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A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.
A published report details discussions by international regulators on the effectiveness of the COVID-19 vaccines on the omicron variant, regulatory requirements for a variant vaccine, and clinical study design. The International Coalition of Medicines Regulatory Authorities (ICMRA) organized the Jan. 12, 2022 workshop on the global response to the COVID-19 omicron variant, which was co-chaired by the European Medicines Agency (EMA) and FDA.
Workshop participants reviewed data on the impact of the variant and concluded that while the current vaccines offer less protection against infection with the COVID-19 omicron variant and mild disease, they do offer protection against severe disease and hospitalization, especially with a booster dose.
“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,” EMA stated in a press release.
According to EMA, regulators are encouraging developers to look for alternative approaches to monovalent vaccines and explore the possibility of developing bivalent or multivalent variant vaccines. Workshop participants stressing that clinical studies should be performed to support the use of a new vaccine. “These studies should be designed to demonstrate that the immune response, measured as neutralizing antibodies, generated by the updated vaccine is superior to that achieved with current vaccines. The ability of the updated vaccines to cross-neutralize other variants of concern would be an additional feature with respect to the breadth of protection provided by the updated vaccine,” EMA stated in the release.