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Vaksinasi Booster COVID-19 di Indonesia 27 Juli 2022.pptx
1. Vaksinasi Booster COVID-19 di Indonesia
(Booster 1, Booster 2, Prioritas)
Samsuridjal Djauzi
Satgas Imunisasi Dewasa PAPDI
2. Rangkuman
A. Cakupan vaksinasi covid19 di Indonesia
B. Manfaat vaksinasi Booster pada kelompok khusus: komorbid, imun kompromais, dan lansia
C. Meningkatkan cakupan vaksin booster 1
D. Persiapan vaksin booster ke 2
3. Cakupan Vaksinasi COVID-19 di Indonesia (tgl 25 Juli 2022)
• [ndikasi vaksinasi covid19 usia 6 tahun keatas
• Vaksinasi booster baru mencapai sekitar 30%. Harus segera ditingkatkan menyusul cakupan
vaksinasi ke 2.
• Vaksinasi booster 1, untuk usia 18 ke atas
• Vaksinasi booster amat bermanfaat bagi Kelompok komorbid, imun kompromais dan usia lanjut.
4. Do some populations require additional protection against COVID-19?
4
Some of the information provided is based on a preprint research paper that has not been peer reviewed. COVID-19 = Coronavirus Disease 2019.
1. Shah ASV et al. N Engl J Med. 2021;385:1718–1720; 2. Hyams C et al. Lancet Infect Dis. 2021;21:1539–1548; 3. Kearns P et al. Preprint published online. SSRN. 2021.
http://dx.doi.org/10.2139/ssrn.3910058. Accessed September 21, 2021.
Increased risk of
exposure to COVID-19
Increased risk of severe
complications from
COVID-19 infection
Reduced immune response
to vaccination
COVID-19 vaccination
of healthcare workers
reduces the risk of
infection for these
workers and their
household members
relative to the period
before vaccination1
COVID-19 vaccination
reduces the risk of
COVID-19-related
hospitalization in
elderly and frail
adults2
Patients with chronic
disease who are
immunocompromised
(through immune
impairment or
immunosuppressive
therapy) may have low
immunogenic
responses to
vaccination3
Correlates of protection and the effects of waning antibodies are currently unclear;
the extent of additional protection required, and in whom to provide it, is yet to be determined
5. Describing the population
experiencing COVID-19
vaccine breakthrough
following second
vaccination in
England: A cohort study
from OpenSAFELY
Green, et al. medRxiv 2021.11.08.21265380; doi:
https://doi.org/10.1101/2021.11.08.21265380
6. PRIORITY GROUPS FOR VACCINATION
• Individuals were classified into seven priority groups based
on the Joint Committee on Vaccination and Immunization
(JCVI) priority groups.
• Individuals were assigned only to their highest priority
group.
INCLUSION/EXCLUSION FLOWCHART
Study methods
Green, et al. MedRxiv preprint, doi: https://doi.org/10.1101/2021.11.08.21265380
7. *Others include – others in priority groups (“At Risk”), some misclassified health/care workers and care home residents (except those age 70+ or shielding who will be included in another
group), carers, household contacts of those at increased risk, and those not in priority groups who had the vaccine opportunistically, e.g., by responding to calls to use up excess doses.
JCVI: Joint Committee on Vaccination and Immunization; CEV: Clinically extremely vulnerable individuals; CI: Confidence interval
Green, et al. MedRxiv preprint, doi: https://doi.org/10.1101/2021.11.08.21265380
Study outcomes based on ‘priority groups’
Option 2
Outcomes in fully vaccinated individuals by JCVI priority groups
12.33 13.36
3.68
11.94
3.96
16.57
14.41
30.94
0
5
10
15
20
25
30
35
All Care home 80+ Healthcare
workers
70-79 CEV 50-69 Others
Incidence
rate
per
1000
person-years
JCVI priority groups
Incidence of positive SARS-CoV-2 test
0.7
2.26
1.86
0.21
0.61
1.27
0.22 0.2
0.12
1.84
0.38
0 0.07 0 0 0
0
0.5
1
1.5
2
2.5
All Care home 80+ Healthcare
workers
70-79 CEV 50-69 Others
Incidence
rate
per
1000
person-years
JCVI priority groups
Incidence of COVID-related hospitalisation
Incidence of COVID-related death
• A total of 16,815 (0.2%) fully vaccinated individuals tested positive for SARS-CoV-2; 955 (0.01%) had hospital admission
(median time to hospitalisation: 33 days); and 145 (0.01%) had COVID-related death (median time to death: 40 days)
• Within the JCVI priority groups, positive SARS-CoV-2 test rates were the highest in the CEV group (16.57, 95% CI 15.73–17.42)
and lowest in individuals over 80 years of age (3.68, 95% CI 3.44–3.92); hospitalization with COVID-19 (2.26, 95% CI 1.58–2.93)
and COVID-19 related death rates (1.84, 95% CI 1.23–2.45) were the highest in the care home group.
