The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended updating the product information for Comirnaty to clarify that each vial contains six doses of the vaccine.
Low dead volume syringes and/or needles should be used to extract six doses from a single vial. The combination of syringe and needle must not exceed a maximum dead volume of 35 microlitres. If standard syringes and needles are used, there may not be enough of the vaccine left to take a sixth dose from a vial.
If the amount of vaccine remaining in a vial after the fifth dose cannot provide a full dose (0.3 ml), the healthcare professional must discard the vial and its content. Using leftovers from several vials to collect a full dose is not permitted. Any unused vaccine should be discarded no later than six hours after dilution.
Further information on all the steps for using Comirnaty is available in the updated product information.
Information for healthcare professionals
- After dilution, it is possible to obtain six doses from a vial if you use low dead volume (≤35 μL) syringes and/or needles for all doses.
- Discard the vial and its contents if the amount of vaccine left in the vial is not enough for a full sixth dose (0.3 ml).
- Do not use leftovers from multiple vials to collect an extra dose.
- Discard any unused vaccine no later than six hours after dilution.
- Read the product information for full instructions.