AU-3S COVID-19 Response Information pack: April 2021 - AUDA ...
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AU-3S COVID-19 Response Information pack: April 2021
Executive summary | AU-3S Programme –
COVID-19 Response and beyond
Objectives Solutions Impact
• In 4 countries (Ethiopia, Ghana, Nigeria, In-country:
AU-3S COVID-19 Response
South Africa): • Capacity strengthening trainings with the
MHRA across safety monitoring activities
• Address the pressing short-term
• AEFI form for Med Safety App to enable • African ownership of safety data and the
safety surveillance gaps highlighted
electronic vaccine data collection process to detect and act on signals found
by COVID-19 vaccine roll-out
• Roll-out support for Med Safety App to EPI
~2 years
• Pilot the effectiveness of solutions • Increased confidence of regulators in
that will form the foundation of the Cross-country: products regulated for use under
longer-term AU-3S programme • Interim Data Integration and Signal Detection emergency use procedures
• Extend the COVID-19 solutions to (DISD) system, to store and analyse cross- • Increased speed of emergency response to
additional African countries to strengthen country AEFI data new product development
safety surveillance • Joint Signal Management Group, to review
• Capacity strengthening for future
cross-country COVID-19 vaccine signals
pandemics and ongoing health systems
improvement
• Improved safety for patients in the African
• Create a sustainable system to enable • Establish AfriVigilance, a centralised African
AU-3S program
Union
African countries to act on safety data safety database that enables the integration
• Increased confidence of the public in
Expanded
~2-5 years
more effectively & analysis of safety data for priority
medicine and vaccine safety
products, and enables evidence-based and
informed regulatory action as needed
1
Smart Safety Surveillance (3S) started pre-
COVID and is now more relevant than ever
Situation Implications & risks Solution
• New vaccines, drugs, and • Patient risk • 3S target: Sustainable
diagnostics specifically Pharmacovigilance systems
developed only for endemic • Product risk
LMIC countries • Limits therapeutic • Public health decisions and
efficacy actions based on robust & real-
• Therefore, endemic countries time evidence
unable to rely on safety • Licensure withdrawal
surveillance from HIC countries • Ethical risk
• Increasing pharma concerns • Systemic risk to global health
• Delayed access
COVID-19: Risks are
amplified during global
pandemics, which impede
accelerated access
2
Pre-COVID-19, 3S pilots covered 3
products in 6 countries (2016-2020)
3S Goals
Strengthening
country/regional PV systems
– to a functional level
Strengthening the safety
profile of products – specific
to country context (in parallel to
systems strengthening)
Accelerate safe access to
patients – enable safe lifecycle
Bedaqueline (Peru, Brazil, Ethiopia, Armenia) of products in country
Rotavac (India)
Tafenoquine (Brazil, Ethiopia, Thailand)
3AUDA-NEPAD’s mandate for safety in Africa
and mission of the AU-3S programme
Mission of AU Smart Safety
Mandate
Surveillance (AU-3S
Text
The AU has made several calls in normal times
and in emergencies for measures to ensure safety of
medical products in Africa (e.g., Ebola Virus Disease
(EVD), COVID-19):
• The African Union (AU) has called upon AUDA- Patients
NEPAD to work with partners to ensure support for
the accelerated development of medical products Public Health
so that African populations can have safe access to
them in a timely manner1 AU-3S's mission is to safeguard the right of every person
• Deliver a Science, Technology and Innovation (STI) in Africa to have safe priority medical products through
Policy response to COVID-19 and other future robust, real-time evidence for better informed public
emergencies2 health decisions
1. Decision on the Report of Heads of State and Government Orientation Committee (HSGOC) on NEPAD Doc. Assembly/AU/10(XXIV) 30 -31 January 2015
Addis Ababa, Ethiopia; 2. Specialised Technical Committee on Education, Science and Technology (STC-EST 3) 30th April 2020 4The AU-3S1 programme aims to
strengthen safety surveillance in Africa
Pharmacovigilance is still at an early stage in AU-3S is a 10-year programme to
