VACCINE DEVELOPMENT
parameters of over 90%. While the vaccine front is undeniably a remarkable success, and effective therapies are now available, these therapies are not the home run we would have hoped for, leaving considerable room for improvement for reductions in morbidity and mortality. With vaccination programmes having been rolled out in many developed countries where there is significant financial opportunity commonly associated with drug development, developers who are in early mid-phase development now find themselves in a difficult situation. They can still hope to rely on infection spreading in vaccine-hesitant pools, but with the caveat that the pools are poorly defined and may be difficult to predict. Developers of vaccines must consider that effective vaccines with real-world demonstrations of efficacy (for instance, AstraZeneca’s Vaxzevria) are being eschewed for vaccines with higher efficacy and more stable supply chains and manufacturing (Pfizer- BioNTech and Moderna). Given the clear efficacies of these vaccines, it likely does not make sense for these countries to continue to allow a number of different vaccines to enter clinical development. Indeed, the US Food and Drink Administration
has previously announced that if a company is not already in discussions for emergency use authorisation (EUA), it cannot be considered for this going forward. European countries have not made a similar announcement, but it would be
90 | Outsourcing in Clinical Trials Handbook
unsurprising if they were also uninterested in additional emergency approvals with such effective tools on hand. This leaves developers few options, with the
most obvious being to run their studies outside of wealthy, developed nations. This will indeed provide an opportunity to demonstrate the utility of a product, but with the downside that developed nations are unlikely to accept the data for use in their own countries. Another option is challenge studies, which are great for proof of principle, but with certain limitations. They might not reflect the protection conferred by whatever strain of the pathogen will be circulating upon launch, and they cannot be conducted with pathogens that are associated with severe disease for ethical reasons. Additionally, they are used largely for vaccines, not treatments, so should numbers of infected patients decrease substantially globally, there may be significant issues in demonstrating the efficacy of a COVID-19 candidate just because there are so few patients to go around. Ultimately, the rollout of effective and stable vaccines that reduce the spread of a disease to the point of not being able to trial a therapeutic candidate is generally a good thing. However, if new variants emerge, or pockets of vaccine- resistant individuals become more prevalent, this will certainly lead to increased cases and reiterate the importance of having therapies on hand even with the existence of safe and effective vaccines.
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