FDA declines to review Moderna application for new flu vaccine
#Moderna #FDA #Flu vaccine #mRNA technology #Biologics License Application #Regulatory approval #Pharmaceuticals
📌 Key Takeaways
- The FDA has issued a refusal to file a review for Moderna's new mRNA-based seasonal flu vaccine application.
- This decision is unexpected as the agency had previously given the project a 'green light' for development.
- Moderna is requesting an immediate meeting with regulators to discuss the refusal and seek a path forward.
- Industry analysts suggest this move could set a new precedent for how all updated and future vaccines are reviewed in the U.S.
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🏷️ Themes
Healthcare Regulation, Biotechnology, Public Health
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General term for rules, including delegated legislation and self-regulation
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Moderna
American biotechnology company
Moderna, Inc. ( mə-DUR-nə) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts, that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to carry instructions for proteins to produce an immune...
Biologics license application
License
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Influenza vaccine
Vaccine against influenza
Influenza vaccines, colloquially known as flu shots or flu jab, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest t...
Food and Drug Administration
Federal agency in the United States
# Food and Drug Administration (FDA) The **Food and Drug Administration (FDA)** is a federal agency within the **United States Department of Health and Human Services (HHS)**. It serves as the primary regulatory body responsible for protecting and promoting public health in the United States. ### ...
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Connections for Regulation:
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📄 Original Source Content
<p>Moderna requests meeting to discuss refusal as decision could have implications for all new and updated vaccines</p><p>US regulators will not review Moderna’s request to license a new, potentially more effective flu shot – even though the US Food and Drug Administration (FDA) previously gave the green light to the project – in a decision that could have implications for all new and updated vaccines in the US.</p><p>It’s the latest move by the <a href="https://