COMIRNATY▼ COVID-19 mRNA Vaccine (tozinameran) | Pfizer Medical Information

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

This medicinal product has been authorised under a conditional approval scheme. This means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and this Summary of Product Characteristics will be updated as necessary.

Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)) was previously called COVID-19 mRNA Vaccine BNT162b2 and supplied under a Regulation 174 temporary supply authorisation. Following conditional Marketing Authorisation, the vaccine is now known by the brand name Comirnaty. If you have a question regarding the COVID-19 mRNA Vaccine BNT162b2 please submit an enquiry on our webform and clearly state this in the question field. The product label information for COVID-19 mRNA Vaccine BNT162b2 can be accessed on Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK (www.gov.uk)

Healthcare Professionals located in Northern Ireland

If you are a Healthcare Professional based in Northern Ireland with a question on Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)), please submit your enquiry on our webform and clearly state this in the question field. The Comirnaty Summary of Product Characteristics for Northern Ireland can be accessed on https://www.emcmedicines.com/en-gb/northernireland

The information provided below is for customers located in Great Britain.

This medicinal product has been authorised under a conditional approval scheme. This means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and the Summary of Product Characteristics will be updated as necessary.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Healthcare Professionals located in Northern Ireland

The information provided below is for customers located in Great Britain.

COMIRNATY▼ COVID-19 mRNA Vaccine Quick Finder

Frequently Asked Questions

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What are the recommended storage requirements for the Comirnaty COVID-19 mRNA Vaccine to be diluted for individuals 12 years of age and older (30 μg/dose; Purple cap)?

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The Summary of Product Characteristics for the Comirnaty formulation to be diluted for individuals 12 years of age and older (30 μg/dose; Purple cap) states the following:

6.3 Shelf life

Unopened vial

Frozen vial

12 months when stored at -90 °C to -60 °C

Within the 12-month shelflife unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C.

When stored frozen at -90 °C to -60 °C, 195 vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vial

1 month at 2°C to 8°C within the 12-month shelf life.

Within the 1-month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation.

Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C.

Thawed vials can be handled in room light conditions.

Once thawed, the vaccine should not be re-frozen.

Handling of temperature excursions once removed from the freezer

Stability data indicate that the unopened vial is stable for up to:

24 hours when stored at temperatures from -3 °C to 2 °C
a total of 4 hours when stored at temperatures from 8 °C to 30 °C; this includes the 2 hours at up to 30 °C detailed above

This information is intended to guide healthcare professionals only in case of temporary temperature excursion.

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For additional storage information on the transfer of frozen vial trays see Section 6.3.

Diluted medicinal product

Chemical and physical in-use stability, including during transportation, has been demonstrated for 6 hours at 2 °C to 30 °C after dilution in sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage

Store in a freezer at -90 °C to -60 °C.

Store in the original package in order to protect from light.

During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

This information can also be found in the Comirnaty (COVID-19 mRNA Vaccine Summary of Product Characteristics. For more information on handling instructions, please refer to section 6.6 Special precautions for disposal and other handling.

Alternatively, for further information, please use the search function above.

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What are the recommended storage requirements for the Comirnaty COVID-19 mRNA Vaccine formulation for children aged 5-11 years (10 μg/dose; orange cap)?

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The Summary of Product Characteristics for Comirnaty for use in children aged 5-11 years (10 μg/dose; Orange cap) states the following:

6.3 Shelf life

Unopened vial

Frozen vial

9 months when stored at -90 °C to -60 °C.

The vaccine will be received frozen at -90 °C to -60 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.

When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 4 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vial

10 weeks storage and transportation at 2 °C to 8 °C within the 9-month shelf life.

Upon moving the vaccine to 2 °C to 8 °C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
If the vaccine is received at 2 °C to 8 °C it should be stored at 2 °C to 8 °C. The expiry date on the outer carton should have been updated to reflect the refrigerated expiry date and the original expiry date should have been crossed out.

Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.

Thawed vials can be handled in room light conditions.

Once thawed, the vaccine should not be re-frozen.

Handling of temperature excursions during refrigerated storage

Stability data indicate that the unopened vial is stable for up to 10 weeks when stored at temperatures from -2 °C to 2 °C, and within the 10 weeks storage period between 2 °C and 8 °C.
Stability data indicate the vial can be stored for up to 24 hours at temperatures of 8 °C to 30 °C, including up to 12 hours following first puncture.

This information is intended to guide healthcare professionals only in case of temporary temperature excursion.

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 12 hours at 2 °C to 30 °C, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage

Store in a freezer at -90 °C to -60 °C.

Store in the original package in order to protect from light.

During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Alternatively, for further information, please use the search function above.

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Reporting an adverse event for the Covid-19 mRNA vaccine

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 the COVID-19 mRNA vaccine 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 anonymized form) and dual reporting will create unnecessary duplicates.