The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s updated Covid-19 vaccine, Comirnaty, for the JN.1 subvariant in infants, children, and adults.
Comirnaty JN.1 vaccine stimulates the immune system to produce antibodies and blood cells that combat Covid-19.
The MHRA has approved four variants of the adapted JN.1 vaccine through the International Recognition Procedure (IRP), via the reference regulator, the European Medicines Agency (EMA).
Introduced in January, IRP enables the MHRA to expedite the evaluation of new medicines using the expertise and decision-making of trusted regulatory partners during the authorisation process.
The four variants were approved after reviewing their safety, quality, and effectiveness as per the UK regulator’s standards.
The Comirnaty JN.1 Vaccine products are extensions of the existing Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
The four approved products include Comirnaty JN.1 30 micrograms/dose dispersion for injection and Comirnaty JN.1 30 micrograms/dose dispersion for injection in a pre-filled syringe, intended for use in adults.
The other two vaccines include the Comirnaty JN.1 10 micrograms/dose dispersion for injection, single-dose vial, specifically for children aged five to 11 years, and Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection.
Comirnaty JN.1 3 is available in a three-dose vial, designed for infants and children aged six months to four years.
The administration of these vaccines varies between adults and children, depending on their age at the time of vaccination.
The British health regulator will continue to keep monitoring this vaccine, as with all other approved products.
MHRA has advised individuals experiencing any side effects to consult their doctor, pharmacist, or nurse.
It includes any potential side effects not mentioned in the product information or the patient information leaflet accompanying the medicine.
In addition, these patients can also directly report suspected side effects themselves through the Yellow Card scheme or have someone else make a report on their behalf.
Last month, Pfizer and BioNTech received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Comirnaty JN.1.
