Global regulators discuss path towards regulatory alignment on response to Omicron variant

News 13/01/2022

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”.

While most available data suggest that the approved COVID-19 vaccines are losing effectiveness in protecting against infection and mild disease, they continue to provide high protection against people developing severe disease and the need for hospitalisation linked to the Omicron variant.

When looking at regulatory requirements for any variant vaccine, there was broad agreement that clinical data are needed for approving a new updated vaccine.

The workshop was co-chaired by Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at US FDA, and Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at EMA, and regulators from South Africa and Israel shared their experiences. It was the third in a series of workshops on COVID-19 vaccine development and virus variants held by ICMRA in 2021. These workshops underline the power of ICMRA’s leadership in achieving alignment between regulators to expedite and streamline global development and authorisation of new or modified COVID-19 vaccines against emerging coronavirus variants. More details on the discussions and the outcomes of the meeting will be shared in the coming days.

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