EMA: Each vial of BioNTech-Pfizer vaccine contains six doses

The Human Medicines Committee of EMA, Amsterdam-based EU drugs regulator, has recommended updating the product information for Comirnaty, which is the name of BioNTech-Pfizer vaccine, to clarify that each vial contains six doses.

For extracting six doses from a single vial should be used low dead-volume syringes and/or needles. The combination of the two 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, which is 0.3 ml, the healthcare professional must discard the vial and its contents, the committee recommends specifying that 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.


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