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Moderna, Inc. (MRNA - Free Report) announced that the phase III COVE study, which is evaluating its coronavirus vaccine candidate mRNA-1273 has met the primary efficacy endpoint at the first interim analysis, demonstrating a vaccine efficacy of 94.5%.
The interim efficacy analysis was conducted by the Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH).
The COVE study enrolled 30,000 participants with diverse backgrounds in the United States. The patient population of the study includes high-risk groups as well as individuals from communities of color. 95 participants in the study were infected with COVID-19 of which 90 cases were observed in the placebo group versus 5 cases in the mRNA-1273 vaccinated group. Importantly, the first analyses identified 11 severe cases of COVID-19, a secondary endpoint of the study, all of which occurred in the placebo group and none in the mRNA-1273 group.
Based on these interim safety and efficacy data, the company plans to submit an emergency use authorization (EUA) to the FDA in the coming weeks. Per FDA’s guidelines, a vaccine will be considered valid if it is at least 50% effective. Additional safety and efficacy data continues to be assessed and the companies will release final results in some time. The efficacy percentage may vary once the full outcome is available.
Shares of Moderna were up 15.4% in pre-market trading following the aforementioned announcement. The stock has skyrocketed 357% so far this year compared with the industry’s rise of 0.5%.
Moderna initiated the phase III study COVE in July on 100-microgram dose of mRNA-1273. The company completed enrollment of 30,000 volunteers in the study on Oct 22.
Upon successful development and potential approval, Moderna plans to have around 20 million doses of mRNA-1273 ready to be shipped within the United States by 2020-end. The company is on track to manufacture 500 million to 1 billion doses of the vaccine in 2021, globally.
We note that last week, both Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) also announced encouraging data from the first interim analysis of their late-stage coronavirus vaccine study. The vaccine candidate BNT162b2 was found to be 90% effective in seven days after the second dose. Both vaccine candidates of Pfizer and Moderna are based on the novel mRNA platform. As of now, Moderna edges past Pfizer as far as vaccine efficacy is concerned.
Apart from Moderna and Pfizer, AstraZeneca (AZN - Free Report) in partnership with Oxford University is evaluating their coronavirus vaccine candidate AZD1222 in late-stage studies. However, this candidate uses an adenovirus-based platform.
In a separate press release, Moderna announced that the shelf life of mRNA-1273 is now extended. Precisely, the vaccine candidate is expected to remain stable at the standard refrigerator temperatures of 2°-8°C (36°-46°F) for 30 days, up from previous estimate of 7 days. This can be a major logistical breakthrough for Moderna and might help the company gain an edge over its competitors.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Moderna's (MRNA) Coronavirus Vaccine Shows 94.5% Efficacy Rate
Moderna, Inc. (MRNA - Free Report) announced that the phase III COVE study, which is evaluating its coronavirus vaccine candidate mRNA-1273 has met the primary efficacy endpoint at the first interim analysis, demonstrating a vaccine efficacy of 94.5%.
The interim efficacy analysis was conducted by the Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH).
The COVE study enrolled 30,000 participants with diverse backgrounds in the United States. The patient population of the study includes high-risk groups as well as individuals from communities of color. 95 participants in the study were infected with COVID-19 of which 90 cases were observed in the placebo group versus 5 cases in the mRNA-1273 vaccinated group. Importantly, the first analyses identified 11 severe cases of COVID-19, a secondary endpoint of the study, all of which occurred in the placebo group and none in the mRNA-1273 group.
Based on these interim safety and efficacy data, the company plans to submit an emergency use authorization (EUA) to the FDA in the coming weeks. Per FDA’s guidelines, a vaccine will be considered valid if it is at least 50% effective. Additional safety and efficacy data continues to be assessed and the companies will release final results in some time. The efficacy percentage may vary once the full outcome is available.
Shares of Moderna were up 15.4% in pre-market trading following the aforementioned announcement. The stock has skyrocketed 357% so far this year compared with the industry’s rise of 0.5%.
Moderna initiated the phase III study COVE in July on 100-microgram dose of mRNA-1273. The company completed enrollment of 30,000 volunteers in the study on Oct 22.
Upon successful development and potential approval, Moderna plans to have around 20 million doses of mRNA-1273 ready to be shipped within the United States by 2020-end. The company is on track to manufacture 500 million to 1 billion doses of the vaccine in 2021, globally.
We note that last week, both Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) also announced encouraging data from the first interim analysis of their late-stage coronavirus vaccine study. The vaccine candidate BNT162b2 was found to be 90% effective in seven days after the second dose. Both vaccine candidates of Pfizer and Moderna are based on the novel mRNA platform. As of now, Moderna edges past Pfizer as far as vaccine efficacy is concerned.
Apart from Moderna and Pfizer, AstraZeneca (AZN - Free Report) in partnership with Oxford University is evaluating their coronavirus vaccine candidate AZD1222 in late-stage studies. However, this candidate uses an adenovirus-based platform.
In a separate press release, Moderna announced that the shelf life of mRNA-1273 is now extended. Precisely, the vaccine candidate is expected to remain stable at the standard refrigerator temperatures of 2°-8°C (36°-46°F) for 30 days, up from previous estimate of 7 days. This can be a major logistical breakthrough for Moderna and might help the company gain an edge over its competitors.
Zacks Rank
Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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