How our vaccines team supports innovation across global healthcare systems

Michael Pfleiderer, PhD

Development of vaccines is a complex, evolving and highly specialized field that spans innovation, regulatory science and public health. Technologies have rapidly emerged as new epidemics and pandemics have developed around the world, which has inevitably meant that regulators are battling to keep up with changes, and health systems are under massive strain.

One of the unique features of vaccines is that they are fundamentally about public health and diseases that have a huge impact on developing countries.

As my colleague, senior consultant Jerry Fuady, Ph.D., has noted, vaccines are very much about preventive care and in many cases are targeted at developing and lower-income countries. That means there is perhaps less incentive for the pharmaceutical industry to develop them, compared with treatments for high-profile diseases. Procurement is also very different in this market, since vaccines are largely bought by governments or non-profit organizations.

Furthermore, because vaccines are given to a large percentage of the population in any geographic region, they must demonstrate that they are safe. This can become a challenging political issue, with population mistrust often fed by anti-vaccination groups.

In such a dynamic industry, the need for experts with deep knowledge of the science, regulatory environment and vastly different public health systems around the world is paramount.

The vaccines team within Biopharma Excellence has become the global go-to resource for vaccine manufacturers worldwide. The team comprises virologists, vaccinologists, a molecular biologist and an experienced former regulator.

As another key member of the team, senior consultant Ilona Baraniak, Ph.D., succinctly put it: “Vaccines are different from other biopharmaceutical products, and that dictates how we work and with whom we are working. Because of that you can’t really mix the expertise from other biopharmaceuticals, because these experiences will not be compatible.”

What makes our team unique is that we work with multiple stakeholders, handling more than 200 vaccine projects across around 50 clients, ranging from start-ups to big pharma, NGOs, governmental and non-governmental institutions, academia, legal firms and more. Our work has even involved collaboration with the World Health Organization.

Projects range from strategic advice, helping companies set up the direction for product development to providing opinions – particularly during the COVID-19 pandemic – either directly or through white papers to support developers and regulatory agencies. The team also prepares dossiers, briefing documents and supports meetings with the agencies and provides strategies to address problems, for example, if a clinical trial application is denied or if marketing applications become more complex than anticipated.

It’s therefore very important that the science is clearly and transparently communicated, and part of our role is to make sure that the development of a vaccine is in accordance with the proper practices and that these are as transparent as possible.

Shaping the industry and regulatory landscape

Our team’s expertise in vaccine and other biopharmaceutical regulations has also helped to shape the current regulatory landscape. We developed regulatory concepts and proposed several innovative solutions that were subsequently successfully implemented, such as in the implementation of regulations for mRNA technologies and the clinical development of SARS-CoV-2 vaccines for those companies who came later to clinical development during the pandemic.

Another area of focus for our team has been to develop a vision for how the CMC, non-clinical and clinical development of the novel vaccine technologies should be merged with smart regulatory solutions worldwide. This requires knowledge and adaptation since guidance from the regulators is never 100% applicable to innovative products.

As we have shown, there’s a difference between licensing a vaccine at the beginning of the pandemic, compared to doing the same much later, since, early on, developers have access to a clinical trial population, whereas well into a vaccine rollout a large portion of the population is vaccinated, so it’s hard to create placebo groups. For example, with one vaccine, we convinced the authorities that you could also license a product by doing comparative immunogenicity with a licensed product.

We also provided support for the first dengue fever vaccine licensed in the EU, in 2017, as well as the Ebola vaccine that was licensed in the EU in 2019.

One major challenge with managing vaccines is that many lower-income countries don’t have a fully functional regulatory system to support vaccine approval and roll-out. This is an area where our team has played a significant role. To help bring vaccine equity to Africa, we were tasked with developing a white book, which evaluates the challenges faced and tools needed to achieve sustainable vaccine manufacturing in Africa through a “tech and reg” transfer.

In June, linked to this important program, Biopharma Excellence was invited to witness the signing of a new Memorandum of Understanding (MoU) between Rwanda FDA and Ghana FDA around the provision of reciprocal technical assistance related to medicines and vaccines manufacturing regulatory oversight.

All of us in the team believe there is no more exciting and important area to work in, since, besides access to clean water, access to vaccines saves the most lives worldwide.

Going forward, we are eager to ensure the expertise has greater visibility across PharmaLex and more broadly, and to build a flexible and sustainable knowledge ecosystem within the unit to ensure knowledge is retained within the organization.

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