With just a week to go until the Congress in Barcelona we are delighted that another of our wonderful speakers has made time to speak to us. Dr Marco Cavaleri will be joining us at the event for no fewer than 3 different sessions! The first is a workshop on vaccine safety; the second is a keynote exploring the future of vaccinology, and the third session will examine correlates of protection. We are very grateful that he made some time to give us an insight into what he might cover in these, and hope you enjoy reading his thoughts. This interview was conducted over email. 

Introducing Dr Cavaleri 

Dr Cavaleri is the head of Health Threats and Vaccines Strategy at the European Medicines Agency (EMA) as well as Chair of the EMA Emergency Task Force. The EMA has been responsible for the scientific evaluation, supervision, and monitoring of medicines in the EU since 1995. Within the EMA is the Emergency Task Force (ETF), which deals with regulatory activities in preparation for and during a public health crisis, such as a pandemic.  

The evolving landscape in Europe 

With his fascinating insight into the European regulatory landscape, we were interested to hear what Dr Cavaleri believes is changing as we emerge from the COVID-19 pandemic. His first response is clear: 

“COVID is still very dynamic as we transition towards endemicity. The virus is still not fully seasonal and new variants are rapidly emerging.”  

These aspects “make it challenging” to “rapidly find a new standard process for the updates” of the COVID-19 vaccines, suggests Dr Cavaleri. There is a need to ensure that the vaccines that are currently available are “adequately updated” before “yearly re-vaccination campaigns”. If a decision is taken “as late as June”, as re-vaccination campaigns target autumn and winter to allow “concomitant vaccination for influenza and maybe also RSV, this is additionally challenging”.

“While mRNA vaccines are amenable to rapid update of the vaccine, more traditional technologies will require somehow longer timeframe.”  

Dr Cavaleri suggests that the desire to offer the possibility of a “broader portfolio of options” demands “an earlier global decision” on strain updates.  

“At the same time, the interest for mucosal vaccines and/or vaccines that are broadly protective should not diminish and we stand ready to support such developments.”
Variation and collaboration 

The EMA is, as stated in the name, a European agency, but it operates on a global stage in an international context. We asked Dr Cavaleri about differences of approach in comparison with other agencies, but also about the potential for collaboration.  

“The international collaboration among regulators has increased over time and the pandemic has shown a massive increase in the dialogue and willingness to reach alignment.”  

However, Dr Cavaleri highlights that “regulatory tools” differed during the pandemic, while “on scientific grounds we generally tended to converge”. His example is Emergency Use Authorisation, which is “not yet available in the EU”.  

“It has been, however, notable that with respect to the use of immune markers to allow the approval of new vaccines, EMA has had a leading role in driving the evolution of the regulatory thinking and in taking up the scientific advancements.” 

Despite the understandable pride in EMA’s “leading role”, Dr Cavaleri is quick to highlight a need for communication to improve future practices. 

“Closer collaboration with the academic community is also an area that we need to enrich.”  
Other areas for improvement 

We also asked Dr Cavaleri about his impression of improvements that can be made after our experience of the pandemic. He identifies “key major public health areas” that need to be addressed. The first is “better preparedness for future threats with advancement of prototype vaccines against key pathogens”.  

“This needs to be linked with the ability to fully leverage the knowledge from platform technologies so to rapidly adapt vaccines to whatever will emerge in the future, causing epidemics and pandemics.”  

Another area for development concerns AMR and TB. Dr Cavaleri suggests that “more efforts and funds” are needed to advance lead candidates for TB prevention and “to prevent bacterial infections” associated with “high burden of disease”.  

“Lastly, with global warming and spread of mosquitoes, we should not undervalue the threat coming from vector-borne diseases and advance vaccines against key pathogens.”  
The Congress 

We asked Dr Cavaleri what he is looking forward to at the event, as we know he is going to be busy. For him, the opportunities for connection are a highlight. 

“Engaging with stakeholders from industry and academia so to advance our ability to progress vaccines that could be lifesaving.”  

We are so grateful to Dr Cavaleri for his insight and time and look forward to hearing more from him at the event next week. It’s not too late for you to join us there; just get your tickets here now. If you can’t make it, why not subscribe for more interviews?