Moderna, in consultation with the European Medicines Agency (EMA) and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, has published a communication regarding the correct volume of the booster dose of the bivalent Spikevax vaccines against COVID-19.
In September and October 2022, EMA approved new bivalent mRNA vaccines adapted to the Omikron subvariant for booster vaccination against COVID-19 in people aged ≥12 years, including Spikevax BA.1 and Spikevax BA.4/BA.5 (p. EMA: we have another COVID-19 mRNA vaccine with an updated formulation, EMA has approved another COVID-19 mRNA vaccine with an updated formulation, EMA has approved two COVID-19 mRNA vaccines -19 with updated composition).
The manufacturer has received reports of inadvertently under-dosing with bivalent Spikevax vaccines, ie 0.25 ml (25 µg) instead of 0.5 ml (50 µg). In most of these cases, the underdose was due to dosing errors, as the baseline booster volume of the monovalent Spikevax previously used in 2022 was 0.25 ml (equivalent to 50 µg). For the new bivalent Spikevax booster vaccines, the correct dose is 0.5 ml (50 µg).-
Full text of the message: Correct dose of Spikevax bivalent booster vaccines.