Nous avons eu l'honneur et le plaisir d'accueillir le Professeur Jean-Michel Dogné, expert au Comité Mondial de Sécurité Vaccinale de l’OMS, à l'occasion d'un Webinar informatif sur le thème de la “Vaccination COVID-19”.
PROGRAMME:
Différentes phases de la contamination à la COVID-19
Quels sont les objectifs de la vaccination ?
Comment le corps fait-il pour développer une immunité ?
Comment le vaccin a-t-il été développé aussi vite ?
La répartition des doses des différents vaccins
Dans quelles circonstances le vaccin sera-t-il efficace ?
Efficacité du vaccin
Composition de l’injection
Qui doit se faire vacciner et pourquoi ?
Potentiels risques du vaccin sur le long terme
Explications sur la politique de transparence via la plateforme AFMPS
A PROPOS DU PROFESSEUR JEAN-MICHEL DOGNÉ:
Fort d’une expertise de 14 ans dans le domaine de la sécurité des médicaments et des vaccins auprès des agences belge (AFMPS) et européenne (EMA) des Médicaments, Jean-Michel Dogné a été nommé début 2020 en tant qu’expert au Comité Mondial de Sécurité Vaccinale de l’Organisation Mondiale de la Santé. Directeur du Département de pharmacie de l’Université de Namur et membre de l’Institut de recherche Narilis, il compte plus de 200 publications en pharmacochimie, pharmacologie, pharmacovigilance et en sécurité du médicament.
PLUS D'INFORMATIONS:
https://www.quality-assistance.com/events/tout-ce-que-vous-voulez-savoir-sur-la-vaccination-covid-19
2. 2
Avertissement
Bien qu’expert auprès de l’Agence fédérale
des médicaments et des produits de santé
(AFMPS) de l’Agence Européenne des
Médicaments (EMA), de l’Organisation
Mondiale de la Santé (OMS) et membre de
la Task Force fédérale « opérationnalisation
de la stratégie de vaccination COVID-19 »,
ma présentation pourrait ne pas refléter le
point de vue de ces agences.
Ma présentation est un point de vue
personnel qui ne lie pas ces institutions.
Je n’ai pas de conflits d’intérêt.
3. 3
SARS-CoV-2 is an enveloped
β-coronavirus, with a genetic
sequence very similar to
SARS-CoV-1 (80%) and bat
coronavirus RaTG13 (96.2%).
The viral envelope is coated
by spike (S) glycoprotein,
envelope (E), and membrane
(M) proteins.
Host cell binding and entry are
mediated by the S protein.
The S1 sub-unit of the S
protein contains the receptor
binding domain (RBD) that
binds to the peptidase domain
of angiotensin-converting
enzyme 2 (ACE2).
BMJ October 23, 2020, doi: https://doi.org/10.1136/bmj.m3862
Lancet October 13, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)32137-1
4. 4
(1) The virus binds to ACE 2 as the host target cell receptor in synergy with the host’s transmembrane serine protease 2 (cell
surface protein), which is principally expressed in the airway epithelial cells and vascular endothelial cells. This leads to
membrane fusion and releases the viral genome into the host cytoplasm (2). Stages (3-7) show the remaining steps of viral
replication, leading to viral assembly, maturation, and virus release.
BMJ October 23, 2020, doi: https://doi.org/10.1136/bmj.m3862
11. 11
Adapté de: Chen RT et al, Vaccine 1994; 12:542-50
Evolution d’un programme de vaccination
Maladie
Augmentation
Couverture
Confiance:
Perte Retour Éradication
Éradication
Couverture
vaccinale
Epidémie
Effets indésirables
reels/perçus
Comment les vaccins modifient la perception
de la maladie ciblée (= du bénéfice)?
23. 23
Le 17 juin 2020, la Commission européenne a présenté sa stratégie visant
à accélérer la mise au point, la production et la mise à disposition de
vaccins efficaces et sûrs contre la COVID-19.
En échange du droit d'acheter un nombre défini de doses de vaccin dans
un délai donné, la Commission finance une partie des
investissements initiaux engagés par les producteurs de vaccins,
sous la forme de contrats d'achat anticipé.
Le financement accordé est considéré comme un acompte sur les vaccins
qui seront effectivement achetés par les États membres sur la base de
contrats d'achat anticipé. Cet acompte sera déduit du prix fixé par dose
dans le contrat au moment de l’achat par les États membres.
