Evaluation of AEFI (Adverse Events Following Immunization)

Efficacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

Nuril Islami and Diana Laila Rahmatillah

Faculty of Pharmacy, Universitas 17 Agustus 1945 Jakarta, Indonesia

Keywords: COVID-19, Sinovac, AEFI (Adverse Events Following Immunization), Efficacy, Children Aged 6-11 Years.

Abstract: Although children are rarely diagnosed in the early days of COVID-19, vaccination of children is still carried

out to achieve herd immunity status in the world. The Indonesian government urges the use of the Sinovac

vaccine for children aged 6-11 years. This study was conducted to evaluate AEFI and the efficacy of the

Sinovac vaccination among children aged 6-11 years in Indonesia and other factors that influence these things.

456 participants who fulfilled the inclusion criteria were involved. This study uses the prospective cross-

sectional method. A valid questionnaire was used in this study with Cronbach alpha 0,8. Those participants

filled out the google form which was shared through social media. It was found that males 194 and females

262. A significant correlation was found between AEFI and Efficacy with gender, comorbidities, age, and

BMI (p value<0,05). 63,04% of participants had pain in the injection area and 44,88% of them had pain in the

upper arm after vaccination. Around 1,8% of participants were infected by Covid-19. From this study, it can

be concluded that Sinovac vaccination has high efficacy and most of them had pain in the injection area event

following immunization as adverse.

1 INTRODUCTION

Coronavirus is part of family Coronaviridae. They

spread amongst many hosts. Clinically, it provides a

diffusion of signs of breathing infections, from the

commonplace bloodless to severe and often even

fatal. The brand-new virus chargeable for this

outbreak turned into originally named "2019-ncov"

or "SARS-cov-2". Sars-cov-2 has recently been

carefully related to SARS-CoV, which has 80%

identification in the RNA sequence (Ramatillah &

Isnaini, 2021). The virus spreads through the air,

could be very easily transmitted between human

beings with a long and threatening incubation

duration, and spreads quickly.

Severe acute respiratory syndrome Coronavirus

2 (SARS-CoV-2), a new coronavirus, was first

detected in the city of Wuhan, China in December

2019 (Dhar et al., 2020). The virus spread to the

sector from China, prompting the sector fitness

agency (WHO) to claim an endemic on March 11,

2020. The national index case was introduced on

March 2nd, traced from a restaurant in South

Jakarta. Nine months later, extra than 7,000 new

cases and more than one hundred fifty each day

deaths had been stated as a seven-day moving

average in Indonesia, without signs and symptoms

of slowing or bending the curve (Ophinni et al.,

2020).

As for children, they are diagnosed exceptionally

not often at the start of the presence of Covid-19

inside the global. To start with, children have been

considered less prone to Covid-19. In a report

through Wu and mcgoogan2, which recorded

instances from December eight to February 20, 2020,

1% of youngsters and 1% of kids under 10 years of

age in China had been affected. Other researchers

said that the hazard of serious illness and death from

Covid-19 turned higher inside the older age

institution. However, more and more young human

beings are being identified because of the sickness

pandemic's progress and the fast Development of

Covid-19 checking out techniques. These days we

recognize that younger humans can also be critically

affected by SARS-cov-2 (Levy et al., 2021). Based

totally on the analysis of Covid-19 statistics on April

10, 2022, the wide variety of Covid-19 sufferers who

died at the age of 3-6 years is said to have been 131

232

Islami, N. and Rahmatillah, D.

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in Indonesia.

DOI: 10.5220/0011979200003582

In Proceedings of the 3rd International Seminar and Call for Paper (ISCP) UTA â

Z45 Jakarta (ISCP UTA’45 Jakarta 2022), pages 232-243

ISBN: 978-989-758-654-5; ISSN: 2828-853X

 2023 by SCITEPRESS – Science and Technology Publications, Lda. Under CC license (CC BY-NC-ND 4.0)

sufferers (0.16%) at the same time as they were aged

elderly 7-12 years had been 246 sufferers (0.14%)

(Per, 2022).

To grow the immunity of kids elderly 6-11

towards publicity to the Covid-19 virus, the

Indonesian government is vaccinating kids of that

age (Kementerian Pendidikan Dan Kebudayaan »

Republik Indonesia, n.d.). The vaccine presently in

use is of the Sinovac type and already has an

Emergency Use Authorization (EUA) (Vaksinasi

COVID-19 Untuk Anak Usia 6-11 Tahun Dimulai 14

Desember – Sehat Negeriku, n.d.). Similarly, the

Indonesian Technical Advisory Group on

Immunization (ITAGI) has also made hints for

implementing the Covid-19 vaccination for

youngsters aged 6-eleven.

The Corona Vac vaccine from Sinovac Biotech in

China is an inactivated SARS cov-2 virus and uses

aluminum hydroxide as an excipient. The maximum

common AEFI from the Covid-19 vaccination is

nearby pain on injection, followed with the aid of

malaise. There is no association between the

occurrence of AEFI symptoms and gender. Both

ladies and men have the same chance of experiencing

symptoms of AEFI. We observed some rare

symptoms which have been suggested, including

drowsiness and dysphagia. The immune response

may additionally play a function in the signs and

symptoms of dysphagia after vaccination (Supangat

et al., 2021).

Although the third clinical trial for the Sinovac

vaccine has been conducted using numerous

international locations thus far in Brazil, Turkey,

Indonesia, and Chile, there are nonetheless minimum

facts on AEFI (Adverse Events After Immunization)

and the efficacy related to the Sinovac vaccine for

children aged 6-11 years (Empat Negara Berbagi

Pengalaman Uji Klinis Tahap-3 Vaksin Sinovac,

n.d.). Based on these matters, further clinical

research to evaluate AEFI (Adverse Events After

Immunization) and the efficacy of the Sinovac

vaccination among children aged 6-11 years in

Indonesia is enormously wished. This takes a look at

becoming conducted with the aid of searching at

diverse elements along with sociodemography that

may link AEFI (Adverse Events Following

Immunization) and the efficacy of the Sinovac

vaccine in youngsters elderly 6-11 years in

Indonesia.

