Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Not applicable.
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.
COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) 21 days apart (see section 5.1).
There are no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 mRNA Vaccine BNT162b2 should receive a second dose of COVID-19 mRNA Vaccine BNT162b2 to complete the vaccination series.
Individuals may not be protected until at least 7 days after their second dose of the vaccine.
For further information on efficacy, see section 5.1.
The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age have not yet been established.
Administer the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle after dilution.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Preparation: The multidose vial is stored frozen and must be thawed prior to dilution.
Frozen vials should be transferred to 2°C to 8°C to thaw; a 195 vial pack may take 3 hours to thaw (see section 6.4). Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 25°C for immediate use. Once thawed, 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.
Allow the thawed vial to come to room temperature and gently invert 10 times prior to dilution. Do not shake. Prior to dilution the vaccine should present as an off-white solution with no particulates visible. Discard the vaccine if particulates or discolouration are present.
The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. This diluent is not provided in the vaccine carton.
Equalise vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
Gently invert the diluted solution 10 times. Do not shake.
The diluted vaccine should present as an off-white solution with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present.
The diluted vials should be marked with the dilution date and time and stored between 2°C to 25°C.
Use immediately, and within 6 hours after dilution.
After dilution, the vial contains 5 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle and syringe and discard any unused vaccine within 6 hours after dilution.
For instructions on disposal see section 6.6.
Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
6 months at -80 °C to -60 °C.
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.
After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once thawed, the undiluted vaccine can be stored for up to 5 days at 2°C to 8°C, or 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 immediately 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 date and time. Once thawed, the vaccine cannot be re-frozen.
Concentrate for solution for injection for 5 doses in a 2 mL clear vial (type I glass) with a stopper (bromobutyl) and a flip-off plastic cap with aluminium seal.
Pack size: 195 vials
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
For instructions on dose preparation of the medicinal product before administration, see section 4.2.
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