UK MHRA Approves Pfizer/BioNTech’s Comirnaty JN.1 Covid-19 Vaccine

UK MHRA Approves Pfizer/BioNTech’s Comirnaty JN.1 Covid-19 Vaccine

By, Admin 26 July 2024

UK MHRA approves Pfizer/BioNTech’s Comirnaty JN.1 Covid-19 vaccine for adults and children from infancy

Overview

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech Covid-19 vaccine (Comirnaty) that targets the JN.1 Covid-19 subvariant.

This vaccine triggers the production of antibodies and blood cells by the immune system to work against Covid-19.

Previous Approvals

Four forms of this adapted Comirnaty JN.1 vaccine have been approved by the MHRA under the International Recognition Procedure after they were found to meet the UK regulator’s standards of safety, quality, and effectiveness.

Close observation- As with all products, the MHRA will keep the safety of this vaccine under close review.

Side Effects

  • A full list of all side effects reported with this medicine is available in the patient information leaflet, which can be obtained from the pharmacy, or from the product information published on the MHRA website.
  • If a patient experiences any side effects, they should talk to their doctor, pharmacist or nurse. This includes any possible side effects not listed in the product information or the PIL which comes with this medicine.

Reporting Side Effects

  • Patients can also report suspected side effects themselves, or a report can be made on their behalf by someone else, directly via the Yellow Card scheme. 
  • By reporting side effects, patients can help provide more information on the safety of this medicine.  

Authorization Grant

  • The authorisation was granted as part of the International Recognition Procedure (IRP), via the reference regulator, the European Medicines Agency (EMA). 
  • Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process.
  • The Comirnaty JN.1 Vaccine products
  • The Comirnaty JN.1 Vaccine products are line extensions of the existing product, Comirnaty 30 micrograms/dose concentrate for dispersion for injection. 

The Four Approved Products Are: 

Comirnaty JN.1 30 micrograms/dose dispersion for injection for use in adults; 
Comirnaty JN.1 30 micrograms/dose dispersion for injection and 
Comirnaty JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe for use in adults; 
Comirnaty JN.1 10 micrograms/dose dispersion for injection

  • Single dose vial for use in children from 5 to 11 years of age; Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial for use in infants and children from 6 months to 4 years of age.
  • Administration of the vaccine differs between adults and children depending on their age at the time of vaccination.

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