COVID-19 mRNA Vaccine BNT162b2
Reg 174 Information for UK Healthcare Professionals
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 12 years of age and over.1
Therefore, a Summary of Product Characteristics for COVID-19 mRNA Vaccine BNT162b2 is currently not available.
The Reg 174 Information for UK Healthcare Professionals document is available and can be accessed by clicking here1
As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.1
Therapeutic indications:
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1
The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.1
Quick Access to Important Information
*If this material is shared with patients it must be downloaded and NOT shown directly to patients from this website which is intended for Healthcare Professionals and Other Relevant Decision Makers.
Adverse event reporting
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 Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2 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.
Access
COVID-19 mRNA Vaccine BNT162b2 is a Prescription only medicine which has been centrally procured by the UK government.
References:
- COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information For UK Healthcare Professionals. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/991411/Temporary_Authorisation_HCP_Information_BNT162_11_0_UK.pdf (accessed: June 2021)
For more information
Contact Pfizer Medical Information
Visit https://www.pfizermedicalinformation.co.uk/en-gb or call 01304 616161
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PP-CVV-GBR-0022 January 2021