NZ scientists to lead largest-ever vaccine monitoring study
NZ scientists to lead largest-ever vaccine monitoring study
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A global collaboration helmed in New Zealand will help assess the safety of COVID-19 vaccines on a massive scale. The Global Vaccine Data Network (GVDN) at the University of Auckland, with its 21 partners in 17 countries, has been awarded funds by the US Centers for Disease Control and Prevention (CDC) to monitor 300 million people for vaccine side-effects.
A global collaboration helmed in New Zealand will help assess the safety of COVID-19 vaccines on a massive scale. The Global Vaccine Data Network (GVDN) at the University of Auckland, with its 21 partners in 17 countries, has been awarded funds by the US Centers for Disease Control and Prevention (CDC) to monitor 300 million people for vaccine side-effects.
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University of Auckland to lead global Covid-19 vaccine monitoring
As Covid-19 vaccines are rolled out around the world, an Auckland-headquartered research network is leading the largest global vaccine monitoring study ever undertaken. UniServices, a wholly owned not-for-profit subsidiary of the University of Auckland, has been awarded nearly NZ$8 million (US$5.6 million) by the U.S. Centers for Disease Control and Prevention (CDC) for the study, which will be undertaken by the Global Vaccine Data Network (GVDN).
The GVDN, which currently has 21 partners in 17 countries, is leading an international effort to collaboratively monitor and assess Covid-19 vaccines over a three-year period. The University of Auckland will act as the global coordinating centre for the study, which will follow some 300 million people – a vastly larger sample than the tens of thousands involved in clinical trials.
“Never before have so many vaccines been developed and deployed so quickly, to meet so urgent a need,” said University of Auckland Associate Professor Helen Petousis-Harris, principal investigator of the project and co-director of the GVDN. “Though clinical trials provided the information needed to authorise vaccines for use across many countries, it is vital to continue monitoring after the vaccines are deployed. There are many new Covid-19 vaccines and it is therefore imperative that there be a global, centralized surveillance process to detect any very rare vaccine safety issues and to allow ongoing risk-benefit assessments.”
The harmonized process gives the GVDN the ability to compare different Covid-19 vaccines using common protocols despite the diversity of the populations studied. Using de-identified, aggregated electronic healthcare data, researchers will assess post-immunisation adverse events such as hospitalisations.
With the huge amount of data being examined, researchers have the statistical power to assess even extremely rare outcomes. They will therefore be able to detect new potential concerns and compare outcomes between vaccines as well as between vaccinated and unvaccinated people. Data mining will be used to detect possible unanticipated adverse events.
“This project puts the University of Auckland, UniServices and New Zealand at global centre stage for the ongoing management of vaccine follow-up data,” said Andy Shenk, CEO of UniServices. “By using scientifically rigorous methods to quantify potential vaccine risks and monitor effectiveness, this initiative will inform immunisation policies around the world and contribute to global public confidence in vaccine safety. It may be one of the most important safety assurance projects in the world at this time.”
The GVDN is an international consortium for vaccine monitoring. Formed in 2019, months before the Covid-19 pandemic, it uses big data to assess vaccine safety and effectiveness across large and diverse populations around the world and over time. Its partners include organisations in lower-income countries as well as higher-income countries on all six populated continents.
The University of Auckland’s lead role in the project builds on the Faculty of Medical and Health Science’s history of groundbreaking vaccine research, collaborations and connections with international health organisations, national agencies such as the CDC and leading scientists in the field.
Petousis-Harris, the project leader, is a vaccinologist who was previously chair of the World Health Organization Global Advisory Committee on Vaccine Safety. She is currently director of the University of Auckland’s Vaccine Datalink and Research Group and an elected member of the International Brighton Collaboration Science Board. She was also a New Zealander of the Year semi-finalist in 2020 for her efforts in vaccine communications.
“While vaccine hesitancy and anti-vaccine communication have become global, the ability to respond to such concerns has remained largely fractured, without coordination between countries,” said Emeritus Professor Steve Black of the University of Cincinnati, a paediatric infectious disease specialist and the other co-director of the GVDN. “This project is a game-changer. Through its scale, transparency, timeliness and open communication, it will contribute to vaccine confidence around the world.”
“New Zealand has demonstrated its commitment to science through its world-leading response to the pandemic,” said Professor John Fraser, Dean of the University of Auckland’s Faculty of Medical and Health Sciences and a UniServices board member. “Coordinating this project gives New Zealand an opportunity to also lead in vaccine monitoring.”
This project is supported by the Centres for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totalling US$5,643,515 with 100% percentage funded by CDC/HHS. The contents are those of the author and do not necessarily represent the official views of, nor an endorsement, by CDC/HHS, or the U.S. Government. For more information, please visit the CDC website.
Expert Comments:
Dr Fran Priddy
Post-approval monitoring of vaccine safety is critical for COVID-19 vaccines which will be administered rapidly to populations including children and immunocompromised people across the globe. We have already seen how strong monitoring systems in the US and Europe have identified rare adverse events and led to rapid changes in vaccine policy.
The global vaccine monitoring capacity of the Global Vaccine Data Network program is critical because it links safety data across many more countries and populations than any individual country could do alone. And it allows countries with less capacity to participate in a rigorous monitoring program. The GVDN's very large and coordinated database can more accurately and rapidly detect and understand safety issues, which will benefit us all.
This knowledge is key to vaccine safety and acceptance to improve vaccination rates and control the pandemic. It is encouraging to see that the US CDC recognizes and supports the need for a global approach and that Dr. Petousis-Harris and her team at University of Auckland have been selected to lead this program.
Associate Professor Helen Petousis-Harris
What will the Global Vaccine Data Network do?
The GVDN will facilitate studies of vaccine safety and effectiveness using health data from diverse populations around the world. Serious adverse events following vaccination are extremely rare, so scientists need to study very large populations.
How did this project arise?
Scientists saw a need for increased collaboration on vaccine monitoring even before Covid-19 struck. Modern computing power and statistical techniques make it technically possible to do massive studies. The Gates Foundation funded an initial meeting in France in 2019, which laid the groundwork for the project now unfolding.
What regions are represented?
Countries across Europe, the Americas, Asia, Africa and Western Pacific are represented. Partner sites can be research institutions, universities or hospitals. Some countries have multiple sites. The aim is to add even more countries and sites.
How was the figure of around 300 million people being monitored arrived at?
It is an estimate based on the number of people each site is working with. Some sites are monitoring just a portion of the country’s population while others like the New Zealand site will monitor the entire population. It is also anticipated that new sites will join the collaboration.
How will monitoring work?
The GVDN will undertake a number of critical activities associated with Covid-19 vaccines. Firstly, it will establish the normal background rates of a range of medical conditions of special interest. It will then assess if more cases of various medical conditions arise after vaccination than might normally be expected. The network will also compare the outcomes of different vaccines, scan for potential unexpected events and perform studies that compare vaccinated people with unvaccinated people. These are all things that are normally done in many countries. What makes the GVDN different is that by using the same methods at all partner sites, we can essentially do the biggest vaccine studies ever undertaken.
Does monitoring imply scientists are worried about the safety of these vaccines?
No. Vaccines have been tested in clinical studies and are now being closely monitored as we use them. Covid-19 vaccines are helping populations around the world to avoid untold suffering and death and to start coming out of long lockdowns. Serious adverse reactions are extremely rare.
Is this project just about Covid-19?
The funding from the U.S. Centers for Disease Control and Prevention (CDC) is specifically for Covid-19 related work but the GVDN is set up to co-ordinate studies of vaccine safety and effectiveness for any vaccine. It aims to do similar global studies on other vaccines in the future.
