Aujemflu (Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture))

Where it stands

Aujemflu (influenza vaccine, surface antigen, inactivated, adjuvanted, prepared in cell culture) is authorised in the EU. The marketing authorisation holder is Seqirus Netherlands B.V. The European Commission decision is dated 2026-08-20, following a positive CHMP opinion on 2026-06-25.

The authorised indication is prophylaxis of influenza in adults aged 50 years and older. The label states that Aujemflu should be used in accordance with official recommendations. In practice, national vaccination policies will shape how it is used.

The CHMP opinion and the EC decision are 56 days apart. The CHMP opinion is the scientific recommendation. The EC decision is the legally binding authorisation across EU Member States.

Regulatory pathway and designations

The records show a CHMP positive opinion followed by an EC decision. That sequence is the EU centralised procedure. The records do not state the legal basis of the application, the review timetable, or whether any clock-stops or additional information requests occurred.

No designations are recorded for this product. The records show no orphan status, PRIME or conditional marketing authorisation. Nothing in them indicates an accelerated or conditional route.

The records list five other EU products under the same substance: Fluad (Authorised), Flucelvax (Authorised), Flucelvax Tetra (Withdrawn), Fluad Tetra (Withdrawn) and Optaflu (Expired). The records do not describe how Aujemflu relates to these products. They also give no information on shared data packages or on the basis of the approval. This listing is context only and should not be read as evidence of equivalence.

Safety and pharmacovigilance

The records contain no safety data. They include no adverse reaction profile, contraindications, risk management plan content or post-authorisation commitments. Any assessment of Aujemflu's benefit-risk balance would need the published product information and the European public assessment report.

As a general matter, centrally authorised vaccines in the EU fall under the standard pharmacovigilance framework. This includes a risk management plan, routine signal detection and periodic safety reporting. Influenza vaccines are also subject to the usual regulatory handling of seasonal strain composition. None of this is specific to Aujemflu, and the records do not say which measures apply to it.

What to watch

The first item is publication of the product information and the EPAR. They should set out the evidence supporting the 50+ indication, the safety profile and any conditions of authorisation. The records do not cover these.

The second is national uptake. The label ties use to official recommendations, so national immunisation advice and reimbursement decisions will determine real-world access. The records give no information on launch timing, supply or pricing.

The third is the portfolio context. Seqirus has other authorised influenza vaccines in the EU (Fluad and Flucelvax), and earlier related products have been withdrawn or have expired. Lifecycle changes across these products may be informative, but the records do not indicate any planned changes.