8. Green, et al. MedRxiv preprint, doi: https://doi.org/10.1101/2021.11.08.21265380
Study outcomes based on comorbidities
Outcomes in fully vaccinated individuals by comorbidity
15.46
13.45
10.81
12.66
6.06
7.29
21.21
15.33
0
5
10
15
20
25
Incidence
rate
per
1000
person-years
Incidence of positive SARS-CoV-2 test
0.83 0.58
2.76
1.66
2.02 1.76
7.49
6.88
0
1
2
3
4
5
6
7
8
Incidence
rate
per
1000
person-years
Incidence of COVID-related hospitalisation
• Rates of individuals testing positive SARS-CoV-2
o were highest in individuals on RRT, with asthma or organ transplant
• Rates of COVID-19 hospital admissions
o were highest in individuals on RRT, with organ transplant or hematological malignancy;
• COVID-19 related death rates
o were highest in individuals with hematological malignancies, or kidney disease
10. Vaccine efficacy in the comorbid population was consistent
with the overall vaccine efficacy result
aComorbidity is defined as BMI ≥ 30 kg/m2, cardiovascular disorder, respiratory disease or diabetes.
BMI = body mass index; CI = confidence interval; UK = United Kingdom.
Medicines and Healthcare products Regulatory Agency. Public Assessment Report Authorisation for Temporary Supply. COVID-19 Vaccine AstraZeneca. March 16, 2021.
• The proportion of subjects with stable comorbidities at baseline was substantial (36%):
Vaccine efficacy (%) 95% CI
Comorbid populationa
(All)
62.7 44.8, 74.8
Comorbid populationa
(COV002, UK only)
75.2 63.7, 83.1
BMI ≥30 kg/m2 Cardiovascular
disorder
Respiratory
disease
Diabetes
20% 12%
Hypertension (8%)
11%
Asthma (7%)
3%
Data cutoff: December 7, 2020
12. UK: COVID-19 Vaccine Effectivenessa Is Reduced in Individuals
With Impaired Immune Function
aVE against symptomatic medically attended disease; The information provided is based off a preprint research paper that has not been peer reviewed.
CHD = chronic heart disease and vascular disease; COVID-19 = coronavirus disease 2019; UK = United Kingdom; VE = vaccine effectiveness.
Whitaker HJ et al. Preprint published online. Knowledge Hub. 2021.
Cohort and nested test-negative case-control vaccine efficacya analyses were conducted in the UK:
Of the 5,642,687 individuals, 1,054,510 belonged to a risk group
CHD
Vaccine effectiveness 28-90 days
after dose 1
Vaccine effectiveness more than 14 days
after dose 2
0 20 40 60 80 100
100
80
60
40
20
0
-20
-40
-60
-80
-100
Chronic kidney
Diabetes
Neurological
Morbid obesity
Chronic respiratory
Immunocompromised
Chronic liver
All vaccines
12
13. United States
COVID-19 Vaccine Effectivenessa Is Reduced in Individuals With
Impaired Immune Function
aVaccine effectiveness was evaluated by comparing odds of prior vaccination with an mRNA vaccine between COVID-19 hospitalized cases and hospital-based controls who tested negative
for SARS-CoV-2; The information provided is based off a preprint research paper that has not been peer reviewed.
CI = confidence interval; COVID-19 = coronavirus disease 2019; mRNA = messenger ribonucleic acid; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; US = United States.
Tenforde MW et al. Preprint published online. medRxiv. 2021. 13
COVID-19 vaccine effectiveness was evaluated in a multicentre case-control analysis of US adults
hospitalized from March 11 to May 5, 2021a
(N=1210 from 18 clinical sites)
Subgroup
Full vaccination
Overall
18 to 49 years of age
50 to 64 years of age
≥65 years of age
Underlying medical condition
Chronic cardiovascular disease
No chronic cardiovascular disease
Chronic lung disease
No chronic lung disease
Diabetes mellitus
No diabetes mellitus
Immunocompromising condition
No immunocompromising condition
Obesity
No obesity
Percentage
(vaccinated case
patients/total case
patients)
9.0 (45/499)
0.5 (1/186)
7.6 (14/185)
23.4 (30/128)
14.5 (38/263)
3.0 (7/236)
14.3 (14/98)
7.8 (31/398)
12.6 (19/151)
7.5 (26/347)
25.3 (20/79)
6.0 (25/417)
7.3 (21/289)
11.8 (24/203)
Percentage
(vaccinated control
patients/total control
patients)
44.0 (215/489)
17.9 (25/140)
28.7 (39/136)
70.9 (151/213)
48.2 (150/311)
36.5 (65/178)
45.6 (72/158)
43.2 (143/331)
45.1 (73/162)
43.4 (142/327)
48.3 (56/116)
42.6 (159/373)
44.2 (95/215)
44.0 (120/273)
Vaccinated
effectiveness
(95% CI)
86.9 (80.4-91.2)
97.3 (78.9-99.7)
74.7 (47.2-87.9)
87.2 (77.6-92.7)
82.8 (72.3-89.3)
95.4 (88.5-98.1)
82.1 (60.3-91.9)
89.0 (82.1-93.2)
