This document discusses COVID-19 vaccines for children. It provides information on different types of vaccine candidates including mRNA, DNA, viral vectors, and inactivated viruses. Clinical trials for the Sinovac vaccine show promising immunogenicity and safety results. Phase III trials are underway in Indonesia, Bangladesh, and Brazil to further evaluate the Sinovac vaccine.
29. • detect viral RNA in patient samples from
the upper and lower respiratory tract (e.g.
nasal or oropharyngeal swabs, sputum, or
bronchial lavage).
• highly sensitive and specific; used
optimally from 1-7 days post-onset of
symptoms.
1. Molecular
Test
• Detect viral proteins in samples from
both the upper and lower respiratory
tract and can be used from 1-14 days
2. Antigen Detection
Tests
30. • detect antibodies produced in the blood of infected
patients starting from 5-10 days post-onset of
symptoms.
• IgM (+) suggestive of recent infection.
• IgG (+) provideevidence of past infection.
3. Antibody Test
Glycoprotein
spike (S)
Membrane
Protein (M)
Envelope (E)
RNA &
nucloecapside
Hemaglutinin
esterase
31. PEDOMAN NASIONAL COVID – 19 – Kemenkes REV 5 – 13 JULI 2020
- Rapid test tidak untuk diagnostic
- Bila Swab RT PCR terbatas:
- Skrining populasi spesifik dan situasi khusus
- Penguatan pelacakan kontak
WHO – 8 April 2020:
“WHO does not recommend the use of antibody-detecting rapid diagnostic tests
for patient care but encourages the continuation of work to establish their
usefulness in disease surveillance and epidemiologic research”
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54. NO VACCINE????
Theoretically possible Building up
SARS-CoV-2 herd immunity through
natural infection
HERD
IMMUNITY
the indirect protection from infection conferred to susceptible individuals when a sufficiently
large proportion of immune individuals exist in a population
Randolph HE, Barreiro LB. Herd Immunity: Understanding COVID-19. Immunity. 2020; 52(5); 737-41. Available from https://doi.org/10/1016/j.immune.2020.04.012
55. Herd Immunity Treshold
Depend on R0 the average number of secondary infections caused by a single infectious
individual introduced into a completely susceptible population
Herd Imunity threshold =1-1/Ro
If R0 = 4
If R0 = 3
Various studies estimated R0 (2-6)
R0 estimate of 3 the herd immunity
threshold is 67% the incidence of
infection will start to decline once the
proportion of individuals with
acquired immunity to SARS-CoV-2 in
the population exceeds 0.67
56.
57. Vaccine
development
Calina D, Docea A O, Petrakis D, Egorov AM, Ishmukhametov AA, Gabibov AG, et al. Toward effective COVID-19 vaccines: update, perpective and challenges. Int J Mol Med. 2020. 46: 3-16.
Available at https://doi.org/10.3892/ijmm.2020.4596
58. mRNA DNA Vaccine Protein
subunit
Viral vector Virus like partikel Inactivated virus Live attenuated
virus
Messenger ribonucleic
acid (mRNA) fragments
Consist only of DNA (as
plasmids)
Minimal
structural
components of
sars-cov-2
Genome of one virus is
used to deliver the
antigen of another
virus
Mimic the molecular
patterns associated with
pathogens, making them
highly visible to the
immune system
Inactivated pathogens
or fractions
Avirulent viruses
• No risk of insertional
mutagenesis
• Half-life, stability and
immunogenicity of
mrna can be tuned
through established
modifications
• Stable and does not
require maintenance
under controlled
conditions
(refrigeration)
• Stimulates both
humoral and cellular
immunity
• Easy to manufacture in
large quantitie
Reduces the risk
of side effects
Large-scale production
of vaccines
Humoral and cell immune
responses
Safer than Live
attenuated virus
Single-dose immunity
without illness
No vaccine based mRNA
technology has been
approved for any disease
• Limited to protein
immunogens
• No vaccine based DNA
technology has been
approved for any
disease
• Pre-existing
immunity in humans
descrease efficacy
of the adenoviral
vector
• Lowered
immunogenicity
requirement
multiple-dose
regimens
• Require adjuvants
• Cold-chain
transportation
• Contra-indication in
the case of
immunocompromise
d persons
• Possible occurrence
of mutations
Moderna -Genexine consortium Medigen vaccine
biologic/ dynavax
-University of
oxford/astrazeneca
-Cansino biological
inc./Beijing institute of
biotechnology
- Medicago -Sinovac Codagenix/ serum of
institute india
59. Sinovac
a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ
clinical trial in adults aged 18~59 years evaluate the immunogenicity and
safety of the experimental SARS-CoV-2 inactivated vaccine A total of 744
subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ.
Participant will be assigned to receive two doses of experimental vaccine or
placebo on the schedule of day 0,14 or day 0,28.
Primary outcome
Safety indexes of adverse
reactions, Immunogenicity
indexes of neutralizing-ab
seroconversion rates for the
emergency and routine
vaccination schedule
• Hasil menunjukkan profil
imunogenisitas & keamanan
yang baik
• klinis fase II memicu ab
penetral stlh 14 hari vaksinasi
dengan jadwal 0,14 hari.
serokonversi 90%
Indonesia (801/1.620 relawan), Bangladesh (4200 relawan), Brazil
Fase III
Available from : https://clinicaltrials.gov/ct2/show/NCT04352608
All the above tests are available as laboratory-based assays or as point of care tests. The performance of these tests is being evaluated as an ongoing effort to ensure the necessary sensitivity and specificity for quality testing. Member States should consider the availability of independent evaluation data on the assays before they select diagnostics for COVID-19. Collaboration among the Member States is encouraged to sharing findings that will speed the process for independent evaluation