The study will follow some 300 million people. A vastly larger sample than the tens of thousands involved in clinical trials.
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.
The University of Auckland will act as the global coordinating center for the study, which will follow some 300 million people—a vastly larger sample than the tens of thousands involved in clinical trials. The Finnish Institute for Health and Welfare (THL) is a partner in this study.
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.
“It may be one of the most important safety assurance projects in the world at this time.”Andy Shenk, CEO OF UniServices
Helen Petousis-Harris, associate professor at the University of Auckland and principal investigator of the project and co-director of the GVDN, said in a statement:
“Though clinical trials provided the information needed to authorize 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-immunization adverse events such as hospitalizations.
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.
“By using scientifically rigorous methods to quantify potential vaccine risks and monitor effectiveness, this initiative will inform immunization 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,” said Andy Shenk, CEO of UniServices.
Professor Steve Black of the University of Cincinnati believes the project will be a “game-changer.” “Through its scale, transparency, timeliness and open communication, it will contribute to vaccine confidence around the world.”
What is the GVDN?
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 organizations in lower-income countries as well as higher-income countries on all six populated continents.
More about the University of Auckland's role:
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 organizations, national agencies such as the CDC and leading scientists in the field.