24. 24
27 Août 2020: AstraZeneca (300 million + 100 million doses).
18 Septembre 2020: Sanofi-GSK (300 million doses).
8 Octobre 2020: Janssen Pharmaceutica (200 million + 200 million)
12 Novembre 2020: Pfizer/BioNTech (200 millions + 100 millions doses)
17 Novembre 2020: CureVac (225 millions + 180 doses)
25 Novembre 2020: Moderna (80 millions + 80 millions doses)
26. 26
Pfizer/BioNTech
COMIRNATY®
Moderna AstraZeneca Janssen
(Johnson &
Johnson)
Curevac Novavax
Plateforme mRNA
BNT162b2
mRNA
mRNA-1273
Non-replicating
viral vector
chimpanzee
adenovirus vector
(ChAdOx1)
Non-replicating
viral vector
adenovirus
serotype 26
mRNA
CVnCoV
NVX-CoV2373
sous-unités
protéique
(nanoparticules
recombinantes)
adjuvant à base
de saponine
Doses 2 2 2 1 ou 2 2 2
Efficacité 95,0% 94,1% 59,5% 66% TBD 89.3% in UK
Phase 3
60% in South
Africa phase 2b
EMA Rolling
review
06/10/2020 16/11/2020 01/10/2020 01/12/2020 - 03/02/2021
EMA opinion 21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Commission
Européenne
(AMM)
21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Quantité de
vaccins
commandés
5 millions
+7,5 millions
(+2,5 millions)
2 millions
+3,8 millions
7,5 millions 5 millions 2,9 millions Under EC
discussion
Vaccins en Belgique
27. 27
Le vaccin sera commercialisé dans l'UE sous la marque
COMIRNATY®, qui représente une combinaison des termes
COVID-19
ARNm
communauté et immunité
pour mettre en évidence la première autorisation d'un vaccin à
ARN messager (ARNm), ainsi que les efforts mondiaux conjoints
https://press.pfizer.be/pfizer-et-biontech-recoivent-lautorisation-de-lunion-europeenne-pour-leur-vaccin-covid-19translation
35. 35
Sécurité:
Réactions locales: douleur, érythème, gonflement
Réactions systémiques: fièvre, maux de tête,
myalgies
• Plus de réactions après la deuxième dose
• Risque moins élevé chez les > 55 ans
• La plupart étaient léger à modéré et résolu rapidement.
38. 38
8 janvier 2021
In order to extract six doses from a single vial, low dead-volume syringes and/or
needles should be used.
The low dead-volume syringe and needle combination should have a dead volume of
no more than 35 microliters.
If standard syringes and needles are used, there may not be enough of the vaccine
to extract a sixth dose from a vial.
44. 44
Recommandations d’utilisation des vaccins
à ARNm
https://www.health.belgium.be/fr/avis-9622-vaccination-contre-la-covid-19-chez-la-femme-enceinte
45. 45
Recommandations d’utilisation des vaccins
à ARNm
https://www.health.belgium.be/fr/avis-9622-vaccination-contre-la-covid-19-chez-la-femme-enceinte
46. 46
Recommandations d’utilisation des vaccins
à ARNm
https://www.health.belgium.be/fr/avis-9622-vaccination-contre-la-covid-19-chez-la-femme-enceinte
47. 47
Recommandations d’utilisation des vaccins
à ARNm
https://www.health.belgium.be/fr/avis-9622-vaccination-contre-la-covid-19-chez-la-femme-enceinte
48. 48
Evaluation post-marketing
La majorité des effets indésirables rapportés sont connus et décrits dans le résumé
des caractéristiques du produit (RCP) et dans la notice des vaccins. Ces effets se
sont généralement résolus en quelques jours après la vaccination.
50. 50
Recommandations d’utilisation
Hypersensibilité et anaphylaxie (RCP)
– Des événements d'anaphylaxie ont été rapportés.
– Un traitement médical et une surveillance appropriés doivent
toujours être disponibles en cas de réaction anaphylactique après
l'administration du vaccin.
– Une observation étroite pendant au moins 15 minutes est
recommandée après la vaccination.
– Une deuxième dose du vaccin ne doit pas être administrée à ceux
qui ont présenté une anaphylaxie à la première dose.
