European regulator to review Moderna’s Omicron-subvariant adapted vaccine

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The European Medicines Agency is set to review Moderna($NASDAQ:MRNA)’s vaccine for the Omicron-subvariant of the coronavirus by the end of this month. The vaccine, which is designed to protect against the BA.4/5 subvariant of the virus, is currently being tested in clinical trials. If approved, it would be the first vaccine in Europe specifically designed to protect against this subvariant. “Discussions are ongoing with Moderna in preparation for an application for a Spikevax BA.4/5 adapted bivalent vaccine,” EMA’s Head of Biological Health Threats and Vaccines Strategy Marco Cavaleri said in a press briefing on Tuesday.

Price History

This news sent Moderna’s stock prices up by 1.4% on Tuesday. The review is a positive step forward for the company, as it looks to get its vaccine approved for use in Europe. The Omicron-subvariant is thought to be more prevalent in Europe than in other parts of the world, so approval from the EMA would be a major boost for Moderna.

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Summary

The review is being conducted on a rolling basis, which means that the EMA will assess the data as it becomes available. Moderna is a biotechnology company that specializes in the development of vaccines and therapeutics. The EMA’s review will assess the safety, efficacy, and quality of the vaccine. Moderna is currently conducting clinical trials of the vaccine in the United States and Europe. The results of these trials will be taken into account during the review process. The EMA is expected to make a decision on whether to approve the vaccine in the first half of 2021.