The Medicines and Healthcare products Regulatory Agency
(MHRA)
has approved an adapted Moderna COVID-19 vaccine (Spikevax) that
targets the JN.1 COVID-19 subvariant. This vaccine is licensed
for adults and children aged 6 months and older.
Spikevax JN.1 stimulates the immune system and works by causing
the body to produce protection (antibodies) against the virus
that causes COVID-19.
As with all products, the MHRA
will keep the safety of this vaccine under close review.
A full list of all side effects reported with this medicine is
available in the patient information leaflet (PIL) or from the product information
published on the MHRA
products website.
If a patient experiences any side effects, they should talk to
their doctor, pharmacist or nurse. This includes any possible
side effects not listed in the product information or the
PIL which comes
with this vaccine.
Patients can also report suspected side effects themselves, or a
report can be made on their behalf by someone else, directly via
the Yellow Card scheme. By
reporting side effects, patients can help provide more
information on the safety of this vaccine.
Notes to editor
- The new marketing authorisation (licence) was granted on 02
September 2024 to Moderna via national procedure.
- These Spikevax JN.1 products are line extensions of the
existing product Spikevax product range (PLGB 53720/0006 – 0008;
PLGB 0011 – 0012). The two approved products are:
- Spikevax JN.1 0.1 mg/mL dispersion for injection
- Spikevax JN.1 50 micrograms dispersion for injection in
pre-filled syringe
- Administration of the vaccine differs between adults and
children depending on their age at the time of vaccination.
