Comparative Evaluation of AEFI (Adverse Event Following

Immunization) and Effectiveness of Astrazeneca and Pfizer Booster

Vaccines among Indonesia Citizen

Ayu Novita Sari, Liandhajani and Diana Laila Ramatillah

Faculty Pharmacy, Universitas 17 Agustus 1945 Jakarta, Indonesia

Keywords: Covid-19, Booster Vaccine, Astrazeneca, Pfizer, AEFI.

Abstract: The booster vaccine was launched amid concerns about the spread of omicron. The booster is effective against

the Omicron variant according to the pseudovirus neutralization test. Complete vaccine plus booster can

provide up to 91% protection from death or other worst risks from Covid-19. This study was conducted to

evaluate the comparison of the effectiveness of the AstraZeneca and Pfizer booster vaccines in the community

in Indonesia. This type of research is observational with cross-sectional. This method is done by direct

observation of the survey data. The most common side effects of receiving the AstraZeneca and Pfizer booster

vaccines are pain at the injection site and pain in the upper arm. This research was conducted using a validated

questionnaire with Cronbach alpha = 0,8. The number of respondents in this study was 600 people, 300

recipients of the AstraZeneca booster vaccine and 300 recipients of the Pfizer booster vaccine. Respondents

in this study were > 18 years. This research requires ethical approval No. 36/KEPK-

UTA45JKT/EC/EXP/07/2022. There is a significant relationsip between socio-demography and AEFI of the

AstraZeneca and Pfizer booster vaccine with p-value <0,05. The effectiveness of the Pfizer booster vaccine

is 98,3% and the AstraZeneca booster vaccine is 97%.

1 INTRODUCTION

At the end of 2019, an infectious disease emerged

which was designated by WHO as "coronavirus

disease (Covid-19)" which originated from the city of

Wuhan, China. The cause of Covid-19 is the SARS-

CoV-2 virus (SanJuan-Reyes et al., 2021). The

chronology of the Covid-19 infection, the first case

occurred in December 2019. On January 2, 2020,

there were 41 confirmed Covid-19 patients. On

January 22, 2020 there were 571 cases of Covid-19.

The Chinese National Committee reported the

first 17 deaths on January 22, 2020 (Ramatillah et al.,

2021). Furthermore, on January 30, 2020, as many as

7734 confirmed Covid-19 in China and 90 other cases

have also been reported from all countries, namely

Taiwan, Thailand, Republic of Korea, UAE, United

States, Philippines, India, Australia, Canada, Finland

and Germany (Ramatillah et al., 2021). The high

death rate is a problem especially in China. On

January 22, 2020, China's National Health

Commission reported 17 deaths (Ramatillah et al.,

2021).

In Indonesia, there were recorded cases of Covid-

19 as of February 17, 2022, namely 63,956 confirmed

cases of Covid-19 including 24,678 active cases,

39,072 confirmed cases recovered and 206 cases died

(Indonesian covid task force, 2022). The fact is that

Indonesian people still do not apply health protocols.

Indonesia launches booster vaccine amid concerns

about the spread of the Omicron variant

(Kompas.com, 2022). Several studies have shown

that antibodies to SARS-CoV-2 gradually decrease

after the second vaccination. Even at 6 months after

vaccination, two-dose mRNA induces long-term

immune memory against the variant SARS-CoV-2

(Seki et al., 2022). Complete vaccination plus booster

can provide protection up to 91% death or other worst

risks from Covid-19 (Kemenkes, 2022). Booster

vaccines are safe for healthy adults aged 18 – 59

years. Vaccines are a way to control outbreaks of

infectious diseases and a way to reduce the risk of

pandemics and epidemics (Seki et al., 2022).

Until 22 February 2022, the number of active

Covid-19 cases was 549,431 people with a total of

37,638 COVID-19 patients being hospitalized,

186

Sari, A., Liandhajani, . and Ramatillah, D.

Comparative Evaluation of AEFI (Adverse Event Following Immunization) and Effectiveness of Astrazeneca and Pﬁzer Booster Vaccines Among Indonesia Citizen.

DOI: 10.5220/0011978400003582

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

Z45 Jakarta (ISCP UTA’45 Jakarta 2022), pages 186-192

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)

consisting of 813 in serious condition and 185 in

critical condition (Kemenkes, 2022). Based on an

analysis of the number of 17,871 patients who were

hospitalized in the period from January 21 to

February 22, 2022, the death toll reached 2,489. Most

of the patients who died were not fully vaccinated.

