The University of Auckland is set to coordinate the largest global vaccine monitoring study ever undertaken.
University subsidiary UniServices has been awarded nearly $8 million by the US Centers for Disease Control and Prevention (CDC) for the major three-year study, which will be undertaken by the Global Vaccine Data Network (GVDN).
The university 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 the study's principal investigator, Associate Professor Helen Petousis-Harris.
"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, centralised surveillance process to detect any very rare vaccine safety issues and to allow ongoing risk-benefit assessments."
The process allowed the GVDN, which currently has 21 partners in 17 countries, 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.
That means they'll be able to detect new potential concerns and compare outcomes between vaccines as well as between vaccinated and unvaccinated people, with data mining to be used to detect any possible unanticipated adverse events.
Petousis-Harris said monitoring didn't imply scientists were worried about the safety of the vaccines.
"Vaccines have been tested in clinical studies and are now being closely monitored as we use them," she said.
"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."
Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo clinical director Dr Fran Priddy said post-approval monitoring of vaccine safety was "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."
UniServices chief executive Andy Shenk said the project put the University of Auckland, UniServices and New Zealand at global centre stage for the ongoing management of vaccine follow-up data.
"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," he said.
"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.
"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," GVDN co-director Emeritus Professor Steve Black said.
"This project is a game-changer. Through its scale, transparency, timeliness and open communication, it will contribute to vaccine confidence around the world."