most African countries strengthen PV capability in Africa
Limited safety data packages before product AU-3S has been launched by AUDA-NEPAD to:
launch (data only from pre-approval trials, targeted •1 Improve medicines and vaccine safety for patients
only to LMICs, release in emergency situations) in Africa and globally
Low adverse event reporting across countries •2 Enable African ownership and the ability to act on
despite recent improvements their own data (e.g. AfriVigilance database - data
integration, analysis, and decision making)
Siloed pharmacovigilance systems with data often •3 Strengthen PV expertise among country and
not fully shared between the EPI and NRA, fully continental stakeholders
analysed, or acted upon •4 Increase confidence in accelerated product
development and in an emergency response
Limited safety expertise to support signal detection
To do so, regulators and AUDA-NEPAD are collaborating
& risk-assessment; focus on signal management
with continental and global partners
of SAEs rather than signal detection
1. AU-Smart Safety Surveillance 5COVID-19 reinforced the need for strong
African Pharmacovigilance
COVID-19 vaccine roll-out In most African countries, PV systems are not yet ready for
will require efficient PV the roll-out of COVID-19 vaccines
• COVID-19 vaccines have been VIRAT1 results - Safety surveillance score per country (%), as per 26 Jan 2021
developed in record time
69 71
• Countries will have to deal with 40% 61 63 63 63
average 56 57 59 59 59
multiple vaccines from different readiness 50
47
developers and various 41 42 42 43 43 43 44
45
38 38 38 39
manufacturing sites 33
29 29 31
25 25 25 25 25
• The African continent has 16 18 19 19 20 20
hosted a limited number of 8
clinical studies
Cameroon
DRC
Guinea
Kenya
Lesotho
South Sudan
Ethiopia
Cote d’lvoire
South Africa
Namibia
Rwanda
Benin
Gabon
Madagascar
Burkina Faso
Togo
Eritrea
Nigeria
Niger
Ghana
Senegal
Liberia
Chad
Eswatini
Mozambique
Algeria
Eq. Guinea
Congo Brazza.
Sierra Leone
Gambia
Angola
Malawi
Cabo Verde
Sao Tome
Mauritius
Central Africa
Botwana
Guinea Bissau
Burundi
Comoros
Seychelles
• Safety surveillance will also be
critical to support and advocate
the immunisation campaign
1. Vaccine Introduction and Readiness assessment; caveat: score reflects what has been reported by countries
Source: WHO AFRO VIRAT 6AU-3S is currently supporting 4 countries'
safety surveillance for COVID-19 vaccines
AU-3S COVID-19 response: Current focus Long-term objectives of AU-3S
Ethiopia
Countries Original entry point for
COVAX
Nigeria
Ghana
Chair of AVAREF & ML3
Ghana Ethiopia
Nigeria
Original entry point for
COVAX
South Africa
South Catalyst for
Largest clinical trial base
Africa in Africa accelerated
progress
AU-3S pilot countries comprise ~30% of Africa's population Continental safety surveillance system
New & innovative products from the 5 African Union
Products COVID-19 vaccines
priority disease areas1
1. Malaria, Tuberculosis, HIV/AIDS, plus emergency diseases: Ebola, COVID-19 7AUDA-NEPAD is one of the key stakeholders
working on COVID-19 safety surveillance
NRAs & PV
centres
Authorise COVID-19 vaccines for Develop a cross-country data WHO AFRO: established African Manage VigiFlow which countries
use integration & signal detection Advisory Committee on Vaccine use to enter AEFIs into VigiBase
system Safety (AACVS)
Key stakeholder in national roll-out Launch the Joint Signal WHO AFRO: launched workshops on Updated VigiFlow to collect
of COVID-19 vaccines Management Group for aggregate WHO HQ COVID-19 vaccine safety additional information for COVID-19
signal reports guidelines AEFIs
Support the EPI to collect data on Facilitate capacity strengthening WHO HQ: Partnership with DHIS2 for Screen data in VigiBase &
AEFIs trainings with the MHRA AEFI package (+ COVID-19 uses) communicate signals via VigiLyze
Analyse data collected & make Expand electronic vaccine data Free training available online on
safety recommendations collection (through Med Safety App) technical PV topics
8AUDA-NEPAD works with a range of
partners and stakeholders in AU-3S
Other stakeholders
Working Group
ACREDT1
Steering Group
Pilot countries
Technical partner
1. ACREDT = African COVID-19 Vaccine Readiness and Deployment Taskforce 9Engagement with the 4 pilot countries is