81.6 (64.5-90.5)
89.8 (82.8-94.0)
59.2 (11.9-81.1)
91.3 (85.5-94.7)
88.7 (79.7-93.8)
84.6 (72.8-91.3)
14. Individuals with an impaired immune response are at increased risk of more
severe disease, hospitalisation and death1-4
14
x40 in adults aged 65-74 years
x95 in adults aged ≥85 years
x1,300 in adults aged 65-74 years
x8,700 in adults aged ≥85 years
a Compared with individuals aged 5-17 years
Rate of
Hospitalisation increases with age
Rate of
Death increases with age
64% of COVID-19 hospitalisations are attributable to
four cardiometabolic conditions2
Increased risk of ICU admission:3c
With CHD or asthma
2-fold 7-fold
c Compared with those without the condition
With obesity
a Compared with individuals aged 5-17 years
c Compared with those without immunosuppression
x1.60 P<0.0001
Increased risk of in-patient deathd
With immunosuppression
Increased risk of hospitalisationd
x2.3
HIV
x4.4
Organ transplant
x6.9
HIV+organ
transplant
x3.4
Any immunosuppression
Suárez-García 2021
b The comorbidities presented do not constitute an exhaustive list (e.g., cancer, CKD and chronic lung diseases, among others, can also increase the risk of severe COVID-19).4
CKD = chronic kidney disease; HRU = healthcare resource use
Sources: 1. CDC 2021; 2. O’Hearn 2021; 3. Bennett 2021; 4. CDC 2021
15. Unmet Need and Increased Burden on High-risk Populations
aImmunosuppressants could include medicines for non-Hodgkin’s lymphoma, lupus, multiple sclerosis, rheumatoid arthritis.3,5
COVID-19 = coronavirus disease 2019; US = United States.
1. Harpaz R et al. JAMA. 2016;316:2547-2448; 2. COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Centers for Disease Control and Prevention. Updated September 2, 2021.
Accessed October 1, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html; 3. Abbasi J. JAMA. 2021;325:2033-2035; 4. Rincon-Arevalo H et al. Sci Immunol.
2021;6:eabj1031. https://dx.doi.org/10.1126/sciimmunol.abj1031. Accessed September 24, 2021; 5. Richard-Eaglin A et al. Nurs Clin N Am. 2018;53:319-334.
Blood cancers3 Active
chemotherapy3
Transplant3 Dialysis4 Taking
immunosuppressantsa
Primary immune
deficiency
of the adult population is moderately to severely
immunocompromised leading to increased
vulnerability to COVID-19a,1-3
In the US
about 3%
16. Kesimpulan
• Pemberian vaksinasi COVID-19 bermanfaat termasuk untuk kelompok komorbid, imun kompromais, dan
usia lanjut
• Pemberian booster pada Kelompok komorbid, imun kompromais dan usia lanjut, menurunkan risiko masuk
rumah sakit dan kematian
• Pemberian booster menurunkan risiko penularan tetapi perlindungannya menurun dengan adanya varian
baru (VOC : Variant of Concern)
• Pemerintah menganjurkan agar Kelompok komorbid, imun kompromais dan usia lanjut diprioritaskan untuk
mendapat vaksin booster
18. Background and rationale
CDC = Centers for Disease Control and Prevention; COVID-19 = coronavirus disease 2019; WHO = World Health Organization.
1. In House Data, AstraZeneca Pharmaceuticals LP. CSP D8111C00001; 2. Centers for Disease Control and Prevention. Clinical care considerations for COVID-19 vaccination.
https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Accessed December 21, 2021; 3. World Health Organization. COVID-19 advice for the public.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice. Accessed January 18, 2022; 4. Sattler A et al. J Clin Invest. 2021;15:131:e150175.
Rationale: to test the hypothesis that immunocompromised adults have similar immunogenicity in response
to ChAdOx1-S (recombinant) to other adults1
Clinical studies supporting the
emergency use of ChAdOx1-S
(recombinant) have, to date,
generally excluded participants
with significantly compromised
immune systems1
WHO and CDC recommend vaccination of
immunocompromised individuals;2,3 recent
evidence in kidney transplant patients on
immunosuppressive medication showed low
rates of seroresponse and humoral response4
Data are urgently needed in
immunocompromised and
immunocompetent cohorts,
to understand:
• The impact of COVID-19 prevention
on mortality in this often
multi-morbid cohort
• The emerging safety signal on
serious thrombosis
19. D8111C00010: immunogenicity and safety study of ChAdOx1-S
(recombinant) in immunocompromised adults
aOne month after Dose 1 and 1 month after Dose 2; bPatients receiving cytotoxic chemotherapy.
