MHRA approves zapomeran (Kostaive) mRNA COVID-19 vaccine

The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday (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.