51. 51
Recommandations d’utilisation
Hypersensibilité et anaphylaxie
– Des réactions anaphylactiques peuvent survenir avec n'importe quel
vaccin, mais sont généralement extrêmement rares - environ une
pour 1 million de doses *
*J Allergy Clin Immunol. 2016. DOI:https://doi.org/10.1016/j.jaci.2015.07.048
https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-
rare-allergic-reactions
63. 63
Pfizer/BioNTech
COMIRNATY®
Moderna AstraZeneca Janssen
(Johnson &
Johnson)
Curevac Novavax
Plateforme mRNA
BNT162b2
mRNA
mRNA-1273
Non-replicating
viral vector
chimpanzee
adenovirus vector
(ChAdOx1)
Non-replicating
viral vector
adenovirus
serotype 26
mRNA
CVnCoV
NVX-CoV2373
sous-unités
protéique
(nanoparticules
recombinantes)
adjuvant à base
de saponine
Doses 2 2 2 1 ou 2 2 2
Efficacité 95,0% 94,1% 59,5% 66% TBD 89.3% in UK
Phase 3
60% in South
Africa phase 2b
EMA Rolling
review
06/10/2020 16/11/2020 01/10/2020 01/12/2020 - 03/02/2021
EMA opinion 21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Commission
Européenne
(AMM)
21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Quantité de
vaccins
commandés
5 millions
+7,5 millions
(+2,5 millions)
2 millions
+3,8 millions
7,5 millions 5 millions 2,9 millions Under EC
discussion
Vaccins en Belgique
64. 64
The adenovirus pushes its DNA
into the nucleus. The
adenovirus is engineered so it
can’t make copies of itself, but
the gene for the coronavirus
spike protein can be read by
the cell and copied into a
molecule called messenger
RNA, or mRNA.
65. 65
The mRNA leaves the nucleus, and the
cell’s molecules read its sequence and
begin assembling spike proteins.
The adenovirus also provokes the
immune system by switching on the cell’s
alarm systems. The cell sends out warning
signals to activate immune cells nearby.
By raising this alarm, the vaccine causes
the immune system to react more
strongly to the spike proteins.
66. 66
Indication and posology
COVID-19 Vaccine AstraZeneca is indicated for active immunisation to
prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age
and older.
Two separate doses of SDSD of 0.5 ml each.
The second dose should be administered between 4 and 12 weeks
=> In studies 002 and 003, 4-12 w represents 86,1%
for intramuscular injection only, preferably in the deltoid muscle of the
upper arm.
67. 67
Safety
The most frequently reported adverse reactions were
injection site tenderness (63.7%),
injection site pain (54.2%),
headache (52.6%),
fatigue (53.1%),
myalgia (44.0%),
malaise (44.2%),
pyrexia
(includes feverishness (33.6%) and fever >38°C (7.9%))
chills (31.9%),
arthralgia (26.4%)
nausea (21.9%).
68. 68
Efficacy
In the pooled analysis for efficacy, participants ≥18
years of age received
two doses (5 × 1010 viral particles per dose
corresponding to not less than 2.5 × 108
infectious units)
Of COVID-19 Vaccine AstraZeneca (N=6,106)
or control (meningococcal vaccine or saline)
(N=6,090)
the interval between dose 1 and dose 2 ranged from 3
to 23 weeks with 86.1% of participants receiving
their two doses within the interval of 4 to 12 weeks.
69. 69
Efficacy
Interval: 4-12 weeks
≥15 days post second dose with at least one COVID-
19 symptom
Vaccine efficacy was 62.6% (95% CI: 50.9; 71.5) in participants receiving two recommended doses with
any dose interval (ranging from 3 to 23 weeks)
70. 70
Efficacy in participants who had one or
more comorbidities
Interval: 4-12 weeks
≥15 days post second dose with at least one COVID-
19 symptom
Participants who
had one or more
comorbidities
AZ Control Efficacy %
(95% CI)
N Number of
COVID-19
cases, n (%)
N Number of
COVID-19
cases
n (%)
4-12 weeks 2,068 25 (1.2%) 2,040 60 (2.9%) 58.3%
(33.6; 73.9)
71. 71
Efficacy in > 55 y/o
AZ Control Efficacy %
(95% CI)
N Number of
COVID-19
cases,
N Number of
COVID-19
cases
n
56-65 y/o 8 9 Not estimated
> 65 y/o 2 6 Not estimated
Interval: 4-12 weeks
≥15 days post second dose with at least one COVID-
19 symptom
72. 72
Efficacy on COVID-19 hospitalisation
In all participants who received at least one dose, as
from 22 days post dose 1
AZ Control Efficacy %
(95% CI)
N Number of
COVID-19
cases, n (%)
N Number of
COVID-19
cases
n (%)
At least 1 dose
From 22 days post
dose 1
8,032 0 (0.0%) 8,024 14 (0.2%) Not estimated
73. 73
Limitations of vaccine effectiveness
Protection starts from approximately 3 weeks after the first
dose persists up to 12 weeks.
