Priyabrata Pattnaik

Rabies, a viral disease, spreads largely through bites or scratches from infected animals. It is a serious global public health threat. Although preventable, it can be fatal if timely medical support is not extended before symptoms appear. We highlight rabies elimination aligned with the UN’s “Zero by 30” goal through evidence-based One Health interventions. This will help public health practitioners and policymakers devise effective health and well-being interventions to contain the ailment, especially in low- and middle-income countries (LMICs).

Rabies is a neglected viral disease that kills nearly 70 000 humans annually, majorly in Africa and Asia. Ingress of compromised counterfeit anti-rabies vaccine raises global concern. Counterfeit vaccine has formulation, packaging, labelling, and supply-chain discrepancies. The sales and purchase of vaccines may need due vigilance through market surveillance to identify and seize to protect from potential harms. Strict regulations and improved monitoring systems may be implemented to counter cold chain failures and illegal activities. Consistent community engagement programs and patient advocacy on rabies to share knowledge and gaps toward sustainable outcomes was needed. “Block-chain” could revamp the existing system to support and enable supply chain management and eliminate illegal activities. To meet the vision of zero human rabies deaths by 2030, issues on strong intervention and collaborative response from all stakeholders could be considered on priority.

Infectious Bovine Rhinotracheitis (IBR) is endemic in India, causing significant losses to dairy enterprises. Until recently, the unavailability of an indigenously manufactured vaccine and the high cost of imported vaccines limited national vaccination efforts. However, an indigenously developed and manufactured inactivated DIVA vaccine has now become available. The exact strategies that other countries have employed for the successful control of IBR may not be applicable in India due to the differences in the production systems and the social values. Hence, we have employed linear deterministic modeling to study the benefits, both in terms of the protection of the animals from the disease and the costs, of vaccination against IBR towards proposing an optimal strategy for immunization-based control of the disease in India. Our findings emphasize the need for proper vaccination practices, appropriate farm biosecurity measures, and biannual re-vaccinations to achieve the desired endpoints in a vaccination program. Based on our findings, a vaccination program aiming for primary vaccination with two doses followed by continuing bi-annual re-vaccination with a single dose to achieve 70% vaccination coverage in the cattle population can be recommended for the control of IBR in India.

Background: Infectious Bovine Rhinotracheitis (IBR), Infectious Pustular Balanoposthitis (IPB), Infectious Pustular Vulvovaginitis (IPV), late-term abortions, and neurological and systemic disease are common manifestations of Bovine Herpesvirus-1 (BoHV-1) infections. IBR is enzootic to India and several other countries across the world. Globally, both live attenuated and inactivated vaccines are available commercially for the control of the disease. This communication reports the results of an open-label, randomized field trial of an inactivated IBR marker vaccine in cattle. Methods: An indigenously developed, inactivated, glycoprotein-E (gE)-deleted marker vaccine was subjected to a field trial involving 90 healthy cattle of more than three months of age, evaluating its safety and immunogenicity. Results: Vaccination was safe without any adverse and serious adverse events, except a self-limiting and self-subsiding induration at the site of injection in a few cases. The vaccine caused elevation of body temperature but within normal physiological range; no derangements in feed intake or milk yield were recorded. A total of 90% of the subjects developed protective titers of SNT₅₀ ≥ 8 after receiving both doses of initial vaccination and maintained protective titers until 180 days thereafter. Conclusions: Altogether, our findings uphold that the indigenously developed, inactivated gE-deleted marker vaccine against IBR is safe and results in protective levels of immunity for at least six months in cattle of more than three months of age.

Vaccines are complex and a very diverse group of products with relatively long product lifecycles. The manufacturing programs for these vaccines need to be continually updated to comply with evolving regulatory expectations. Members of the Parenteral Drug Association (PDA) Vaccines Interest Group (VIG) authored and published PDA Technical Report No. 89 Strategies for Vaccine Development and Lifecycle Management (TR 89) which seeks to provide context to vaccine developers and manufacturers regarding key aspects of new or legacy vaccines such as control strategy from process development to vaccine lifecycle management, comparability and lifecycle management including technical, validation, quality and regulatory perspectives. To further explain and illustrate the concepts and topics discussed, seven relevant situations were selected as either case studies associated with changes implemented or proposed process development strategies, which are discussed in this article. The situations described are: working cell bank, modification or update of externally supplied product contact components for vaccine manufacturing, raw material change, new product at an existing site, vaccine development acceleration by leveraging existing platforms, selection and implementation of potency method, and modeling for stability forecast prediction. For each situation, the applicable key concepts from TR#89 are discussed as follows: Control Strategy, Prior Knowledge, Relying on PQS, Classification of Parameters, Validation Approach, Use of a Risk-based Approach, Comparability, Use of ICHQ12 and Additional Regulatory Considerations.