[Alexander Bernier]

Collaborative meeting notes (main session): https://docs.google.com/document/d/1NZmtKAPOScNjID5ZrmYLaZ-D3Fle2NbOhH41qYsdkiM/edit?usp=sharing
Collaborative meeting notes (repeat session): https://docs.google.com/document/d/1gAWnGoTqZqd-W1MVhxV7FiyVxuu7rzUchZHdLNtP_QY/edit?usp=sharing
 
Meeting agenda *
Part 1: Presentations (45-50­­­ min)
An examination of current frameworks for COVID-19 vaccine data sharing relevant COVID-19 vaccine public health decision-making
Speakers to be confirmed; 1 from a manufacturer of a COVID-19 vaccine; 1 from a regulatory authority; 1 from an ethics committee, 1 from government public health advisor on vaccines; 1 from a patient (vaccinee). Maximum 5 speakers (speakers to be confirmed)
Part 2: Interactive discussion: 40-45 min (Moderators: Two moderators and panellists to be confirmed)

The impact of COVD-19 vaccine data sharing on posology decision-making
The impact of COVID-19 vaccine data sharing on pharmacovigilance
Steps to improved COVID-19 vaccine data sharing to improve public health outcomes

Conclusion
Actions points for contributing to a potentially new chapter on Vaccinations to the existing RDA COVID-19 Recommendations and Guidelines.

Are you willing to hold your session at multiple times to accommodate various time zones?
Yes

Brief introduction describing the activities and scope of the group

 

Brief introduction describing the activities and scope of the group *
 The RDA-COVID-19 legal-ethical working group is an interdisciplinary group set up first as a sub-group of the 2020 RDA COVID-19 working group. As described above it addresses in terms of reference documents, guidelines and recommendations the legal and ethical aspects in sharing data related to COVID-19, with the objective of preparing paths in case of future pandemics. Beyond contributing to the document produced by the whole WG COVID-19 with all its sub-groups, it sustains a follow-up work in order to update the issues to address and draw conclusions from confronting to the reality of the evolving pandemic and the documents endorsed in June 2020.  (See above  description of the work done and current work, in objectives) The working group will include a subsection on potentially the A new chapter on Vaccinations to eventually be included in the existing RDA COVID-19 Recommendations and Guidelines. (A proposal is in development.)
 

Group chair serving as contact person
Alexander Bernier

Meeting objectives
Meeting Objectives
The principal objective of this session is to examine the role and impact of data sharing on COVID-19 vaccine data sharing on public health decision-making. The rollout of the first COVID-19 vaccines through Emergency Medical Authorization and similar procedures, including the first introduction of mRNA vaccines, has highlighted the need for the sharing of reliable pre-clinical, clinical, and pharmacovigilance data for public health decision making. The first generation COVID-19 vaccines are being complemented by the additional development of new vaccines. Governments, with the support of vaccine experts and public health officials, face difficult decisions regarding vaccine allocation, posology, and pharmacovigilance.
The specific objectives include the following:

An examination of COVID-19 data sharing practices by vaccine manufacturers;
An examination of COVID-19 vaccine data sharing practices by government regulatory authories;
WHO and other international guidances on COVID-19 vaccine data sharing;
A review of COVID-19 vaccine data sharing practices and their potential impact on posology decision-making by public health authorities; and
Steps to improve COVID-19 vaccine data sharing practices between HICs and LMICs to better improve COVID-19 vaccine knowledge and vaccine implementation by public health experts

Other
To be confirmed – no strong preferences if scheduling asynchronous / live should be more convenient for the RDA

Please indicate the breakout slot (s) that would suit your meeting
Breakout 1, Breakout 2, Breakout 3, Breakout 4, Breakout 5, Breakout 6, Breakout 7, Breakout 8, Breakout 9, Breakout 10, Breakout 11

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Discussion