Moderna

Moderna's COVID-19 mRNA vaccine for SARS-CoV-2 variant JN.1 received a positive opinion from EMA's CHMP, recommended for the 2024-2025 EU vaccination season, pending final authorization. This vaccine is part of Moderna's strategy to adapt to evolving variants, with approvals already in Japan, Taiwan, the UK, and the US.

EMA's CHMP recommends marketing authorization for Moderna's updated COVID-19 mRNA vaccine targeting SARS-CoV-2 variant JN.1, for individuals 6 months and older, pending European Commission approval for the 2024-2025 vaccination season.

Moderna's mRNA-based mpox vaccine, mRNA-1769, shows promise in a monkey trial, outperforming older vaccines in reducing illness severity and lesion count, suggesting potential for better protection against mpox and related Orthopoxviruses.

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U.S. to offer free COVID tests by mail starting late September, with each household able to order up to four tests. The program has distributed over 900 million tests since the pandemic began. The tests aim to help detect the virus and prevent its spread during the holiday season.

Moderna's updated COVID-19 vaccine targeting KP.2 variant of SARS-CoV-2 has been approved by the U.S. FDA for individuals 12 years and above, with EUA granted for those 6 months through 11 years. The vaccine aims to prevent COVID-19 and is expected to be available soon.

The FDA approved updated COVID-19 vaccines from Moderna and Pfizer for 2024-2025, targeting the Omicron KP.2 strain. Approved for ages 12+ and authorized for 6 months-11 years, these vaccines aim to enhance protection against current variants. Vaccination is emphasized as key to COVID-19 prevention, with recommendations for high-risk groups and all individuals 6 months and older.

AI is increasingly used across the drug lifecycle, from discovery to post-market surveillance, enhancing efficiency and safety. Regulatory agencies emphasize transparency and explainability in AI applications to ensure informed decision-making. Challenges include adapting regulatory frameworks for AI's evolving role, with specific actions proposed for each drug development stage. Collaboration between regulators, developers, and AI experts is crucial for leveraging AI's potential while maintaining safety standards.

Moderna's shares dropped nearly 20% after lowering its 2024 financial forecasts due to decreased COVID-19 vaccine sales, deferred government contracts, and competition. The company expects low EU sales and contract deferrals, impacting revenue. Moderna is optimistic about future growth, focusing on new vaccines and cost-cutting measures, including AI investments.