Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA, at least 6 doses can be obtained from each vial of BioNTech/Pfizer vaccine - AIFA, at least 6 doses can be obtained from each vial of BioNTech/Pfizer vaccine

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AIFA, at least 6 doses can be obtained from each vial of BioNTech/Pfizer vaccine

With the aim of using all the product available in each vial and avoiding any waste, AIFA, in accordance with the provisions of its Technical Scientific Committee, informs that, without prejudice to the need to ensure the administration of the correct quantity of 0.3 ml to each vaccinated subject through the use of appropriate syringes, it is possible to have at least 1 additional dose compared to the 5 doses declared in the Summary of Product Characteristics (SmPC).

The dose of vaccine to be administered to each person is 0.3 ml. This dose should be extracted, under aseptic conditions and using appropriate precision syringes, from a vial of vaccine containing 2.25 ml, after the intended dilution with 0.9% sodium chloride solution.

Any residues from different vials, even those belonging to the same batch number, should not be mixed.


Published on: 28 December 2020

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