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when will moderna be fda approved ?

**When Will Moderna Be FDA Approved?**

The COVID-19 pandemic has brought unprecedented attention to vaccine development, with companies like Moderna, Pfizer, and Johnson & Johnson leading the charge. Among these, Moderna’s COVID-19 vaccine has been a subject of interest, particularly regarding its FDA approval status. In this blog post, we’ll explore the latest updates on Moderna’s journey toward full FDA approval and what this means for the public.

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### **Moderna’s Application for Full FDA Approval**

Moderna submitted its application for full FDA approval in June 2021, following the completion of its rolling submission process. This application included extensive data from clinical trials, including the Phase 3 COVE study, which demonstrated the vaccine’s efficacy in preventing symptomatic COVID-19. The vaccine, now officially named **Spikevax**, has shown consistent results, with an efficacy rate of approximately 90% in preventing symptomatic infection.

While Moderna’s application came shortly after Pfizer’s, the FDA’s review process is thorough and time-consuming. The agency evaluates not only the vaccine’s efficacy but also its safety profile, manufacturing quality, and other critical factors. This process ensures that only vaccines meeting the highest standards receive full approval.

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### **Timeline for FDA Approval**

The FDA typically takes several months to review applications for full approval. Pfizer’s vaccine, for example, received full approval in August 2021, about four months after its application. Moderna’s approval timeline has been slightly longer, but the FDA has been working diligently to complete the review.

As of January 2022, the FDA has granted full approval to Moderna’s Spikevax vaccine, making it the second COVID-19 vaccine to receive this distinction in the United States. This milestone marks a significant step forward in the fight against COVID-19, as full approval may increase public confidence in the vaccine’s safety and efficacy.

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### **Emergency Use Authorization vs. Full Approval**

It’s important to understand the difference between emergency use authorization (EUA) and full FDA approval. The EUA was granted to Moderna’s vaccine in December 2020, allowing its use during the pandemic under specific conditions. However, full approval requires a more comprehensive review of the vaccine’s long-term safety and efficacy.

The FDA’s decision to grant full approval to Spikevax is a testament to the robust data supporting its use. This approval also opens the door for potential booster shots and expanded use in different populations, such as children.

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### **Recent Updates and Bivalent Vaccines**

In addition to full approval, Moderna has been working on bivalent vaccines, which target both the original COVID-19 virus and its variants, such as Omicron. In September 2022, the FDA authorized updated bivalent versions of both Moderna’s and Pfizer’s vaccines for emergency use. These updated vaccines aim to provide broader protection against emerging variants and are expected to play a crucial role in the ongoing pandemic response.

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### **Conclusion**

Moderna’s journey toward full FDA approval has been a long and rigorous process, but the end result is a vaccine that has been thoroughly vetted for safety and efficacy. With Spikevax now fully approved, Moderna continues to be a key player in the global effort to combat COVID-19. As the pandemic evolves, ongoing research and development will remain essential to ensuring vaccines remain effective against new variants.

For more information on Moderna’s COVID-19 vaccine and its approval status, you can visit the FDA’s official website or refer to trusted news sources like [Newsweek](https://www.newsweek.com) and [NBC News](https://www.nbcnews.com).

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### **Additional Resources**

– [FDA Official Website](https://www.fda.gov)
– [Moderna COVID-19 Vaccine Updates](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines)
– [YouTube Video on FDA Approval](https://www.youtube.com/watch?v=S7L-WFNFl4M)

Stay informed, and let’s continue to navigate the pandemic together with science and solidarity!