The risk of death of non-comorbid elderly who

received a booster was 0.49%, while the risk of death

of non-comorbid elderly who received two full doses

of the vaccine was 2.9%, while the risk of death in the

elderly without comorbidities who received the full

dose of the vaccine was 22.8% (Kemenkes, 2022).

The number of deaths in the comorbid group that did

not get the complete vaccine was 739 deaths

compared to those who received the booster only 20

deaths (Kemenkes, 2022).

Vaccines are a way to control outbreaks of

infectious diseases and a way to reduce the risk of

pandemics and epidemics (Excler et al., 2021). The

occurrence of an adverse reaction to the vaccine

indicates that the vaccine is effective and the

recognition of the disease increases (Francis et al.,

2021). According to the Centers for Disease Control

and Prevention (CDC) and other studies, there are

several reactions that occur after vaccination, namely

injection site symptoms (backache, fatigue, headache,

joint pain, body aches, chills, fever and nausea)

(Francis et al., 2021).

Symptoms of patients infected with SARS-CoV-

2 range from minimal symptoms to heavy breathing

with multiple organ failure. On computerized

tomography (CT) scans, characteristic opacities of the

lung base glass can be seen even in asymptomatic

patients. Symptoms of Covid-19 start from 2-14 days

of exposure, symptoms include dry cough, fever, and

fatigue. In some cases, the symptoms of Covid-19

patients may include pain, nasal congestion, diarrhea,

loss of smell and chills (Al-Awwal et al., 2022).

Vaccines are a way to control outbreaks of

infectious diseases and a way to reduce the risk of

pandemics and epidemics (Excler et al., 2021). The

Pfizer vaccine uses RNA or genetic code to make

body cells produce specific spikes for the coronavirus

(Health AGD, 2022). Astrazeneca-Oxford is an

adenovirus viral vector vaccine (Francis et al., 2021).

The viral vector vaccine uses an adenovirus-based

safe vector that does not cause disease, but can

function as a vector to deliver the genetic material of

the Covid virus to host cells. The host cell creates a

copy of the corona virus protein (spike protein)

making an immune response, producing T-

lymphocytes and antibodies against viral antigens

(spike protein) (Shekhar et al., 2021).

After the first and second doses, the immune

response slowly decreases. The second dose causes a

second, larger immune response, which gradually

declines over time. However, a large number of

memory B cell pools (with higher affinity for antigen

affinity maturation) are left behind, favoring a

broader and faster stage of the immune process

against the same pathogen in the future (Shekhar et

al., 2021).

A third or subsequent dose of the Covid-19

vaccine has the potential to increase titers of

neutralizing antibodies against SARS-CoV-2 and its

variants, particularly in immunocompromised

individuals or individuals with underlying

comorbidities or who are at increased risk of COVID-

19 exposure and transmission. However, it is

imperative to apply appropriate use criteria for the

third or subsequent doses of the Covid-19 vaccine

without jeopardizing global vaccination efforts and

further exacerbating global vaccine inequities

(Shekhar et al., 2021).

2 MATERIALS AND METHODS

2.1 Design

This research uses mixed methods and prospective

cross-sectional study. This research was conducted

for 3 months (May - July). The data

collection technique was carried out using a survey

method using google form which will later be

distributed through social media to all Indonesian

people who have carried out booster vaccinations

with the Astrazeneca and Pfizer booster vaccines

using the convenience sampling method. The method

is carried out by direct observation of the survey data.

The purpose of this survey method is to measure the

output value and to find out how the AEFI and the

effectiveness of the Astrazeneca and Pfizer booster

vaccines in people aged >18 years. The instrument

used in this study was a questionnaire used to collect

research data and was made based on existing

references.

2.2 Instrument

This research was conducted using a validated

questionnaire with Cronbach alpa = 0,8 and it

distributed through social media (WhatsApp,

Facebook, Instagram, Telegram, and Twitter). Data

collection was carried out from May to July 2022. The

data collected were 600 respondents during the study.

Only 600 respondents fulfilled the criteria inclution.

Comparative Evaluation of AEFI (Adverse Event Following Immunization) and Effectiveness of Astrazeneca and Pﬁzer Booster Vaccines

Among Indonesia Citizen

187

2.3 Statistical Analysis

Figure 1. Research Framework.

3 RESULT AND DISCUSSION

3.1 Result

Based on table 1. It shows that most of the

respondents in this study were female with a

percentage of Astrazeneca vaccine booster recipients

65,3% while men with a percentage of 34,6%. while

women recipients of Pfizer booster vaccine with a

percentage of 68.3% and men with a percentage of

31.6%. The same as the research of Araminda et al.

that reported women were predominant than men it

was found that the majority of respondents were

women than men (Araminda & Ramatillah, 2022).

