The Medicines and Healthcare products Regulatory Agency (MHRA) authorised zapomeran (brand name Kostaive) on 2 January 2026 for use in individuals aged 18 and over. The decision adds another licensed COVID‑19 booster option in the UK and was taken under the International Recognition Procedure (IRP), with the European Medicines Agency (EMA) acting as Reference Regulator for dossier reliance (EMA product code EMEA/H/C/006207).
Under the IRP, the MHRA may take into account assessments by trusted regulators while retaining sovereign decision‑making. The process operates on 60‑day (Recognition A) or 110‑day (Recognition B) timetables, shorter than standard national routes, and includes partners such as the EMA alongside regulators in Australia, Canada, Japan, Singapore, Switzerland and the United States.
Kostaive is administered as a single 0.5 mL intramuscular booster in the upper arm. It uses self‑amplifying mRNA (sa‑mRNA) encoding the SARS‑CoV‑2 spike protein; the construct also encodes a replicase enzyme that temporarily produces additional copies of the spike mRNA inside cells before these components are broken down.
The EMA public assessment report states that, for previously vaccinated adults, a booster may be given at least five months after the most recent COVID‑19 dose; additional doses can be considered for some people with severely weakened immune systems. The UK Summary of Product Characteristics (SmPC) will confirm the national instructions when published by the MHRA, expected within seven days of authorisation.
MHRA notes very common reactions include injection‑site pain or tenderness, tiredness, chills, fever, muscle or joint pain, headache and dizziness, with most effects mild and resolving within a few days. Suspected adverse reactions should be reported to the MHRA Yellow Card scheme; the agency will keep safety and effectiveness under close review as rollout expands.
“Patient safety is our top priority,” said Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, adding that Kostaive provides another option for adult protection against COVID‑19.
The UK decision draws on an established European regulatory record. Kostaive received a CHMP positive opinion on 12 December 2024, followed by a European Commission marketing authorisation on 12 February 2025. The EMA lists the vaccine under additional monitoring and names Seqirus Netherlands B.V. as the marketing authorisation holder.
For vaccination providers, the immediate tasks are operational. Monitor publication of the UK SmPC and Patient Information Leaflet on the MHRA Products website, update local clinical protocols once UK‑specific dosing intervals and contraindications are confirmed, and ensure staff can signpost patients to Yellow Card reporting. Stock management, coding and consent materials can be readied once supply information is available.
What comes next is document‑led. The SmPC and PIL are due within seven days of 2 January 2026; programme guidance from public health authorities will determine where Kostaive sits within the 2026 booster offer. Until those details are issued, scheduling decisions that depend on co‑administration or interval specifics should be deferred.