Individuals may not be fully protected until 15 days after the
second dose.
As with all vaccines, vaccination with COVID-19 Vaccine
AstraZeneca may not protect all vaccine recipients
Currently available clinical trial data do not allow an
estimate of vaccine efficacy in subjects over 55 years of age.
77. Regeringscommissariaat Corona
Commissariat Corona du Gouvernement
Le vaccin AstraZeneca est prévu pour les groupes suivants, dans cet
ordre :
les professionnels des soins de santé de 18 à 55 ans (environ 200.000
personnes)
les résidents et le personnel (18-55 ans) des autres institutions de soins
collectifs, telles que les centres de revalidation, les institutions psychiatriques
et les institutions pour personnes avec un handicap (donc qui ne sont pas dans
des maisons de repos et de soins ou dans des ins tu ons où la majorité de la
population est âgée de plus de 55 ans)
les groupes à risque présentant des comorbidités (18-55 ans), par ordre d'âge
décroissant (entre 500.000 et 1.000.000 de personnes). Exception : les
personnes souffrant de troubles immunitaires ou traitées avec des
immunosuppresseurs
les 18-55 ans dans les fonctions critiques. Il s'agit des forces de police, donc les
unités d'intervention sur le terrain au sein de la police
80. 80
SARS-CoV-2 is an enveloped
β-coronavirus, with a genetic
sequence very similar to
SARS-CoV-1 (80%) and bat
coronavirus RaTG13 (96.2%).
The viral envelope is coated
by spike (S) glycoprotein,
envelope (E), and membrane
(M) proteins.
Host cell binding and entry are
mediated by the S protein.
The S1 sub-unit of the S
protein contains the receptor
binding domain (RBD) that
binds to the peptidase domain
of angiotensin-converting
enzyme 2 (ACE2).
BMJ October 23, 2020, doi: https://doi.org/10.1136/bmj.m3862
Lancet October 13, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)32137-1
81. 81
Variants of concern
B.1.1.7 lineage
UK
(a.k.a. 20I/501Y.V1 Variant
of Concern (VOC)
202012/01)
B.1.351 lineage
South Africa
(a.k.a. 20H/501Y.V2)
P.1 lineage
Brasil & Japan
(a.k.a. 20J/501Y.V3)
First time detected September 2020 in Kent in
UK
October 2020 in the Nelson
Mandela Bay
in Japan in four travelers
from Brazil January 2021
Mutations Total: 23
Proteine S: 9
Including:
N501Y
asparagine (N) to tyrosine
(Y) in the RBD
Total: 21
Prot S: 9
Including:
N501Y
E484K
Glutamic acid (E) to lysine (K)
K417N
in the RBD
Total: 17
Prot S: 10
Including:
N501Y
E484K
K417N/T
in the RBD
Transmission vs wild-type 36%–75% more + 50% more ? Possibly yes
Virulence no evidence of higher
severity
no evidence of higher severity ?
Detection PCR (S drop-out) Sequencing Sequencing
The presence of E484K and N501Y substitutions in the same SARS-CoV-2 genome may be particularly relevant for viral evolution. This combination
was shown to induce more conformational changes than the N501Y mutant alone, potentially altering antibodies’ complementarity to this region
resulting in the above mentioned immune escape phenomena.
https://doi.org/10.1101/2021.01.27.426895
82. 82
Variants of concern
B.1.1.7 lineage
UK
(a.k.a. 20I/501Y.V1 Variant
of Concern (VOC)
202012/01)
B.1.351 lineage
South Africa
(a.k.a. 20H/501Y.V2)
P.1 lineage
Brasil & Japan
(a.k.a. 20J/501Y.V3)
Vaccin efficacy
m-RNA Vaccines
Yes
Early reports found no
evidence to suggest that the
variant has any impact on
vaccine efficacy
Decreased
There is some evidence to
indicate that one of the
spike protein mutations,
E484K, may affect
neutralization by some
polyclonal and monoclonal
antibodies
Decraesed?
There is evidence to suggest
that some of the mutations
in the P.1 variant may affect
its transmissibility and
antigenic profile, which may
affect the ability of
antibodies generated
through a previous natural
infection (*) or through
vaccination to recognize
and neutralize the virus.
