Sunday, April 14, 2024

EMA’s Strategic Transition to Trivalent Influenza Vaccines: Enhancing EU’s Public Health Response

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The European Medicines Agency (EMA) has initiated a significant transition from quadrivalent to trivalent seasonal influenza vaccines across the European Union to align with the latest scientific insights and global health policy directions. This strategic shift, deeply informed by an analysis of virus circulation patterns and vaccination outcomes, reflects a comprehensive approach to optimizing vaccine formulations to meet the evolving challenges of influenza control and prevention. It stands as a testament to the EU’s commitment to adopting evidence-based strategies that not only enhance the efficacy of influenza vaccines but also streamline immunization efforts to better protect public health.
The decision to move towards trivalent influenza vaccines is based on meticulous surveillance and research, indicating a diminished prevalence of the B/Yamagata virus lineage in recent years, which has led to its exclusion from the upcoming season’s vaccine composition. By adapting vaccine components to more accurately reflect the current influenza virus landscape, the EMA aims to improve the precision of seasonal influenza protection, thereby increasing the overall effectiveness of vaccination campaigns across member states.
This adaptation of vaccine strategy also underscores the EU’s agility in responding to public health needs, demonstrating a proactive stance in the face of changing epidemiological data. The shift to trivalent influenza vaccines is expected to simplify vaccine production and distribution processes, potentially leading to enhanced accessibility and coverage of influenza vaccination across diverse populations within the EU. Moreover, this move is anticipated to facilitate a more focused allocation of healthcare resources, optimizing the utilization of medical and economic resources in the fight against seasonal influenza.
Through this transition, the EMA not only aims to bolster the EU’s defenses against influenza but also to set a precedent for future vaccine strategy adaptations, highlighting the importance of flexibility and responsiveness in vaccine policy formulation. This pivotal change in the EU’s public health strategy exemplifies a forward-thinking approach to disease prevention, emphasizing the need for continuous evaluation and adjustment of immunization practices to safeguard the health and well-being of its citizens.

EU’s Shift from Quadrivalent to Trivalent Formulations Amid Changing Virus Patterns

In the realm of influenza prevention, influenza vaccines have traditionally been categorized into trivalent (TIVs) and quadrivalent (QIVs) formulations. TIVs incorporate two strains of influenza A and one strain of influenza B, selected based on predictions of the most prevalent strains for the upcoming flu season. On the other hand, QIVs, which have been the standard in the EU, include an additional B virus lineage, offering broader protection. However, the absence of the B/Yamagata virus lineage in global surveillance data since March 2020 has led to a reevaluation of the necessity of including this antigen in seasonal vaccines.

Global health databases, including the Global Initiative on Sharing All Influenza Data (GISAID) and the World Health Organization’s FluNet, have not reported any detections of the B/Yamagata strain for the past four years. This absence, coupled with the effectiveness of public health measures against SARS-CoV-2, which may have also limited the spread of influenza viruses, has diminished the public health threat posed by the B/Yamagata lineage. Consequently, the World Health Organization (WHO) has advised a swift transition to manufacturing seasonal influenza vaccines without the B/Yamagata component, recommending formulations that only include A/(H1N1)pdm09, A/(H3N2), and B/Victoria subtypes for both live attenuated and inactivated vaccines.

In response to these developments and WHO recommendations, the EMA’s Emergency Task Force (ETF) has advocated for a structured shift towards trivalent influenza vaccines. This approach aims to phase out the inclusion of the B/Yamagata antigen, which is now considered redundant. Despite this strategic pivot, the ETF emphasizes the importance of continued vigilance in monitoring influenza virus patterns to confirm the sustained absence of the B/Yamagata lineage.

Influenza Vaccines

EU’s Strategic Shift to Trivalent Influenza Vaccines: Addressing Regulatory and Logistical Challenges

A review of the regulatory status of EU-approved seasonal influenza vaccines has been undertaken to identify and mitigate potential challenges during this transition. This comprehensive review involved consultations with EU public health authorities and vaccine manufacturers, leading to the recommendation of prioritizing the re-authorization of TIVs, especially for live attenuated vaccines due to the hypothetical risk of reintroducing the B/Yamagata strain through vaccination.

The transition to TIVs, particularly for inactivated influenza vaccines, presents logistical and regulatory challenges, given the current approval status of these vaccines at the national level and the predominant approval of newer influenza vaccines as QIV formulations. Nonetheless, the ETF suggests that the removal of the B/Yamagata lineage from live attenuated vaccines could ideally begin in the 2024/2025 influenza season, with a broader goal of transitioning all influenza vaccines to trivalent formulations by the 2025/2026 season.

This strategic realignment in vaccination policy underscores the EU’s commitment to adapting its public health strategies in response to emerging scientific evidence and global health trends. It reflects a proactive stance in optimizing vaccine protection against influenza, ensuring that immunization efforts are both scientifically grounded and aligned with current public health needs.


Resource: Europian Medicines Agency, March 26, 2024

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