MHRA has granted a UK marketing authorisation for Aujemflu, an adjuvanted trivalent influenza vaccine, for adults aged 50 and over. The approval was issued on 4 June 2026 to Seqirus UK Limited, allowing the product to be placed on the UK market for flu prevention in this age group. (gov.uk) The decision is regulatory rather than operational. MHRA states that it has judged the vaccine's benefits to outweigh its risks, which is the threshold for authorisation, but that does not by itself determine how the product will be used across NHS vaccination pathways. (gov.uk)
Aujemflu is a trivalent vaccine, meaning it targets three influenza strains, and MHRA says those strains are aligned with World Health Organization recommendations for the 2025/2026 season. The product also contains an adjuvant, intended to strengthen immune response, and is prepared in cell culture rather than eggs. (gov.uk) For clinicians and service planners, that combination is notable because it adds an egg-free adjuvanted option to the authorised market. For patients, MHRA is explicit that none of the ingredients can cause flu. (gov.uk)
The evidence cited by MHRA comes from a study involving 7,699 participants aged 50 and over. Four weeks after vaccination, participants who received a quadrivalent version of the product showed a stronger immune response than those who received a quadrivalent adjuvanted egg-based influenza vaccine, and a comparable response to a quadrivalent recombinant influenza vaccine against three of four flu strains. (gov.uk) This is the key clinical point in the authorisation notice. The case set out by the regulator rests on comparative immune response data in the target age group, rather than on broad public claims about complete protection from seasonal flu. (gov.uk)
The application was approved under the MHRA's national assessment procedure. MHRA guidance describes that route as the UK-wide process for marketing authorisation applications, with separate requirements and timetables from the International Recognition Procedure. (gov.uk) The agency says the Summary of Product Characteristics and Patient Information Leaflet will be published on the MHRA Products website within seven days of approval. Once published, those documents provide the formal reference point for licensed use, safety information and product handling. (gov.uk)
MHRA says Aujemflu is administered as a single injection into the upper arm by a doctor, nurse or pharmacist. Patients are directed to the leaflet for the full side-effect profile and are encouraged to report suspected adverse reactions through the Yellow Card scheme. (gov.uk) The agency has also said the vaccine's safety and effectiveness will remain under close review after authorisation. That means post-authorisation safety reporting remains active as real-world use begins. (gov.uk)
The wider policy point is that a product licence and NHS programme use are related but separate decisions. Government flu programme guidance for 2026 to 2027 says providers must use JCVI-preferred vaccines for the relevant cohort to receive payment, and adjuvanted vaccines are among the reimbursed options for adults aged 50 to 64 in clinical risk groups and for those aged 65 and over. (gov.uk) For that reason, this authorisation is best read as an expansion of the regulated product base rather than a stand-alone change to eligibility. The exact place Aujemflu takes in NHS delivery will depend on seasonal programme guidance and reimbursement rules alongside the licence itself. This final sentence is an inference drawn from the distinction between MHRA authorisation and programme reimbursement rules set out in government guidance. (gov.uk)