On December 31, 2019, the WHO China country

workplace received records of approximately a case

of pneumonia of unknown etiology detected in

Wuhan (Hubei Province of China), which would

later be considered the center of the spread of SARS-

cov-2. The emergence of Covid-19 is presently

already the third excessive epidemic resulting from -

cov in people during the last many years, after

excessive Acute respiration Syndrome (SARS) and

center East Respiratory Syndrome (MERS), in 2002

and 2012.

The pathogenesis of Covid-19 is complex.

However, it could be defined conceptually using

traditional models for three predominant

pathological methods associated with irritation of the

local manifestations of classical (canonical) general

irritation, acute systemic inflammation, and

continual systemic infection of low depth

(Matsuzawa et al., 2022).

The destructive impact of Covid-19 during the

last year has led to a worldwide attempt to build herd

or network immunity, starting with immunity on the

individual degree to boost the population stage. Viral

immunity is mediated by immunological memory,

which develops after the number one immune

response is generated to viral antigens. The natural

immunity of SARS-cov-2 can increase from previous

infections; this could result in a speedy and powerful

immune response, accordingly, defending the

devotee. However, the presence and length of SARS-

cov-2- precise immune memory cells that offer

dependable protecting immunity in individuals with

beyond infections is still poorly understood.

Statistics concerning these responses can be useful in

figuring out whether received immunity will

successfully contribute to the Development of herd

immunity (Mistry et al., 2019).

As of August 29, 2020, it was expected that about

15.8 in keeping with 100,000 children ages 0-4 and

9.2 consistent with 100,000 in those elderly5- 17

years were hospitalized within the U.S. due to Covid-

19 virus infection. From these records, it is regarded

that there are fewer youngsters hospitalized because

of Covid-19 virus infection, but this still exceeds the

pre-vaccine technology hospitalization burden from

different viruses that can currently be averted via

vaccination. About a third of the kids hospitalized

with Covid-19 positive, 80% of them have the

multisystem inflammatory syndrome in kids (MIS-

C) and are admitted to extensive care devices (ICU).

Further, the deaths of youngsters from Covid-19 had

been no longer expected to be close to 110-188

deaths (Qona et al., 2022).

Some of the corona viruses can cause respiratory

infections in humans ranging from mild symptoms

such as coughs and colds to more serious symptoms.

Symptoms of COVID-19 are usually mild and appear

gradually. some infected individuals may be

asymptomatic and still feel well (Ramatillah et al.,

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

233

2021). People who get infected may also experience

asymptomatic viral shedding or fever, fatigue,

myalgia, arthralgia, rhinorrhea, sore throat, and/or

conjunctivitis at one point of the spectrum. But it can

also progress to fever, cough, hemoptysis, silent

hypoxia, chest pain or tenderness, respiratory failure,

or even multiorgan failure. Olfactory (hyposmia,

anosmia, and parosmia) or taste (dysgeusia)

problems have been identified as important

chemosensory problems in Covid-19. Non-

conductive olfactory disorder (OD) may be the only

manifestation. Different extrapulmonary

manifestations consist of diarrhea, lymphopenia,

thrombocytopenia, impaired liver and kidney

function, rhabdomyolysis, meningoencephalitis,

stroke, seizures, Guillain-Barré syndrome, cardiac

arrhythmias or heart block, pancreatitis, multisystem

vasculitis including Kawasaki disease, rash or

lesions including have a cold. chills,

thromboembolism, and acute thyroiditis.

Six months after the onset of symptoms of Covid-

19, more than 60% of the patients were observed to

have persistent symptoms of fatigue or muscle

weakness. Sleep problems (26%), anxiety, or

melancholy (23%) are also not uncommon. Other

symptoms namely disturbances in smell or taste,

palpitations, joint pain, dizziness, diarrhea, vomiting,

and chest pain, a series of signs known as "Covid-19

acute-delivery syndrome". Those with severe

diseases need assisted breathing to overcome

impaired diffusion from the lungs.

In general, children have shorter and milder

illnesses than adults. However, at some point in the

healing phase of the disorder, an extraordinary but

life-threatening Kawasaki-like disease is seen, called

early life multisystem inflammatory syndrome (MIS-

C) or pediatric inflammatory syndrome transiently

associated with SARS-cov-2. Children with MIS-C

tend to be older, have fewer lymphocytes and

platelets, and have higher CRP and ferritin levels

than children with Kawasaki disease (Kai-Wang To

et al., 2021).

Research for the expansion of a robust vaccine

for SARS-cov-2 began early in the Covid-19

pandemic (Rashedi et al., 2022). Several vaccines

have been developed to reduce the morbidity and

mortality associated with Covid-19 and prevent

transmission of the virus (Eid et al., 2021). More than

70 SARS-cov-2 vaccines developed from the unique

vaccine platform, including inactivated whole

manufacture virions, live attenuated viruses, nucleic

acid viruses, viral vectors, and recombinant S

proteins, are already in clinical trials (Kai-Wang To

et al., 2021).

Active immunization can produce herd immunity

and expanding the newly formulated and approved

Covid-19 vaccine using the US Food and Drug

Administration (FDA) is being rolled out. Covid-19

vaccines, such as messenger RNA (mRNA; Pfizer-

BioNTech Comirnaty - BNT162b2 & Moderna -

mrna-1273), protein-based (Novavax – NVX-

cov2373), and viral vector-based (Johnson &

Johnson Janssen - Ad26.COV2. S , Oxford-

AstraZeneca - AZD1222/chadox1, Sputnik V

vaccine - gamcovid-Vac- rad26/rad5), mainly goal

spike protein (S), while inactivated conventional

vaccines (Sinopharm-BBIBP-corv, Sinovac-

coronavac, Covaxin - BBV152) targets the complete

virus (Mistry et al., 2019).

