Netherlands takes key role in coronavirus vaccines, EU cooperation

Dutch researchers are going to play a leading role in monitoring the safety and efficacy of vaccines against the coronavirus in Europe. This project was commissioned by the European Medicines Agency (EMA) and will be led by UMC Utrecht and Utrecht University. Project ACCESS will focus on preparing Europe to properly and jointly monitor the effectiveness and safety of Covid-19 vaccines that enter the market.

The researchers will investigate how often Covid-19, the respiratory disease caused by the novel coronavirus, occurs both with and without vaccination. In the coming months, the researchers will map out how the disease spreads and presents itself in different communities, before anyone is vaccinated against it. This will be done using available historical, anonymous care data from more than 100 million people in seven European countries, including the Netherlands.

Once a vaccine is approved and released for use, the researchers will continue to monitor Covid-19's spread and presentation. By comparing the before and after vaccination data, the researchers will be able to determine how effective the vaccine is.

They will also keep a close eye out for rare side effects and syndromes that may not have been revealed in the clinical trials. A list of side effects will then be drawn up, in collaboration with the EMA and World Health Organization (WHO).

It is very important to be prepared, said Miriam Sturkenboom, professor of Observational Data Analysis and working at UMC Utrecht. "Normally, the development of a vaccine takes about 10 to 15 years, now that has to be done within a year," she explained. "The developers do not skip any steps, but they accelerate every step. If a vaccine comes on the market, it will probably only have been tested in several thousand people. Because of the short lead time, the research group is limited and certain subgroups such as the elderly, pregnant women, and children will hardly have been included in the research."

A total of 22 European organizations are involved in this project, including Dutch public health institute RIVM, side effects center Lareb, and the Pharmo Institute - a research institute located in Utrecht.