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

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.

COMIRNATY was previously called COVID-19 mRNA Vaccine BNT162b2 and supplied under a Reg 174 temporary supply authorisation. Following conditional Marketing Authorisation, the vaccine is now known by the brand name COMIRNATY. Please be aware that there may be some residual supply of COVID-19 mRNA Vaccine BNT162b2 within the UK health system. 

 

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.

If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

Alternatively, adverse events of concern in association with COMIRNATY can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.

Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates.

By reporting side effects, you can help provide more information on the safety of this medicine.

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.

 

References

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

 

PP-CMR-GBR-0174 | January 2022