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?
Marco Cavaleri: There are many vaccines undergoing clinical trials at the moment, each using different platform technologies, and all presenting interesting features that could provide a diversified portfolio of options. The mRNA vaccines from Moderna and BioNTech/Pfizer are certainly among the most advanced, and the clinical data on their efficacy and safety is already available. The EMA has started a rolling review of these two mRNA vaccines and could come up with a positive opinion for at least one of them to be approved as early as the end of this year. The viral vectored vaccine from Oxford/AstraZeneca has also already entered the rolling review process. Another non-replicating viral vectored vaccine at an advanced stage of development is the adenovirus (Ad26) viral vectored vaccine from Janssen. Other vaccines cover the adjuvanted subunit vaccines e.g. Novavax and Sanofi Pasteur, and the replicating viral vectored vaccine, such as VSV- and measles-vectored ones.
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.