MHRA Approves New mRNA Vaccine for COVID-19
On 2 January 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for the zapomeran (Kostaive) mRNA vaccine, aimed at immunising individuals aged 18 and above against COVID-19. This new vaccine represents an alternative to existing options, offering a single booster dose via injection.
Details of the Vaccine
Zapomeran is administered as a 0.5 mL booster shot into the upper arm muscle. The vaccine utilises self-amplifying messenger RNA (sa-mRNA), which encourages the body’s cells to produce the spike protein of the SARS-CoV-2 virus. This process aims to prime the immune system to better recognise and combat the virus in the future.
Statements from the MHRA
Julian Beach, Interim Executive Director for Healthcare Quality and Access at the MHRA, emphasised the agency’s commitment to patient safety, stating that the introduction of zapomeran provides an additional option for adults seeking to protect themselves from COVID-19. Beach also assured that the safety of the vaccine will be scrutinised continuously as its administration increases.
Potential Side Effects
Individuals receiving the zapomeran vaccine may experience very common side effects, including pain or tenderness at the injection site, fatigue, chills, fever, muscle and joint pain, headache, and dizziness. These mild side effects typically resolve within a few days following vaccination.
For a comprehensive list of side effects, individuals are advised to refer to the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be uploaded to the MHRA website within a week of the vaccine’s approval.
Monitoring Safety
The MHRA will maintain vigilant oversight of zapomeran’s safety profile and effectiveness. Those who suspect they are experiencing side effects from the vaccine are encouraged to consult healthcare professionals and report their concerns through the MHRA Yellow Card scheme, available online or via mobile applications.
Background
The MHRA’s approval of zapomeran comes under the International Recognition Procedure (IRP), with the European Medicines Agency serving as the reference regulator for this vaccine. The MHRA is responsible for ensuring the safety and efficacy of medicines and medical devices in the UK, making decisions based on thorough and evidence-driven analysis.
Source: official statements, news agencies, and public reports.
https://www.gov.uk/government/news/mhra-approves-zapomeran-kostaive-mrna-covid-19-vaccine
