Saturday, April 20, 2024

Transitioning Flu Vaccines: The Challenge of Removing the B/Yamagata Strain

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The B/Yamagata strain of the flu B virus has vanished during the COVID-19 pandemic, leading the World Health Organization (WHO) and some national drug regulators to recommend removing it from flu vaccines. However, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) suggests that a complete transition for Northern Hemisphere flu vaccines will occur in the 2025-2026 cycle, with Southern Hemisphere vaccines following in winter 2026. This adjustment is not as straightforward as it may seem due to regulatory and manufacturing hurdles.

Typically, flu vaccines target four virus types, including two influenza A viruses and two flu B viruses (B/Victoria and B/Yamagata). Including both flu B viruses in vaccines is a relatively recent development aimed at increasing effectiveness. However, B/Yamagata viruses have been less prevalent and evolving slower than B/Victoria viruses, leading to suggestions for their removal from vaccines.

The shift from quadrivalent to trivalent vaccines is complicated by regulatory requirements across different countries and the need for revalidation and approval of manufacturing processes. This transition involves substantial logistical challenges with approximately 350 trivalent vaccine licenses requiring updates and coordination with roughly 170 regulatory agencies.

Flu Vaccine

Global Advocacy for Synced Transition in Flu Vaccine Manufacturing

The IFPMA is advocating for a synchronized global shift to prevent supply problems. Some experts believe the U.S. could transition faster due to its existing regulatory frameworks. However, the U.S. Food and Drug Administration (FDA) and vaccine manufacturers are still discussing the specifics of this change. The situation is expected to become more apparent after the WHO’s meeting in February, where strain selections for the following flu vaccines are determined.

The disappearance of the B/Yamagata strain of the flu B virus and the recommendation for its removal from flu vaccines present significant regulatory and manufacturing challenges. The IFPMA suggests a global, synchronized shift is necessary to prevent supply issues. The situation should become clearer following the WHO’s February meeting.

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