Covid vaccines less effective against Omicron variant infections. This is what the European Medicines Agency Ema has specified. “Although most of the available data suggests that approved Covid vaccines are losing effectiveness in protecting against infection and mild disease, continue to provide high protection against severe forms and the need for hospitalization linked to the Omicron variant of Sars-CoV-2 “, reads a note in which the EMA reports on a summit that was held yesterday, January 12, among the regulatory bodies around the world, to make a common front and align themselves on a possible path to follow to get to make available, if necessary, new or updated vaccines against the mutant on the rise globally.
“Today it’s not just about the regulatory response to Omicron, but about set the stage for a more strategic discussion of what types of vaccines may be needed in the long term to properly manage Covid-19“, said Emer Cooke during the summit. Cooke also looks to the future and to a long-term management in a scenario that sees the virus still present. And he points out:” These decisions are not only for the regulators. Collaboration is needed between all actors in this space, including public health decision makers at national, regional and global levels. In this context, we must stress the importance of collaborating with the World Health Organization (WHO) to make a decision on the updates of the Sars-CoV-2 strains on which to base the vaccines.
The vaccine node and the response to the Omicron variant was on the table at the summit between regulatory bodies from around the world, chaired by the European drug agency Ema and the American Food and Drug Administration (Fda) which was held on 12 January . Objective: “Align”, collaborate. And outline a path to “support the development of a possible adapted vaccine” for the new mutant. The EU regulatory authority explained, “the global regulatory response to the variant, under the aegis of the International Coalition of Medicines Regulators (ICMRA)”, was discussed.
The aim of the meeting, which was also attended by experts from the World Health Organization (WHO) and the European Commission, was to “review the available evidence on the efficacy of approved vaccines against the Omicron variant and achieve alignment on key regulatory requirements “to eventually accompany the launch of an ‘updated’ version.
“Looking at the regulatory requirements for any viral variant vaccine, there was broad consensus that clinical data is needed to approve a new, updated vaccine,” said experts attending the meeting.