regular and varied
Stakeholders Engagement Ways of working
• NRA representatives in Working
• Weekly working group meeting • Collaborative – across
Group
with all countries countries and organisations
• NRA CEOs in Steering Group
• Weekly in-country planning • Consensus-driven
• NRA & EPI representatives for session with each country
• Supportive, not directive
country-specific working sessions
• Ad hoc engagement across
• Going far and fast together
• Engagement with experts in PV, topics as requested by countries
Track & Trace, IT and
Communications
10Preliminary dates
Phases of work in AU-3S COVID-19
response
Engage with NRAs & EPIs Design solutions to Support in-country teams Continuing support to 4
to identify challenges to address identified gaps, to rapidly roll-out the countries to entrench and
readiness for COVID-19 and develop a roll-out solutions in the 4 countries optimise the AU-3S
vaccine safety surveillance strategy for them solutions
Oct – Dec '20 Nov '20 – Feb '21 Feb – May '21 May '21 – Apr '22 Beyond Apr '22
Assess safety Roll-out Support solutions Continue AU-3S
Scope solutions
landscape solutions Scale solutions programme
Scale the COVID-19 Revert to initial objectives
solutions to other African and activities of longer-
countries term AU-3S programme
11Assess safety landscape | First, the AU-3S
team conducted a landscape assessment
Landscape assessment was …to identify critical safety surveillance gaps in each of
conducted by AU-3S team… the 4 pilot countries
Reviewed 31 safety monitoring-
related policies, laws, guidelines
and forms
Capabilities Tools and policies Collaboration
• Capability & • Need to move from • Limited coordination
capacity gaps paper reporting to e- between NRA
Held 15 meetings with NRAs and
across all countries reporting to help & EPI
other key stakeholders in safety monitoring drive data quality
• Limited ability to
that need to be filled and reporting rates
share information
• Safety monitoring between countries
Synthesised findings to determine gaps in policies &
areas for project support guidelines
12Non-exhaustive
Assess safety landscape | Summary of
risks and gaps identified
Capabilities Tools & policies Collaboration
Extensive data collection training required for HCPs Currently low rate of AEFI reporting
Under-resourcing of EPI & NRA at district & region Electronic systems underutilised for reporting
Manual entry of AEFI data into national databases
Track & Trace won't be fully implemented
Long timelines for data sharing from EPI to NRA
Delay in doing causality assessment on signals
Delay in responding to signals from AEFI data
Significantly higher number of AEFIs will be reported than expected
Incomplete / unreadable AEFI reports are used for signal detection & causality assessment
Challenge to communicate safety information to the public
Follow-ups are not always done on AEFIs when required
Limited experience with active surveillance
Key risk/gap
13Scope solutions | Second, the AU-3S team
developed solutions to strengthen PV
Data storage Signal Signal response & Safety
Data collection
& analysis management decision making communication
1 2
Cross-country
Develop a cross-
country data Launch the Joint Signal Management Group for
integration & signal aggregate signal reports
detection system
3
Facilitate capability strengthening trainings with the MHRA
In-country
4
Expand electronic
vaccine data collection
(through Med Safety
App)
14Back-up
1 Scope solutions | Build a cross-country
DISD system
Objectives
Mitigate capacity constraints Provide a case study to pilot
Strengthen countries' ability to
during COVID-19 by automating approach to longer-term
quickly detect potential signals &
some tasks required for signal AfriVigilance system & gain key
identify cross-country signals
detection learnings
Description Looking ahead
• Interim DISD system is being developed in partnership with the MHRA to complement – not replace • Data for other
– the data analysis done by UMC through the suite of Vigi-tools vaccines could be
routed through the
• Data will at all times remain African-owned DISD system
• The system enables: • Ultimate aim for AU-
• Analysis of AEFIs at national & continental levels to detect signals and trends from the data 3S is to create an
