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Moderna (MRNA) Seeks Nod for Emergency Use of COVID-19 Vaccine
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Moderna, Inc. (MRNA - Free Report) announced that it has completed primary efficacy analysis of the phase III COVE study evaluating its novel coronavirus vaccine candidate, mRNA-1273. Data from the analysis showed that the vaccine achieved an efficacy rate of 94.1% against COVID-19 infection. Moreover, the candidate seems to be 100% effective against severe COVID-19 infection. The candidate has not raised any serious safety concerns so far.
The primary analysis was based on 196 cases of COVID-19 in the COVE study, among which 11 cases were from mRNA-1273 arm and the rest in the placebo arm. Moreover, all 30 cases of severe COVID-19 infections and one COVID-related death in the study were from the placebo arm.
Based on these data, the company filed to the FDA, requesting Emergency Use Authorization (“EUA”) for mRNA-1273. Moderna also plans to file an application for Conditional Marketing Authorization with the European Medicines Agency, where the company’s regulatory application seeking approval for mRNA-1273 is under rolling review. It also intends to seek Prequalification and/or Emergency Use Listing with the World Health Organization.
The company also stated that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is scheduled for Dec 17, which will review the safety and efficacy data package for mRNA-1273. An EUA will likely be significantly beneficial for Moderna as one analyst projects total sales at $13 billion for the company in 2021, primarily led by the coronavirus vaccine.
The candidate had demonstrated a vaccine efficacy of 94.5% during the first interim analysis. Meanwhile, the company continues to accrue additional data relevant to safety and efficacy of mRNA-1273 and will continue to do so even after an EUA for final analysis of the study.
Shares of Moderna shot up more than 20% on Nov 30 following the announcement. The company’s shares were also up almost 7% during after-hours trading. Shares of the company have skyrocketed 680.9% so far this year compared with the industry’s rise of 2.1% majorly on accelerated and encouraging development of its coronavirus vaccine.
We note that Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) have already submitted a request to the FDA to grant EUA to their mRNA-based coronavirus vaccine candidate, BNT162b2, in November and an advisory committee meeting is scheduled on Dec 10. Both, mRNA-1273 and BNT162b2, are expected to gain an EUA around mid- December and the respective companies seem confident to start delivery of the vaccines shortly after getting one. However, Moderna may gain logistical advantage over Pfizer as mRNA-1273 can remain stable at standard refrigerator temperatures (2°-8°C) for 30 days while BNT162b2 needs to be stored for up to 15 days at extremely low temperatures (-70°C±10°C).Once thawed, Pfizer’s vaccine can stay in standard refrigerator temperature (2°-8°C) for up to 5 days.
There is an alarming rise in the number of cases of COVID-19 globally and stricter restrictions are being imposed in countries like the United States and Japan. The need of a COVID-19 vaccine is rising with each passing day. Positive vaccine news has thus been propelling stock markets to newer highs on anticipated hopes of accelerated recovery in the economies. Several other companies are also developing coronavirus vaccine candidate including J&J’s (JNJ - Free Report) and AstraZeneca/Oxford University's COVID-19 vaccines that are in late-stage development.
Imagine getting in early on a young industry primed to skyrocket from $17.7 billion in 2019 to an expected $73.6 billion by 2027.
Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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Moderna (MRNA) Seeks Nod for Emergency Use of COVID-19 Vaccine
Moderna, Inc. (MRNA - Free Report) announced that it has completed primary efficacy analysis of the phase III COVE study evaluating its novel coronavirus vaccine candidate, mRNA-1273. Data from the analysis showed that the vaccine achieved an efficacy rate of 94.1% against COVID-19 infection. Moreover, the candidate seems to be 100% effective against severe COVID-19 infection. The candidate has not raised any serious safety concerns so far.
The primary analysis was based on 196 cases of COVID-19 in the COVE study, among which 11 cases were from mRNA-1273 arm and the rest in the placebo arm. Moreover, all 30 cases of severe COVID-19 infections and one COVID-related death in the study were from the placebo arm.
Based on these data, the company filed to the FDA, requesting Emergency Use Authorization (“EUA”) for mRNA-1273. Moderna also plans to file an application for Conditional Marketing Authorization with the European Medicines Agency, where the company’s regulatory application seeking approval for mRNA-1273 is under rolling review. It also intends to seek Prequalification and/or Emergency Use Listing with the World Health Organization.
The company also stated that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is scheduled for Dec 17, which will review the safety and efficacy data package for mRNA-1273. An EUA will likely be significantly beneficial for Moderna as one analyst projects total sales at $13 billion for the company in 2021, primarily led by the coronavirus vaccine.
The candidate had demonstrated a vaccine efficacy of 94.5% during the first interim analysis. Meanwhile, the company continues to accrue additional data relevant to safety and efficacy of mRNA-1273 and will continue to do so even after an EUA for final analysis of the study.
Shares of Moderna shot up more than 20% on Nov 30 following the announcement. The company’s shares were also up almost 7% during after-hours trading. Shares of the company have skyrocketed 680.9% so far this year compared with the industry’s rise of 2.1% majorly on accelerated and encouraging development of its coronavirus vaccine.
We note that Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) have already submitted a request to the FDA to grant EUA to their mRNA-based coronavirus vaccine candidate, BNT162b2, in November and an advisory committee meeting is scheduled on Dec 10. Both, mRNA-1273 and BNT162b2, are expected to gain an EUA around mid- December and the respective companies seem confident to start delivery of the vaccines shortly after getting one. However, Moderna may gain logistical advantage over Pfizer as mRNA-1273 can remain stable at standard refrigerator temperatures (2°-8°C) for 30 days while BNT162b2 needs to be stored for up to 15 days at extremely low temperatures (-70°C±10°C).Once thawed, Pfizer’s vaccine can stay in standard refrigerator temperature (2°-8°C) for up to 5 days.
There is an alarming rise in the number of cases of COVID-19 globally and stricter restrictions are being imposed in countries like the United States and Japan. The need of a COVID-19 vaccine is rising with each passing day. Positive vaccine news has thus been propelling stock markets to newer highs on anticipated hopes of accelerated recovery in the economies. Several other companies are also developing coronavirus vaccine candidate including J&J’s (JNJ - Free Report) and AstraZeneca/Oxford University's COVID-19 vaccines that are in late-stage development.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
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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Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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