28 августа, 2020

Important Information Note on Spikevax Bivalent Vaccines

AIFA Agenzia Italiana del Farmaco

Important Information Note on Spikevax bivalent vaccines

The Italian Medicines Agency wishes to inform you of the following:

Reports have been received of accidental underdose of the booster dose of Spikevax bivalent vaccines administered as a dose of 0.25 mL (equivalent to 25 μg) instead of 0.5 mL (50 μg).  In most cases, this underdose was due to dose confusion, as the volume of the booster dose for the original monovalent Spikevax vaccine used in early 2022 was 0.25 mL (equivalent to 50 μg).

Booster doses with Spikevax bivalent vaccines were recently approved by the EMA for use in individuals aged 12 years and older.The correct dose is 0.5 mL (50 μg).

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Source — https://www.univadis.it/viewarticle/nota-informativa-importante-su-vaccini-bivalenti-spikevax

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