* Re-infection A recent study reported on a cluster of cases in Manaus, the largest city in the Amazon region, in which the P.1 variant was identified in
42% of the specimens sequenced from late December.[5] In this region, it is estimated that approximately 75% of the population had been infected
with SARS-CoV2 as of October 2020. However, since mid-December the region has observed a surge in cases. The emergence of this variant raises
concerns of a potential increase in transmissibility or propensity for SARS-CoV-2 re-infection of individuals.
https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html
84. 84
Data not yet available
South Africa has halted administration of the AstraZeneca vaccine
after preliminary results of a small trial with 2000 participants
indicated that the vaccine provides minimal protection against
mild-moderate COVID-19 infection from the B.1.351 variant.
Unfortunately, efficacy against severe COVID-19 disease could not
be assessed in the trial because the average age of the population
studied was only 31, at low risk of developing severe disease.
Researchers also noticed that sera from vaccinated individuals
displayed substantially reduced neutralization against the B.1.351
variant, as compared to the original SARS-CoV-2 strain.
The findings are not publicly available yet but should appear soon
in one of the pre-print platforms. AstraZeneca's could be the first
vaccine found to be ineffective against the South Africa variant,
which has already been found in at least 32 countries.
86. 86
Sarah Gilbert, lead researcher for the Oxford
team, told the BBC on Sunday that “we have
a version with the South African spike
sequence in the works.”
“It looks very likely that we can have a new
version ready to use in the autumn,” she
added.
89. 89
Comment réagir face aux variants
Accélérer autant que possible la campagne de vaccination
tant que le virus dominant est sensible aux vaccins
disponibles ;
Lancer dès maintenant la production de vaccins adaptés au
nouveaux variants (les firmes ont déjà commencé);
Soutenir le développement de traitements capables d’agir
sur tous les virus SARS-CoV, présent et à venir.
Soutenir la recherche sur de nouveaux vaccins à large
spectre en tirant parti de l’intelligence artificielle
Prof. Michel Goldman
91. 91
Manufacturers must be prepared to adjust to the SARS-CoV-2 viral
evolution, including potentially providing future booster shots and
adapted vaccines, if found to be scientifically necessary.
Trials must be designed and maintained to allow any changes in
efficacy to be assessed, and to be of sufficient scale and diversity
to enable clear interpretation of results.
Enhanced genomic surveillance must be backed by rapid sharing of
genetic and meta-data to allow for global coordination and
response.
https://www.gavi.org/news/media-room/covax-statement-new-variants-sars-cov-2
Comment réagir face aux variants
92. 92
Priority should be given to vaccinating high-risk groups
everywhere in order to ensure maximum global protection against
new strains and minimize the risk of transmission.
Governments and donors, as well as development banks, should
further support COVAX in order to ensure equitable access and
delivery, as well as meet ongoing research and development costs
for next-generation vaccines.
WHO is enhancing an existing mechanism for tracking and
evaluating variants that may affect vaccine composition and
expanding that mechanism to provide guidance to manufacturers
and countries on changes that may be needed for vaccines.
https://www.gavi.org/news/media-room/covax-statement-new-variants-sars-cov-2
Comment réagir face aux variants
93. 93
Pfizer/BioNTech
COMIRNATY®
Moderna AstraZeneca Janssen
(Johnson &
Johnson)
Curevac Novavax
Plateforme mRNA
BNT162b2
mRNA
mRNA-1273
Non-replicating
viral vector
chimpanzee
adenovirus vector
(ChAdOx1)
Non-replicating
viral vector
adenovirus
serotype 26
mRNA
CVnCoV
NVX-CoV2373
sous-unités
protéique
(nanoparticules
recombinantes)
adjuvant à base
de saponine
Doses 2 2 2 1 ou 2 2 2
Efficacité 95,0% 94,1% 59,5% 66% TBD 89.3% in UK
Phase 3
60% in South
Africa phase 2b
EMA Rolling
review
06/10/2020 16/11/2020 01/10/2020 01/12/2020 - 03/02/2021
EMA opinion 21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Commission
Européenne
(AMM)
21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Quantité de
vaccins
commandés
5 millions
+7,5 millions
(+2,5 millions)
2 millions
+3,8 millions
7,5 millions 5 millions 2,9 millions Under EC
discussion
Vaccins en Belgique
95. 95
topline efficacy and safety data from the
Phase 3 ENSEMBLE clinical trial
Overall efficacy
28 days after vaccination
ONE dose
66%
in preventing moderate to severe COVID-19,
72% in the United States
66% in Latin America
57% in South Africa (where Variant from the B.1.351
Lineage is prevalent)
Efficacy on severe disease
(death and hospitalization)
28 days after vaccination
ONE dose
85 %
Efficacy against severe disease increased over time with
no cases in vaccinated participants reported after day 49.
