The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of Pfizer-BioNTech’s adapted Comirnaty vaccine to combat the JN.1 Covid-19 subvariant.

The vaccine stimulates the immune system to produce antibodies and blood cells against Covid-19.

This approval encompasses four variations of the Comirnaty JN.1 vaccine, following the International Recognition Procedure (IRP).

The IRP, initiated in January 2024, expedites new medicine assessments by incorporating decisions from trusted regulatory partners, including the European Medicines Agency (EMA).

The four Comirnaty JN.1 vaccine products authorised are intended for age groups from infants to adults.

The Comirnaty JN.1 injectable dispersion of 30 microgrammes per dosage and the Comirnaty JN.1 30 micrograms/dose dispersion for injection in a pre-filled syringe are both indicated for use in adults.

A single dosage vial of Comirnaty JN.1 10 micrograms/dose dispersion for injection is intended for children aged five to 11 years.

A three-dose vial of Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is intended for usage in infants and children aged six months to four years.

These products are extensions of the existing Comirnaty 30micrograms/dose concentrate for injection.

The UK regulator will carry out continuous monitoring of the vaccine's safety.

Detailed information on side effects is available in the patient information leaflet and on the MHRA website.

Patients are encouraged to report any side effects through the Yellow Card scheme, which could contribute to the vaccine's safety data.

The latest development comes after the UK MHRA approved a new indication of Novo Nordisk’s semaglutide, marketed as Wegovy, to lower the risk of serious heart problems in overweight or obese adults.