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COMIRNATY®▼ (COVID-19 mRNA Vaccine (nucleoside modified))

What is COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) and what is it used for?

COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) is a vaccine that has been developed by BioNTech and Pfizer.

COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) is a vaccine indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1,2

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

COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) 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.

 

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 less comprehensive data than normally required.3

 

REPORTING OF 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
  • The Patient Information Leaflet for Great Britain* can be accessed here
  • The Patient Information Leaflet for Northern Ireland can be accessed here

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

This medicine is subject to additional monitoring.

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.1,2

Alternatively, adverse events of concern in association with COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.1,2

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.1,2

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 (COVID-19 mRNA Vaccine (nucleoside modified)) Summary of Product Characteristics, Great Britain. Available at: https://www.medicines.org.uk/emc/product/12740/smpc Accessed: July 2021

  2. COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)) Summary of Product Characteristics, Northern Ireland. Available at: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=3d622de2-... Accessed: July 2021

  3. European Medicines Agency. COMIRNATY. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty Accessed: July 2021

PP-CMR-GBR-0031 / July 2021

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

If you get any side effects when taking this or any other medicine, talk to your doctor or other relevant health professional e.g. pharmacist, nurse.. This includes any possible side effects not listed in the packaging leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.