« The potential to significantly reduce the burden of
severe disease, by providing an effective and well-
tolerated vaccine with just one immunization, is a critical
component of the global public health response”
Efficacy starts? The onset of protection was observed as early as day 14.
96. 96
Pfizer/BioNTech
COMIRNATY®
Moderna AstraZeneca Janssen
(Johnson &
Johnson)
Curevac Novavax
Plateforme mRNA
BNT162b2
mRNA
mRNA-1273
Non-replicating
viral vector
chimpanzee
adenovirus vector
(ChAdOx1)
Non-replicating
viral vector
adenovirus
serotype 26
mRNA
CVnCoV
NVX-CoV2373
sous-unités
protéique
(nanoparticules
recombinantes)
adjuvant à base
de saponine
Doses 2 2 2 1 ou 2 2 2
Efficacité 95,0% 94,1% 59,5% 66% TBD 89.3% in UK
Phase 3
60% in South
Africa phase 2b
EMA Rolling
review
06/10/2020 16/11/2020 01/10/2020 01/12/2020 - 03/02/2021
EMA opinion 21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Commission
Européenne
(AMM)
21/12/2020 06/01/2021 29/01/2020 TBD TBD TBD
Quantité de
vaccins
commandés
5 millions
+7,5 millions
(+2,5 millions)
2 millions
+3,8 millions
7,5 millions 5 millions 2,9 millions Under EC
discussion
Vaccins en Belgique
98. 98
UK Phase 3 Results: 89.3% Efficacy on
variant
Preliminary analysis indicates that the UK variant strain that was
increasingly prevalent was detected in over 50% of the PCR-
confirmed symptomatic cases (32 UK variant, 24 non-variant, 6
unknown). Based on PCR performed on strains from 56 of the 62
cases, efficacy by strain was calculated to be:
– 95.6% against the original COVID-19 strain
– 85.6% against the UK variant strain [post hoc].
99. 99
South Africa Results: Approximately 90% of COVID-
19 cases attributed to South Africa escape variant
In HIV negative (represents 94% of the population)
– In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI:
19.9 – 80.1) for the prevention of mild, moderate and severe COVID-
19 disease
– Twenty-nine cases were observed in the placebo group and 15 in the
vaccine group. One severe case occurred in the placebo group and all
other cases were mild or moderate.
Overall: in HIV negative (94%) and HIV positive (6%)
– Efficacy of 49.4% (95% CI: 6.1 – 72.8).
100. 100
Spoutnik V
Russia
Sinopharm
BBIBP-CorV
Sinopharm
China
CoronaVac
Sinovac
China
Plateforme Non-replicating viral
vector
Adénovirus 26
Adénovirus 5
Inactivated virus Inactivated virus
Doses 2 (0-21) 2 (0-21) 2 (0-28)
Efficacité 91,6% 79.3% (unpublished) Unpublished
Data from Turkey and
Brasil are unclear
91% in small study in
Turkey
Around 50% in Brazil?
EMA Rolling review Scientific Advice
Possible
- -
EMA opinion - - Possible
Vaccins en discussion?
111. 111
Opérationnalisation de la vaccination
9 centres majeurs
31 centres de proximité
centres itinérants
Vaccination grand public (phases 1B/2)
- 9 centres majeurs ( x 10 lignes de vaccination, adaptées à la demande)
- 31 centres de proximité ( x 2 - 3 lignes de vaccination, adaptées à la demande)
- Plusieurs centres Itinérants (à définir avec les Gouverneurs)
117. 117
It’s not the beginning of the
end of the pandemic but, more
likely, “the end of the
beginning,” to borrow a phrase
from Winston Churchill.
https://www.statnews.com/2020/12/22/beware-the-danger-of-vaccine-euphoria/
118. 118
« Le recours à la vaccination volontaire
est absolument justifié si, dans le même
temps, une information adéquate permet
aux citoyens de saisir l’impact de leur
décision (se faire vacciner ou pas) pour
la collectivité »
Avis n° 75 du 11 décembre 2020 relatif aux repères éthiques en vue du déploiement de la vaccination anti-COVID-19 au bénéfice
de la population belge