Executive summary

On 31st August 2020, COVAX, supported by the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Alliance for Vaccines and Immunizations (GAVI), and the World Health Organization (WHO), hosted a COVID-19 Vaccine Safety Developers Workshop. The main aim was to identify the key vaccine safety issues developers need assistance with.

Co-chairs Dr Ajoke Sobanjo-ter Meulen (Gates Foundation) and Dr Bob Chen (Brighton Collaboration) opened the workshop and welcomed participants.
Dr Jakob Cramer (CEPI) presented an overview of COVAX, the vaccine pillar of the Access to COVID-19 tools (ACT) accelerator. The ACT accelerator was formed in April 2020 as a global collaboration to accelerate development, production, and equitable access to new COVID-19 diagnostics, therapeutics, and vaccines.

Dr Emer Cooke (WHO) gave an overview of WHO’s ongoing COVID-19 vaccine safety initiatives. The WHO has been working closely with regulators across the globe since the start of the pandemic, within all three pillars (diagnostics, treatments, and vaccines) of the ACT accelerator, to support regulatory issues, facilitate harmonisation and preparedness, and collaborate to provide a platform for rapid exchange of information. The WHO aims to promote regulatory alignment to facilitate access to quality, safe, and effective products as quickly as possible. On-going WHO COVID-related regulatory activities range from issuing Emergency Use Listing (EUL) to developing guidance for COVID-19 vaccine safety work at global, regional, and national levels.

Dr Kathy Edwards presented an overview of key past studies with notable adverse events following immunisation (AEFI), including the multicentre acellular pertussis vaccine studies, rotavirus vaccine studies, inactivated measles vaccine, dengue vaccines, and post-licensure studies of H1N1 pandemic vaccine. Lessons learned from AEFI surveillance were discussed and how this might relate to COVID-19 vaccine safety.

Results of the Developer Needs Survey were reviewed and a guided discussion about specific needs and other concerns ensued. Developers discussed each milestone in detail, including risk management plan (RMP), post-licensure safety surveillance, Phase II/III, licensure application, WHO prequalification, first-in-human, and communication plan. Specific concerns or needs related to each milestone were identified.

Dr Bob Chen discussed some basics of vaccine safety assessment including how to clarify the causal link between an adverse event and vaccine. He then identified potential cross-cutting COVID-19 vaccine safety assessment issues including comparison of safety data, willingness to contribute data to allow evaluation of safety data on similar new technology platforms across different candidates, tracking of vaccine exposure information, plans for obtaining and using background rates of AEFI and adverse event of special interest (AESI) for post introduction studies, and process for formally declaring a “safety signal” and how this information will be shared/action plan if this should occur.

Dr Steve Black (Brighton Collaboration) summarised the key takeaways from the workshop and Dr Sobanjo-ter Meulen outlined the next steps, including continuing to map relevant resources to enable assessment of post-licensure safety and COVAX alignment with WHO regarding vaccine safety efforts. The meeting was then adjourned and attendees thanked for their participation.

Full Report : Workshop Report | COVAX Vaccine Safety Working Group: Developer Needs Workshop