COMIRNATY®
(TOZINAMERAN) COVID-19 mRNA VACCINE (NUCLEOSIDE MODIFIED)

What is COMIRNATY and what is it used for?

COMIRNATY is a vaccine that has been developed by BioNTech and Pfizer.

COMIRNATY has the following indications: 

  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1,2
     
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.3,4

The vaccine triggers the body’s natural production of antibodies and stimulates immune cells to help protect against COVID-19 disease.

 

Licensing Information

This medicinal product has been granted a conditional Marketing Authorisation. A conditional Marketing Authorisation was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from a review of less comprehensive data than normally required.5

 

Reporting Side Effects

As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. You can help by reporting any side effects that you may get. To report any side effects that you may get, please refer to the information at the bottom of this page.

The information provided on this site is intended for general information and education for UK based members of the public and is not intended to be a substitute for advice provided by a doctor or other qualified healthcare professional.

 

Reference Information

Great Britain

  • The Patient Information Leaflet for Comirnaty 30 micrograms/dose concentrate for dispersion for injection can be accessed here
  • The Patient Information Leaflet for Comirnaty 10 micrograms/dose concentrate for dispersion for injection can be accessed here.

Northern Ireland

  • The Patient Information Leaflet for Comirnaty 30 micrograms/dose concentrate for dispersion for injection can be accessed here
  • The Patient Information Leaflet for Comirnaty 10 micrograms/dose concentrate for dispersion for injection can be accessed here.

*The Patient Information Leaflet for Great Britain covers England, Scotland and Wales.

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://coronavirus-yellowcard.mhra.gov.uk for how to report side effects.

Pfizer is unable to provide advice on personal medical matters. Please consult your doctor or other relevant health professional for specific, health-related advice and support.

If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. When completing a report please include the vaccine brand and batch/lot number if available.

 

References

  1. COMIRNATY® (tozinameran) 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available here. Accessed May 2022.
  2. COMIRNATY® (tozinameran) 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Northern Ireland. Available here. Accessed May 2022.
  3. COMIRNATY® (tozinameran) 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available here. Accessed May 2022.
  4. COMIRNATY® (tozinameran) 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Northern Ireland. Available here. Accessed May 2022.
  5. European Medicines Agency. COMIRNATY. Accessed May 2022.

 

PP-CMR-GBR-0255 / May 2022