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 16 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 here


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 16 years of age and older.
1
The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.1

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 and 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.

Frequently Asked Questions (FAQs)

For further information on COVID-19 mRNA Vaccine BNT162b2 please refer to Reg 174 for UK Healthcare Professionals.

SUPPLY

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Can I purchase COVID-19 mRNA Vaccine BNT162b2 direct from Pfizer?

COVID-19 mRNA Vaccine BNT162b2 is a Prescription only medicine which has been centrally procured by the UK government and is not currently available to buy direct from Pfizer at this time.2

​​​​​​​I am a provider as part of the COVID-19 Vaccination Programme - how do I order the vaccine?

For Trusts and Primary Care Network (PCN) designated sites, details about the ordering process for COVID-19 vaccines can be found in the Standard Operating Procedures on the Specialist Pharmacy Service website.3

For COVID-19 Vaccination Centres, information on allocations and ordering COVID-19 vaccines can be found in the COVID-19 Vaccination Centres: Operating Framework Document.4
​​​​​

What pack sizes of multidose vials are available?

Each pack contains 195 multidose vials.1​​​​​​​

For further information please refer to Reg 174 for UK Healthcare Professionals.

What are the dimensions of each pack?

One pack (195 multidose vials contained in a white box) has the following dimensions:
​​​​​​​
23cm x 23cm x 4cm5

The white box is recyclable (made of corrugated translucent or white Poly-Propylene).5

Is diluent supplied with a pack of multidose vials?

Diluent is not provided in the vaccine carton.1
Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used.1

References:

  1. 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/955899/Temporary_Authorisation_HCP_Information_BNT162_6_0_UK_editclean.pdf (accessed: February 2021)
  2. Pfizer UK. Data on file.
  3. Specialist Pharmacy Service. COVID-19 Vaccines. Dealing with delivery issues associated with the Covid-19 vaccines and consumables. Available at: https://www.sps.nhs.uk/articles/delivery-enquiries-relating-to-covid-19-vaccine/ (accessed February 2021) 
  4. NHS England and NHS Improvement. Coronavirus. COVID-19 Vaccination Centres: Operating Framework. Available at: https://www.england.nhs.uk/coronavirus/publication/covid-19-vaccination-centres-operating-framework/ (accessed February 2021)
  5. Pfizer UK. Data on file.​​​​​​​​​​​​​​​​​​​​​​​​​​​​
PP-CVV-GBR-0070 February 2021

For more information

Contact Pfizer Medical Information
Visit https://www.pfizermedicalinformation.co.uk/en-gb or call 01304 616161


The product information provided in this site is intended only for Healthcare Professionals and Other Relevant Decision Makers resident in the United Kingdom.
​​​​​​​
​​​​​​​The product discussed may have different product labelling in other countries.

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This website is not intended for patients or for members of the general public. The website contains promotional content.

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If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition of Healthcare Professional is members of the medical, dental, pharmacy and nursing professions and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

**The ABPI Code definition of ‘Other Relevant Decision Makers’ particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.

PP-CVV-GBR-0022 January 2021