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We hope you find these news items and stories interesting and informative. We look forward to hearing from you, whether you’d like to comment on a story we’ve posted or you know of a story that our readers would be interested in. News items and stories are selected in consultation with one of the GVDN’s two co-directors. Comments are moderated by the epidemiological team at the coordinating centre. We do not collect, use or share personal data, including information such as e-mail addresses or telephone numbers.

Ensuring safety of COVID-19 vaccines

Mario Christodoulou* recently spoke with vaccine safety expert, Dr Robert Chen, Science Director of The Brighton Collaboration — the largest global organisation of scientific experts on vaccine safety — about how vaccine safety is assessed in clinical trials and how regulators and vaccine developers are ensuring the safety of COVID-19 vaccines whilst also moving at great speed.

Dr Chen answers questions such as ‘How can we be sure safety isn’t being compromised?’ and ‘What should we be focused on once COVID-19 vaccines are introduced?’ Dr Chen is also working with CEPI, as part of the Safety Platform for Emergency vACcines (SPEAC) Project, to examine the safety profiles of the COVID-19 vaccines CEPI is funding.

*Mario Christodoulou is Communications and Advocacy Manager at the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership launched in 2017 to develop vaccines to stop future epidemics.

Supporting healthcare workers and other stakeholders with timely evidence-based responses to questions about vaccine safety

The Canadian Vaccination Evidence Resource and Exchange Centre (CANVax) has provided public health professionals with access to a centralized resource centre focused on vaccine acceptance and uptake. COVID-19 Vaccine Questions and Answers for Healthcare Providers consists of evidence-based answers to questions about vaccine safety, such as ‘What measures ensure safe vaccines?’, ‘What are the common side effects expected with the vaccines?’ and ‘Should pregnant women receive the vaccine?’ Each answer is written by an expert member of the CONSIDER (COvid-19 vacciNe Safety questIons anD hEalthcare pRoviders) working group and reviewed by two or more other members. This resource will soon be available in multiple languages.

Update on GVDN preparations for assessing vaccines, including COVID-19 vaccines

The Global Vaccine Data Network constitutes a network of sites ready to conduct globally coordinated active surveillance epidemiologic studies of the safety of vaccines, including COVID-19 vaccines, as they are introduced. For COVID-19 vaccines, this work will be undertaken under a common protocol and will include development of background rates of adverse events of special interest (AESI) in study sites prior to the COVID pandemic and also in the first six months of 2020. The common protocol will identify these AESI with predefined time periods and age strata, and will take account of the impact of the pandemic on healthcare utilization patterns. In addition, the protocol will use common definitions and procedures for comparative analyses across sites to assess the safety of COVID vaccines as they are introduced and will include evaluation of AESI as well as procedures for identifying unanticipated events.

Article: Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines

The article ‘Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines’ by Flanagan et al. appeared in the October 2020 edition of Frontiers in Immunology. The authors review current knowledge about the immune response to SARS-CoV-2 as it pertains to the design of effective and safe SARS-CoV-2 vaccines and the range of novel and established approaches to vaccine development being taken. They provide details of some of the frontrunner vaccines and discuss potential issues including adverse effects, scale-up and delivery.

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.

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