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

June 24, 2022

Several COVID-19 vaccine vials lined up on a table.

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

Regulatory and procedural requirements


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.

Download Procedural Guidance

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.


Computer generated illustration of mRNA molecule

August 21, 2023

COVID-19 and mRNA: A Vaccine Breakthrough

COVID-19 has presented humankind with the challenges expected from a pandemic with over 700 million cases and almost 7 million deaths1. While the mRNA technology was not widely known in the news, it...

July 5, 2022

Global regulators agree on key principles on adapting vaccines to tackle virus variants

News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...

October 19, 2022

What You Need to Know About Developing Vaccines

An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may come in the form of renewed attention towards approaches to vaccine development. The Importance of Vaccines The...