Nine standard options can help guide whether a

Covid-19 vaccine for children should be mandated.

The criteria can be divided into three classes: four

criteria related to vaccines, 2 related to disease, and

3 related to implementation. Typically, each of these

criteria will be considered in determining whether a

vaccine should be mandated for children, although

those given for each criterion may be exceptional. At

a time of great demand for public wellness, together

with the current pandemic, it is proposed that every

criterion remains in vaccine policymaking. However,

five criteria should be prioritized. The criteria that

should be prioritized over relaxation are paramount:

there must be evidence that the Covid-19 vaccine is

safe for children at an acceptable stage of risk.

Assembly of these standards usually requires a pre-

licensed safety process and data from license-issuing

studies to reveal facet results after the vaccine has

been administered to more than one human. 4

different standards want to be prioritized in

considering whether the Covid-19 vaccine is

mandatory for young people. First, the severity of the

Covid-19 disorder must be large and sufficient, at

least for a portion of the population (the fifth

criterion). Second, vaccinating children must reduce

the threat of disease transmission (criterion 6). The

basis of a necessary vaccine policy regarding

children is that a higher proportion of those who are

immune saves you from harming others.

This criterion, rather than the role of children in

the transmission of SARS-cov-2 characters to

individuals, is still lacking. 1/3, the Covid-19 vaccine

must also be effective in protecting children from

disease (second criterion). It doesn't need to be 100%

strong, similar to other vaccines we currently order

for children. Fourth, because the benefits of the

Covid-19 vaccine will mostly be felt by adults who

are too threatened, not children, they should not feel

lazy for children; or, in place of, the parent or mother

ISCP UTA’45 Jakarta 2022 - International Seminar and Call for Paper Universitas 17 Agustus 1945 Jakarta

234

or father of the child, to comply with the vaccine

mandate (criterion 9). This means that mandated

vaccines must be widely available, easy on the hands,

and inexpensive to anyone (Medical Association,

2020).

Protein-based vaccines or inactivated vaccines

are currently used repeatedly in children in general

with added aluminum salts. Picovacc, also called

coronavac, is an alum-adjuvanted inactivated virus

vaccine (SARS-cov-2 pressure CN2) that produces

neutralizing antibodies extensively in rodents and

non-human primates and demonstrates safety in

established doses in demanding situations (Gao et al.,

2020).

AEFI can be classified as Serious Adverse Events

(SAE), which are events that require hospitalization,

endanger the patient (cause a risk of death and

require immediate clinical intervention to prevent

death), and cause significant and/or permanent

dysfunction. Disability, resulting in congenital

abnormalities or causing death; or Non-Serious

Adverse Events (NSAE), i.e., all events that do not

meet the SAE criteria. Any serious, undesirable, or

unexpected signs or symptoms that manifest in

individuals who have received any type of

immunobiologist are considered AEFI and can be

caused by several factors related to the

immunobiological component, the vaccination

process, or people who have been vaccinated (da

Silva et al., 2021).

Clinical trials of vaccines before distribution

permission received crucial information

approximately AEFI and due to the fact Covid-19

vaccines were advanced the usage of new

technology, publish-advertising surveillance has

become critical to detecting uncommon or lengthy-

time period side consequences (Kant et al., 2022; Tan

et al., 2022). Most of the discovered AEFI had been

expected and associated with local reactions at the

site of vaccine administration (Živanović et al.,

2021). AEFI, which was recorded right away after

the injection of the vaccine, couldn't expressly

display a causal dating c (Gianfredi et al., 2021).

Non-allergic AEFI that is regularly related to the

covid-19 vaccine usually appears to be the same as

other existing vaccines (Kim et al., 2021).

Mechanically, most AEFI is caused by using organ

hypersensitive reactions or immune responses to

vaccines (Fu et al., 2021). Participants who had

Covid-19 (confirmed with a positive test)

experienced one or more of the well-known systemic

extra frequently after the primary dose than after the

second dose (Kant et al., 2022). Primarily based on

previous research conducted in Indonesia, it is said

that side outcomes skilled by way of recipients of the

overall dose of the Sinovac vaccine are expected,

which include ache on the injection website online,

fever, drowsiness, and pain in the upper limbs (Kezia

& Ramatillah, 2022).

MATERIALS AND METHODS

2.1 Design

This is a prospective cross-sectional study. The

method was carried out to evaluate AEFI (Adverse

Events Following Immunization) and the efficacy of

the Sinovac vaccination among children aged 6-11

years in Indonesia using a questionnaire. This

research was conducted for three months, starting

from March to June 2022. The data collection

technique carried out in this study is convenience

sampling. Sampling takes all the items that make up

the research inclusion criteria. The inclusion criteria

in this study include all children aged 6-11 years in

the country who received a full dose of the Sinovac

vaccine and provided informed consent to be included

in this study. Then the exclusion criteria are children

aged 6-11 years who have not been vaccinated with a

full dose, suffering from cancer, HIV/AIDS,

tuberculosis (TBC), and autoimmune patients.

2.2 Participants

Participants in this study were all children in

Indonesia aged 6 to 11 years that have been

conducting a full dose of vaccination with the vaccine

Sinovac. The total of participants in the study was 456

respondents.

2.3 Instruments

This study uses a questionnaire distributed through

social media, such as WhatsApp, Twitter, Facebook,

Instagram, and Telegram. The total of questions in the

questionnaire in this study were 85 questions

consisting of questions about identity, efficacy of

Sinovac vaccine after the first and second

vaccinations, AEFI (Adverse Event Following

Immunization) vaccines obtained after the first and

second doses of vaccination in a short time. and long-

term vaccines and combine efficacy and AEFI for 3

months after vaccination.

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

235

2.4 Statistical Analysis

AEFI of the vaccine. The value of p<0.05 is

considered significant.

