Marco Cavaleri is Head of Office, Biological Health Threats and Vaccines Strategy at the European Medicines Agency (EMA). He is also the chair of the COVID-19 EMA pandemic Task Force and is responsible for EMA activities regarding emerging pathogens, vaccines and antimicrobial resistance. He is a pharmacologist who has spent several years in industry in research and development, mainly in the field of anti-infectives, and has held various positions in preclinical and clinical development.
In your opinion, which trial is the most promising and when could the vaccine become available for people in the EU?
What follow-up measures does the EMA take as part of the vaccine evaluation procedures to guarantee a vaccine’s safety post-approval?
Marco Cavaleri: At the time of approval, the safety data for these vaccines will be quite extensive: in the order of several thousand pages. Surveillance of safety post-approval to make sure that any emergent safety issues that could not be detected in clinical trials because they occur very rarely are rapidly evaluated and characterised. Sponsors will have obligations under the agreed risk management plan to monitor the safety of the vaccines post-approval with further reports to the EMA. The EMA and the ECDC, are working together to set up additional studies to monitor the safety and effectiveness of the vaccines.
In your opinion, does the rapid development of the Russian and Chinese vaccines compromise quality or raise safety concerns? If so, why?
Marco Cavaleri: The EMA has not yet assessed the data relating to the quality of these vaccines. The timeframe for their development does not differ much from what we have seen for the vaccines we usually deal with. The speed of development is not a cause for concern in itself, as long as all the required tests have been conducted.
How will the EMA rolling review guarantee the safety, efficacy and quality of the vaccine, despite the rapid evaluation procedure?
Marco Cavaleri: In a rolling review, data are assessed as they become available, which allows us to save time as the assessment can progress continuously until the last set of data is submitted. This process is rather intense and time-consuming, but allows the timelines for assessment to be compressed without any compromise in the quality of the regulatory review.
Do you fear that vaccine hesitancy could undermine efforts to bring the pandemic under control? What do you think the EU should do about this?
Marco Cavaleri: Vaccine hesitancy is a threat to vaccination campaigns against many serious pathogens, and could also play a detrimental role in the current pandemic. The EMA is committed to providing accurate and transparent scientific information on the benefits and risks of any vaccine that is approved. The Commission, the ECDC, and the relevant authorities in Member States need to work together to make sure that there is a proactive approach to communication on vaccines.