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FDA Approves Moderna's mRNA Flu Vaccine After Initially Refusing To Review It
Engadget • • general
Key Points:
- The FDA has approved Moderna's mRNA seasonal flu vaccine, mFlusiva (mRNA-1010), for adults aged 50 and older, following a Phase 3 trial involving over 40,000 participants across 11 countries.
- The vaccine targets the four most common influenza strains and was found to be superior to standard-dose licensed vaccines in preventing influenza-like illness in adults 50 and older.
- While mFlusiva showed higher rates of mild to moderate adverse events such as injection-site pain, fatigue, headache, and muscle pain compared to existing flu vaccines, these side effects were transient.
- The FDA initially refused to review Moderna's application due to concerns over the comparator vaccine used in the trial but reversed its decision within a week after previously approving the comparator choice.
- Moderna's mRNA flu vaccine benefits from the platform's known advantages, including rapid development, high efficacy, adaptability to new strains, and a strong immune response without altering human DNA.
