EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus

8 June 2022
EMA/175959/2021 Rev.2
Human Medicines Division

Regulatory and procedural requirements

Introduction

In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may be necessary to modify the authorised human coronavirus vaccines composition so as to protect against new or multiple variant strain(s). Such changes, which include the replacement or addition of a serotype, strain, antigen or coding sequence or combination of serotypes, strains, antigens or coding sequences, should be considered as variations to the marketing authorisation in accordance to the Commission Regulation (EC) No 1234/2008 as amended by Commission Delegated Regulation (EU) 2021/756, provided the technological platform of the vaccine remains similar. The same approach should be followed for all human coronaviruses as set out in the Commission Delegated Regulation (EU) 2021/756. This guideline lays down the procedural aspects related to the submission of a variation to change the composition of a marketing authorisation for COVID-19 vaccines in the centralised procedure.

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