ICMRA COVID-19 Omicron variant workshop

ICMRA COVID-19 Omicron variant workshop
12 January 2022 [published 20 Jan 2022]
Co-chairs: Peter Marks (FDA, US) and Marco Cavaleri (EMA, EU)

Welcome by Emer Cooke, ICMRA chair (EMA)
The ‘COVID-19 Omicron variant’ workshop is the third ICMRA vaccines workshop, following the workshop organised in June 2021 entitled ‘Vaccine development: future steps’. The objective of this workshop was to reach international regulatory alignment on dealing with Omicron variant, on the criteria for the selection of adapted vaccines and fostering a strategic discussion between all public health authorities on the long term needs against SARS-CoV-2…

Closing remarks and next steps
While current vaccines are losing protection against Omicron with respect to infection and mild disease, there is still considerable protection from hospitalisation and severe COVID-19, especially after a booster dose. It is becoming increasingly clear that a booster dose is needed to extend vaccine protection.


Particularly from the perspective of a global strategy, additional boosters of current vaccines administered with short intervals to restore protection over time would not be the preferable approach to protect public health and a longer-term strategy should be defined. 

With respect to updated vaccine composition, other alternatives should be considered besides a monovalent omicron vaccine as it is not yet defined what would be the preferable approach.

In principle, clinical data are needed for approving a new updated vaccine. Clinical studies should demonstrate that the immune response, measured as neutralising antibodies, with the updated vaccine is superior to the immune response achieved with the prototype vaccine against the variant included in the updated vaccine. Cross-neutralisation of other variants of concern would be additional relevant evidence with respect to the breadth of coverage provided by the updated vaccine. These criteria have to be considered as a minimum requirement to support variant vaccine approval.

Global coordination of changes in vaccine composition to cover potential variants of concern will be important.