AEs = adverse events; AESI = adverse event of special interest; anti-S = anti-spike antibody; COVID-19 = coronavirus disease 2019; CVST = cerebral venous sinus thrombosis; GBS
= Guillain-Barré syndrome; GMT = geometric mean titre; HIV = human immunodeficiency virus; HSCT = haematological stem cell transplant; IM = intramuscular; SAEs = serious
adverse events; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
In House Data, AstraZeneca Pharmaceuticals LP. CSP D8111C00001.
Status: planned
Primary efficacy: magnitude of SARS-CoV-2 specific binding (anti-S) and pseudo-neutralisation titres (GMT titres) at
baseline; seroresponse rate of SARS-CoV-2 specific binding (anti-S) and pseudo-neutralisation titres (≥4-fold rise in
titres from Dose 1)a
Key secondary: reactogenicity; unsolicited AEs, SAEs and AESI; occurrence of SAEs and AESIs
Study investigates the immunogenicity, safety and exploratory efficacy of ChAdOx1-S (recombinant) for the prevention of COVID-19 in immunocompromised adults
≥18 years. Adults aged ≥18 years with stable immunocompromising conditions or on stable doses of immunocompromising therapeutics will be stratified equally in
five disease cohorts of ~60 participants each: (1) solid organ transplant, (2) haematological stem cell transplant, (3) solid organ cancer patients receiving cytotoxic
chemotherapy, (4) chronic inflammatory disorders, (5) primary immunodeficiency and asplenia. A sixth cohort of immunocompetent individuals will also be recruited.
Study design
Open-label, uncontrolled, multicenter
52-week study
N~360
Study overview
Key inclusion criteria:
• Adults aged ≥18 years
Key exclusion criteria:
• History of allergic disease
• History of, or active SARS-CoV-2 infection
• Thrombocytopenia ≥ Grade 2
• HIV positive
• Clinically significant bleeding disorder or history
of significant bleeding or bruising following
IM injections
• History of CVST or GBS
• Planned or prior COVID-19 vaccination
Endpoints
Healthy
Primary immunodeficiency
and asplenia
Chronic inflammatory
disorders
Solid organ cancerb
HSCT
Solid organ transplant
ChAdOx1-S (recombinant)
(two doses with 4-week interval)
20. Key conclusions
Green, et al. MedRxiv preprint, doi: https://doi.org/10.1101/2021.11.08.21265380
Some individuals contract COVID-19 even after vaccination and are at a risk of serious COVID-19 outcomes.
Literature is sparse on how breakthrough COVID-19 varies between key priority and clinical/demographic
groups and based on comorbidities.
•Within the priority groups, care needs to be taken in clinically vulnerable patients as they are at the highest risk
for a positive COVID-19 test and in care homes individuals as they are at a high risk for COVID-19 hospital
admissions and COVID-19 related deaths.
Within the clinical/demographic and comorbidities groups, special attention needs to be given to individuals
who are immunocompromised, have haematological malignancies, or respiratory conditions or have undergone
renal replacement therapy, or organ transplant(s), as they are at a high risk for COVID-19 infection and related
hospitalisation and mortality. Advancing age is also an important risk factor for COVID-19 related hospitalisation
and mortality in fully vaccinated individuals.
21. Vaccine in efficacy and safety in older Adults:
Immunogenicity, safety, and efficacy
22. Phase II/III trial in the UK (COV002)
• Immunogenicity
• Safety
• ChAdOx1-S (recombinant) induced SARS-CoV-2-specific antibody and T-cell
responses in all age groups
• Reactogenicity profile reduced compared with younger adults
• There is currently limited information on efficacy in participants aged ≤65 years
23. In participants who received two doses, ChAdOx1-S (recombinant) induced similar
anti-SARS-CoV-2 IgG responses 28 days after boost dose across all age groups
aData points are medians, with whiskers showing the interquartile ranges. Solid lines show participants who received two doses and dashed lines show participants who received one
dose. b5×10¹⁰ virus particles.
Ab = antibody; IgG = immunoglobulin G; RBD = receptor-binding domain; S = spike; SARS-CoV-2 = severe acute respiratory syndrome coronavirus-2.
Ramasamy MN et al. Lancet. 2020;396:1979-1993.
Ab response to SARS-CoV-2 S protein
(standard dose)a,b
Ab response to the RBD of the SARS-CoV-2
S protein (standard dose)a,b
Dose 2
Dose 1
Days since vaccination
Ab
titers
(AU/mL,
log-scale)
1
10
100
1000
10000
100000
0 28 42 56
10000
1000
100
10
0 28 42 56
Days since vaccination
Ab
titers
(AU/mL,
log-scale)
Dose 2
Dose 1
56–69 years (2 doses)
18–55 years (2 doses)
≥70 years (1 dose)
56–69 years (1 dose)
≥70 years (2 doses)
24. Neutralizing Abs against SARS-CoV-2 induced by ChAdOx1-S (recombinant)
were similar across all age groups, within the same dose regimen
aData points are medians, with whiskers showing the interquartile ranges. Solid lines show participants who received two doses and dashed lines show participants who received one
dose. Horizontal dotted lines show upper and lower limits of assay (values outside this range set to 640 beyond the upper limit and 5 beyond the lower limit). b5×10¹⁰ virus particles.