Table 1: Gender.

Variab

Astrazenec

a n=300

Pfizer

n=300

Male 104/34,

95/31,6

Female 196/65,

205/68,3

As many as 600 respondents who filled out the

questionnaire, the age of 18-25 years old recipients of

the Astrazeneca booster vaccine was 161 people with

a percentage of 53,6%, and 181 people who received

the Pfizer booster vaccine with a percentage of

60,3%. There were 118 people aged 26-40 years who

received the Astrazeneca booster vaccine with a

percentage of 39,3% and 109 people who received the

Pfizer booster vaccine, with a percentage of 36,3%.

Ages 41-50 years were recipients of the Astrazeneca

booster vaccine with a percentage of 4,6% and the

recipients of the Pfizer booster vaccine were 1,3%.

Ages 51 – 67 years are recipients of the Astrazeneca

booster vaccine with a percentage of 3% while the

Pfizer booster vaccine recipients are 2%. the age

between 26-40 years is a productive society. Their

work requires vaccination before they come to the

office. we can see people who have been vaccinated

are around 18-40 years old. Booster vaccine

recipients in Indonesia are over 18 years of age and

over (kemenkes, 2022a). The priority target recipients

of the booster vaccine are the elderly (kemenkes,

2022a).

Table 2. Age.

e Astrazeneca

n=300

Pfizer

n=300

–

years

161/53,6% 181/60,3

–

years

118/39,3% 109/36,3

–

years

14/4,6% 4/1,3

–

years

9/3% 6/2%

This research was conducted throughout

Indonesia, namely Java with a percentage of 88.33%,

Sumatera at 7.67%, Kalimantan at 3.00%, Bali at

0.67%, and Sulawesi at 0.33%. The Covid-19 booster

vaccination on August 3, 2022 for the category of

people and the elderly, namely Java 30,062,042 with

a percentage of 31.76%, Bali as much as 1,467,027

with a percentage of 55.72%, Kalimantan 2,152,076

with a percentage of 22.66%, Sulawesi 1,317,983

with a percentage of 12.25% , and Sumatra 7,752,729

with a percentage of 23.83% (kemenkes, 2022b).

Reserch (approval of

research and ethical

approval)

Conclusion

Questionnare

deployment using

social media

Questionnare

deployment using

social media

Assement of

questionnaire by

expert

Questionnare valid

and reliable with

cronbach alpha 0,8

Pilot Study (30

respondens

Received up of

questionnare

Validity and

reliability test

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

188

Figure 2. Prevalence Domicile.

3.1.1 Adverse Event Following

Immunization

Table 3: Adverse Event Following Immunization.

Variable Frekuensi/Persenta

(

n=600

)

Feve

266/44,3%

Pain at the injection

site

401/66,8%

Cou

h 64/10,6%

Flu 95/15,8%

auseous 50/8,3%

Diarrhea 37/6,1%

Dizz

214/35,6%

Drowsiness 287/47,3%

Thirst or

deh

dration

96/16%

Bleedin

4/0,6%

Pain in the upper

292/48,6%

Heart

roblems 10/1,6%

Based on table 3. the common AEFIs felt by

respondents after the Astrazeneca and Pfizer booster

vaccines were fever 44.3%, pain in the injection area

66.8%, cough 10.6%, flu 15.8%, nausea 8.3%,

diarrhea 6 .1%, dizziness 35%, drowsiness 47.3%,

thirst or dehydration 16%, bleeding 0.6%, pain in the

upper arm 48.6% and heart problems 1.6%.

Table 4. Correlation between gender and AEFI.

Variable

Male

(n=199)

Female

(n=401)

p-value

Astrazene

Pfizer Astra

zenec

Pfizer

Fever after

booster

vaccine

40/20,1% 34/17

,0%

96/23

,9%

98/24

,4%

0,015*

Sleepy after

booster

vaccine

14/7,0% 25/12

,5%

58/14

,4%

60/14

,9%

0,010*

Diarrhea 4/2,0% 3/1,5 13/3, 22/5, 0,017*

after

booster

vaccine

% 2% 4%

Headache

after

booster

vaccine

11/5,5% 22/11

,0%

44/10

,9%

56/13

,9%

0,022*

Monitoring

after 1

month of

booster

vaccine for

menstrual

roblems

0 0 19/4,

11/2,

0,000#

*Fisher Test #Chi Square Test

Table 4. shows that there are more women than men.

