Special precautions for disposal and other handling: Handling instructions: COMIRNATY should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
Thawing prior to dilution: The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 195-vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 °C for immediate use.
Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
Dilution: 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.
Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe.
Gently invert the diluted dispersion 10 times. Do not shake.
The diluted vaccine should present as an off-white dispersion with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present.
The diluted vials should be marked with the appropriate date and time.
Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
Preparation of individual 0.3-mL doses of COMIRNATY: After dilution, the vial contains 2.25 mL corresponding to 5 doses of 0.3 mL. Withdraw the required 0.3-mL dose of diluted vaccine using a sterile needle.
Discard any unused vaccine within 6 hours after dilution.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.