In short
In parallel with the roll-out of the Belgian COVID-19 vaccination campaign, Sciensano has launched the LINK-VACC project. The objective of this project is to assess which percentage of the population (and of certain target groups) is already vaccinated. It also allows to continuously monitor the vaccine’s effectiveness and to keep the safety of the vaccine guaranteed. With this project, Sciensano contributes to the so called post-authorization surveillance of the COVID-19 vaccines.
Project description
The LINK-VACC-project will link the vaccine registry (VACCINNET+), that collects information on all administered COVID-19 vaccines, with other already existing databases that contain relevant and detailed information.
The aim of the project is threefold:
1. Determining the uptake and coverage of the COVID-19 vaccine.
The uptake and coverage are two important indicators to evaluate the roll-out of the vaccination campaign and to adjust the campaign where necessary. Therefore, it is also important to estimate these parameters as detailed as possible (by region, type of vaccine, age groups, target groups, …).
2. Determining the effectiveness of the vaccine.
The efficacy of the vaccine as measured in clinical trials may differ from the effectiveness measured after the roll-out of the vaccination campaign. Indeed, clinical trials are typically run in strictly controlled circumstances within well-described populations as opposed to a “real-life setting”. Moreover, potential mutations in the virus that may emerge could in time affect the effectiveness of the vaccine. Consequently, the follow-up of the vaccine effectiveness is crucial to evaluate which part of the population is effectively protected and to guide the country’s vaccination policy accordingly.
A test-negative case-control study design will be used to determine the effectiveness of the different vaccines used in Belgium against the development of a (lab-confirmed) COVID-19 infection.
Here too, vaccine effectiveness in certain subgroups (according to age, sex, specific risk groups,…) will be investigated in as much detail as possible.
3. Contributing to the monitoring of the vaccine safety
The LINK-VACC project will also monitor certain safety signals, making sure the safety of the vaccine continues to be guaranteed. Amongst others, break-through cases (COVID-19 cases occurring in fully vaccinated persons) will be detected, characterized (level of severity, delay of onset…) and examined as to whether they are associated to a certain vaccination site or lot number. In this way, the project will support the Federal Agency for Medicines and Health Products (FAMHP) in the fulfillment of its tasks.
All data will be pseudonymized, which implies that the identity of the persons whose data are involved cannot be traced by the researchers.
Information letter for participants to the LINK-VACC project
Contact the LINK-VACC team for more information.