2.5 Ethical Consent

This research has received ethical approval from the

ethics committee of health research at the University

of August 17 1945 Jakarta, with approval letter

No.35/KEPK-UTA45JKT/EC/FB/07/2022.

RESULTS AND DISCUSSION

In this study, the number of respondents obtained was

456 respondents. All these respondents were children

aged 6-11 years who had done a full dose of Covid-

19 vaccination with Sinovac which was the inclusion

criterion in this study.

It is known that in this study there were more

female respondents with a percentage of 57.5%

compared to male respondents (42.5%). (Figure 1)

Respondents in this study were spread almost all

over Indonesia. The percentage of respondents'

domicile is 83.1% for the island of Java. This shows

that in this study most of the respondents live on the

island of Java such as West Java, Banten, DKI

Jakarta, Central Java, DI Yogyakarta, and East Java.

Then Sumatra Island 12.5%, Kalimantan Island 2.4%,

and the least proportion is Nusa Tenggara Island and

Bali at 2.0%. In this study, the researcher did not find

respondents who live in Sulawesi Island and Maluku

& Papua Island (Lemhannas RI, 2020). This may be

due to the lack of power in social media that

researchers have. (Figure 2)

Of 456 respondents, only 3 respondents had

comorbidities, namely one respondent with

comorbidity of sinusitis and 2 respondents with

comorbidities asthma. The percentage of those

comorbities can be seen in figure 3.

3.1 AEFI (Adverse Events Following

Immunization) Vaccine

Based on kipi.covid-19.go.id, the AEFI of the Covid-

19 vaccine is usually mild and only temporary. These

mild AEFI reactions include arm pain in the injection

area, headache, muscle pain, joint pain, chills, nausea,

vomiting, fatigue, fever, and also flu (Informasi

Tentang KIPI Atau Reaksi Setelah Vaksinasi COVID-

19, n.d.). Regarding monitoring, although there has

been no official research related to AEFI menstrual

cycle disorders, in some studies it is known that the

Covid- 19 vaccine can affect changes in the menstrual

cycle in reproductive women (Mahasing et al., 2022).

In this study, it was found that there were many

relationships between sociodemographics and the

AEFI of vaccines.

3.1.1 Relationship Between Gender with

AEFI Vaccine

After data analysis using fisher and chi-square tests,

it was found that there was a relationship between

gender and vaccine AEFI. (Table 1).

57,5%

42,5%

Figure 1. The percentage of gender among vaccinate

children with Sinovac (6-11 years)

Figure 3. The percentage of comorbidities among

vaccinated children with Sinovac (6-11 years)

0,4%

0,2%

99.4%

2.0%

2,4%

12,5%

83,1%

Figure 2. The percentage of domicile among vaccinate

children with Sinovac (6-11 years)

ISCP UTA’45 Jakarta 2022 - International Seminar and Call for Paper Universitas 17 Agustus 1945 Jakarta

236

Table 1: Relationship of gender with AEFI vaccine.

Variable Male (n=194) Female (n=262) p-

value

Frequen

Percenta

Frequen

Percenta

AEFI after the first vaccination

Thirst or

dehydrati

29 14,95% 60 22,90% 0,03

Diarrhea

0,52%

3,44% 0,03

Cough 14 7,22% 35 13,36% 0,03

AEFI vaccine after the second vaccination

Cough 20 10,31% 12 4,58% 0,01

Fever 46 23,71% 39 14,89% 0,01

Monitoring after 1 month of vaccination

Menstrua

l cycle

roblems

0,76% 0,00

0 #

Monitoring after 2 months of vaccination

Menstrua

l cycle

roblems

0,38% 0,00

0 #

Monitoring after 3 months of vaccination

Menstrua

l cycle

roblems

0,38% 0,00

0 #

Chi-Square test #Fisher test

It is known that vaccine recipients with a female

gender experience AEFI more than male vaccine

recipients. After the first vaccination, 22.90% of

female respondents experienced thirsty AEFI or

dehydration (p=0.034) after doing the first dose of

vaccination, while for male respondents, only 14.95%

experienced AEFI. After the second vaccination, it

was found that there was a difference that male

respondents who received the vaccine experienced

more AEFI than female respondents. Likewise, with

AEFI diarrhea (p=0.035) and cough (p=0.018),

female respondents who experienced AEFI diarrhea

were 3.44%, and for AEFI, the cough was 13.36%

while male respondents were 0.52% for AEFI diarrhea

and 7.22% for AEFI cough. (Table 1)

After the chi-square test was carried out to see if

there was a relationship between gender and vaccines

on monitoring 1-3 months after vaccination, it was

found that there was a relationship between gender

and the AEFI vaccine, namely, female respondents

experienced menstrual cycle problems with a p-

value<0.05. The above is by research that has been

carried out previously in Thailand. The study stated

that the AEFI of the Covid-19 vaccine was more

experienced by women. AEFI is usually spelled out at

the time of introducing a new vaccine. Similarly, in

this study, the Sinovac- CoronaVac vaccine is the first

Covid-19 vaccine and has only been introduced to the

Indonesian people since the beginning of the

vaccination recommendation for Covid-19. The

study also mentioned that the Covid-19 vaccination

can affect the menstruation cycle in reproductive

women which may be caused by the stress

experienced in these women (Mahasing et al., 2022).

(Table 1)

3.1.2 Relationship Between Comorbidities

with AEFI Vaccine

After data analysis using fisher and chi-square tests,

it was found that there was a relationship between

comorbidities and vaccine AEFI. (Table 2)

Table 2: Relationship between comorbidities with AEFI

vaccine.

