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Moderna (MRNA) Starts COVID-19 Vaccine Study in Adolescents
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Moderna Inc. (MRNA - Free Report) has initiated a phase II/III study to evaluate safety, reactogenicity and immunogenicity of its mRNA-based coronavirus vaccine candidate, mRNA-1273, in adolescent patients aged 12 to less than 18. The company announced that it has started dosing in the study. The company plans to generate sufficient data by mid-2021 to support regulatory filings, seeking emergency authorization/approval for use of mRNA-1273 in adolescents.
The study is being conducted by the company in collaboration with Biomedical Advanced Research and Development Authority (BARDA). The study is perhaps the first coronavirus vaccine study for adolescent patients initiated by any of the leaders of the vaccine race. Majority of the companies developing coronavirus vaccines are focusing on adult patients, especially elderly patients or those with co-morbidities who are assumed to be at high risk of COVID-19 infection.
Please note that mRNA-1273 has demonstrated encouraging efficacy rate of 94.1% during primary efficacy analysis from the phase III COVE study evaluating it in adult patients. The candidate was also well-tolerated among participants. Meanwhile, Moderna has filed for Emergency Use Authorization (“EUA”) in the United States and Conditional Marketing Authorization in Europe. An FDA advisory committee will discuss the company’s filing for EUA for its vaccine candidate on Dec 17.
Several other regulatory filings for emergency use of the candidate have been filed or are under review in several other countries as well.
Riding the progress of its coronavirus vaccine candidate, Moderna’s shares have skyrocketed 700.6% so far this year compared with the industry’s rise of 5.9%. Any positive data from the study in adolescents will boost shares further as the targeted segment holds potential for additional revenues.
However, we note that Moderna is currently lagging Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) in the coronavirus vaccine race. Their mRNA-based vaccine candidate, BNT162b2, became the first vaccine to get emergency use approval anywhere in the world when the government of the United Kingdom granted the same last week. Earlier this week, the candidate gained emergency use approval in Canada. Moreover, an FDA advisory committee recommended the candidate for an EUA on Thursday. An FDA decision is expected soon. Meanwhile, Moderna’s mRNA-1273 is yet to receive authorization anywhere.
Although Moderna is currently lagging, this is unlikely to mar its opportunity as the world needs several billions of doses of coronavirus vaccines. Companies like AstraZeneca (AZN - Free Report) and J&J with candidates still in late-stage studies also hold potential to generate revenues from their vaccines, if successful, due to this huge requirement. Moreover, Moderna’s candidate has logistical advantage over Pfizer’s BNT162b2 as the latter needs to be stored and shipped at ultra-low temperature while mRNA-1273 can remain stable at standard refrigerator temperatures. However, the impact of this advantage remains to be seen.
Meanwhile, Pfizer/BioNTech’s COVID-19 vaccine has raised new safety concerns following its authorization. While there have been reports about allergic reactions in some patients, the FDA has mentioned some side effects related to Bell’s palsy, a form of temporary facial paralysis, that cropped up in the phase III study. These side-effects may fuel concerns about Pfizer’s vaccine and others as well and may lead to stronger anti-vaccine movements.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Shutterstock
Moderna (MRNA) Starts COVID-19 Vaccine Study in Adolescents
Moderna Inc. (MRNA - Free Report) has initiated a phase II/III study to evaluate safety, reactogenicity and immunogenicity of its mRNA-based coronavirus vaccine candidate, mRNA-1273, in adolescent patients aged 12 to less than 18. The company announced that it has started dosing in the study. The company plans to generate sufficient data by mid-2021 to support regulatory filings, seeking emergency authorization/approval for use of mRNA-1273 in adolescents.
The study is being conducted by the company in collaboration with Biomedical Advanced Research and Development Authority (BARDA). The study is perhaps the first coronavirus vaccine study for adolescent patients initiated by any of the leaders of the vaccine race. Majority of the companies developing coronavirus vaccines are focusing on adult patients, especially elderly patients or those with co-morbidities who are assumed to be at high risk of COVID-19 infection.
Please note that mRNA-1273 has demonstrated encouraging efficacy rate of 94.1% during primary efficacy analysis from the phase III COVE study evaluating it in adult patients. The candidate was also well-tolerated among participants. Meanwhile, Moderna has filed for Emergency Use Authorization (“EUA”) in the United States and Conditional Marketing Authorization in Europe. An FDA advisory committee will discuss the company’s filing for EUA for its vaccine candidate on Dec 17.
Several other regulatory filings for emergency use of the candidate have been filed or are under review in several other countries as well.
Riding the progress of its coronavirus vaccine candidate, Moderna’s shares have skyrocketed 700.6% so far this year compared with the industry’s rise of 5.9%. Any positive data from the study in adolescents will boost shares further as the targeted segment holds potential for additional revenues.
However, we note that Moderna is currently lagging Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) in the coronavirus vaccine race. Their mRNA-based vaccine candidate, BNT162b2, became the first vaccine to get emergency use approval anywhere in the world when the government of the United Kingdom granted the same last week. Earlier this week, the candidate gained emergency use approval in Canada. Moreover, an FDA advisory committee recommended the candidate for an EUA on Thursday. An FDA decision is expected soon. Meanwhile, Moderna’s mRNA-1273 is yet to receive authorization anywhere.
Although Moderna is currently lagging, this is unlikely to mar its opportunity as the world needs several billions of doses of coronavirus vaccines. Companies like AstraZeneca (AZN - Free Report) and J&J with candidates still in late-stage studies also hold potential to generate revenues from their vaccines, if successful, due to this huge requirement. Moreover, Moderna’s candidate has logistical advantage over Pfizer’s BNT162b2 as the latter needs to be stored and shipped at ultra-low temperature while mRNA-1273 can remain stable at standard refrigerator temperatures. However, the impact of this advantage remains to be seen.
Meanwhile, Pfizer/BioNTech’s COVID-19 vaccine has raised new safety concerns following its authorization. While there have been reports about allergic reactions in some patients, the FDA has mentioned some side effects related to Bell’s palsy, a form of temporary facial paralysis, that cropped up in the phase III study. These side-effects may fuel concerns about Pfizer’s vaccine and others as well and may lead to stronger anti-vaccine movements.
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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Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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