Sciensano & Post-authorisation surveillance of COVID-19 vaccines

Last updated on 10-2-2021 by Wesley Van Dessel

Sciensano actively participates in multiple aspects of the post-authorisation surveillance of the COVID-19 vaccines, in support of the Federal agency for medicines and health products.

Monitoring vaccine uptake & coverage, vaccine effectiveness and vaccine safety

Through the LINK-VACC project, Sciensano’s service of Epidemiology of infectious diseases with the technical support of Healthdata.be will be monitoring COVID-19 vaccine uptake in Belgium, assessing vaccine coverage in key sub-populations, and evaluating vaccine effectiveness. In addition, the project will support the Federal agency for medicines and health products in the monitoring of COVID-19 vaccine safety through the detection of specific safety signals.

In addition, several of the surveillance networks that have been implemented to monitor COVID-19 epidemiology will record information on the vaccine status of participants. These include the surveillance of hospitalised COVID-19 cases and of nursing homes. All epidemiological updates and details about thematic aspects are available in Dutch and French.

Using established influenza surveillance systems to give additional estimates of COVID-19 vaccine effectiveness

Sciensano’s epidemiological sentinel networks of general practitioners, hospitals and nursing homes, and its National Reference Centre for Influenza virus together provide the data to estimate vaccine effectiveness of the influenza vaccine. For more information, please consult the influenza surveillance project pages.

As COVID-19 symptoms overlap with those of flu, we have slightly adapted the influenza surveillances this winter in order to provide additional information on the effectiveness of the COVID-19 vaccine in specific risk groups of patients in selected health care settings.

Evaluating vaccine acceptance and organising citizen consultations

Sciensano conducts vaccine acceptance surveys addressing attitudes towards the new COVID-19 vaccines, both in the general population and in specific groups such as in healthcare workers. In addition, we have implemented a citizen consultation, aiming at formulating recommendations for a COVID-19 vaccination policy based on citizen values and principles.

Controlling the quality of vaccines released by pharmaceutical companies

Sciensano’s Quality of vaccines and blood products service ensures independent second line quality testing of the vaccine batches prior to their marketing in Belgium and Europe as required by EU legislation. Sciensano is part of the European Official Medicines Control Laboratories (OMCL) network (coordinated by the European Directorate for Quality of Medicines & Healthcare), which tests all vaccine batches destined for Europe. The independent testing of each vaccine lot ensures the quality and conformity to product specifications, in order to guarantee the safety and efficacy of the vaccines.

These tests are performed under a system of mutual recognition, which means that a vaccine batch is tested by one of the European OMCL and the issued certificate is recognised by all EU member states. Vaccine batches distributed by the manufacturers in Belgium will therefore have been tested and approved either by Sciensano or by another European OMCL.

Measuring immune responses to COVID-19 vaccines

The Immune response service of Sciensano has developed and validated multiple laboratory assays that can be used to evaluate immune-responses to COVID-19 vaccines. These include serology (study of blood serum to assess the immune system’s response to a pathogen), multiplex assays (allowing to detect different agents in one single test), pseudo-particles assays (a method to study whether antibodies offer protection against a SARS-CoV-2 virus infection) and neutralizing assays (these detect the presence and magnitude of antibodies that prevent a SARS-CoV-2 virus infection).

Sciensano conducts multiple seroprevalence studies (=studies to determine the proportion of a population with antibodies against a specific pathogen), including studies in the general population, in nursing homes, in first-line healthcare workers and in schools. The main objective in these studies is to assess over time at several time points how many people of the different target populations have developed antibodies against SARS-CoV-2. Presence of antibodies is a correlate of immune response either to a past COVID-19 disease or to vaccination.

More information

The Belgian and European health authorities closely monitor the outbreak. Stay tuned and check the general information on vaccines and vaccination on the websites of the Belgian federal authorities, the Flemish regional authorities, the Walloon and Brussels regional authorities, the website of the authorities of the German-speaking region , and the European vaccination information portal.

Complementary information on COVID-19 vaccines for Health professionals is available on the website of the Belgian federal government (available in Dutch and French only). There’s also a Q&A from the Federal agency for medicines and health products on vaccines (available in Dutch and French), as well as an update on research and development of vaccines and a webpage about the notification of adverse effects. More information can also be found on the website of the European Medicines Agency.

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