Variable Sinusitis

(

n=1

)

Asthma

(

n=2

)

value

Frequen

Percenta

Frequen

Percenta

AEFI after the first vaccination

Nauseou

- - 2 100% 0,00

Heart

attac

1 100% - - 0,00

AEFI vaccine after the second vaccination

Cough 1 100% - - 0,00

Thirst or

dehydrati

1 100% 1 50% 0,00

Monitoring 1 month after vaccination

Menstrua

l cycle

roblems

1 100% - - 0,00

0 #

Thirst or

dehydrati

1 100% 1 50% 0,01

4 #

Monitorin

2 months after vaccination

Menstrua

l cycle

roblems

1 100% - - 0,00

0 #

Thirst or

dehydrati

1 100% - - 0,00

0 #

Tired 1 100% - - 0,00

3 #

Chi-Square test #Fisher test

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

237

It is known that respondents who have sinusitis

disease experience more AEFI than respondents who

have asthma-borne diseases. Just like the

Relationship of comorbidities with a vaccine after the

first and second vaccinations, in monitoring after 1-3

months after vaccination, respondents with

concomitant diseases,

d sinusitis experienced more

AEFI than respondents

with asthma comorbidities.

On monitoring 3 months after vaccination, no

relationship was found between comorbidities and

AEFI vaccines. The above can occur because sinusitis

patients are susceptible to the virus (Marin et al.,

2023). Another possibility is due to the presence of

invasive fungal infections in respondents receiving

the vaccine. Based on invasive fungal infection

sinusitis case reports seen in the literature, the fungal

infection is very influential on the severity of Covid-

19 (Borrelli et al., 2022). More research is needed on

the Relationship between comorbidities and AEFI

covid-19 vaccines, especially Sinovac. (Table 2)

3.1.3 Relationship Between Age and AEFI

Vaccine

Table 3. Relationship between age with AEFI vaccine.

Variable

(

n=456

)

p-value

Frequenc

Percentage

AEFI afte

the first vaccination

Nauseous 46 10,09% 0,014*

Upper arm

ain

232 50,88% 0,041*

AEFI afte

the secon

vaccination

Feve

85 18,64% 0,020*

Dizz

76 16,67% 0,004 #

Easy to get

sleep

150 32,89% 0,007 #

Thirst or

dehydration

52 11,40% 0,044 #

Upper arm

ain

179 39,25% 0,005 #

Monitorin

1 month afte

vaccination

Menstrual

cycle

roblems

0,44% 0,009 #

Monitoring 2 months afte

vaccination

Menstrual

cycle

roblems

0,22% 0,036 #

* Mann-Whitney test #Kruskal Wallis test

Figure 4. Diagram of the relationship between age with

AEFI Vaccine

After data analysis using the Mann-Whitney Test for

questions related to the AEFI vaccine and the Kruskal

Wallis test for monitoring questions 1-3 months after

vaccination, it was found that there was a relationship

between age and AEFI vaccine. This is indicated with

a p-value of less than 0.05. The most experienced

AEFI of respondents was upper arm pain after the

first vaccination (p=0.041) with a percentage of

50.88% and the least was at the time of AEFI

monitoring until 3 months after vaccination, namely

changes in the menstrual cycle after 2 months of

vaccine acceptance (p=0.036) with 0.21%. (Table 3)

It is known that younger children have less AEFI.

This can happen because the immune systems of

younger people are Stronger and more efficient than

those of older people. Another possibility that can

occur is the clinical symptoms of the inflammatory

response to the lung injury of the younger children are

milder than those older children (Qona et al., 2022).

(Figure 4)

ISCP UTA’45 Jakarta 2022 - International Seminar and Call for Paper Universitas 17 Agustus 1945 Jakarta

238

3.1.4 Relationship between BMI and AEFI

Vaccine

Table 4: Relationship of gender with vaccine efficacy.

Variable

BMI (n=456)

p-value

Frequency Percentage

AEFI after the first vaccination

Fever 203 42,38% 0,021*

Pain in the injection

area

338 70,56% 0,00*

Nauseous 48 10,02% 0,036*

Dizzy 145 30,27% 0,003*

Easy to get sleepy 228 47,60% 0,000*

Upper arm pain 242 50,52% 0,036*

AEFI after the second vaccination

Pain in the injection

area

266 55,53%

0,050*

Flu

26 5,43%

0,039*

Easy to get sleepy

162 33,82%

0,026*

Upper arm pain

188 39,25%

0,004*

Monitoring 2 months after vaccination

Menstrual cycle

problems

0,21%

0,007 #

Easily Tired

30 6,26%

0,000 #

Upper arm pain

31 6,47%

0,000 #

Thirst or dehydration

20 4,18%

0,000 #

Bleeding

0,63%

0,000 #

Monitoring 3 months after vaccination

Easily Tired

1,25% 0,016 #

Upper arm pain

1,25%

0,016 #

*Mann-Whitney test #Kruskal Wallis test

Figure 5: Relationship between BMI and AEFI vaccine.

After analyzing the data using Mann-Whitney for

questions related to the vaccine AEFI and the Kruskal

Wallis test to find out 3 months after vaccination it

was found that there was a relationship between BMI

and vaccine AEFI with a p-value of 0.05, which can

be seen in table 1. the data that can be used in the

graph in Figure 2, it is known that the respondents

who received the vaccine the most experiencing AEFI

were children aged 6-11 years who had low body

weight. (Table 4)

The results obtained in this study are following

previous studies related to the side effects of Sinovac

in adolescents aged 12-18 years that have been

carried out by Qona et al. In this study, it was found

that respondents who received vaccines with BMI

<18.5 (less body weight) had the majority of AEFI

vaccines (Qona et al., 2022). The results obtained in

this study may be caused by the respondents obtained

by the researchers having a BMI of less than 18.5

(less body weight). (Figure 5)

3.2 Vaccine Efficacy

The efficacy of the Sinovac vaccine was 98.46% after

all respondents had the first vaccination and 99.34%

in the second vaccination. Based on this, it can be

known that the efficacy of the Sinovac vaccine after

all respondents have been vaccinated in the first and

second doses or the full dose is 98.2%. (Figure 6)

Figure 6: Diagram of vaccine efficacy.

