MHRA approves Pfizer-BioNTech’s Comirnaty JN.1

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the use of Pfizer-BioNTech's updated Comirnaty vaccine to address the JN.1 Covid-19 subvariant. This newly approved vaccine is designed to activate the immune system, encouraging the production of antibodies and blood cells to combat Covid-19.

This regulatory decision covers four different versions of the Comirnaty JN.1 vaccine, all authorised through the International Recognition Procedure (IRP). The IRP, which began in January 2024, is a streamlined process that leverages decisions made by respected regulatory bodies such as the European Medicines Agency (EMA) to speed up the assessment of new medicines.

The four approved versions of the Comirnaty JN.1 vaccine cater to various age groups, from infants to adults. Specifically, the Comirnaty JN.1 injectable dispersion at 30 micrograms per dose and the Comirnaty JN.1 30 micrograms/dose dispersion for injection in a pre-filled syringe are both intended for adults. For children aged five to eleven, a single dosage vial of Comirnaty JN.1 with 10 micrograms per dose has been approved. Additionally, a three-dose vial of Comirnaty JN.1 at 3 micrograms per dose is designated for infants and young children aged six months to four years. These new products are extensions of the existing Comirnaty 30 micrograms/dose concentrate for injection.

The UK regulator, MHRA, will continue to monitor the safety of the vaccine rigorously. Detailed information on potential side effects is available in the patient information leaflet and on the MHRA website. Patients are urged to report any side effects through the Yellow Card scheme, which plays a crucial role in gathering safety data for the vaccine.

This significant development follows the recent approval by the UK MHRA of a new indication for Novo Nordisk's semaglutide, marketed under the name Wegovy. This medication is now approved to reduce the risk of severe heart problems in overweight or obese adults.