News Category: Regulatory news
The EMA's human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains six doses of the vaccine.
In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microliters. If standard syringes and needles are used, there may not be enough of the vaccine to extract a sixth dose from a vial.
If the amount of vaccine remaining in the vial after the fifth dose cannot provide a full dose (0.3 ml), the healthcare professional must discard the vial and its contents. There should be no pooling from multiple vials to make up a full dose, and any unused vaccine should be discarded 6 hours after dilution.
Further information on all the steps for using Comirnaty is available in the updated product information. Additional details are available on the EMA website.