Published 18:04 IST, November 16th 2020
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.
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Anuncing results of its phase three trials, Moderna on Monday reported that its COVID-19 vaccine candidate has proven to be 94.5% effective. biotechlogy company has informed that it intends to submit COVID-19 vaccine candidate for an Emergency Use Authorization (EUA) with United States' Food & Drug ministration (FDA). analysis released by Moderna which has reported 94.5% efficacy of COVID-19 vaccine was based on results of more than 30,000 participants in US. Moderna's report comes days after Pfizer and BioNtech reported that its COVID vaccine candidate was found to be more than 90% effective.
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analysis report of Moderna vaccine revealed that 'preliminary analysis suggests a broly consistent safety and efficacy profile across all evaluated subgroups.' biotechlogical firm also plans to submit applications for authorizations to global regulatory ncies. By end of 2020, Moderna has projected to have approximately 20 million doses of mRNA-1273 (COVID Vaccine) rey to ship in U.S. 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 development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with intent to protect as many people around world as possible. All along, we have kwn that each day matters. This positive interim analysis from our Phase 3 study has given us 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 100 µg dose level in 30,000 participants in U.S., s 18 and older. trials also included Americans who are under of 65 but have high-risk chronic diseases that put m at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.
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Pfizer's vaccine candidate
On vember 10, Pfizer Inc anunced that its mRNA-based COVID-19 vaccine candidate which was found 90 percent effective in first interim analysis from Phase III study, will be distributed in December across US, Pfizer confirmed in a press release. Developed with German partner BioNTech SE, Pfizer’s COVID-19 vaccine was declared effective against SARS-CoV-2 by independent Data Monitoring Committee (DMC) in an analysis conducted on vember 8, 2020. US’ top infectious diseases expert, Dr. Anthony Fauci, meanwhile, said at a presser that first doses of a safe and effective vaccine will be available for high-risk Americans in late December.
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18:04 IST, November 16th 2020