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.
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 to editors
-
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).
-
More information can be found in the SmPC and PIL which will
be published on the MHRA Products website within 7 days of
approval.
