13 January 2021
Co-chairs: Emer Cooke (EMA, EU) and Prof. John Skerritt (DOH/TGA, Australia)
1. Welcome and objectives of workshop
The workshop was called to identify areas for proactive and practical collaboration post-deployment of the COVID-19 vaccines; in areas such as safety analyses, signal detection, and information sharing.
Participants were keenly aware that approval is just one aspect, with post-deployment safety monitoring and ensuring public trust being other equally important roles of regulatory authorities. Other stakeholders are also paying close attention, including healthcare professionals, media and general public.
2. Update on global emergency approval and authorisation status
Many regulators have provided some form of emergency approvals or conditional authorisations for COVID-19 vaccines, which require submission and assessment of additional data.
Two novel messenger RNA vaccines (from BioNTech/Pfizer and Moderna) have been approved in different jurisdictions around the world, based on large data sets supporting high efficacy. These are already being actively deployed in many countries, but deployment is limited by the need for cold chain system requirements and costs.
A viral vector vaccine from AstraZeneca/Oxford has temporary authorization in the UK; other vaccines are under active review by several regulators.
Authorities in China and Russia have approved vaccines developed and manufactured locally (Sinopharm/BIBP and Sinovac, and Gamaleya Research Institute respectively), which are under review by regulators in other regions.
WHO has approved the emergency use listing of the BioNTech/Pfizer mRNA vaccine and is currently assessing a number of other candidates.
A spreadsheet of approval status of the different vaccines will be shared as a common resource for ICMRA members.
3. Collaboration efforts of authorities with COVID-19 vaccine experience
Petra Dörr, WHO, introduced the WHO’s safety surveillance strategy for COVID-19 vaccines, which is based on reliance, work-sharing and collaboration with partners. Various tools and forums for information exchange and best-practices are now in place at global and regional levels. Collaboration, reliance and information sharing are key to optimise efforts of regulators in high and lower-resource settings.
John Skerritt, DOH/TGA, Australia, spoke how the existing ICMRA COVID-19 Vaccine Pharmacovigilance Network had allowed members to understand better how different pharmacovigilance approaches, systems and tools. The group is now exploring areas for collaboration, for example sharing the evaluation of emerging safety signals, agreeing an approach on sharing sensitive communications, tools for establishing causality for adverse events of special interest, etc. The group agreed to perform a ‘tabletop’ simulation exercise to prepare for the next months.
Pierre Sabourin and Kelly Robinson, Health Canada, Canada, presented the national experience with COVID-19 vaccines. New proactive regular communication efforts (such as a ‘one-stop-shop’ web portal with information for patients, healthcare professionals, academics) have been used to promote public confidence. International collaboration to promote transparency is seen as a core pillar of ensuring confidence in the vaccines and should be developed. There was also support for active engagement with international partners to support scientific review and for collaboration on pharmacovigilance.
Philip Bryan, MHRA, UK, spoke about moving ICMRA collaboration onto the next level, especially since the vaccines are being deployed and there is a need for rapid exchange of information. Areas for collaboration include more visibility of general safety experience, observed v. expected analysis, rapid notification & intelligence sharing, support for incident management, etc. A confidential platform or mechanism for exchanging information would facilitate this sort of collaboration.
Peter Marks, FDA/CBER, USA, outlined the importance of national efforts to draw together data from healthcare system sources to support active safety and efficacy surveillance. He stressed the importance of real-time data exchange for collaborative efforts, and of the contribution that all partners can make either from passive or active surveillance systems. Areas for collaboration included working together to identify ‘false’ safety signals (including distinguishing between natural background events and events occurring at the same time) at a time of large-scale vaccination roll-out.
Georgy Genov, EMA, EU, recognised the importance of information sharing and proposed two collaboration initiatives. The first is the routine sharing between ICMRA members of vaccine-specific updates on emerging safety concerns, including planned investigations and completed risk assessments. The second is ad hoc conference calls with ICMRA partners on new safety signals ahead of their assessment by the Agency’s Pharmacovigilance Risk Assessment Committee. He also supported the proposal for a desktop simulation exercise, based on one or more ongoing examples.
4. Discussion on further opportunities to reinforce vaccine safety collaboration
- Information sharing
Timely information sharing is at the heart of what the ICMRA coalition can facilitate as part of the COVID-19 response. It was important to remember that the objective is ultimately to reinforce vaccine confidence and how vaccines contribute to saving lives, not just to support science-based decisions and foster regulatory alignment.
Information sharing may be limited by local data protection regimes, but there are opportunities offered by confidentiality arrangements between different ICMRA members.
Information sharing is seen as the first step of collaboration only.
- Tabletop simulation exercise
There was wide support for a tabletop simulation exercise to identify specific concrete areas for cooperation.
This could look on a known suspected adverse event of special interest as a test case, for example Bell’s palsy, or the alert raised when Norway reported deaths in frail elderly vaccinees. Other comments related to the importance of collaboration to understand better background incident rates, as well as differential benefit-risk for different populations and the importance of consistent responses at global level.
- Communications platform
There was support to put in place a secure platform or other mechanisms for ICMRA members, which would facilitate exchanging confidential information.
5. Closing remarks and next steps
- The main conclusion was that presenting the national systems and sharing information was not sufficient and that joint work was needed to learn from each other, take appropriate mitigating measures where needed and communicate in a consistent way across regions to develop public trust in vaccines.
- The Vaccine Pharmacovigilance Network will be tasked to develop and deliver the desktop simulation exercise, with the support of TGA, MHRA and EMA. The exercise should be simple, practical and allow identification of concrete opportunities for collaboration. The focus should be on collaborative actions for adverse events of special interest.
As part of this, the Vaccine Pharmacovigilance Network mandate should be refocused from best practice and experience-sharing to actionable deliverables.
- Promote collaboration on exchange of information between members, leading to evaluation of signals and public communication. A differential approach could operate, with rapid exchange between members able to exchange information under confidentiality arrangements, and urgent ad hoc meetings with wider membership on new safety issues before or as they are in the process of going into the public domain or public advisory committees.
This should include exchange of excluded or discounted signals, regular public safety updates, etc. aimed at supporting regulators in public vaccine confidence communications.
- Collaborate on identification of adverse events of special interest (AESI) and sharing of information on background or baseline incident rates, including tools for establishing causality of AESIs.
This should include looking at AESIs in different populations and ethnic groups, and information and safety data for populations excluded from clinical trials such as paediatric, pregnancy and lactating mothers, and geriatric populations.