International regulators’ recommendations on COVID-19 vaccines and the Omicron variant

News 21/01/2022

International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against the COVID-19 Omicron variant, regulatory requirements for a variant vaccine and considerations on clinical study design. The workshop on the global response to the COVID-19 Omicron variant was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and took place on 12 January 2022.

Reviewing data on the impact of Omicron, the participants concluded that current vaccines offer less protection against infection and mild disease caused by this variant. However, vaccination continues to offer considerable protection from hospitalisation and severe COVID-19 with Omicron, especially after a booster dose. It is becoming increasingly clear that a booster dose is needed to extend vaccine protection.

When looking at possible vaccination approaches against Omicron and other virus variants, the meeting participants agreed that the administration of multiple booster doses at short intervals is not a sustainable approach in the longer term. There is a need to develop a long-term strategy on the types of vaccines needed to manage COVID-19 in the future. This is an ongoing global discussion, that sits at the crossroads of science, public policy and public health and will require coordination among public health decision-makers at all levels.

With respect to updated vaccine compositions, global regulators encourage the international scientific community and vaccine developers to look at alternative approaches to monovalent vaccines. In the regulators’ view, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine if they offer advantages to monovalent vaccines.

Meeting participants also stressed that clinical studies should be undertaken to support the use of a new vaccine. These studies should be designed to demonstrate that the immune response, measured as neutralising antibodies, generated by the updated vaccine is superior to that achieved with current vaccines. The ability of the updated vaccines to cross-neutralise other variants of concern would be an additional feature with respect to the breadth of protection provided by the updated vaccine.

The meeting built upon the knowledge and experience gained from previous workshops on COVID-19 vaccine development and virus variants held in 2021, where international regulators emphasised the need for regulatory alignment to expedite and streamline global development and authorisation of new or modified COVID-19 vaccines against emerging coronavirus variants. It brought together delegates representing 24 members and 13 associate members as well as the World Health Organization (WHO).

The meeting was co-chaired by EMA and the US Food and Drug Administration (FDA).

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