In The News: Pandemic Propels Global Efforts to Study Rare Vaccine Side Effects

Science reports on a substantial effort undertaken by scientists from over 20 countries across six continents to gather data for the world’s largest vaccine safety project. Initiated more than a decade ago, the Global Vaccine Data Network (GVDN) struggled to secure stable funding until a proposal was accepted by the CDC last year following the massive vaccination campaign in response to the COVID-19 pandemic. The network will now address knowledge gaps in our understanding of the causes of rare adverse events following COVID-19 immunization.

The idea behind the network came from the disparity of reported side effects from the pandemic H1N1 influenza vaccine. Researchers hope more consistent data could clarify why some regions reported side effects to the vaccine while others did not. However, the size of that vaccination effort limited the conclusions that could be drawn. To comprehensively evaluate these rare adverse events, the network needed a large data pool to review, which the billions of COVID-19 doses could likely provide.

Simultaneously, the International Network of Special Immunization Services (INSIS) is finalizing funding agreements to examine the biology and immunology of postvaccine problems as they happen. This project brings together expert clinicians, immunologists, and biologists from six countries to study immune response dynamics. INSIS is partnering with GVDN to identify patients and share data. The projects will work together in hopes of identifying risk factors for vaccine side effects and ways to offset or prevent them.

GVDN intends to use the CDC grant over three years to study side effects of the COVID-19 vaccines in several ways. One project will study individuals experiencing post-vaccination myopericarditis, which have been reported most commonly after the Pfizer and Moderna mRNA vaccines. Another project investigates post-vaccination thrombosis and thrombocytopenia syndrome (TTS), which have been reported after receipt of the Johnson & Johnson and AstraZeneca adenovirus-vectored vaccines.

It is hoped that initial data will be available this summer. The data in turn may lead to more funding, which will be needed to stabilize the projects. Stable funding could then lead to not only continuing the work, but expanding its scope, as well.

INSIS leader Karina Top, a PIDS member, is quoted in the story and commented on the projects, saying, “Vaccines have been critical in reducing morbidity and mortality from COVID-19; however, global mass vaccination campaigns have uncovered certain rare adverse events following immunization (AEFIs), such as myocarditis. These projects highlight both the critical need for, and chronic underfunding of, global efforts to study rare side effects. The GVDN and INSIS have potential to uncover the risk factors and mechanisms underlying rare AEFIs to better identify, treat and ultimately prevent them; however, adequate funding of these global vaccine safety efforts will be essential to ensure their success.”