Our next interview in the Congress Conversations series from the European Congress is with Dr Walter Straus of Moderna. He joined us to moderate the workshop on vaccine safety, which explored key concerns about the safety of current and future vaccines, including those developed in response to the COVID-19 pandemic. We were glad that he had time to join us for a conversation about the vaccine safety landscape, and we hope that you enjoy hearing from him as much as we did!
Introducing Dr Straus
Dr Straus kindly explains that he works in the vaccine safety area at Moderna, with a team responsible for “oversight of clinical safety for products in development as well as for safety assessment post-authorisation”.
“For all practical purposes that’s primarily involved the COVID programme for the better part of three years, and now I’m working on pipeline areas as well.”
Retaining lessons from COVID-19
Dr Straus mentions his experience during the COVID-19 pandemic, so we asked him about some of the key lessons he might hope to see taken on board as the global response changes gear. He reflects that the “terrible” pandemic was the worst we’ve seen in 100 years.
“But it’s also been said that you should never waste a crisis; you should learn from the opportunities that are created in the setting of a pandemic.”
Indeed, Dr Straus recognises “some pretty significant steps forward”. One of these is a “much greater level of communication” across borders and organisations. This communication “facilitated the efficient development of vaccines tested at scale”.
“And yet we didn’t cut any corners.”
For Dr Straus, “certain efficiencies” were identified to allow different steps, which may have been “formerly conducted in series”, to be conducted in parallel “without any significant safety cost”. With this “major improvement” in mind, Dr Straus reflects that discussions now are focused on retaining lessons as we move to an “endemic period”. However, he suggests that we must be aware of the resource allocation that took place during the pandemic.
“Not only were additional resources added to support pandemic control, but also within the entire biomedical research and public health and regulatory communities, resources were diverted to support the needs of addressing the pandemic, potentially at the expense of some other areas.”
Vaccine expectations
With COVID-19 vaccines in mind, we asked Dr Straus how other expectations of other vaccines might be shaped in the future. He suggests that one consideration is the “much greater level of frequency and intensity” of communication between regulatory bodies and sponsors.
“These communications provided an opportunity I think to provide a much, a much more sensitive way of identifying and evaluating any sort of emerging safety issues.”
On the other hand, something we might not see taken forward is the “extraordinary regulatory reporting requirements” that were established in a “pandemic setting”. The example that Dr Straus gives, monthly periodic safety update reports, is “exceptional” and will probably not be “necessary or justified” in “more standard vaccines”.
Key concerns at the workshop
With the workshop that Dr Straus moderated in mind, we asked him to share some key themes or concerns from the vaccine safety discussions he had participated in so far. He begins by stating that some of the platforms, such as mRNA, were used to develop vaccines that were “introduced at such a large scale” that the “safety profiles are very well understood”. This means that we’ve been able to identify “exceedingly rare events”. Examples include several adverse reactions observed with different platforms, including vaccine induced immune mediated thrombotic thrombocytopenia, myocarditis, and pericarditis.”
“Both of these topics have received a lot of attention. And I think that now the risk profiles are well understood.”
However, our efforts to understand the immunopathogenesis of these adverse reactions is ongoing, which is true for other adverse reactions as well. Another issue that was raised at the event was vaccine hesitancy, and Dr Straus prefaces his reflection on this with the reminder that everyone in the vaccine community is confident in the purpose of their work.
“All of us firmly believe in the value, the extraordinary public health value of vaccines.”
Despite this, he states that we are finding ourselves in a world in which there are increasing doubts about the safety and also the efficacy of vaccines – and for a range of reasons. For Dr Straus and colleagues this can be a “source of consternation”.
“It creates a real dissonance because you can develop the best vaccine in the world but if it’s not used it doesn’t provide any public health value.”
Communication concerns
Our next question addresses an element of what Dr Straus is discussing: communicating safety concerns and confidence. We asked if there is consensus on how best to approach it.
“I don’t think there is a consensus because there are a lot of different groups that have their own concerns about vaccines for various reasons and so one size does not fit all.”
An observation from the workshop is that we are experiencing “many who doubt the value of science”. Therefore, “new ways of communication” need to be developed. Dr Straus reminds us that the scientific community relies upon studies and publications to evaluate questions and communicate findings, but most people obtain their information in other ways, such as personal communication, communities of faith, the traditional popular news, and more recent social media. Most scientists working in biomedical research aren’t conversant with communicating science through these approaches, regardless of whether they are based in academia, regulatory or public health agencies, or industry. To advance the optimal use of vaccines, he suggests that the community will need to learn to communicate in ways that “are probably not so familiar”.
Why WVC?
As always, we asked Dr Straus what his intentions for the Congress were, and why he was joining us. He states that over recent years it has become a “forum that brings together stakeholders from different parts of the biomedical research community”, providing opportunities for “dialogue around topics of common interest”.
“This is an area where you learn about new approaches that are being taken by colleagues across the biomedical research community.”
We are so grateful for Dr Straus’ time and insight in this interview, and hope that you enjoyed hearing from him. We’re thrilled that he will be returning to join us in Washington next year, so do get your tickets if you’d like to hear more from him! If you enjoyed this interview do make sure you subscribe for more like it!
