A Case Study of European Collaboration between the Veterinary and Human Field for the Development of RSV Vaccines.

The One Health (OH) approach describes the interconnection between the health of animals, humans, and the environment. The need for collaboration between the veterinary and human fields is increasing due to the rise in several infectious diseases that cross human-animal barriers and need to be addressed jointly. However, such collaboration is not evident in practice, especially for non-zoonotic diseases. A qualitative research approach was used to explore the barriers and enablers influencing collaborative efforts on the development of vaccines for the non-zoonotic RSV virus. It was found that in the European context, most veterinary and human health professionals involved in RSV vaccine development see themselves as belonging to two distinct groups, indicating a lack of a common goal for collaboration. Next to this, the different conceptualizations of the OH approach, and the fact that RSV is not a zoonotic disease, strengthens the opinion that there is no shared need for collaboration. This paper adds insights on how, for a non-zoonotic situation, collaboration between human and veterinary professionals shaped the development of vaccines in both areas; thus, improving public health requires awareness, mutual appreciation, and shared goal setting.

Innovations in the veterinary intestinal health field: A patent landscape analysis.

In recent years it has become evident that a healthy intestinal microbiome is beneficial for the overall health of an individual. A healthy microbiome is diverse, increasing stability and resilience and strengthening the immune system. In addition, healthy intestinal metabolisms have a beneficial effect on many physiological processes such as the brain function. Looking from the One Health perspective, which recognizes that health of humans is closely connected to the health of animals and environment, it is inherently beneficial to stimulate the health of animals for the well-being of humans. However, the intensive administration of antibiotics to livestock for prevention and cure of disease, and even stimulation of growth, disrupts a healthy microbiome. With the rapid increase of emerging zoonotic diseases, alternatives to the use of antimicrobial compounds are urgently necessary. This research analyses the development of alternatives for antibiotic use contributing to veterinary intestinal health through an in-depth patent analysis of inventions for fodder additives. In the period 1999-2020, 1269 unique patent families describing the use of probiotics, enzymes and prebiotics for swine, poultry and ruminants were identified. Innovation trends, geography, key applicants, and classification of patents were analysed. Asian industrial applicants applied for the majority of patents comprising the largest share of patents for probiotics and enzymes in combination with fodder for swine. Followed by North American and European industrial applications, applying for patents for probiotics in combination with fodder for poultry, swine, and ruminants. Overall, our results do not show a clear increase in innovations, suggesting that innovations in the use of probiotics and enzymes in animal feed appear to be stalling. While in the near future a combination of the use of antibiotics and alternatives is most likely to be implemented, the use of probiotics stands a good chance of replacing antibiotics in animal husbandry and limiting the adverse effects of antibiotic abuse.

Identifying Cross-Utilization of RSV Vaccine Inventions across the Human and Veterinary Field.

The respiratory syncytial virus (RSV) has two main variants with similar impact, a human and a bovine variant. The human respiratory syncytial virus (HRSV) is the most frequent cause of acute respiratory disease (pneumonia) in children, leading to hospitalization and causing premature death. In Europe, lower respiratory tract infections caused by HRSV are responsible for 42-45 percent of hospital admissions in children under two. Likewise, the bovine respiratory syncytial virus (BRSV) is a significant cause of acute viral broncho-pneumonia in calves. To date no licensed HRSV vaccine has been developed, despite the high burden of the disease. In contrast, BRSV vaccines have been on the market since the 1970s, but there is still an articulated unmet need for improved BRSV vaccines with greater efficacy. HRSV/BRSV vaccine development was chosen as a case to assess whether collaboration and knowledge-sharing between human and veterinary fields is taking place, benefiting the development of new vaccines in both fields. The genetic relatedness, comparable pathogeneses, and similar severity of the diseases suggests much can be gained by sharing knowledge and experiences between the human and veterinary fields. We analyzed patent data, as most of pharmaceutical inventions, such as the development of vaccines, are protected by patents. Our results show only little cross-utilization of inventions and no collaborations, as in shared IP as an exchange of knowledge. This suggests that, despite the similarities in the genetics and antigenicity of HRSV and BRSV, each fields follows its own process in developing new vaccines.

Barriers Influencing Vaccine Development Timelines, Identification, Causal Analysis, and Prioritization of Key Barriers by KOLs in General and Covid-19 Vaccine R&D.

A frequently mentioned factor holding back the introduction of new vaccines on the market are their prohibitively long development timelines. These hamper their potential societal benefit and impairs the ability to quickly respond to emerging new pathogens. This is especially worrisome since new pathogens are emerging at all-time high rates of over one per year, and many age-old pathogens are still not vaccine preventable.Through interviews with 20 key-opinion-leaders (KOLs), this study identified innovation barriers that increase vaccine development timelines. These innovation barriers were visualized, and their underlying causes revealed by means of qualitative root cause analysis. Based on a survey the innovation barriers were quantitatively ranked based on their relative impact on both regular, and Covid-19 vaccine development timelines. KOLs identified 20 key innovation barriers, and mapping these barriers onto the Vaccine Innovation Cycle model revealed that all phases of vaccine development were affected. Affected by most barriers is the area between the preclinical studies and the market entry. Difficult hand-off between academia and industry, lack of funding, and lack of knowledge of pathogen targets were often mentioned as causes. Quantitative survey responses from 93 KOLs showed that general vaccine development and Covid-19 vaccine development are impacted by distinct sets of innovation barriers. For the general vaccine development three barriers were perceived of the highest impact; limited ROI for vaccines addressing disease with limited market size, limited ROI for vaccines compared to non-vaccine projects, and academia not being able to progress beyond proof of principle. Of highest impact on Covid-19 vaccine development, are lack of knowledge concerning pathogen target, high risk of upscaling unlicensed vaccines, and proof of principle not meeting late-stage requirements. In conclusion, the current study demonstrates that barriers hampering timelines in vaccine development are present across the Vaccine Innovation Cycle. Prioritizing the impact of barriers in general, and in Covid-19 vaccine development, shows clear differences that can be used to inform policies to speed up development in both war and peace time.