3.2.1 Relationship Between Gender and

Vaccine Efficacy

After data analysis using fisher tests, it was found that

there was a relationship between comorbidities and

vaccine efficacy. (Table 5)

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

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239

Table 5: Relationship of gender with vaccine efficacy.

Variable

Male (n=194) Female (n=262)

value

Frequency Percentage Frequency Percentage

Infected with Covid-19 after vaccination

Second

vaccination

1,55%

0,043*

Self-

isolation

1,55%

0,043

Mild

symptoms

1,55%

0,043

*Fisher Test #Chi-Square Test

It is known that in this study, only a relationship was

found between gender and vaccine efficacy after

vaccination respondents carried out the second dose

of vaccination. Likewise, it can also be seen that only

respondents of the male gender were infected with

covid-19 after receiving the second dose

vaccination. Based on the data above, it can be

concluded that in female respondents the Sinovac

vaccine works more effectively against Covid-19.

The possibility that can happen because in general,

women practice more preventive behaviors and avoid

behaviors at risk of contracting Covid-19

(Khubchandani et al., 2021). (Table 5).

3.2.2 Relationship Between Comorbidities

and Vaccine Efficacy

After data analysis using fisher tests, it was found that

there was a relationship between comorbidities and

vaccine efficacy. (Table 6).

Table 6: Relationship between comorbidities and vaccine

efficacy.

Variable Sinusitis (n=1) Asthma (n=2) p-

value

Frequenc

Percenta

Frequenc

Percenta

After the first vaccination

Loss of

sense of

disengageme

nt an

taste

100%

0,000

Respiratory

distress

100%

50% 0,000

Cough and

sore throat

100% 0,002

Diarrhea

100%

0,000

Skin rash

100%

0,000

After the second vaccination

Loss of

sense of

disengageme

nt an

taste

100%

0,000

Respiratory

distress

100%

0,000

Headache

100%

0,019

*Fisher test

It is known that respondents who have congenital

sinusitis ailment revel in extra symptoms of being

inflamed with Covid-19. That is inconsistent with

preceding research on continual Rhinosinusitis and

Covid-19. Inside the observation, it became said that,

although CRS patients are vulnerable to exacerbation

of viral infections, CRS has now not been said chief

comorbidity and isn't a dangerous aspect for Covid-

19, there can also be a defensive role towards SARS-

cov-2 infection, and CRS is not related to severe

Covid- 19. Even though the observation also referred

to that in CRS sufferers who were unresponsive to

medical remedies and carried out surgical processes,

the treatment could affect the danger of SARS-Cov-2

infection with the aid of modulating the host’s

immune response to viral infections, ACE2

expression in airway epithelial cells, and pre-present

syntonic irritation resulting from CRS (Marin et al.,

2023). (Table 6)

3.2.3 Relationship Between Age and Vaccine

Efficacy

After data analysis using the Mann-Whitney test, it

was found that there was a relationship between age

and vaccine efficacy. (Table 7)

Table 7: Relationship between age with vaccine efficacy.

Variable Age (n=456) p-value

Frequency Percentage

After the first vaccination

Respiratory

distress

21 4,61% 0,000*

After the second vaccination

Cough and sore

throat

32 7,02% 0,010*

Fever 64 14,04% 0,032*

Headache 53 11,62% 0,015*

*Mann-Whitney test

ISCP UTA’45 Jakarta 2022 - International Seminar and Call for Paper Universitas 17 Agustus 1945 Jakarta

240

Figure 7. Diagram of Relationship between age and vaccine

efficacy

It can be concluded that there is a relationship

between age and vaccine efficacy. The most common

symptoms of Covid-19 experienced by respondents

receiving the Sinovac vaccine were fever with

14.04% (p = 0.032). The aforementioned are

supported with a p-value of less than 0.05. There was

no relationship between age and vaccine efficacy on

monitoring for 3 months after vaccination. (Table 7)

It is known that respondents receiving vaccines

with older age experience more symptoms of Covid-

19 than younger vaccine respondents. This is not

much different from previous studies preliminary

reports show that only a small percentage of Covid-

19 cases occur in children and adolescents (aged 0–

18 years), with the incidence increasing with age

(European Centre for Disease Prevention and

Control, 2020). (Figure 7)

3.2.4 Relationship Between BMI and

Vaccine Efficacy

Table 8: Relationship of BMI with vaccine efficacy.

Variable

BMI (n=456)

p-value

Frequency Percentage

After the first vaccination

Cough and sore throat 67 14,69% 0,007*

Diarrhea 19 4,17% 0,047*

AEFI after the second vaccination

Loss of sense of

disengagement

taste

1,54% 0,033*

Cough and sore throat 32 7,02% 0,005*

Diarrhea

1,97% 0,049*

*Mann-Whitney test

Figure 8: Diagram of Relationship BMI with vaccine

efficacy.

After data analysis using the Mann-Whitney test, it

was found that there was a relationship between BMI

and vaccine efficacy with a p-value of less than 0.05

(Table 8). In the data that has been described in the

graph, it is known ones who experience the most

symptoms of Covid-19 are children who have low

body weight. (Figure 8)

A cohort study conducted by previous researchers

stated that people with very low BMI risk of being

hospitalized or dying from Covid-19 than people with

normal weight (Wilder-smith & Frahsa, 2022).

4 CONCLUSIONS

The efficacy of the Sinovac vaccine among children

aged 6-11 years is very high at 98.2%. The

sociodemography that results in the most severe

AEFI

is comorbidities. The vaccine AEFI that most

respondents felt was upper arm pain and pain in the

injection area after the first vaccination. Meanwhile,

the vaccine AEFI that most respondents felt at 3

months of monitoring was upper arm pain after 2

months after vaccination.

