrichment for males, adolescents, and racial and ethnic minorities. • Despite its severe presentation, overall short-term outcome is good. • The WHO MIS definition is preferred, as it is more precise, while encompassing most cases.
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Objective There is limited information on the severity of COVID-19 infection in children with comorbidities. We investigated the effects of pediatric comorbidities on COVID-19 severity by means of a systematic review and meta-analysis of published literature. Methods PubMed, Embase, and Medline databases were searched for publications on pediatric COVID-19 infections published January 1st to October 5th, 2020. Articles describing at least one child with and without comorbidities, COVID-19 infection, and reported outcomes, were included. Results 42 studies containing 275,661 children without comorbidities and 9,353 children with comorbidities were included. Severe COVID-19 was present in 5.1% of children with comorbidities, and in 0.2% without comorbidities. Random-effects analysis revealed a higher risk of severe COVID-19 among children with comorbidities than for healthy children; relative risk ratio 1.79 (95% CI 1.27 – 2.51;I² = 94%). Children with underlying conditions also had a higher risk of COVID-19-associated mortality; relative risk ratio 2.81 (95% CI 1.31 – 6.02; I² = 82%). Children with obesity had a relative risk ratio of 2.87 (95% CI 1.16 – 7.07 I² = 36%). Conclusions Children with comorbidities have a higher risk of severe COVID-19 and associated mortality than children without underlying disease. Additional studies are required to further evaluate this relationship.
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Whether all children under 12 years of age should be vaccinated against COVID-19 remains an ongoing debate. The relatively low risk posed by acute COVID-19 in children, and uncertainty about the relative harms from vaccination and disease mean that the balance of risk and benefit of vaccination in this age group is more complex. One of the key arguments for vaccinating healthy children is to protect them from long-term consequences. Other considerations include population-level factors, such as reducing community transmission, vaccine supply, cost, and the avoidance of quarantine, school closures and other lockdown measures. The emergence of new variants of concern necessitates continual re-evaluation of the risks and benefits. In this review, we do not argue for or against vaccinating children against COVID-19 but rather outline the points to consider and highlight the complexity of policy decisions on COVID-19 vaccination in this age group.
A billion COVID vaccine doses: India's landmark achievement in 10 charts
  • India Times Of
Times of India [internet]. A billion COVID vaccine doses: India's landmark achievement in 10 charts. October 21, 2021. [cited Dec 12, 2021]. Available from: https://timesofindia.indiatimes.com/india/in-10-charts-indias-road-to-a-billion-covid-vaccine-doses/articleshow/87179358.cms
Young people with no comorbidities at risk in 2 nd wave
  • India Times Of
Times of India [internet]. Young people with no comorbidities at risk in 2 nd wave. May 22, 2021. [cited Dec 12, 2021]. Available from:https://timesofindia.indiatimes.com/india/ young-people-with-no-comorbidities-at-risk-in-2nd-wave/ articleshow/82849169.cms
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
  • Fda
  • Gov
FDA.Gov [internet]. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. Oct 29, 2021. [cited Dec 12, 2021]. Available from: https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccineemergency-use-children-5-through-11-years-age
Factbox: Countries vaccinating children against COVID-19
  • Reuters
Reuters [internet]. Factbox: Countries vaccinating children against COVID-19. Dec 2, 2021 [cited Dec 12, 2021]. Available from:https://www.reuters.com/business/healthcare-pharmaceuticals/countries-vaccinating-children-against-covid-19-2021-06-29/
Press release: DBT-BIRAC supported ZyCoV-D developed by Zydus Cadila Receives Emergency Use Authorization
  • Pib
  • Gov
PIB.gov [internet]. Press release: DBT-BIRAC supported ZyCoV-D developed by Zydus Cadila Receives Emergency Use Authorization. Aug 20, 2021. [cited Dec 12, 2021]. Available from:https://www.pib.gov.in/PressReleasePage. aspx?PRID=1747669
No need for COVID-19 vaccine for children at the moment: NTAGI
  • India Today
India Today [internet]. No need for COVID-19 vaccine for children at the moment: NTAGI. Dec 21, 2021. [cited Dec 22, 2021]. Available from: https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/story/covid-19-vaccine-forchildren-not-a-priority-ntagi-centre-1890416-2021-12-21