MHRA authorizes Seqirus’ Aujemflu, an adjuvanted trivalent cell‑based influenza vaccine, for adults aged 50+, supported by Phase III trial data showing stronger immune responses versus egg‑based comparators.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to Aujemflu, an adjuvanted trivalent influenza vaccine developed by Seqirus UK Limited, for the prevention of seasonal influenza in adults aged 50 years and older.
The June 4, 2026 decision expands access to a cell-based, egg-free influenza vaccine that incorporates an adjuvant to strengthen immune responses in older adults, a population at heightened risk of severe flu-related complications.
Cell-Based Manufacturing and Adjuvant Technology
Aujemflu is produced using cell-culture technology rather than traditional egg-based manufacturing, avoiding egg-derived components while utilizing a modern vaccine production platform. The vaccine incorporates an adjuvant to strengthen and broaden immune responses, addressing the reduced immunogenicity often observed in older adults.
By targeting three influenza virus strains selected according to World Health Organization recommendations for the 2025/2026 season, Aujemflu stimulates protective antibody generation without containing ingredients capable of causing flu infection.
Clinical Evidence Supporting Approval
Authorization was supported by data from a Phase III study (NCT06015282) involving 7,699 participants aged 50 years and older. The trial evaluated a quadrivalent version of the vaccine, which demonstrated stronger immune responses compared with a quadrivalent adjuvanted egg-based influenza vaccine and comparable responses to a quadrivalent recombinant influenza vaccine against three of the four strains assessed.
These findings supported the vaccine’s ability to generate broad immune protection against seasonal influenza in older adults. Although the pivotal study evaluated a quadrivalent formulation, the MHRA concluded that the immunogenicity findings were applicable to the trivalent version authorized for use in the UK.
Safety Profile and Pharmacovigilance
The MHRA concluded that Aujemflu’s benefits outweigh its risks following a review of quality, safety, and immunogenicity data.
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, stated that the agency will continue to closely monitor the vaccine’s safety and effectiveness following authorization.
Safety surveillance will continue through routine pharmacovigilance activities and the UK’s Yellow Card reporting system, which allows patients and healthcare professionals to report suspected adverse events. Aujemflu is administered as a single intramuscular injection in the upper arm by a healthcare professional.
Regulatory Perspective and Market Positioning
The approval was granted through the MHRA’s national assessment procedure, with product information, including the Summary of Product Characteristics and Patient Information Leaflet, expected to be published on the MHRA Products website within seven days.
The authorization strengthens the UK’s seasonal influenza vaccine portfolio and adds a new adjuvanted, cell-based vaccine option for adults aged 50 years and older alongside existing egg-based and recombinant influenza vaccines.
Clinical and Regulatory Outlook
With authorization secured, Aujemflu becomes a new vaccination option for UK adults aged 50 years and older ahead of upcoming seasonal immunization campaigns. The approval expands access to influenza vaccines that use alternative manufacturing technologies while supporting efforts to improve protection among populations at increased risk of flu-related hospitalization and mortality.
As seasonal influenza continues to place a significant burden on healthcare systems, the addition of Aujemflu provides healthcare providers with another tool to help protect older adults against circulating influenza strains recommended for the 2025/2026 season.
Reference
Adjuvanted trivalent influenza vaccine authorised for adults aged 50 and over – GOV.UK
About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.