As with any medicine, the MHRA will keep the safety and effectiveness of zapomeran under close review.
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
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).
