A COVID-19 vaccine is administered by a doctor to a patient

A new international study will examine the rare side effects caused by COVID-19 vaccines to ensure even better safeguards are in place for future pandemics.

The University of Alberta in Canada is spearheading the study through the International Network of Special Immunization Services (INSIS), a global consortium of academic medical centres including Murdoch Children's Research Institute (MCRI), who are using their expertise to examine the very rare adverse events that can occur after vaccination to COVID-19.

The study aims to understand the causes and risk factors behind these occurrences, ensuring the development of even safer vaccines in potential future health crises.

INSIS is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with up to US $15.3 million provided over four years.  The focus of the consortium is to investigate adverse reactions classified as very rare, affecting less than 0.001 per cent of the population.

Dr Karina Top, a pediatric infectious disease professor at the University of Alberta said, “The bar for safety with vaccines is very high because we’re giving them to healthy people to prevent them from getting sick. We don’t want these events to occur, and we want to understand why, so we can prevent them in the future.”

The research conducted by INSIS is crucial, considering the unprecedented impact of COVID-19 vaccines during the pandemic. In the first year of their roll-out, these vaccines were responsible for saving about 20 million lives globally.

SAEFVIC director and MCRI Professor Nigel Crawford said vaccination played a major role in the Australian public health response to COVID-19.

COVID-19 expert and sAEFVIC director Professor Nigel Crawford

Image: Professor Nigel Crawford

“Rare, but serious adverse events following immunisation were detected and managed by jurisdictional vaccine safety services, such as SAEFVIC in Victoria,” he said.

“CEPI funding to assist in investigating these rare events is extremely important as we look to understand the why and aim to try and prevent their occurrence in the future.”

Adverse events linked to immunisations are often discovered after vaccines are distributed to the general population. Clinical trials, which involve a relatively small number of participants, may not fully represent the diverse population that receives the vaccine post-approval. INSIS will leverage cutting-edge techniques to analyse human blood samples, compiling extensive global data to compare individuals who experienced rare adverse events with those unaffected.

The goal of INSIS is to enhance the safety assessment of vaccine candidates developed to combat emerging infectious threats before emergency authorisation. This objective aligns with the 100 Days Mission, aiming to expedite vaccine development against potential pandemics within just 100 days of identification.

Dr Jakob Cramer, Director of Clinical Development at CEPI said, “Compressing vaccine development against emerging pathogens down to 100 days will be critical to combatting future pandemic threats. Data from INSIS will help to inform health authorities on the most appropriate type of vaccine that should be used in specific outbreak settings and populations.

“If we can identify risk factors and identify causal mechanisms for potential serious adverse events ahead of time, immunisation campaigns can be adapted to mitigate such risks in those who are potentially vulnerable to harm, contributing to increased levels of public confidence in vaccines and enabling the development of even safer vaccines.”

The global study also brings together researchers from B.C. Children’s Hospital Research Institute, the Precision Vaccines Program at Boston Children’s Hospital, Mayo Clinic’s Vaccine Research Group, the Vanderbilt Vaccine Research Program at Vanderbilt University Medical Centre, the Global Vaccine Data Network co-ordinated from New Zealand, Ospedale Pediatrico Bambino Gesù in Italy, Global Healthcare Consulting co-ordinated from India and the African Leadership in Vaccinology Expertise (Wits-ALIVE). 

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About Murdoch Children’s Research Institute

Murdoch Children's Research Institute is the largest child health research institute in Australia committed to making discoveries and developing treatments to improve child and adolescent health in Australia and around the world. They are pioneering new treatments, trialling better vaccines and improving ways of diagnosing and helping sick babies, children and adolescents. It is one of the only research institutes in Australia to offer genetic testing to find answers for families of children with previously undiagnosed conditions.


The study is funded by the Coalition for Epidemic Preparedness Innovations (CEPI).