MHRA Approves Pfizer/BioNTech Omicron JN.1 COVID-19 Vaccine

Pfizer/BioNTech’s Omicron JN.1-adapted COVID-19 vaccine has received authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for use across all age groups, from infants to adults. The UK regulator granted approval to four versions of the adapted Comirnaty JN.1 vaccine, recognizing their adherence to safety, quality, and effectiveness standards under the International Recognition Procedure.

For adults, the Comirnaty JN.1 vaccine is available in two formats: a 30mg dose for injection and a pre-filled syringe. For children aged five to eleven years, a 10mg single-dose vial injection has been approved, while for infants and young children from six months to four years, a 3mg three-dose vial injection has been authorized.

This vaccine aims to stimulate the immune system to produce antibodies and blood cells to combat COVID-19, an infectious disease caused by the SARS-CoV-2 virus. This follows recommendations from the World Health Organization’s Technical Advisory Group and the European Medicines Agency’s (EMA) Emergency Task Force to update COVID-19 vaccines to target the JN.1 variant. This variant is currently the most prevalent worldwide, noted for its rapid spread and enhanced ability to evade the immune system.

The approval was granted based on positive results and real-world evidence that demonstrated the safety and efficacy of the Comirnaty vaccines. Studies showed that the JN.1-adapted vaccine elicited a significantly better immune response against several Omicron JN.1 sublineages, such as KP.2 and KP.3, as well as other circulating sublineages, compared to the companies’ previous Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

This latest approval follows the EMA’s human medicine committee's recommendation of the Omicron JN.1-adapted monovalent COVID-19 vaccine for individuals aged six months and older.

Earlier in February, the MHRA approved a modification to the license of the Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine. This approval came after the UK regulator's decision in September 2023 to authorize the vaccine for individuals aged six months and older.

Further, in October 2023, Pfizer/BioNTech announced promising results from an ongoing phase 1/2 study of their mRNA-based combination vaccine for influenza and COVID-19. They also outlined plans to advance this combination vaccine into late-stage development.