• Automated activities including data coding / mapping, duplicate verification, and signal Africa-wide safety
detection, which will mitigate capacity constraints in-country vigilance system –
AfriVigilance – for
• Weekly signal reports will be outputted by the interim DISD system
continental data
• Specific data runs based on different "pools" of data can be set, e.g. single country, cross-
storage & analysis
country, cross-country + UK, to facilitate signal detection
• Sensitivity settings can be changed depending on the volume of data
DISD = Data integration and signal detection 15Back-up
2 Scope solutions | Launch the JSM
Group for aggregate signal reports
Objectives
Identify cross-country signals & Provide a forum for knowledge & Support national committees if
strengthen countries' ability to experience sharing between asked in providing a wider forum
respond effectively & timeously African NRAs, peer NRAs, and for discussion of in-country
to COVID-19 vaccine signals other expert groups signals
Description Looking ahead
• The JSM Group will validate & review aggregate signal reports (i.e. reports from combined data) of • JSM Group's scope
COVID-19 vaccine AEFIs from the interim DISD system can be extended to
other vaccines
• The JSM Group comprises a secretariat, members and ad hoc members, as follows:
• Secretariat, doing signal validation: AUDA-NEPAD (through AU-3S), with technical support • Ultimate aim is to
from MHRA and representatives from pilot countries for capability strengthening make the JSM Group
• JSM Group members, doing signal review: Country representatives (from NRA & EPI); an African-wide forum
national committee chairpersons where possible to strengthen signal
• Ad hoc members, supporting on signal review: Additional experts as required, depending on management on the
the AEFI under discussion continent
• National committees will keep their full scope of responsibilities & activities, with decisions regarding
the JSM Group's recommendations to be taken by countries' NRAs
DISD = Data integration and signal detection; JSM = Joint Signal Management 16Back-up
3 Scope solutions | Facilitate capability
strengthening trainings with the MHRA
Objectives
Show examples of "good
Strengthen countries' safety Provide countries with training
practice" from MHRA & provide a
monitoring capabilities across all material to enable roll-out to a
platform for Q&A on safety
levels & activities wider audience
monitoring activities, tools, etc.
Description Looking ahead
• Training on end-to-end safety monitoring activities across 5 e-learning modules: • Virtual trainings can
• Data collection be distributed to a
• Signal detection & management wider range of
• Benefit risk assessment countries outside the
• Safety communication AU-3S programme
• Pharmacovigilance Expert Advisory Committee
• Trainings are not
• Training on use of Vigilance Hub exclusive to COVID-
19 or vaccines, and
• Delivered by MHRA in "live" virtual training sessions from Jan to Apr 2021, for core participants from can be used in future
countries' NRAs & EPIs in-country training
programmes
• Rolled-out in-country to a wider & larger audience through distribution of online webinar & support
from AU-3S in developing a "train-the-trainer" strategy
17Back-up
4 Scope solutions | Expand electronic Vx
data collection (through Med Safety App)
Objectives
Support countries to effectively & Ensure that all data required for Create high awareness of the
timeously collect AEFI reports causality assessment can be Med Safety App, to ensure it is
from COVID-19 vaccines collected in initial report well-utilised for reporting
Description Looking ahead
• Development of basic AEFI form, rolled out in February 2021: • AEFI form can be
• Applicable to all vaccines, i.e. not COVID-19-specific shared with any
• Available to HCPs & the general public country who has the
• Aligned to the WHO's 25 core variables Med Safety app
• User acceptance testing done by country representatives to ensure the form is fit for purpose
• Learnings from
• Development of adapted AEFI form, to be rolled out April 2021: countries' roll-outs can
• Inclusion of additional country requirements such as district, diluent information, and public / be applied when
