Moderna, Inc. (MRNA - Free Report) announced that the FDA has granted emergency use authorization (“EUA”) to its mRNA-based coronavirus vaccine, mRNA-1273, for use in individuals 18 years of age or older. The vaccine candidate becomes the second one to get an emergency approval in the United States. The approval came just a day after an advisory committee recommended its approval. The vaccine has achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study. The company continues to gather additional data and plans to file a biologics license application (“BLA”) for full U.S. licensure next year.
The allocation and distribution of the vaccine in the United States will be managed by the Department of Defense (DoD), in partnership with the Department of Health and Human Services (“HHS”) and the U.S. Centers for Disease Control and Prevention (“CDC”), as part of Operation Warp Speed. Vaccines are being delivered to healthcare personnel treating patients and residents in long-term care facilities in the first phase (phase Ia) of the rollout. CDC has partnered with delivery majors — United Parcel Services (UPS - Free Report) and FedEx — for delivery of vaccine shots to various locations in the country.
Moderna’s shares have skyrocketed 617% so far this year compared with the industry’s rise of 9.8%.
Notably, the FDA granted EUA to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) coronavirus vaccine, BNT162b2, earlier this month and vaccination is in full swing. An additional vaccine will likely help the U.S. government to contain the widely spreading COVID-19 infection in the country, which has caused more than 300,000 deaths so far.
Moderna plans to deliver approximately 20 million doses of the vaccine in the United States by year-end. Per a Reuters article, 5.9 million and 2 million vaccine shots of Moderna and Pfizer, respectively, are expected to be delivered to individuals by the U.S. government this week. Moderna has the agreement in place to supply 100 million doses of mRNA-1273 by the first quarter of 2021, followed by another 100 million doses in the second quarter. The U.S. government has the option to purchase another 300 million doses of mRNA-1273.
Pfizer’s logistical hurdle related to ultra-low temperature requirement for the storage of its vaccine and lower storage duration compared to Moderna’ mRNA-1273 will likely be beneficial for the latter in the near-term. The U.S. government may exercise its option for additional 300 million doses of mRNA-1273.
In a separate press release, Moderna announced that the European Commission has exercised its option for additional doses. The company now has a supply agreement for 160 million doses with Europe. The company’s emergency use approval request is currently under review in Europe and several other countries.
Alarmingly, a new strain of coronavirus has been reported in a few countries, including the United Kingdom, which is assumed to spread faster. However, the resiliency of this new strain of the virus against vaccines has not been confirmed yet and the effectiveness of the vaccine remains to be seen.
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Moderna, Inc. (MRNA - Free Report) announced that the FDA has granted emergency use authorization (“EUA”) to its mRNA-based coronavirus vaccine, mRNA-1273, for use in individuals 18 years of age or older. The vaccine candidate becomes the second one to get an emergency approval in the United States. The approval came just a day after an advisory committee recommended its approval. The vaccine has achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study. The company continues to gather additional data and plans to file a biologics license application (“BLA”) for full U.S. licensure next year.
The allocation and distribution of the vaccine in the United States will be managed by the Department of Defense (DoD), in partnership with the Department of Health and Human Services (“HHS”) and the U.S. Centers for Disease Control and Prevention (“CDC”), as part of Operation Warp Speed. Vaccines are being delivered to healthcare personnel treating patients and residents in long-term care facilities in the first phase (phase Ia) of the rollout. CDC has partnered with delivery majors — United Parcel Services (UPS - Free Report) and FedEx — for delivery of vaccine shots to various locations in the country.
Moderna’s shares have skyrocketed 617% so far this year compared with the industry’s rise of 9.8%.
Notably, the FDA granted EUA to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) coronavirus vaccine, BNT162b2, earlier this month and vaccination is in full swing. An additional vaccine will likely help the U.S. government to contain the widely spreading COVID-19 infection in the country, which has caused more than 300,000 deaths so far.
Moderna plans to deliver approximately 20 million doses of the vaccine in the United States by year-end. Per a Reuters article, 5.9 million and 2 million vaccine shots of Moderna and Pfizer, respectively, are expected to be delivered to individuals by the U.S. government this week. Moderna has the agreement in place to supply 100 million doses of mRNA-1273 by the first quarter of 2021, followed by another 100 million doses in the second quarter. The U.S. government has the option to purchase another 300 million doses of mRNA-1273.
Pfizer’s logistical hurdle related to ultra-low temperature requirement for the storage of its vaccine and lower storage duration compared to Moderna’ mRNA-1273 will likely be beneficial for the latter in the near-term. The U.S. government may exercise its option for additional 300 million doses of mRNA-1273.
In a separate press release, Moderna announced that the European Commission has exercised its option for additional doses. The company now has a supply agreement for 160 million doses with Europe. The company’s emergency use approval request is currently under review in Europe and several other countries.
Alarmingly, a new strain of coronavirus has been reported in a few countries, including the United Kingdom, which is assumed to spread faster. However, the resiliency of this new strain of the virus against vaccines has not been confirmed yet and the effectiveness of the vaccine remains to be seen.
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Get the latest research report on PFE - FREE
Get the latest research report on UPS - FREE
Get the latest research report on MRNA - FREE
Get the latest research report on BNTX - FREE