MHRA approves Spikevax JN.1 COVID-19 vaccines for adults and children from infancy
The MHRA has approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant.
On 2 September 2024, The Medicines and Healthcare products Regulatory Agency (MHRA) 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.