International regulatory authorities this week released a report highlighting their discussions on the efficacy of current vaccines against the Omicron COVID-19 variant, regulatory requirements for a variant vaccine, and considerations on clinical study design. The workshop on the global response to the COVID-19 Ómicron variant was organized under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and took place on January 12, 2022.
Reviewing the data on the impact of Omicron, participants concluded that current vaccines offer less protection against infection and mild disease caused by this variant. However, vaccination still offers considerable protection against hospitalization and severe COVID-19 with this variant, especially after a booster dose. “It is becoming increasingly clear that a booster dose is needed to extend the protection of the vaccine,” the report says.
In reviewing potential vaccination approaches against Omicron and other variants of the virus, meeting participants agreed that giving multiple booster doses at short intervals “is not a sustainable long-term approach.” For this reason, they consider that it is necessary to develop a long-term strategy on the types of vaccines necessary to manage the disease in the future. “This is an ongoing global debate, which sits at the crossroads of science, public policy and public health and will require coordination between those responsible for public health at all levels.”
Alternative Approaches
With regard to updated vaccine compositions, global regulators encourage the international scientific community and vaccine developers to seek alternative approaches to monovalent vaccines. In the view of regulators, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine whether they offer advantages over monovalent vaccines.
Meeting participants also stressed that clinical trials must be conducted to support the use of a new vaccine. These studies should be designed to show that the immune response, measured as neutralizing antibodies, generated by the updated vaccine is superior to that achieved by current vaccines. The ability of the updated vaccines to neutralize other variants of interest would be an additional feature relative to the breadth of protection provided by the updated vaccine.
The meeting built on insights and experience gained from previous workshops on COVID-19 vaccine and variant virus development held in 2021, where international regulators emphasized the need for regulatory alignment to accelerate and expedite the global development and licensing of new or modified vaccines against emerging variants of the coronavirus. It brought together delegates representing 24 members and 13 associate members, as well as the World Health Organization (WHO).
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