ECDC and EMA look to generate real-world, independent evidence on vaccines

By Jane Byrne

- Last updated on GMT

© GettyImages/aydinynr
© GettyImages/aydinynr

Related tags vaccine scepticism vaccine hesitancy Ema ECDC

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) are collaborating on vaccine safety and effectiveness monitoring studies.

The agencies convened the first meeting of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB) of the Vaccine Monitoring Platform (VMP) in Amsterdam on December 6-7.

The VMP is their joint initiative aimed at strengthening the continuous monitoring of the safety and effectiveness of vaccines in the EU.

The goal of the EMA and ECDC alliance is to build a network and a powerful infrastructure across Europe to generate real-world evidence on vaccines that is completely independent from industry interests and studies, using EU funds only, said ECDC director, Andrea

Through the VMP, the two agencies will coordinate and oversee such EU-funded, independent post-authorisation research.

Emer Cooke, EMA’s executive director, said the additional evidence generated this way would enable it to continuously monitor the safety and effectiveness of vaccines. “This will improve the robustness of our decision making, which is essential to build and maintain people’s trust in these key products.”

Ammon acknowledged the rising levels of vaccine scepticism around COVID-19 shots, but also for other vaccines, and said this kind of work could help counter that uncertainty.

We also want to build a stronger bridge between the regulatory and public health dimension of vaccine assessment and the pandemic has shown how critical this is.”

The IVMAB is the advisory body supporting the operations of the VMP, co-chaired by EMA and ECDC. It is a multidisciplinary forum that brings together vaccine regulatory experts as well as representatives from EU national public health authorities. Its role is to provide advice on the prioritisation, design, implementation, and interpretation of VMP studies to help inform regulatory and public health decisions on key vaccines used in EU immunisation programs.

The first EU-funded study on the effectiveness and safety of Imvanex (mpox / monkeypox vaccine) is ongoing. 

Coordinated EU approach on vaccination urged 

Last week the Council of the EU urged a renewed effort to combat vaccine hesitancy and it encouraged an even more coordinated EU approach on vaccination to prevent and limit the spread of epidemics and vaccine-preventable diseases.

"Vaccination is an effective means against infectious diseases. Strong cooperation among EU member states on vaccination got us through the COVID pandemic and will continue to be the right approach in the future,"​ said Vlastimil Válek, Czech deputy prime minister and minister of health.

The COVID-19 pandemic demonstrated the threats and challenges of mis- and disinformation for society, said the Council. To counter the ensuing risks to human health, health systems and effective crisis management, it asks the EU Commission to establish an expert forum on vaccine hesitancy, to strengthen the coordination between EU policies on vaccination and on fighting disinformation, and to develop training opportunities for health professionals to become more versed in techniques and tools for countering vaccine mis- and disinformation.

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