The Medicines and Healthcare products Regulatory Agency (MHRA) approved the zapomeran (Kostaive) mRNA COVID-19 vaccine on January 2, 2026. This approval applies to the immunization of individuals aged 18 years and older.
Vaccine Administration and Mechanism
Zapomeran is administered as a single 0.5 mL booster dose, injected into the muscle of the upper arm. The vaccine utilizes a self-amplifying messenger RNA (sa-mRNA) technology. This sa-mRNA instructs the body’s cells to temporarily produce the SARS-CoV-2 spike protein, thereby educating the immune system to counter the virus in the future.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, noted that the approval of zapomeran (Kostaive) offers an additional vaccine option for adults in preventing COVID-19 caused by SARS-CoV-2. The MHRA indicated its intent to continuously monitor the vaccine's safety as its usage becomes more widespread.
Reported Side Effects
Very common side effects, observed in more than 1 in 10 individuals, include:
- Pain or tenderness at the injection site
- Tiredness
- Chills
- Fever
- Muscle and joint pain
- Headache
- Dizziness
Most of these side effects are typically mild and subside within a few days of vaccination. A comprehensive list of side effects will be available in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC) on the MHRA website within seven days of the approval date.
Safety Monitoring
The MHRA stated it would maintain a close review of zapomeran's safety and effectiveness. Individuals who believe they are experiencing a side effect from the vaccine are advised to consult their doctor, pharmacist, or nurse and report the effect directly to the MHRA Yellow Card scheme.