Pfizer/BioNTechs Omicron JN.1-adapted COVID-19 vaccine approved by MHRA – PMLiVE

Pfizer/BioNTechs Omicron JN.1-adapted COVID-19 vaccine has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) for adults and children from infancy.

Four versions of the adapted Comirnaty JN.1 vaccine have been approved by the UK regulator under the International Recognition Procedure after meeting the standards of safety, quality and effectiveness.

Both the Comirnaty JN.1 30mg dose for injection and in a pre-filled syringe have been approved for use in adults, while 10mg for single-dose vial injection has been approved for use in children aged five to 11 years of age and 3mg for three-dose vial injection has been authorised for infants and children from six months to four years of age.

The vaccine is designed to trigger the production of antibodies and blood cells by the immune system to work against COVID-19, an infectious disease caused by the SARS-CoV-2 virus, following the recommendation from the World Health Organizations Technical Advisory Group and the European Medicines Agencys (EMA) Emergency Task Force to update COVID-19 vaccines to target the JN.1 variant the most widely circulating variant worldwide, which continues to grow quickly compared to other variants and is either more transmissible or better at evading the immune system.

The approval was based on positive results and real-world evidence supporting the safety and efficacy of the Comirnaty vaccines, which showed that the JN.1-adapted vaccine generated a substantially improved response against several Omicron JN.1 sublineages, including KP.2, KP.3, as well as other currently circulating sublineages, in comparison to the companies Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

The approval comes after the EMAs human medicine committee recommended the Omicron JN.1-adapted monovalent COVID-19 vaccine for individuals aged six months and older.

Previously, in February, the MHRA approved a change to the licence of the Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine following approval from the UK regulator in September 2023 for use in individuals aged six months and older.

Additionally, in October 2023, the companies announced positive results from an ongoing phase 1/2 study of their mRNA-based combination vaccine for influenza and COVID-19, as well as outlined plans to enter late-stage development.

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Pfizer/BioNTechs Omicron JN.1-adapted COVID-19 vaccine approved by MHRA - PMLiVE