Ab = antibody; MNA80 = microneutralization assay 80; SARS-CoV-2 = severe acute respiratory syndrome coronavirus-2.
Ramasamy MN et al. Lancet. 2020;396:1979-1993.
Neutralizing Ab titers against SARS-CoV-2
(standard dose)a,b
Dose 1 Dose 2
Days since vaccination
Ab
titers
inducing
80%
virus
neutralization
(log-scale)
300
100
30
10
0 28 42 56
Neutralizing Ab titers
were similar across all
three age cohorts 28
days after boost dose
56–69 years (2 doses)
18–55 years (2 doses)
≥70 years (1 dose)
56–69 years (1 dose)
≥70 years (2 doses)
25. According to interim Phase II/III data, ChAdOx1-S (recombinant) was well tolerated
and presented a lower reactogenicity profile in older adults compared with younger
adults, with no increase in reactogenicity with the second dose
AE = adverse event.
Ramasamy MN et al. Lancet. 2020;396:1979-1993.
Most of the reported local and systemic AEs were mild-to-moderate
in severity and reduced after the second dose
Solicited local and systemic reactions were more common in the
ChAdOx1-S (recombinant) group than in the control vaccine group
(injection-site pain, feeling feverish, muscle ache, and headache), but
were less common in adults aged ≥56 years than in younger adults
ChAdOx1-S
(recombinant)
reactogenicity
reduced with
increasing age
13 serious adverse events occurred during the study period, none of which was considered to be related
to ChAdOx1-S (recombinant), and occurred at frequencies expected for these conditions in the
general population
26. Summary of Phase II/III interim data
Ab = antibody; AE = adverse event; S = spike; SARS-CoV-2 = severe acute respiratory syndrome coronavirus-2.
Ramasamy MN et al. Lancet. 2020;396:1979-1993.
ChAdOx1-S (recombinant) induced a specific Ab response to the SARS-CoV-2 S protein and to its receptor-binding
domain after a single dose, that was boosted after a second dose, across all age groups, including adults aged 70
years and older
ChAdOx1-S (recombinant) showed a safe and tolerable profile, consistent with the Phase I interim results and
previously reported studies of ChAdOx1-vectored vaccines. Reactogenicity after the second dose did not increase
compared with the first dose
27. Meningkatkan Cakupan Vaksinasi Booster 1
• Meningkatkan kesadaran masyarakat
• Kesiapan layanan
• Logistik
• Peraturan pendukung
• Prokes harus tetap dijalankan
28. Vaksin booster 1
• Homolog (vaksin booster sama dengan vaksin primer)
• Heterolog (vaksin booster berbeda dengan vaksin primer)
• Pemberian booster 1 tiga sampai 6 bulan setelah selesai suntikan primer
• Pemberian vaksin booster juga dipengaruhi oleh ketersediaan vaksin
29. Vaksin Booster 2
• Selesaikan dulu vaksinasi booster 1
• Bila keaadan mendesak dapat bersamaan dan diberikan prioritas pada komorbid, imun
kompromais , usia lanjut dan tenaga kesehatan
• Jenis vaksin booster 2 sebaiknya berbeda dengan booster 1
• Ada upaya untuk mengembangkan vaksin baru yang efektifitasnya tinggi terhadap varian baru
namun upaya ini akan memerlukan waktu dan dana yang besar
• Kemungkinan untuk Indonesia booster 2 akan menggunakan vaksin yang ada.
30. Vaksin booster 2 untuk tenaga kesehatan
• Tenaga kesehatan pada umumnya berisiko lebih sering terpapar Sars-Cov2
• Penelitian Kemenkes melalui survey yang melibatkan sekitar 10.000 subjek tenaga kesehatan
yang terinfeksi Sars-Cov2 setelah booster 1 sekitar 2% dan Sebagian besar mereka yang
terinfeksi mengalami sakit ringan atau tanpa gejala
• Virus Sars-Cov2 yang sedang bersirkulasi sekarang ini omicron (omicron BA.5) yang mudah
menular namun keparahan Penyakit dan angka kematian rendah.
• Pemerintah telah memutuskan untuk memberikan vaksin booster 2 pada nakes
31. Executive summary
• AZ vaccine as a 3rd dose booster has demonstrated >80% effectiveness against severe disease1,2
– Homologous (AZ/AZ/AZ): >80% against Omicron or Delta1
– Heterologous (X/X/AZ): >98% following an inactivated vaccine2
• AZ vaccine as a 4th dose booster has demonstrated >95% effectiveness against severe disease21
– Heterologous (X/X/X/AZ): >73% against Omicron infection21
– Heterologous (X/X/X/AZ): >95% against severe disease due to Omicron21
• Vaccine effectiveness against severe disease is the most important outcome
– Correlates of protection have not yet been determined
– Total antibody titers are higher for mRNA vaccines; however, demonstrated effectiveness against severe disease is comparable with
AZ vaccine1–9
• AZ vaccine is well tolerated with a favorable safety profile when used as a booster3,15–17
– Benefits of vaccination and being protected against COVID-19 outweigh the potential risks18–20
AZ = COVID-19 Vaccine AstraZeneca; VOC = variant of concern.
