The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 2 January 2026, approved zapomeran (Kostaive) mRNA COVID-19 vaccine, for the immunisation of individuals aged 18 years of age and older.
Zapomeran is given as a single 0.5 mL booster dose by injection into the muscle of the upper arm. It contains a self-amplifying messenger RNA (sa-mRNA) which instructs the body’s cells to temporarily make the SARS-CoV-2 spike protein. This teaches the immune system to fight off the virus in the future.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said:
Patient safety is our top priority.
The approval of zapomeran (Kostaive) provides an alternative vaccine for use in adults to prevent COVID-19 caused by SARS-CoV-2.
As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.
Very common side effects (which may affect more than 1 in 10 people) include pain or tenderness at the injection site, tiredness, chills, fever, muscle and joint pain, headache and dizziness. Most side effects are mild and disappear within a few days of vaccination.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.
As with any medicine, the MHRA will keep the safety and effectiveness of zapomeran under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
The approval was granted on 2 January 2026 under the International Recognition Procedure (IRP). The Reference Regulator was the European Medicines Agency (EMA) (EMEA/H/C/006207/0000).
More information can be found in the SmPC and PIL which will be published on the MHRA Products website within 7 days of approval.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
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