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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 and comments are moderated by the epidemiological team at the coordinating centre. We guarantee the independence of editorial content from funding sources. We do not collect, use or share personal data, including information such as e-mail addresses or telephone numbers.

Vaccine safety experience updates from the US CDCs Vaccine Safety Technical Subgroup (VaST)

The Vaccine Safety Technical Subgroup of the US CDC’s Advisory Committee on Immunization Practices (ACIP) met on March 1, 2021 to share vaccine safety experience updates and to discuss three sources of vaccine safety monitoring information: Digital apps, Passive surveillance, and the Vaccine Safety Datalink. A video of the one hour long meeting has been posted on YouTube. The updates will be published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) but there’s a great summary of the three sources of vaccine safety monitoring information on the Skeptical Raptor blog, which regularly comments on the science of vaccines.

New Zealand takes first steps to monitor the safety of COVID-19 vaccines

Work is under way at the Department of General Practice and Primary Health Care within the University of Auckland to gather baseline data on medical events that have potential to be associated with COVID-19 vaccines. Defining these potential Adverse Events of Special Interest (AESI) and calculating the rate at which they have occurred in New Zealand in the past are prerequisites for monitoring the safety of COVID-19 vaccines. If these adverse events occur after a vaccine is introduced to the population, New Zealand will have a frame of reference with which to compare the rates of these events to assess if there is a safety concern or not. The Brighton Collaboration has already defined 22 AESI and Assoc. Prof. Helen Petousis-Harris and her team are currently gathering data to calculate the background rates of these events, with funding provided by the New Zealand Ministry of Health.

As Millions Get Shots in USA, the F.D.A. Struggles to Get Safety Monitoring System Running

While there may have been a lot of attention on developing COVID vaccines, there has been less interest in investing in the vaccine safety monitoring mechanisms required under these extraordinary conditions. There is an urgency to get these systems in place both nationally and globally. An article in the New York Times explains how the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.

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.

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