UK MHRA Nods Pfizer/BioNTech's Covid-19 Vaccine for Adults, Children

UK MHRA has provided the approval to a modified Pfizer/BioNTech Covid-19 vaccine (Comirnaty) designed for the JN.1 Covid-19 subvariant. The vaccine stimulates the immune system to generate antibodies and blood cells to combat Covid-19.

The patient information leaflet or the MHRA website has a complete list of all reported side effects of this medication. If a patient has any side effects, they should consult with their doctor, pharmacist, or nurse. This covers any potential side effects not mentioned in the medication's product information or the patient information leaflet provided with this medicine.

Four versions of the adjusted Comirnaty JN.1 vaccine have been authorized by the MHRA through the International Recognition Procedure due to meeting the safety, quality, and efficacy requirements of the UK regulator. The safety of this vaccine will be closely monitored by the MHRA, as is done with all products.

Patients have the option to self-report potential side effects or have someone else make a report for them through the Yellow Card scheme. Patients can contribute to the safety information of this medicine by reporting any side effects they experience.

The approval was provided through the International Recognition Procedure (IRP), by the regulatory body known as the European Medicines Agency (EMA). Introduced in January of this year, the IRP enables the MHRA to speed up the evaluation of new medications by considering the knowledge and decision-making of reliable regulatory partners during the authorization procedure.