Moderna President Discusses Cancer Vaccine Breakthroughs and mRNA Flu Vaccine

FDA Review of mRNA Flu Vaccine

• 💉 Moderna's mRNA flu vaccine has received FDA review, with a decision expected by August 5th.
• 💡 The vaccine is proposed for full approval for adults 50-64 and accelerated approval for those 65+, with required post-market studies.
• 🥚 Current flu vaccines, largely made in eggs, often have strain mismatches due to early strain selection (February) and egg adaptation mutations, leading to reduced effectiveness.
• 🚀 mRNA technology allows for later strain selection (May/June), potentially improving vaccine match and real-world efficacy.

Cancer Vaccine Progress

• 🔬 Personalized cancer vaccines, developed in combination with Merck's Keytruda, have shown a 49% reduction in relapse or death risk for melanoma patients over five years.
• 📈 Confirmatory Phase 3 trials for the melanoma vaccine are fully enrolled, with initial readouts expected mid-year.
• 🚀 Further trials are underway for renal cell carcinoma, bladder cancer, pancreatic cancer, and gastric cancer, with significant data anticipated in the next 12 months.

Business and Investment Outlook

• 🌍 Moderna anticipates most of its growth in the next two years to come from international markets, with significant partnerships in Canada, the UK, Australia, Latin America, and Asia.
• 💰 The company is focusing on maturing its business, controlling costs, and reinvesting in R&D to drive growth and achieve break-even in its vaccines business within the next year or two.
• 🇺🇸 While international growth is prioritized, new product introductions in the US are expected to drive growth returning to the domestic market in about three years.

Regulatory Environment and Investment

• ⚠️ Regulatory delays and uncertainty can significantly impact investment cycles for new medicines and vaccines, which often take over a billion dollars and 10 years to develop.
• 🤝 Clear, consistent, and transparent guidance from regulators is crucial for companies to confidently invest in future research and development.
• 🚀 The success of the COVID-19 vaccine development, completed in less than a year, was facilitated by a crisis situation and prior foundational work, including an executive order in 2019 to modernize vaccine manufacturing away from eggs.