In a surprising move, Intervet International B.V. has withdrawn its application for marketing authorization for Equilis EHV 1+4, an equine herpesvirus (EHV) inactivated vaccine. Submitted to the European Medicines Agency (EMA) in February 2023, the application aimed to secure approval for using this vaccine in horses. It notably targeted reducing the severity and duration of clinical signs of respiratory diseases, such as rhinopneumonitis, caused by EHV-1 and EHV-4. The strategic withdrawal on July 19, 2024, occurred at a critical juncture—during the clock-stop at day 120 of the procedure—when Intervet cited insufficient resources as the stumbling block to resolving existing issues.
Application Intentions and Structure
Intervet International, a known entity in the veterinary sector, presented Equilis EHV 1+4 for active immunization as part of the centralised procedure under Article 42(4) of Regulation (EU) 2019/6. The vaccine comprises inactivated EHV-1 (strain RAC-H) and EHV-4 (strain 2252), administered intramuscularly to horses. The submission was engineered to align with full applications under Article 8 requirements, potentially culminating in a milestone approval for equine health within the EU. However, the application’s withdrawal has redirected attention toward the complexities encountered during the evaluation by the Committee for Medicinal Products for Veterinary Use (CVMP).
Reasons and Repercussions
Intervet’s retreat stemmed from an internal assessment revealing inadequate resources to address procedural challenges. This decision interrupts implementation strategies for the vaccine, leaving a void in the efforts to mitigate EHV outbreaks amongst equine populations. The EMA’s publication of the withdrawal assessment report provides transparency and insights into these challenges while reflecting on what remains unfinished.
Key takeaways from the situation include:
- The intricacies and demands of securing EMA approval for veterinary vaccines.
- The importance of strategic resource allocation and planning in product development timelines.
- The impact of regulatory processes on vaccine availability in the market.
The journey of Equilis EHV 1+4 underscores the hurdles in veterinary medicine authorization. Intervet’s decision highlights both the rigorous standards and uncertainties embroiled in bringing new medical solutions to market. The approach of transparent communication by EMA, through assessment reports and shared documentation, offers a learning curve for stakeholders. As equine health remains a priority, the industry anticipates either eventual resolution or alternative interventions poised to curb equine herpesvirus impact effectively. Efforts must intensify to cover ground in veterinary vaccine advancements, focusing on strategic foresight, adaptability, and innovation for robust health management systems.
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