REFERENCES

Borrelli, M., Nasrollahi, T., Ulloa, R., Raskin, J., Ference,

E., & Tang, D. M. (2022). Invasive Fungal Sinusitis

During Active COVID-19 Infection. 0(0), 1–3.

https://doi.org/10.1177/01455613221112337

da Silva, R. B., da Silva, T. P. R., Sato, A. P. S., Lana, F. C.

F., Gusmâo, J. D., Souza, J. F. A., & Matozinhos, F. P.

(2021). Adverse events following immunization against

SARS-CoV-2 (covid-19) in the state of Minas Gerais.

Revista de Saude Publica, 55, 01–10.

https://doi.org/10.11606/s1518-8787.2021055003734

Dhar, J., Samanta, J., & Kochhar, R. (2020). Corona Virus

Disease-19 pandemic: The gastroenterologists’

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

241

perspective. Indian Journal of Gastroenterology, 39(3),

220–231. https://doi.org/10.1007/s12664-020-01075-2

Eid, E., Abdullah, L., Kurban, M., & Abbas, O. (2021).

Herpes zoster emergence following mRNA COVID-19

vaccine. Journal of Medical Virology, 93(9), 5231–

5232. https://doi.org/10.1002/jmv.27036

Empat Negara Berbagi Pengalaman Uji Klinis Tahap-3

Vaksin Sinovac. (n.d.). Retrieved June 28, 2022, from

https://kemlu.go.id/beijing/id/news/11971/empat-

negara-berbagi-pengalaman-uji-klinis-tahap-3-vaksin-

sinovac

European Centre for Disease Prevention and Control.

(2020). COVID-19 in children and the role of school

settings in COVID-19 transmission. Ecdc, Stockholm,

August, 31.

Fu, Q., Xie, H., Zhou, L., Li, X., Liu, Y., Liu, M., Wang,

C., Wang, X., Wang, Z., Tang, J., Xiao, H., Xiao, Z.,

Zhou, J., Feng, C., Wang, L., Ao, Z., Chen, X., Su, C.,

Wu, X., … Jiang, L. (2021). Auricular acupressure for

adverse events following immunization related to

COVID-19 vaccine injection: study protocol for a

multicenter, three-arm, blinded randomized controlled

trial. Trials, 22(1), 1–12.

https://doi.org/10.1186/s13063-021-05837-x

Gao, Q., Bao, L., Mao, H., Wang, L., Xu, K., Yang, M., Li,

Y., Zhu, L., Wang, N., Lv, Z., Gao, H., Ge, X., Kan, B.,

Hu, Y., Liu, J., Cai, F., Jiang, D., Yin, Y., Qin, C., …

Qin, C. (2020). Development of an inactivated vaccine

candidate for SARS-CoV-2. Science, 369(6499), 77–

81. https://doi.org/10.1126/science.abc1932

Gianfredi, V., Minerva, M., Casu, G., Capraro, M.,

Chiecca, G., Gaetti, G., Mazzocchi, R. M., Musarò, P.,

Basteri, P., Bertini, B., Ferri, C., Odone, A., Signorelli,

C., Alberti, V. F., & Gastaldi, G. (2021). Immediate

adverse events following covid-19 immunization. A

cross-sectional study of 314,664 Italian subjects. Acta

Biomedica, 92(7).

https://doi.org/10.23750/abm.v92iS6.12365

Informasi Tentang KIPI atau Reaksi Setelah Vaksinasi

COVID-19. (n.d.). Retrieved July 28, 2022, from

https://kipi.covid19.go.id/

Kai-Wang To, K., Sridhar, S., Hei-Yeung Chiu, K., Ling-

Lung Hung, D., Li, X., Fan-Ngai Hung, I., Raymond

Tam, A., Wai-Hin Chung, T., Fuk-Woo Chan, J., Jian-

Xia Zhang, A., Chi-Chung Cheng, V., & Yuen, K.-Y.

(2021). Lessons learned 1 year after SARS-CoV-2

emergence leading to COVID-19 pandemic.

https://doi.org/10.1080/22221751.2021.1898291

Kant, A., Jansen, J., Balveren, L. Van, & Hunsel, F. Van.

(2022). Description of Frequencies of Reported

Adverse Events Following Immunization Among Four

Different COVID ‑ 19 Vaccine Brands. Drug Safety,

45(4), 319–331. https://doi.org/10.1007/s40264-022-

01151-w

Kementerian Pendidikan dan Kebudayaan » Republik

Indonesia. (n.d.). Retrieved June 1, 2022, from

https://www.kemdikbud.go.id/main/blog/2021/12/vaks

inasi-covid19-bagi-anak-usia-611-tahun-dorong-

optimalisasi-pembelajaran-tatap-muka-terbatas

Kezia, V., & Ramatillah, D. L. (2022). Intensive

Monitroing of Sinovac Vaccine for Safety and Efficacy

Among Indonesian Population. International Journal

of Applied Pharmaceutics, 14(Special issue 2), 44–48.

https://doi.org/10.22159/ijap.2022.v14s2.44748

Khubchandani, J., Sharma, S., Price, J. H., Wiblishauser,

M. J., Sharma, M., & Webb, F. J. (2021). COVID-19

Vaccination Hesitancy in the United States: A Rapid

National Assessment. Journal of Community Health,

46(2), 270–277. https://doi.org/10.1007/s10900-020-

00958-x

Kim, M. A., Lee, Y. W., Kim, S. R., Kim, J. H., Min, T. K.,

Park, H. S., Shin, M., Ye, Y. M., Lee, S., Lee, J., Choi,

J. H., Jang, G. C., & Chang, Y. S. (2021). COVID-19

vaccine-associated anaphylaxis and allergic reactions:

Consensus statements of the KAAACI

urticaria/angioedema/anaphylaxis working group.

