On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Spikevax. The marketing authorisation holder for this medicinal product is Moderna Biotech Spain, S.L.

The CHMP adopted two extensions to the existing indication, to extend the use of the vaccine from 6 years of age and older to children from 6 months of age and older and to extend the use of the vaccine to individuals regardless of their vaccination status. For information, the full indication for Spikevax bivalent Original/Omicron BA.4-5 is as follows:¹

Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID‑19 caused by SARS-CoV-2 in individuals 6 years months of age and older who have previously received at least a primary vaccination course against COVID‑19 (see sections 4.2 and 5.1).

The use of this vaccine should be in accordance with official recommendations.

For information, the indications for other compositions of the vaccine are provided in the summary of product characteristics (SmPC) for Spikevax.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

¹ New text in bold, removed text as strikethrough