On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron variant during a workshop, co-chaired by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The goal of the meeting was to review available evidence for the effectiveness of the approved COVID-19 vaccines against the Omicron variant and reach alignment on the key regulatory requirements to support development of a possible adapted vaccine.
Welcoming the participants from the 24 members and 13 associated members and experts from the World Health Organization (WHO) and the European Commission, Emer Cooke, EMA’s Executive Director and chair of ICMRA said: “Today is not only about the regulatory response to Omicron but is also part of setting the scene for a more strategic discussion about what types of vaccines might be needed in the long-term to adequately manage COVID-19. These decisions are not for regulators alone. Collaboration is needed across all the actors in this space, including public health decision-makers at national, regional and global level. In that context, we need to emphasize the importance of the collaboration with WHO to take a decision on strain updates”…