See references in slide notes.
AstraZeneca is committed to improving public health and patients’ lives through
prevention and treatment ofinfectious diseases, including COVID-19
32. AZ vaccine booster following inactivated vaccine had high effectiveness
against severe COVID-19 and infection, comparable to mRNA vaccine – Chile
a≥14 days post-booster dose – February–November 2021 in Chile: Alpha, Beta, Gamma, and Delta were circulating; however, Delta was dominant at the time the study was conducted.
bA stratified version of the extended Cox proportional-hazards model was fit to test the robustness of the estimates to model assumptions, stratifying by age, sex, region of residence, income, nationality, and whether the
patient had underlying conditions that have been associated with severe COVID-19.
Total number of participants: 11,174,257; 54% female, 68% with no comorbidities. 1,921,340 (46.5%) participants received a third dose of AZ vaccine; 2,019,260 (48.9%) participants received
a third dose of BNT162b2.
AZ vaccine = COVID-19 Vaccine AstraZeneca; BNT = BNT162b2; CI = confidence interval; COVID-19 = coronavirus disease 2019; CVC = CoronaVac; ICU = intensive care unit.
Jara A et al. Online ahead of print. Lancet. 2022.
CVC/CVC/AZ CVC/CVC/BNT
93%
(92.9, 93.6)
Symptomatic infections 97%
(96.2, 96.7)
98%
(97.3, 98.0)
Hospitalization
96%
(95.3, 96.9)
99%
(98.5, 99.2)
ICU admission
96%
(94.6, 97.3)
98%
(97.3, 98.6)
Death 97%
(93.9, 98.3)
Vaccine effectiveness (95% CI) against:a,b
Chile: 3 doses
33. Baseline characteristics, Delta period: No 4th doses administered
There were 19,235 COVID-19 cases and 156 deaths during the Delta period
92.2
7.8
27,301 Individuals
SARS-CoV-2 negative SARS-CoV-2 positive
0
5
10
15
20
25
30
35
18─29 30─39 40─49 50─59 60─69 ≥70
Percentage
Percent of Total Group by Age Group
SARS-CoV-2 negative SARS-CoV-2 positive
0
10
20
30
40
50
60
70
80
90
100
SARS-CoV-2 negative SARS-CoV-2 positive
Vaccination Status
Unvaccinated 1 dose only 2 doses only 3 doses
50.7
36.6
10.2
1.5
1
0.1
0.02
Primary series (%)
CVC/BIBP-AZ
CVC-CVC or BIBP-BIBP
AZ-AZ
BNT-BNT
AZ-BNT/mRNA-1273
BIBP/CVC-BNT/mRNA-1273
mRNA-1273-mRNA-1273
17.6
73.4
9
Third dose (%)
BNT
AZ
mRNA-1273
AZ = ChAdOx1; BIBP = COVID19 vaccine BIBP; BNT = BNT162b2; CVC = CoronaVac; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Chariyalertsak S, et al. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
34. Baseline characteristics, Omicron period:
mRNA and adenoviral vaccines were used as a 4th dose
There were 296,064 COVID-19 cases and 175 deaths during the Omicron period
AZ = ChAdOx1; BIBP = COVID19 vaccine BIBP; BNT = BNT162b2; CVC = CoronaVac; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Chariyalertsak S, et al. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
59.4
40.6
36,170 Individuals
SARS-CoV-2 negative SARS-CoV-2 positive 0
10
20
30
40
50
60
70
80
90
100
SARS-CoV-2 negative SARS-CoV-2 positive
Vaccination Status
Unvaccinated 1 dose only 2 doses only 3 doses only 4 doses
0
5
10
15
20
25
30
35
40
45
50
18─29 30─39 40─49 50─59 60─69 ≥70
Percentage
Percent of Total Group by Age Group
SARS-CoV-2 negative SARS-CoV-2 positive
43.5
17.2
2.2
13.1
20.5
0.7
2.9
Primary series
CVC/BIBP-AZ
CVC-CVC or BIBP-BIBP
AZ-AZ
BNT-BNT
AZ-BNT/mRNA-1273
CVC/BIBP-BNT/mRNA-1273
mRNA-1273-mRNA-1273
46.1
35.7
17.9
Third dose
BNT
AZ
mRNA-1273
50.3
6.4
43.3
Fourth dose
35. AZ, mRNA vaccines can be integrated into 3rd and 4th dose boosting schedules
Chariyalertsak S, et al. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
Across all vaccines
A third dose boosts
protection against Delta
infection to >95%
Across all vaccines
A fourth dose boosts
protection against
Omicron infection to
>75%
VE was consistent
across age groups for
both Delta and Omicron
infection
These findings provide urgently needed data to support the booster vaccination programs for
COVID-19 vaccines, and supports a flexible approach enabling the incorporation of different vaccines into
schedules according to local supply and logistical considerations
Coverage, rather than vaccine type, may be a much stronger predictor of protection
36. Pesan untuk diingat
• Tetap jalankan Prokes secara konsisten
• Selesaikan vaksinasi covid-19 booster 1
• Siapkan vaksinasi covid-19 booster 2 terutama untuk Kelompok yang berisiko
Note:
Present the slide.
