COVID-19 mRNA Vaccine BNT162b2

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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 immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.

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.

Useful Links

COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information for UK Healthcare Professionals

NHS Coronavirus Page

UK Government Vaccination Programme

Joint Committee on Vaccination and Immunisation

Pfizer UK Coronavirus Updates

Clinical.trials.gov

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How can 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.¹

For COVID-19 Vaccination Centres, information on allocation and ordering COVID-19 vaccines can be found here.²

1: Specialist Pharmacy Service. COVID-19 Vaccines Dealing with delivery issues associated with the Covid-19 vaccines and consumables: https://www.sps.nhs.uk/articles/delivery-enquiries-relating-to-covid-19-vaccine Accessed February 2021

2: NHS England and NHS Improvement.COVID-19 Vaccination Centres: Operating Framework: https://www.england.nhs.uk/coronavirus/publication/covid-19-vaccination-centres-operating-framework Accessed February 2021.

What are the recommended storage requirements for the vaccine?

COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information for UK Healthcare Professionals states the following in Section 6.4 Special precautions for storage:

Store in a freezer at -80 °C to -60 °C.

Store in the thermal container at -90 °C to -60 °C.

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

Once removed from the freezer, the undiluted vaccine can be stored for up to 5 days at 2 °C to 8 °C, and up to 2 hours at temperatures up to 25 °C, prior to use. During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions.

After dilution, store the vaccine at 2 °C to 25 °C and use as soon as practically possible and within 6 hours. The vaccine does not contain a preservative. Discard any unused vaccine.

Once diluted, the vials should be marked with the dilution time and discarded within 6 hours of dilution.

Once thawed, the vaccine cannot be re-frozen.

This information can also be found in the COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information for UK Healthcare Professionals.

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

How do I prepare and administer the vaccine?

The COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information for UK Healthcare Professionals states the following in Section 4.2 Posology and method of administration:

Method of administration

Administer the COVID-19 mRNA Vaccine BNT162b2 intramuscularly in the deltoid muscle after dilution.

After dilution, vials of COVID-19 mRNA Vaccine BNT162b2 contain six doses of 0.3 mL of vaccine. In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

Preparation: The multidose vial is stored frozen and must be thawed prior to dilution.

Further detailed information on the preparation of the vaccine can be found in Section 4.2 of the COVID-19 mRNA Vaccine BNT162b2 Reg 174 Information for UK Healthcare Professionals.

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

Contact Pfizer Medical Information

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Report Adverse Event
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.
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Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In the event of a suspected adverse event or side effect with no associated medical information enquiry, please contact [email protected]. Please always specify your country. If you have a medical information enquiry including those with associated adverse events, contact Medical Information.