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Moderna (MRNA - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to its mRNA-based RSV vaccine for use in older adults aged 60 years and older.
This recommendation is based on data from data from the phase III ConquerRSV study, which evaluated Moderna’s RSV vaccine mResvia in about 37,000 older adults across 22 countries. Patients who received the vaccine achieved a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) after 3.7 months of median follow-up.
The CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision is expected shortly. If authorized, mResvia will be Moderna’s second approved product in the region.
The RSV vaccine is already approved by the FDA in May 2024, becoming Moderna’s second approved product after its blockbuster COVID-19 vaccine.
Year to date, Moderna’s shares have risen 19.4% against the industry’s 6.3% fall.
Image Source: Zacks Investment Research
The above news comes just a few days after Moderna suffered a major setback after the U.S. Centers for Disease Control and Prevention (CDC) revised their recommendation for the use of RSV vaccines for the upcoming respiratory virus season.
Unlike last year, when the CDC endorsed vaccine shots for all individuals aged 60 years and older, this time, the agency recommended the vaccine for use in adults aged 75 years and older. For individuals aged between 60 and 74, the agency recommended vaccinations only for those at higher risk of severe RSV due to underlying medical conditions.
The CDC also clarified that it is not recommending RSV vaccines on an annual basis, which is usually the case seen with vaccines for the prevention of other respiratory viruses like COVID-19 and influenza.
Moderna’s stock also took a hit last week after it presented new data on mResvia to the CDC, which showed that the vaccine’s efficacy fell sharply in the second year, especially compared with rival vaccines marketed by GSK plc (GSK - Free Report) and Pfizer (PFE - Free Report) .
An 18-month analysis of follow-up data showed that Moderna’s RSV vaccine was just about 50% effective in preventing RSV-LRTD. This efficacy rate was significantly lower when compared with GSK’s Arexvy and Pfizer’s Abrysvo, both of which are also approved for similar use by the FDA. These companies also presented data on their respective RSV vaccines to the CDC.
Per GSK, a single dose of Arexvy was 78.6% effective in preventing severe RSV-LRTD over two calendar years. Pfizer also reported similar efficacy data, which showed that Abrysvo was 77.8% effective through the second season.
Though study comparisons are difficult, Moderna’s reported data raises concern over the long-term efficacy of its vaccine compared with those reported by GSK and Pfizer, both of which are currently dominating the RSV vaccine space.
Currently, the only marketed product in Moderna’s portfolio is 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.
By 2028, Moderna intends to launch 15 new marketed products. Management is currently in 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 next commercial product launch, which is expected in the second half of 2025. We expect these product launches could help Moderna not only boost its top-line but also diversify the same.
Image: Bigstock
CHMP Endorses Moderna's (MRNA) mRNA-based RSV Vaccine
Moderna (MRNA - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to its mRNA-based RSV vaccine for use in older adults aged 60 years and older.
This recommendation is based on data from data from the phase III ConquerRSV study, which evaluated Moderna’s RSV vaccine mResvia in about 37,000 older adults across 22 countries. Patients who received the vaccine achieved a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) after 3.7 months of median follow-up.
The CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision is expected shortly. If authorized, mResvia will be Moderna’s second approved product in the region.
The RSV vaccine is already approved by the FDA in May 2024, becoming Moderna’s second approved product after its blockbuster COVID-19 vaccine.
Year to date, Moderna’s shares have risen 19.4% against the industry’s 6.3% fall.
Image Source: Zacks Investment Research
The above news comes just a few days after Moderna suffered a major setback after the U.S. Centers for Disease Control and Prevention (CDC) revised their recommendation for the use of RSV vaccines for the upcoming respiratory virus season.
Unlike last year, when the CDC endorsed vaccine shots for all individuals aged 60 years and older, this time, the agency recommended the vaccine for use in adults aged 75 years and older. For individuals aged between 60 and 74, the agency recommended vaccinations only for those at higher risk of severe RSV due to underlying medical conditions.
The CDC also clarified that it is not recommending RSV vaccines on an annual basis, which is usually the case seen with vaccines for the prevention of other respiratory viruses like COVID-19 and influenza.
Moderna’s stock also took a hit last week after it presented new data on mResvia to the CDC, which showed that the vaccine’s efficacy fell sharply in the second year, especially compared with rival vaccines marketed by GSK plc (GSK - Free Report) and Pfizer (PFE - Free Report) .
An 18-month analysis of follow-up data showed that Moderna’s RSV vaccine was just about 50% effective in preventing RSV-LRTD. This efficacy rate was significantly lower when compared with GSK’s Arexvy and Pfizer’s Abrysvo, both of which are also approved for similar use by the FDA. These companies also presented data on their respective RSV vaccines to the CDC.
Per GSK, a single dose of Arexvy was 78.6% effective in preventing severe RSV-LRTD over two calendar years. Pfizer also reported similar efficacy data, which showed that Abrysvo was 77.8% effective through the second season.
Though study comparisons are difficult, Moderna’s reported data raises concern over the long-term efficacy of its vaccine compared with those reported by GSK and Pfizer, both of which are currently dominating the RSV vaccine space.
Currently, the only marketed product in Moderna’s portfolio is 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.
By 2028, Moderna intends to launch 15 new marketed products. Management is currently in 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 next commercial product launch, which is expected in the second half of 2025. We expect these product launches could help Moderna not only boost its top-line but also diversify the same.
Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.