Luc Gagnon, vice president of vaccine sciences at Nexelis, gives an insight into the increase in vaccine hesitancy and the role that pharmaceutical and R&D industries need to take to address the problem.
The rise of an anti-vaccination sentiment
Vaccinations have been a key innovation from the health industry in safeguarding us from previously serious and deadly diseases, protecting us in new ways to major public health threats. Vaccines represent a landmark shift from treatment to prevention, saving countless lives and improving the health and life expectancy of millions around the world.
Despite all this, vaccines have historically always attracted criticism and controversy. Whether vaccines are addressing measles, mumps, and rubella (MMR), smallpox or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), their safety and efficacy have come into question by some. The anti-vaccination movement has often focused their messaging to manipulate reports or cherry-pick data to present misinformation with conclusions that cause confusion among the public. For example, the US Centers for Disease Control and Prevention updated their definition of a vaccine in 2021 to add clarity and transparency around vaccine effectiveness; however, this was regarded by some to be because ‘COVID-19 vaccines are ineffective’, a view that has been widely discredited.
Unfortunately, as SARS-CoV-2 vaccination programmes have been rolled out across the world, we have seen in parallel the growth of anti-vaccination sentiment. With the World Health Organization previously describing vaccine hesitancy as a global health threat, what can the clinical research community do to address concerns and ensure the growing movement does not threaten current or future vaccine programmes?
Vaccine development under accelerated timelines
If you examine the rationale behind vaccine hesitancy, one reason often cited is the speed at which SARS-CoV-2 vaccines have been developed, often compared with other therapies and medicines that take a decade from identifying a candidate to securing approval for use commercially. Reasons for explaining the speed of SARS-CoV-2 vaccine development could be because of the use of new mRNA technology, and due to new levels of collaboration and resource pooling seen across the research and development (R&D) industry.
Astute clinical research organisations (CROs) had established partnerships long before the pandemic, which allowed companies to respond quickly when the need arose. Public health and safety have always been a priority for Nexelis, and in preparedness collaborated with the UK Health Security Agency (UKHSA) over two years prior to the outbreak of COVID-19. Existing partnerships such as these facilitated the rapid development of reference vaccine and drug efficacy assessment SARS-CoV-2 assays, enabling industry partners to get ahead when it came to developing new vaccines to tackle this unprecedented public health threat.
In parallel, key non-governmental organisation partnerships such as the Coalition for Epidemic Preparedness Innovation (CEPI) have established a centralised laboratory network to reliably assess and compare immunological responses generated by COVID-19 vaccine candidates. Nexelis is a key partner within this network, playing an integral role in the development and standardisation of assays and strengthening concerted efforts for efficient assay transfers vital to supporting the rapid development of new vaccines.
Importantly, scientific rigor was not compromised throughout this accelerated process of vaccine development, with robust strategies in place for accurate and precise assays, in-house production of critical reagents, and process regulations to ensure lot-to-lot control.
So where can R&D support the fight against vaccine hesitancy?
R&D approaches to build confidence
Industry must improve and act faster to harness the science at an early stage, to quickly build an understanding and confidence in vaccine development. R&D teams must aim to provide results at a faster pace for pandemic-related candidates.
There is also a need for ongoing studies for post-approval efficacy endpoints and real-world data studies to alleviate mistrust. These are all important areas in which R&D can play a role.
Partnerships between industry and leading bodies and networks who recognise the importance of public health and safety, such as the UKHSA and the Bill & Melinda Gates Foundation, help ensure the right technical expertise is in place to allow people to feel confident in the processes and work undertaken. These partnerships continue to promote and expedite advances in research, enabling the use of laboratory techniques and technology, including the development of humoral and cellular assays to continue to expand upon how we approach efficacy testing for new infectious diseases and infectious diseases without effective vaccines. The vaccine assays selected can be driven by sponsor request, regulatory requirement, or best scientific rationale for the infectious disease.
Several infectious diseases require a BSL-3 laboratory for research, including yellow fever, West Nile virus, chikungunya, and COVID-19. CROs with BSL-3 laboratory facilities are a vital resource to the industry, providing vaccine manufacturers with the flexibility to perform assays and handle infectious diseases within a BSL-3 laboratory while operating with the efficiency and control needed for preclinical to late-phase trials.
Delivering excellence with true partners
It is clear that vaccines save lives. To keep those lives at the centre of everything we do, we must align between laboratories. At the beginning of the pandemic, there was a massive shift to create more alignment which was science-driven, and we must maintain that momentum for continued success.
As vaccine programmes have become embedded across countries and regions, education and transparency are paramount in building trust. CROs are fully blinded from sponsor results, so there are limitations in what they can do in influencing transparency and data sharing. However, R&D organisations can ensure assays are reliable and developed to the highest standard. This offers confidence in the accuracy of the scientific information.
Every day we continue to generate new data around COVID-19 vaccines, whether that is on the emerging validity of vaccines in different patient populations or the evidence behind giving boosters to vulnerable patient populations to continue to protect them. These data offer vital tools in the continued fight against the virus to help educate the public on the prevention options. CROs acting as an extension of the sponsor’s laboratory can collaborate with and challenge their partners to excel and publish data at the earliest opportunity.
Ensuring engagement with the right stakeholders with the right scientific expertise at the forefront of R&D developments can provide critical thinking and understanding to optimise the success of vaccines in the future. The driving force for success is setting new standards and collaboration across the industry, allowing us to move more quickly and more efficiently.
Through a solid grounding in evidence and facts, we in the industry must continue to challenge misinformation at every opportunity. After all, we have a responsibility to develop an effective vaccine, but we must also ensure continued clarity around its efficacy and safety to garner confidence and support in widespread uptake.