Moderna's COVID vaccine reports 94.5% efficacy, to seek US FDA's emergency authorization

Announcing results of its phase three trials, Moderna on Monday reported that its COVID-19 vaccine candidate has proven to be 94.5% effective. The biotechnology company has informed that it intends to submit the COVID-19 vaccine candidate for an Emergency Use Authorization (EUA) with the United States' Food & Drug Administration (FDA). The analysis released by Moderna which has reported 94.5% efficacy of the COVID-19 vaccine was based on results of more than 30,000 participants in the US. Moderna's report comes days after Pfizer and BioNtech reported that its COVID vaccine candidate was found to be more than 90% effective.

We just announced that mRNA-1273, our COVID-19 vaccine candidate, has met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study.
Read more: https://t.co/vYWEy8CKCv pic.twitter.com/YuLubU1tlx

— Moderna (@moderna_tx) November 16, 2020

 

The analysis report of the Moderna vaccine revealed that the 'preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.' The biotechnological firm also plans to submit applications for authorizations to global regulatory agencies. By the end of 2020, Moderna has projected to have approximately 20 million doses of mRNA-1273 (COVID Vaccine) ready to ship in the U.S. The company has also informed that it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

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“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

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Moderna's Phase 3 Trials 

Moderna's Phase 3 trials are randomized and including providing vaccine shots at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The trials also included Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.

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Pfizer's vaccine candidate 

On November 10, Pfizer Inc announced that its mRNA-based COVID-19 vaccine candidate which was found 90 percent effective in the first interim analysis from Phase III study, will be distributed in December across the US, Pfizer confirmed in a press release. Developed with the German partner BioNTech SE, Pfizer’s COVID-19 vaccine was declared effective against SARS-CoV-2 by the independent Data Monitoring Committee (DMC) in an analysis conducted on November 8, 2020. US’ top infectious diseases expert, Dr. Anthony Fauci, meanwhile, said at a presser that the first doses of a safe and effective vaccine will be available for high-risk Americans in late December. 

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