The World Vaccine Congress, a meeting dedicated to vaccines, was recently held October 10 – 13, in Barcelona. The meeting covers basic research to commercial manufacture, along the whole vaccine value chain where science, government and manufacturers come together to create progress.
 
Shelley McLendon, Senior Vice President of Vaccine and Infectious Diseases Program Management at ICON spoke at the conference on the topic of fortifying vaccines against future pandemics. Shelley discusses the importance of disease surveillance, developments in early outbreak detection, and the role of smart data reporting and adaptive trial designs. –KB 
 
Contract Pharma: What’s the importance of disease surveillance and reporting with regards to emerging infectious diseases?
 
Shelley McLendon: While disease surveillance and reporting can be critical to responding quickly to an emerging infectious disease (EID) outbreak and preventing its spread, it also has a significant impact on vaccine development and clinical trials. Although vaccine candidates may be developed in the absence of an outbreak, to prove efficacy, they must be tested in a population where the target disease is being actively transmitted. However, EID outbreaks can be unpredictable and often move quickly, making it difficult to select appropriate clinical trial sites and enroll patients swiftly enough to gather sufficient vaccine efficacy data. 
 
Robust surveillance and reporting systems greatly increase the ability to make better informed decisions regarding where and when to conduct a vaccine efficacy trial, and to take action in a timely manner. Early alert systems, in particular, can play a critical role in responding to an EID outbreak, as the earlier an outbreak is detected, the faster it can be acted upon. 
 
Contract Pharma: What are some promising developments in early outbreak detection?
 
Shelley McLendon: Wastewater surveillance is one particularly promising new development. For some diseases, clinical monitoring can be challenging, and does not always present the complete information regarding the presence of a disease in a population. This can be due to a number of reasons, ranging from the lack of resources to test for a particular disease, to limited access, or unwillingness, to seek healthcare on the part of patients. Monitoring wastewater, however, can detect the presence and prevalence of a given pathogen in human stool and other waste across an entire population, and does not rely on testing every individual for accuracy.
 
This method has been put to the test during the COVID-19 pandemic. In September of 2020, the Centers for Disease Control and Prevention launched the National Wastewater Surveillance System (NWSS) to coordinate and build the nation’s capacity to track the presence of SARS-CoV-2 in wastewater samples collected across the United States. The NWSS has worked with local health departments to track levels of SARS-CoV-2 in communities and respond quickly, as wastewater surveillance can be an early indicator that the numbers of people with COVID-19 within a community are rising or declining.
 
Contract Pharma: What role do smart data reporting and adaptive trial designs play in the clinical trial process?
 
Shelley McLendon: Disease surveillance relies on smart, effective data reporting to aggregate, access and analyze the epidemiological information that surveillance systems gather. Local and regional systems of data reporting can effectively inform site selection and the implementation of vaccine efficacy trials. Additionally, reliable and centralized data reporting can play an integral role in providing the information needed to develop vaccines for EIDs. In the case of COVID-19, researchers lost invaluable time in January and February 2020, as they were only able to access and analyze scraps of data from official reports, newspaper articles, and social media posts. As one example of an effort to modernize the U.S.’s outdated public health data system and drive effective decision-making, the National Center for Epidemic Forecasting and Outbreak Analytics was created in 2021.
 
For clinical trials to make use of surveillance data and act upon them quickly, responsive trial strategies are an effective option. These help to counter the difficulty, mentioned earlier, of unpredictable and swiftly moving outbreaks, which render traditional site selection and enrolment too slow. In contrast, responsive strategies help clinical trials follow where disease risk goes. Researchers can identify geographic areas and communities that are at high risk for disease and respond to surveillance data from those areas in real time, allowing for trial sites and enrolment to be activated by disease transmission. For instance, ring trials — such as those used to test the efficacy of a novel Ebola vaccine during the 2014-2016 epidemic in West Africa — identify and vaccinate all the contacts of an individual confirmed to be infected with the target disease.
 
Adaptive trial designs can help to improve the efficiency of vaccine trials by creating a plan to modify trial elements, depending on the data it generates. This involves conducting pre-scheduled analyses of trial data and making pre-specified adjustments accordingly — such as refining the sample size, abandoning treatments or doses, or stopping the trial early, if success or lack of efficacy is clear. This flexibility can reduce the number of needed participants or resources for a trial, saving time and money as a result. 
 
Of course, there are a number of other components to an effective vaccine strategy against an EID. To recruit and retain participants in vaccine clinical trials, as well as protect public health, institutional trust in pharmaceutical companies and vaccines must be encouraged. With regard to comprehensive vaccine development, an equitable and accessible vaccine distribution plan for all of those at risk for disease, regardless of income, should be top priority. While challenging, these aspects of vaccine strategy and development are crucial for global health in the face of EIDs.