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Scientific webinar on Assessment of Vaccine Mediated Enhanced Disease in Epidemiologic Studies Monitoring COVID-19 Vaccines

On September 10th, 2020, the Vaccine monitoring Collaboration for Europe (VAC4EU) and the Brighton Collaboration’s Safety Platform for Emergency vACcines (SPEAC) project jointly held a Scientific webinar on how to assess Vaccine Associated Enhanced Disease (VAED) in epidemiologic studies monitoring COVID-19 vaccines. Speakers provided an update on the Brighton Collaboration’s case definition of VAED and on algorithms for establishing background rates, and participants discussed some of the challenges they face.

Commentary: The rationale for globally coordinated monitoring of the safety of vaccines after roll out

The continued success of the global vaccination effort relies upon both the use of safe vaccines and public confidence in their benefit and safety. We need to assess and quantify potential vaccine risks using scientifically rigorous methods in a timely manner for benefit-risk decisions. Uncommon Adverse Events Following Immunization (AEFI) are rare and include outcomes that are delayed and outcomes that occur beyond clinical trial study follow‐up. AEFI, including those among subpopulations excluded from initial clinical programs (e.g., pregnancies, immune-compromised), can only be evaluated in post introduction pharmacovigilance (PIPV) studies. Historically, PIPV has relied on spontaneous reports or passive surveillance for AEFIs. Such passive systems suffer from many weaknesses such as biased/under-reporting, lack of denominators and comparison groups. They can generate hypotheses of new safety concerns but cannot test them to see if they are likely to be caused by vaccines or not.

Commentary: Progress Toward a Global Vaccine Data Network

‘Progress Toward a Global Vaccine Data Network’ is a special article in the Pediatric Infectious Disease Journal. It provides an update on preparations for a global network to monitor the safety and effectiveness of vaccines, including COVID-19 vaccines, across geographically and demographically diverse sites. It covers the need for such a network, how it is coordinated, criteria for participation and plans for capacity development. The need for a common data model and flexible models for analysis are also described.

Assessing the safety of COVID-19 vaccines

The Global Vaccine Data Network (GVDN) is gearing up to be able to collaboratively assess the safety of COVID-19 vaccines once they have been introduced. Part of this work involves collecting information about background rates of potential Adverse Events of Special Interest (AESI) i.e. medical conditions that may be related to vaccinations. Fears about AESIs often don’t take account of background rates.

Survey of partners

We recently completed a survey of GVDN partners to get a better understanding of their experience in vaccine studies and the different kinds of data they have access to. This information will help determine the kinds of studies that GVDN partners can do. We also captured information about their countries’ vaccination schedule and the availability of vaccination history information for children and adults. Outputs from the survey will form part of a journal article co-authored by partners.

Partner Caitlin Dodd, invited two of her colleagues at research centres in Ethiopia and Ghana to test our survey of partners. We would like to thank Malede Mequanent Sisay and Nana Akosua Ansah for their goodwill and for the rich information they provide about their sites’ capacity to conduct vaccine safety studies. Their health and demographic surveillance systems use a variety of data sources to monitor births, deaths, causes of death, migration, and other health and socio-economic indicators, and they collect national immunization coverage information for vaccine-preventable diseases. These two research centres are potential data sources for the GVDN.