private reporter scaling up the solutions
• AU-3S team provides general guidance on roll-out strategy and implementation planning, including across Africa
good practice sharing from the MHRA and amongst the 4 countries
• AU-3S is also supporting in-country development of a revised operating model for data collection
(with Med Safety App & paper forms) and a communications plan to drive awareness of the App
HCPs = Health Care Professionals; Vx = vaccine 18Scope solutions | AU-3S solutions are
being piloted for COVID-19 vaccines
In-country Cross-country Continental / Global
Med Safety App • Paper-based report also to be entered into the Vigilance Hub
• Integration of data from other reporting sources under
investigation
PV tools
Vigilance Hub DISD system VigiBase
Piloted with
COVID-19 Vx
signals only
VigiFlow
PV stakeholders
AACVS GACVS
National committees AU-3S JSM Group
Other African countries Other relevant
& bodies stakeholders
• AU-3S JSM Group will not replace country signal detection & management
• AU-3S JSM Group will highlight additional signals found in the combined
cross-country data
AU-3S COVID-19 response solution AEFI reports Signal reports Safety findings & recommendations
AACVS = African Advisory Committee on Vaccine Safety; DISD = Data integration & signal detection; GACVS = Global Advisory Committee on Vaccine 19
Safety; JSM = Joint Signal Management; Vx = VaccineScope solutions | Additional AU-3S
activities to support 4 pilot countries
Review in-country Develop Provide funding for Support experience Identify relevant
PV regulations & recommendations in-country safety sharing between stakeholders,
policies compared to implement strengthening countries, notably on resources & tools
to WHO's COVID-19 guidance from activities Track & Trace, to to support countries
safety surveillance WHO COVID-19 strengthen in non-safety areas,
policy safety manual capabilities notably advocacy
20Subject to change
Roll-out solutions | Solutions are being rolled-
out for COVID-19 and beyond
Data storage Signal Signal response & Safety
Data collection
& analysis management decision making communication
Apr-May 21 Apr-May 21
Cross-country
Develop
a cross-country data Launch the Joint Signal Management Group for
integration & signal aggregate signal reports
detection system
Jan-May 21
Facilitate capability strengthening trainings with the MHRA
In-country
Expand electronic Completed Creation of a vaccines AEFI reporting form for the Med Safety App
vaccine data collection
(through Med Safety Support NRA & EPI in roll-out of Med Safety App for COVID-19 vaccine (including
App) Ongoing communications, training & operating model changes)
Roll-out timeline 21Roll-out solutions | Roll-out has started
and should be completed by Apr / May
Cross-country
Business requirements defined Dataflows from countries to the DISD system built Agreements drafted & signed
Operating model defined First data mining run performed SOPs drafted & signed
Operating model defined Roles & structure confirmed Members confirmed Kick-off held Strategic review meeting held
Terms of reference approved
SOPs & guidelines drafted
Jan Feb Mar Apr May
Module 1 Module 2 Module 3 & Vigilance Hub Modules 4 & 5
Support roll-out of data collection training
Launch of basic AEFI form Launch of expanded AEFI form
Support development of communications plan for AEFI reporting Support development of long-term, ongoing communications plan
In-country Define OM changes required Support on OM process changes
Develop a cross- Launch the Facilitate capability strengthening Expand electronic vaccine data
country DISD system JSM Group trainings with the MHRA collection (through Med Safety App)
22
DISD = Data integration & signal detection; JSM = Joint Signal Management; OM = Operating modelScale solutions | Looking ahead –
what's next?
Once rolled-out in the 4 pilot countries, AU-3S objectives are to:
In the short-term, continue In the medium-term, scale-up the In the longer-term, expand the AU-
support to 4 pilot countries to AU-3S solution for COVID-19 3S solution for other priority
entrench and optimise the AU-3S vaccines to other African products
solutions countries
23THANK YOU
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