AEFI in women is more dominant than men. Such as

fever after booster vaccine in women with

Astrazeneca booster vaccine by 23,9% and Pfizer

recipients by 24,4%, while men with astrazeneca

booster vaccine by 20,1% and Pfizer booster

recipients by 17,0%. women experienced fever after

the Astrazeneca booster vaccine with a percentage of

14,4% and 14,9% of the recipients of Pfizer booster,

while men recipients of Astrazeneca booster with

percentage 7,0% and recipients of Pfizer vaccine

12,5%. 3,2% of female respondents who received

Astrazeneca booster vaccine and 5,4% of the

respondents who received the Pfizer booster vaccine

recipients had diarrhea. While on male recipents are

2,0 of Astrazeneca booster vaccine and 1,5% of Pfizer

booster vaccine recipents. Female respondents who

experienced headache are 10,0% of Astrazeneca

vaccine booster recipents and 13,9% of Pfizer vaccine

booster recipents. While on male recipents the

percentage are 5,5% of Astrazeneca booster vaccine

recipents and 11,0% of Pfizer booster vaccine

recipents. Female respondents who experienced a

change in their menstrual cycle are 4,7% of

Astrazeneca vaccine booster recipents and 2,7% of

Pfizer vaccine booster recipents.

3.1.2 Correlation Between Age and Vaccine

AEFI

Table 5. Correlation Between Age and Vaccine AEFI.

Variable Astrazeneca

n=300

Pfizer

n=300

value

(

median=26,4

)

Cough and

sore throat

after booster

vaccine

113/37,6% 101/33,6%

0,025

Fever after

booster

vaccine

155/51,6% 132/44% 0,041

Comparative Evaluation of AEFI (Adverse Event Following Immunization) and Effectiveness of Astrazeneca and Pﬁzer Booster Vaccines

Among Indonesia Citizen

189

Monitorin

after 1 month of booster vaccine

Menstrual

roblems

19/6,3% 11/3,6% 0,000 #

Tired easil

35/11,6% 31/10,3% 0,009 #

Pain in the

arm

40/13,3% 41/13,6% 0,003 #

Thirst or

deh

dration

28/9,3% 31/10,3% 0,037 #

Heart

roblems

5/1,6% 5/1,6% 0,002 #

*Mann-whitney, #Kruskal Wallis Test

Table 5. shows that the perceived AEFIs include

cough, sore throat, and fever. The average age in this

study was 26.4. From the results of the study, the

AEFI of old age is felt to be less than that of yaoung

age. Meanwhile, the AEFI felt by Astrazeneca

booster vaccine recipients such as cough and sore

throat was 37,6% and fever was 51,6%. while 33,6%

of Pfizer booster vaccines received had cough and

sore throat and 44% had fever.

3.1.3 Correlation Between BMI and Vaccine

AEFI

Table 6. Correlation Between BMI and Vaccine AEFI.

Variable Astrazeneca

n=300

Pfize

n=300

P-value

Median = 21

Cough

after

booster

vaccine

36/12% 28/9,3% 0,017*

Diarrhea

after

booster

vaccine

27/9% 10/3,3% 0,027*

Covid-19

infection

after 1

month of

booster

vaccine

9/3% 5/1,6%% 0,024*

Monitoring

after 1

month of

booster

vaccine for

menstrual

roblems

19/6,3% 11/3,6% 0,000#

*Mann-whitney Test, #Kruskal Wallis Test

Based on table 6. BMI (Body Mass Index) also affects

AEFI with p-value <0.05. Respondents who received

the Astrazeneca booster vaccine experienced AEFI

cough and diarrhea with a percentage of 12% and 9%

respectively. while the recipients of the pfizer booster

vaccine who experienced cough and diarrhea with a

percentage of 9,3% and 3,3%. Covid-19 infection

after 1 month of Astrazeneca booster vaccine was 3%

and menstrual problem by 6,3%. While 9,3% of the

recipents of Pfizer booster vaccine experienced AEFI

of cough and 3,3% experienced diarrhea.

3.1.4 Relationship between Vaccine Types

and AEFI

Table 7. Relationship between vaccine types and AEFI.

