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Moderna (MRNA) Secures FDA Nod for mRNA-Based RSV Vaccine
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Moderna (MRNA - Free Report) announced that the FDA approved its mRNA-based RSV vaccine mRNA-1345 to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults aged 60 years and above. The vaccine will be marketed under the trade name mResvia.
The FDA approval is based on data from the phase III ConquerRSV study, which evaluated mResvia in about 37,000 older adults across 22 countries. Patients who received the vaccine achieved a vaccine efficacy of 83.7% against RSV-LRTD after 3.7 months of median follow-up.
Post the FDA’s approval, the Moderna vaccine is up for review by a CDC advisory committee whose decision is expected by the end of this month. The vaccine is expected to be launched commercially in the country by the 2024-2025 respiratory virus season, which usually starts in the late fall. Per management, mResvia is the only RSV vaccine available in single-dose pre-filled syringes.
Following approval, mResvia is MRNA’s second marketed product. Prior to this approval, the only marketed product in the company’s portfolio was its COVID-19 vaccine. With the end of the pandemic, demand for the COVID vaccines dropped significantly, leading to a steep decline in Moderna’s sales and profits.Management is hoping this new vaccine approval can help boost revenues and reduce dependence on just one product for revenues.
Moderna also submitted similar regulatory filings for mResvia in Europe and Australia, which are currently under regulatory review.
Year to date, Moderna’s shares have gained 43.3% against the industry’s 6.6% fall.
Image Source: Zacks Investment Research
Once commercially launched, Moderna’s RSV vaccine will face stiff competition from GSK (GSK - Free Report) and Pfizer (PFE - Free Report) , who market their respective RSV vaccines, Arexvy and Abrysvo, to prevent RSV-LRTD in older adults.
Up until last year, there were no FDA-approved vaccines against RSV infections anywhere in the world. Both GSK and Pfizer vaccines were approved by the agency last year in May and commercially launched in third-quarter 2023. While GSK generated £1.2 billion (around $1.5 billion) from Arexvy sales in 2023, Pfizer recorded about $890 million from Abrysvo sales during the same period.
By 2028, Moderna intends to launch 15 new marketed products. Management is currently engaged in ongoing discussions with health regulators for its influenza vaccine mRNA-1010 and intends to start seeking regulatory approvals later this year. Given management’s timetable, we expect the flu vaccine to be Moderna’s third commercial product launch, which is expected in second-half 2025.
Image: Bigstock
Moderna (MRNA) Secures FDA Nod for mRNA-Based RSV Vaccine
Moderna (MRNA - Free Report) announced that the FDA approved its mRNA-based RSV vaccine mRNA-1345 to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults aged 60 years and above. The vaccine will be marketed under the trade name mResvia.
The FDA approval is based on data from the phase III ConquerRSV study, which evaluated mResvia in about 37,000 older adults across 22 countries. Patients who received the vaccine achieved a vaccine efficacy of 83.7% against RSV-LRTD after 3.7 months of median follow-up.
Post the FDA’s approval, the Moderna vaccine is up for review by a CDC advisory committee whose decision is expected by the end of this month. The vaccine is expected to be launched commercially in the country by the 2024-2025 respiratory virus season, which usually starts in the late fall. Per management, mResvia is the only RSV vaccine available in single-dose pre-filled syringes.
Following approval, mResvia is MRNA’s second marketed product. Prior to this approval, the only marketed product in the company’s portfolio was its COVID-19 vaccine. With the end of the pandemic, demand for the COVID vaccines dropped significantly, leading to a steep decline in Moderna’s sales and profits.Management is hoping this new vaccine approval can help boost revenues and reduce dependence on just one product for revenues.
Moderna also submitted similar regulatory filings for mResvia in Europe and Australia, which are currently under regulatory review.
Year to date, Moderna’s shares have gained 43.3% against the industry’s 6.6% fall.
Image Source: Zacks Investment Research
Once commercially launched, Moderna’s RSV vaccine will face stiff competition from GSK (GSK - Free Report) and Pfizer (PFE - Free Report) , who market their respective RSV vaccines, Arexvy and Abrysvo, to prevent RSV-LRTD in older adults.
Up until last year, there were no FDA-approved vaccines against RSV infections anywhere in the world. Both GSK and Pfizer vaccines were approved by the agency last year in May and commercially launched in third-quarter 2023. While GSK generated £1.2 billion (around $1.5 billion) from Arexvy sales in 2023, Pfizer recorded about $890 million from Abrysvo sales during the same period.
By 2028, Moderna intends to launch 15 new marketed products. Management is currently engaged in ongoing discussions with health regulators for its influenza vaccine mRNA-1010 and intends to start seeking regulatory approvals later this year. Given management’s timetable, we expect the flu vaccine to be Moderna’s third commercial product launch, which is expected in second-half 2025.
Moderna, Inc. Price
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Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.