Allergy, Asthma and Immunology Research, 13(4),

526–544. https://doi.org/10.4168/aair.2021.13.4.526

Lemhannas RI. (2020). Daftar 34 Provinsi Beserta Ibukota

di Indonesia. 1–15.

http://www.lemhannas.go.id/images/2020/08/PPID/4_

Daftar_Nota_Kesepahaman_2020.pdf

Levy, E. R., Blumenthal, J., & Chiotos, K. (2021).

Coronavirus disease 2019 in children. Current Opinion

in Infectious Diseases, 34(5), 500–509.

https://doi.org/10.1097/QCO.0000000000000762

Mahasing, C., Yasopa, O., Sansilapin, C.,

Rattanathumsakul, T., Thammawijaya, P.,

Suphanchaimat, R., & Doung-Ngern, P. (2022).

Investigation of a Cluster of Immunization Stress-

Related Reactions after Coronavirus Disease 2019

(COVID-19) Vaccination, Thailand, 2021. Vaccines,

10(3), 1–12. https://doi.org/10.3390/vaccines10030441

Marin, C., Hummel, T., Liu, Z., & Mullol, J. (2023).

Chronic Rhinosinusitis and COVID-19. The Journal of

Allergy and Clinical Immunology in Practice, 10(6),

1423–1432. https://doi.org/10.1016/j.jaip.2022.03.003

Matsuzawa, A., Vaccarezza, M., Gusev, E., Sarapultsev,

A., Solomatina, L., & Chereshnev, V. (2022). SARS-

CoV-2-Specific Immune Response and the

Pathogenesis of COVID-19.

https://doi.org/10.3390/ijms23031716

Medical Association, A. (2020). Should We Mandate a

COVID-19 Vaccine for Children?

https://doi.org/10.1001/jamapediatrics.2020.3019

Mistry, P., Barmania, F., Mellet, J., Peta, K., le Strydom,

A., Viljoen, I. M., James, W., Gordon, S., Pepper, M.

S., Martin Centre, L., & William Dunn, S. (2019).

SARS-CoV-2 Variants, Vaccines, and Host Immunity.

https://doi.org/10.3389/fimmu.2021.809244

Ophinni, Y., Hasibuan, A. S., Widhani, A., Maria, S.,

Koesnoe, S., Yunihastuti, E., Karjadi, T. H., Rengganis,

I., & Djauzi, S. (2020). COVID-19 Vaccines: Current

Status and Implication for Use in Indonesia. Acta

Medica Indonesiana, 52(4), 388–412.

Per, U. (2022). ANALISIS DATA COVID-19 INDONESIA.

April

Qona, A., Ibnatus, A. H., & Ramatillah, D. L. (2022).

Original Article EVALUATION COMPARISON

ISCP UTA’45 Jakarta 2022 - International Seminar and Call for Paper Universitas 17 Agustus 1945 Jakarta

242

BETWEEN SINOVAC AND PFIZER VACCINE

AMONG INDONESIAN CHILDREN AND TEENAGER

UNDER 18 YEARS OLD. 14(2), 22–30.

Ramatillah, D. L., Gan, S. H., Sulaiman, S. A. S., Puja, D.,

Abubakar, U., Jaber, A. A. S., Lukas, S., & Jusnita, N.

(2021). Evaluation of treatment outcome for pneumonia

among pre-vaccinated covid-19 patients with/without

comorbidity in a public hospital in Bengkulu,

Indonesia. Vaccines, 9(12), 1–9.

https://doi.org/10.3390/vaccines9121411

Ramatillah, D. L., & Isnaini, S. (2021). Treatment profiles

and clinical outcomes of COVID-19 patients at private

hospital in Jakarta. PLoS ONE, 16(4 April), 1–11.

https://doi.org/10.1371/journal.pone.0250147

Rashedi, R., Samieefar, N., Masoumi, N., Mohseni, S., &

Rezaei, N. (2022). COVID-19 vaccines mix-and-

match: The concept, the efficacy and the doubts.

Journal of Medical Virology, 94(4), 1294–1299.

https://doi.org/10.1002/jmv.27463

Supangat, Sakinah, E. N., Nugraha, M. Y., Qodar, T. S.,

Mulyono, B. W., & Tohari, A. I. (2021). COVID-19

Vaccines Programs: adverse events following

immunization (AEFI) among medical Clerkship

Student in Jember, Indonesia. BMC Pharmacology and

Toxicology, 22(1), 1–7.

https://doi.org/10.1186/s40360-021-00528-4

Tan, A. Y., Chang, C. T., Yu, Y. K., Low, Y. X., Fatehah,

N., Razali, M., Tey, S. Y., Wen, S., & Lee, H. (2022).

Adverse Events Following BNT162b2 mRNA COVID-

19 Vaccine Immunization among Healthcare Workers

in a Tertiary Hospital in Johor , Malaysia. 2, 1–8.

Vaksinasi COVID-19 untuk Anak Usia 6-11 Tahun dimulai

14 Desember – Sehat Negeriku. (n.d.). Retrieved June

1, 2022, from

https://sehatnegeriku.kemkes.go.id/baca/rilis-

media/20211212/1938972/vaksinasi-covid-19-untuk-

anak-usia-6-11-tahun-dimulai-14-desember/

Wilder-smith, A., & Frahsa, A. (2022). Impact of BMI on

COVID-19 vaccine effectiveness Second brain tumours

after pituitary irradiation : lower risk than once thought.

THE LANCET Diabetes & Endocrinology, 10(8), 551–

552. https://doi.org/10.1016/S2213-8587(22)00170-X

Živanović, D., Jovin, V. M., Javorac, J., Ilić, M., & Zelić,

P. (2021). Commentary: Registered adverse events

following COVID-19 immunization in Serbia.

European Review for Medical and Pharmacological

Sciences, 25(20), 6408–6410.

https://doi.org/10.26355/eurrev_202110_27014

Evaluation of AEFI (Adverse Events Following Immunization) Efﬁcacy of Sinovac Vaccination Among Children Aged 6-11 Years in

Indonesia

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