Variable Astrazeneca

n=300

Pfizer

n=300

P-value

Flu after

booster

vaccine

57/19% 38/12% 0,044*

Diarrhea

after

booster

vaccine

25/8,3% 12/4% 0,040*

Skin rash

after

booster

vaccine

46/15,3% 27/9% 0,024*

*Mann-whitney

Table 7. show that the AEFI of Astrazeneca booster

vaccine such as fluwhit percentage of 19%, diarrhea

8,3%, and skin rashes 15,3%. Meanwhile AEFI of

Pfizer booster vaccine such as flu whit a percentage

of 12%, diarrhea 4%, and skin rashes 4,5%.

3.1.5 Effectiveness of Astrazeneca and

Pfizer Booster Vaccines Based on

Exposure to Covid-19 After Booster

Vaccination

Figure 3. Exposure to covid-19.

From the results of the study, it is known that the

effectiveness of the vaccine is seen from the number

of people exposed to Covid. Among total 600

respondent, 300 respondents recipients booster

vaccine and 300 recipients of Pfizer booster vaccine.

After the Astrazeneca booster vaccine, 9 respondent

were exposed to Covid-19 and 5 respondents who

received the Pfizer booster vaccine were exposed to

Covi-19 after vaccination.

Astrazeneca Pfizer

exposed to

covid

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

190

Figure 4. Effectiveness vaccine.

From the results of this study, the effectiveness of

the Pfizer booster vaccine was 98,3% and the

Astrazeneca booster vaccine was 97%.

3.2 Discussion

Based on the results of this study, similar to that of

David Hillus et al., it was found that the most

frequently felt AEFIs were pain at the injection site

and tenderness. Local reactions are usually mild to

moderate. No major differences were observed in the

frequency or severity of local reactions after the

primary or booster vaccine, except of a slightly higher

frequency of local reactions after the heterologous

Astrazeneca – Pfizer booster vaccination compared

with the homologous Pfizer booster vaccine. The

frequency of local reactions was lower after

homologous Astrazeneca booster vaccination than

after heterologous Astrazeneca– Pfizer vaccination

(Hillus et al., 2021).

AEFI and vaccine effectiveness were not related

because there was no significance between the two

variables. In other studies, there is no evidence that

AEFIs affect the effectiveness of vaccines.

Gender has a p-value <0.05 which means it has a

significant relationship with AEFI. According to

research, because of psychological factors, AEFI in

women in the form of pain is higher than in men

(Alghamdi et al., 2021). According to another study,

women produce antibody titers after vaccination and

have a stronger immune system so they experience

higher AEFI (Iguacel et al., 2021). Monitoring after 1

month after the booster vaccine found menstrual

cycle problems in women with a percentage of 7.4%.

According to research conducted by Muhaid, after 1

week of vaccination, symptoms of changes in the

menstrual cycle appear, then menstruation returns to

normal after 2 months of vaccination (Muhaidat et al.,

2022).

This is in accordance with previous research

where the AEFI of the elderly is less pronounced than

the younger age. Elderly AEFI is less pronounced

than younger people because immune cells are aging

combined with T cell depletion as atrophy

exacerbates the loss of new pathogens or vaccines and

age-related immunity (Kezia & Ramatillah, 2022).

According to research by Zare et al, AEFI is

highest in people with a BMI above 25 (Zare et al.,

2020). From the results of the study, it was found that

BMI and AEFI were significant in the form of

coughing and diarrhea, this might occur because most

of the respondents had a BMI less than 25.

The results showed that the AEFI of the

Astrazeneca booster vaccine was more dominant than

the Pfizer booster vaccine. Respondents felt that their

skin rash was due to hypersensitivity to vaccine

ingredients or the active ingredients of a vaccine

(Cebeci & Kartal, 2021).

From the results of this study, the effectiveness of

the Pfizer booster vaccine was 98,3% and the

Astrazeneca booster vaccine was 97%. Another study

reported that ChAdox1-S COVID-19 booster

vaccination againt the Omicron and Delta variants in

Englandhad the effectivity 82,3% (64,2 to 91,3%)

(Kirsebom et al., 2022).

4 CONCLUSIONS

From the result of this study it can be observed that

the effectiveness of the Pfizer booster vaccine is

98,3% and the Astrazeneca booster vaccine is 97%.

The AEFI in the Astrazeneca booster vaccine was

higher than the pfizer booster vaccine. Most of those

participants are from Java and this study female more

predominant than male. The AEFI felt by the

respondents were fever, pain at the ijection site,

diarrhea, dizzinezz, drowsiness and pain above the

arm. AEFI in female more than male such as fever,

drowsiness, diarrhea, headaches, and menstrual

problems. AEFI on BMI such as cough and diarrhea.

Astrazeneca booster vaccine AEFI are more felt than

Pfizer booster vaccine recipients.

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