COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements | European Medicines … – European Medicines Agency |

International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition of Medicines Regulatory Authorities and the World Health Organization (WHO).

Currently authorised vaccines, particularly those that have already gone through adaptation of the composition, continue to be effective at preventing hospitalisation, severe disease and death due to COVID-19. However, protection wanes over time and as new SARS-CoV-2 variants emerge. For this reason, update of vaccine composition has to be considered on a regular basis. Meeting participants stressed that international convergence on the process and timing of COVID-19 vaccine strain updates are therefore critical in view of the continuous evolution of SARS-CoV-2.

The meeting report provides an overview of key regulatory considerations related to updated COVID-19 vaccine composition. It also highlights data requirements for authorised vaccines to support the approval of strain changes. Workshop participants also discussed virus evolution and circulation in different regions of the world.

The conclusions detail how international regulators and WHO will put in place a structured process to support and optimise timing around COVID-19 vaccine antigen recommendations.

The workshop brought together representatives of national regulatory authorities, WHO, scientists, and industry to present their perspectives and experience with the updating of the COVID-19 vaccine composition and to propose a way forward. Participants acknowledged that regular meetings with key stakeholders, including vaccine manufacturers, will contribute to timely regulatory approvals and the use of updated COVID-19 vaccines in national vaccination programmes.

The two-day workshop was held virtually on 26 and 27 February 2024. The meeting aimed to identify a structured and aligned process to optimise timely vaccine antigen composition recommendations and regulatory approval for vaccines with an updated composition. Delegates representing more than 35 medicines regulatory authorities globally, as well as experts from WHO, the European Commission and industry engaged in the scientific discussions.

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COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements | European Medicines ... - European Medicines Agency |