Moderna has withdrawn its request for FDA approval of its mRNA-1083 combination vaccine, which targets both the flu and COVID-19, on May 21. The company plans to reapply once it has data from a Phase 3 trial for its separate mRNA-1010 flu vaccine, expected later in 2024.
• The withdrawal comes as the FDA requires more rigorous clinical trials for COVID-19 booster approvals, influenced by new Commissioner Dr. Marty Makary.
• Moderna’s stock fell 1. 4% in premarket trading, adding to a 30% drop this year due to reduced sales of COVID-19 vaccines.
• Critics of multi-antigen mRNA vaccines highlight potential risks, like immune dysregulation, while advocates emphasize addressing existing vaccine safety concerns.
• Stricter FDA policies also include plans to stop recommending COVID-19 vaccines for pregnant women and children, reflecting a focus on safety and transparency.
• Despite setbacks, Moderna anticipates FDA approval for its mRNA-1273 COVID-19 vaccine by the end of June.
• Challenges for Moderna include declining demand for its vaccines, leading to a lawsuit over claims of efficacy.
Moderna's decision to withdraw its application marks a significant shift in vaccine policy, emphasizing long-term safety and transparency over rapid approvals, amid growing skepticism about new vaccine formulations.
https://www.naturalnews.com/2025-05-26-moderna-withdraws-application-for-flu-covid-vaccine.html
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