References:
Shah ASV, Gribben C, Bishop J, et al. Effect of vaccination on transmission of SARS-Cov-2. N Engl J Med. 2021;385:1718–1720.
Hyams C, Marlow R, Maseko Z, et al. Effectiveness of BNT162b2 and ChAdOx1 nCoV-19 COVID-19 vaccination at preventing hospitalisations in people aged at least 80 years: a test-negative, case-control study. Lancet Infect Dis. 2021;21:1539–1548.
Kearns P, Siebert S, Willicombe M, et al. Examining the immunological effects of COVID-19 vaccination in patients with conditions potentially leading to diminished immune response capacity – the OCTAVE Trial [preprint published online ahead of print, not peer reviewed]. SSRN. 2021. http://dx.doi.org/10.2139/ssrn.3910058. Accessed October 21, 2021.
Notes:
Present the slide.
Reference:
Medicines and Healthcare products Regulatory Agency. Public Assessment Report Authorisation for Temporary Supply. COVID-19 Vaccine AstraZeneca, solution for injection in multidose container. COVID-19 Vaccine (ChAdOx1-S [recombinant]). Medicines and Healthcare products Regulatory Agency website. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf. Accessed March 16, 2021.
Note:
Present slide.
Reference:
Whitaker HJ, Tsang RSM, Byford R, et al. Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response among individuals in clinical risk groups [preprint published online]. Knowledge Hub. 2021. https://khub.net/documents/135939561/430986542/RCGP+VE+riskgroups+paper.pdf/a6b54cd9-419d-9b63-e2bf-5dc796f5a91f. Accessed August 18, 2021.
Note:
Present slide.
Reference:
Tenforde MW, Patel MM, Ginde AA, et al. Effectiveness of SARS-CoV-2 mRNA vaccines for preventing COVID-19 hospitalizations in the United States [preprint published online July 8, 2021]. medRxiv. 2021. https://doi.org/10.1101/2021.07.08.21259776. Accessed August 18, 2021.
Centers for Disease Control and Prevention. Risk for COVID-19 infection, hospitalization and death by age group. 2021. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html. Accessed 16 June 2021.
O'Hearn M, Liu J, Cudhea F, et al. Coronavirus Disease 2019 Hospitalizations Attributable to Cardiometabolic Conditions in the United States: A Comparative Risk Assessment Analysis. J Am Heart Assoc. 2021;10(5):e019259.
Bennett KE, Mullooly M, O’Loughlin M, et al. Underlying conditions and risk of hospitalisation, ICU admission and mortality among those with COVID-19 in Ireland: A national surveillance study. The Lancet Regional Health. 2021;5:100097.
Centers for Disease Control and Prevention. People with certain medical conditions. 2021. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Accessed 17 June 2021.
Note:
Present slide.
References:
Harpaz R, Dahl RM, Dooling KL. Prevalence of immunosuppression among US adults, 2013. JAMA. 2016;316:2547-2448.
COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Centers for Disease Control and Prevention. Updated September 2, 2021. Accessed October 1, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.
Abbasi J. Researchers tie severe immunosuppression to chronic COVID-19 and virus variants. JAMA. 2021;325:2033-2035.
Rincon-Arevalo H, Choi M, Stefanski AL, et al. Impaired humoral immunity to SARS-CoV-2 BNT162b2 vaccine in kidney transplant recipients and dialysis patients. Sci Immunol. 2021;6:eabj1031. https://dx.doi.org/10.1126/sciimmunol.abj1031. Accessed September 24, 2021.
Richard-Eaglin A, Smallheer BA. Immunosuppressive/autoimmune disorders. Nurs Clin N Am. 2018;53:319-334.
Notes
Present the slide.
References
1. In House Data, AstraZeneca Pharmaceuticals LP. Clinical study protocol D8111C00001. April 20, 2021.
2. Centers for Disease Control and Prevention. Clinical care considerations for COVID-19 vaccination. Last updated March 5, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Accessed December 21, 2021.
3. World Health Organization. COVID-19 advice for the public: getting vaccinated. 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice. Accessed January 18, 2022.
4. Sattler A, Schrezenmeier E, Weber U, et al. Impaired humoral and cellular immunity after SARS-CoV2 BNT162b2 (tozinameran) prime-boost vaccination in kidney transplant recipients. J Clin Invest. 2021;131:e150175.
