MHRA Approves Zapomeran (Kostaive), First Self-Amplifying mRNA COVID-19 Vaccine for Adults
核心洞察
The UK's Medicines and Healthcare products Regulatory Agency approved zapomeran (Kostaive) on January 2, 2026, marking the first self-amplifying mRNA COVID-19 (搜索) vaccine for adults aged 18 and older.
The vaccine uses self-amplifying messenger RNA technology to instruct cells to produce SARS-CoV-2 (搜索) spike protein (搜索), teaching the immune system to fight future infections.
Zapomeran is administered as a single 0.5 mL booster dose via intramuscular injection in the upper arm.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved zapomeran (Kostaive), a novel self-amplifying mRNA COVID-19 (搜索) vaccine for adults aged 18 years and older. The approval, granted on January 2, 2026, represents the first authorization of a self-amplifying mRNA vaccine technology for COVID-19 prevention.
Novel Self-Amplifying mRNA Technology
Zapomeran employs self-amplifying messenger RNA (sa-mRNA) technology, which instructs the body's cells to temporarily produce the SARS-CoV-2 (搜索) spike protein (搜索). This mechanism teaches the immune system to recognize and fight off the virus in future encounters. The vaccine is administered as a single 0.5 mL booster dose by injection into the muscle of the upper arm.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, emphasized the agency's commitment to patient safety: "Patient safety is our top priority. The approval of zapomeran (Kostaive) provides an alternative vaccine for use in adults to prevent COVID-19 (搜索) caused by SARS-CoV-2 (搜索)."
Safety Profile and Side Effects
The vaccine's safety profile shows very common side effects affecting more than 1 in 10 people, including pain or tenderness at the injection site, tiredness, chills, fever, muscle and joint pain, headache, and dizziness. According to the MHRA, most side effects are mild and disappear within a few days of vaccination.
Regulatory Pathway and Monitoring
The approval was granted under the International Recognition Procedure (IRP), with the European Medicines Agency (搜索) (EMA) serving as the Reference Regulator. The MHRA will continue to monitor the vaccine's safety and effectiveness closely as it becomes more widely used.
Beach stated: "As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used." The agency encourages anyone experiencing suspected side effects to report them through the MHRA Yellow Card scheme, available via website or mobile app.
The complete Patient Information Leaflet and Summary of Product Characteristics will be published on the MHRA website within seven days of approval, providing healthcare professionals and patients with comprehensive safety and efficacy information.