Collaborating Expert on contribution of RWE to the Regulatory Assessment of Vaccine

Strategic area / objective

This work will support EMA in understanding the use and establishing the value of RWE for EU regulatory decision-making for vaccines. It will also promote transparency by building on EMA’s experience with existing/past submissions, while maximising the knowledge and impact of EMA’s work to support the translation of innovation into vaccines to reach and add value to more EU citizens on the basis of better data and evidence generation.

Specific projects

Real-world data (RWD) plays an important role in generating insightful real-world evidence (RWE) to support the evaluation of medicinal products. Use of RWE to support vaccine applications is growing, particularly in the lifecycle phase. Lessons from vaccine applications to EMA over the years, including for the approval and monitoring of COVID-19 vaccines, can be leveraged to support the use of RWE to assess the benefit-risk of any vaccines in the future and inform preparedness for public health emergencies. 
The collaborative expert will design and conduct a structured review of all vaccine submissions in SIAMED, EMA’s electronic database of products, relating to a centralised marketing authorisation application (MAA) or subsequent modifications to the initial MAA submitted to EMA over an approximately 15-year period. 
The objectives of this research will be to identify vaccine submissions including RWE; analyse the purpose of use of RWD/RWE (e.g., disease epidemiology/unmet medical need, safety/effectiveness claim, expansion to special populations); analyse its contribution to decision-making in terms of type and suitability of RWD and methodology. Results will be analysed and reported by vaccine product, class of vaccines, and/or disease/pathogen targeted.
The EMA RWE team already benefited from a similar and successful collaboration, which resulted in a published manuscript (Bakker et al. Clin Pharmacol Ther. 2023;113:135-151). While such work on the use of RWE for regulatory decision-making on medicines continues at EMA, the context and methodology (including search criteria and duration of the evaluation period) differ for vaccines, due to the peculiarities of this class of products and the need to conduct a focused, stand-alone analysis (a preliminary search identified >200 vaccine applications between 2005 and 2021, including initial applications and types II variations). Therefore, this research will bring complementary insight into the use of RWE and guide EMA on what constitutes adequate RWE for benefit-risk evaluation in the specific setting of vaccines. It will also provide valuable information to support the workplan of the EU Vaccine Monitoring Platform.
 

Deliverables

•    Protocol outlining the methodology of the research (an initial high-level draft is already available), to be published on the HMA-EMA Catalogue of real-world data studies (europa.eu)
•    Manuscript for publication in a peer-reviewed journal
 

Benefits for the expert

•    Gain experience of working with experts from the EMA and better understand EMA’s work and role in regulatory science.
•    Contribute to gather vaccine use cases related to RWE submitted in regulatory dossiers, and further understand their scope.
•    Support the strategy of EMA to establish use and value of RWE in regulatory decision-making in the specific setting of vaccines.
 

Benefits for the collaborating institution

•    Exchange of knowledge and expertise.
•    Joint research undertaking and joint publication
•    Building personal and inter-institutional collaboration with EMA.
 

Essential requirements

Eligibility criteria:  
•    Be an EU or EEA national
•    Meet the requirements stated in the profile description;
•    Be a paid employee from European academia, research institutions, public sector or international organisations, or a post graduate student within such organisations. Proof of employment/student status and agreement in principle of employer/academic institution will be requested.;
•    Have a thorough knowledge of English (at least level C1). Good knowledge of another official EU language (at least B2) is an asset, as per the Common European Framework for Languages.

University degree(s)

Essential: 
•    Minimum of a university degree in biomedical sciences, or public health, or regulatory science, or epidemiology/pharmacoepidemiology 
Desirable: 
•    Master or PhD degree in pharmacoepidemiology
 

Experience and additional skills

Essential: 
•    Demonstrated experience in writing, analysis and reporting of results in scientific reports and peer-reviewed publications. 
•    Demonstrated knowledge in the field of RWE generation.
•    High-level knowledge of regulatory procedures 
Desirable: 
•    Knowledge in the field of vaccinology/vaccine monitoring/vaccine RWE generation
 

Behavioural competencies
Essential:
•    Communication skills 
•    Interpersonal skills 
•    Working with others 
•    Adaptability 
•    Working with others but also with some degree of autonomy