Credit: iStock

Auckland scientists to lead largest-ever vaccine monitoring study – Expert Reaction

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), 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.

The SMC asked independent experts and the project’s co-director to comment on the research. 

Dr Fran Priddy, Clinical Director Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo:

“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.”

Conflict of interest statement: Dr Priddy is Clinical Director of the Government-funded Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo, a partnership between the Malaghan Institute, the University of Otago and Victoria University of Wellington.

Associate Professor Helen Petousis-Harris, Co-Director, Global Vaccine Data Network; and vaccinologist, University of Auckland, comments:

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.”

Dr Petousis-Harris is the co-director of the Global Vaccine Data Network.