JN.1 mRNA COVID-19 Vaccine for Adults and Children Approved in the U.K.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) today approved an adapted Pfizer/BioNTech mRNA COVID-19 vaccine (Comirnaty) targeting the JN.1 COVID-19 subvariant.

On July 24, 2024, the MHRA announced four forms of this adapted Comirnaty JN.1 vaccine have been approved by the MHRA under the International Recognition Procedure after they were found to meet the U.K. regulator’s safety, quality, and effectiveness standards.

The MHRA confirmed that the vaccine administration differs between adults and children from infancy, depending on their age at the time of vaccination.

These forms are as follows:

Comirnaty JN.1 30 micrograms/dose dispersion for injection and Comirnaty JN.1 30 micrograms/dose dispersion for injection in a pre-filled syringe for use in adults.

Comirnaty JN.1 10 micrograms/dose dispersion for injection, single-dose vial for use in children from 5 to 11 years of age.

Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial for use in infants and children from 6 months to 4 years of age.

If a patient experiences any Comirnaty-related side effects, they should talk to their doctor, pharmacist, or nurse. A full list of all side effects reported with this medicine is available in the patient information leaflet, which can be obtained from the pharmacy or the product information published on the MHRA website.