Conversations with the Academy series webinar, February 26, 2021
Tackling the plethora of emerging situations, Otfried Kistner, Independent Vaccine Expert and Consultant, Soneil Guptha, Pharmaceutical Physician-Scientist, and Kamlesh Thakker, Clinical Pharmacologist and Independent Consultant, delineated the urgent need for safe and effective vaccines, which, if deployed with timely distribution and extensive populations coverage, could potentially contribute to generating herd immunity and effective control of COVID-19, having afflicted tens of millions of people in a worldwide pandemic.
The panel warned that SARS-CoV-2 is a novel viral strain that is spreading rampantly and globally – even with evolving mutant strains — and consequently, traditional processes and timelines for vaccine development would fail to provide an immediate and comprehensive solution. In a pandemic situation, urgent clinical development and widespread rollout of new vaccines become paramount. While emphasizing adherence to the principles of relevance and limitations of immune response markers and systematic approaches to assessing safety and reactogenicity, a re-thinking around the efficient design of efficacy and safety studies, with clinically relevant case definitions, is warranted. More importantly, this knowledge needs to be continually supplemented and updated with real-world monitoring and evaluation of disease understanding and the comparative effectiveness of vaccines across diverse patient demographics and against new mutant forms.
To address this pressing challenge globally, several vaccines developed in such an accelerated manner have been authorized by nations across the world for emergency use in the pandemic and for large-scale deployment against the spread of COVID-19 and the rapid achievement of herd immunity. While some of these have even utilized novel mRNA platforms, it is critical to continually underscore that fundamental clinical development principles are not compromised. The panel cautioned that the utility of both traditional and newer approaches needs to be assessed in the context of transparent data and peer-reviewed results for the various Emergency Use Authorization (EUA) products.
Moreover, as has been the concerning experience with earlier vaccines, it is imperative to dispel COVID-19 vaccine hesitancy, even while advocating for equitable vaccine access across the world’s nations, if the desired herd immunity is to be successfully achieved. Judicious communication and intervention strategies to educate an often-circumspect public and dispel disinformation contributing to such vaccine hesitancy will need to be proactively considered and implemented, alongside fairness with access and vaccination outreach.
Additionally, the global audience was apprised on the spectrum across fundamentals and translational science considerations in vaccine development targeting SARS-CoV-2, encompassing accelerated clinical development of COVID-19 vaccines and the evolving regulatory considerations and guidance for their EUA and disbursement. Perspectives on the fast-tracked clinical assessment and development of COVID-19 vaccines during this pandemic were also shared. What could have been done differently to benefit and/or improve the outcomes and assessments? What elements could gainfully be extrapolated to overall medicines development? The potential implications of this paradigm shift on future drug development processes and access to innovative medicines, especially in critical care and rare diseases, are already the subject of intense public interest and scrutiny.
The panel also explored the typical profile of the vaccine refuser – stemming from a distrust of governments and staunch religious and political beliefs, among other personal experiential factors – and stressed the value and importance of medically factual disease and vaccine education in countering vaccine hesitancy and combating disinformation, while seeking to optimize access and vaccination rates amongst the world’s diverse populations.