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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.
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.
The vaccines from Pfizer and Moderna both use tiny snippets of genetic code called messenger RNA, or mRNA, to prompt the immune system into producing antibodies to the coronavirus, without using bits of the virus itself. For more information, read the USA CDC article entitled ‘Understanding mRNA 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.
Recent TED talk given by Helen Petousis-Harris on how vaccines are assessed for their safety and effectiveness. Despite controversial claims, vaccines have been a vital part of combating pandemic outbreaks. Lots and lots of money and time are being put into developing safe enough vaccines to be used in the community. But what is the reason for hesitancy towards vaccines?
The European Medicines Agency and the national competent authorities in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed. Read more here
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.
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.
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.