Notes
Present the slide.
References
In House Data, AstraZeneca Pharmaceuticals LP. Clinical study protocol D8111C00001. April 20, 2021.
Notes:
Humoral responses at baseline and after vaccination were assessed using Meso Scale Discovery multiplexed immunoassay against the S protein of SARS-CoV-2 and a standardized total IgG ELISA against trimeric SARS-CoV-2 spike protein
Reference:
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2020;396:1979-1993. https://dx.doi.org/10.1016/S0140-6736(20)32466-1. Accessed March 16, 2021.
Notes:
Humoral responses at baseline and after vaccination were assessed using a live SARS-CoV-2 microneutralization assay MNA80, which was carried out at Public Health England (Porton Down, UK)
Anti-S-protein Ab levels after vaccination across all time points in those who received two doses of vaccine were highly correlated with neutralizing titers in all age groups and for both low-dose and standard-dose vaccines
Neutralizing Ab titers after the second dose were similar across all age groups
By 14 days after the boost dose, 208 (>99%) of 209 boosted participants had neutralizing antibody responses
Reference:
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2020;396:1979-1993. https://dx.doi.org/10.1016/S0140-6736(20)32466-1. Accessed March 16, 2021.
Notes:
Present the slide.
Reference:
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2020;396:1979-1993. https://dx.doi.org/10.1016/S0140-6736(20)32466-1. Accessed March 16, 2021.
Notes:
Present the slide.
Reference:
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2020;396:1979-1993. https://dx.doi.org/10.1016/S0140-6736(20)32466-1. Accessed March 16, 2021.
Notes
SLIDE REFERS TO EXTERNAL UNPUBLISHED DATA: Difference in T cell response at 8 months (Parry et al; manuscript under submission)
References
Kirsebom F et al. KHub [preprint published online]. 2022;
Jara A et al. Online ahead of print. Lancet. 2022UKHSA: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1050721/Vaccine-surveillance-report-week-4.pdf;
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Altmann DM, Boyton RJ. Science. 2022;375:1127-1132;
Chuenkitmongkol S et al. Research Square. 2022. [Preprint available online] https://doi.org/10.21203/rs.3.rs-1575499/v1 (Accessed April 28, 2022);
Sritipsukho P et al. Emerg Microbes Infect. 2022;11:585-592.
GeurtsvanKessel CH, et al. Supplementary appendix Sci Immunol. 2021; http://dx.doi.org/10.1126/sciimmunol.abo2202. Accessed February 09, 2022.
Swanson II PA et al. Sci Transl Med 2021;13:eabj7211
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Ramasamy MN et al. Presented at: ECCMID Congress; April 23–26, 2022; Lisbon, Portugal
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Chariyalertsak S, et al. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
Notes
Overall vaccine effectiveness from the FONASA Chile trial is high across endpoints for either booster (AZ vaccine or mRNA), and generally comparable
References
Notes
During the Delta period, cases and controls were of similar ages
A slightly higher proportion of females were included vs males
No fourth booster dose reported for study population during the Delta period
Vaccine use varied between the Delta and Omicron periods
People who received a 3rd dose were significantly older than those who received 1 or 2 doses during the Delta period [Back up slide]
Reference
Chariyalertsak S, Intawong K, Chalom K, Wonghirundech T, Kowatcharakul W, Thongprachum A, Chotirosniramit N, Teacharak W, Khammawan P, Waneesorn J, Iamsirithaworn S. Effectiveness of heterologous 3rd and 4th dose COVID-19 vaccine schedules for SARS-CoV-2 infection during delta and omicron predominance in Thailand. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
Notes
During the Delta period, cases and controls were of similar ages
A slightly higher proportion of females were included vs males
No fourth booster dose reported for study population during the Delta period
Vaccine use varied between the Delta and Omicron periods
People who received a 3rd dose were significantly older than those who received 1 or 2 doses during the Delta period [Back up slide]
Reference
Chariyalertsak S, Intawong K, Chalom K, Wonghirundech T, Kowatcharakul W, Thongprachum A, Chotirosniramit N, Teacharak W, Khammawan P, Waneesorn J, Iamsirithaworn S. Effectiveness of heterologous 3rd and 4th dose COVID-19 vaccine schedules for SARS-CoV-2 infection during delta and omicron predominance in Thailand. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022
Notes
Preliminary analysis of hospital databases indicate that booster vaccinations offer protection against severe disease and death due to COVID-19
Reference
Chariyalertsak S, Intawong K, Chalom K, Wonghirundech T, Kowatcharakul W, Thongprachum A, Chotirosniramit N, Teacharak W, Khammawan P, Waneesorn J, Iamsirithaworn S. Effectiveness of heterologous 3rd and 4th dose COVID-19 vaccine schedules for SARS-CoV-2 infection during delta and omicron predominance in Thailand. Research Square 2022. Preprint published online, not peer reviewed. https://doi.org/10.21203/rs.3.rs-1792139/v1. Accessed 29 June 2022