Gently invert the diluted solution 10 times. This diluent is not provided in the vaccine carton.Įqualise vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. 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. Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles. When the thawed vial is at room temperature gently invert 10 times prior to dilution. When removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 1 month (31 days) at 2 ☌ to 8 ☌, and and additional 2 hours at temperatures up to 25 ☌ in preparation for dilution. Alternatively, frozen vials may also be thawed and kept at temperatures up to 25 ☌ for a maximum of two hours in preparation for dilution for use. Preparation: The multidose vial is stored frozen and must be thawed prior to dilutionįrozen vials should be transferred to 2 ☌ to 8 ☌ to thaw. Do not pool excess vaccine from multiple vials.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.Each dose must contain 0.3 mL of vaccine.Irrespective of the type of syringe and needle: If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. Method of administrationĪdminister the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle after dilution.Īfter dilution, vials of COVID-19 mRNA Vaccine BNT162b2 contain 6 doses of 0.3 mL of vaccine. The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 12 years of age have not yet been established. One dose of COVID-19 mRNA Vaccine BNT162b2 may be administered as a third dose at least 8 weeks after the second dose of an mRNA or adenovirus-vectored COVID-19 vaccine when the potential benefits outweigh any potential risks.įor further information on efficacy, see section 5.1. Individuals may not be maximally protected until at least 7 days after their second dose of the vaccine. 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. There are no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with other COVID-19 vaccines to complete the vaccination series. 4.2 Posology and method of administration Posology Individuals 12 years of age and older:ĬOVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) at least 21 days apart (see section 5.1). The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance. Clinical particulars 4.1 Therapeutic indicationsĪctive immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older. The vaccine is a white to off-white frozen solution. Tozinameran is highly purified single-stranded, 5’-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.Įxcipients with known effect: For the full list of excipients, see section 6.1. 1 vial (0.45 mL) contains 6 doses of 30 micrograms of tozinameran, a BNT162b2 RNA (embedded in lipid nanoparticles), see section 4.2. This is a multidose vial and must be diluted before use. Name of the medicinal productĬOVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection 2. See section 4.8 for how to report adverse reactions. Healthcare professionals are asked to report any suspected adverse reactions. 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.Īs with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. 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. Regulation 174 Information for UK healthcare professionals Please see here for latest product information. Stock authorised under Regulation 174 is no longer in use.
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