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Moderna (MRNA) Shares Decline on RSV Vaccine Efficacy Data
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Shares of Moderna (MRNA - Free Report) lost 11% on Wednesday after it presented new data on its RSV vaccine, mResvia, at a CDC advisory committee meeting. Investors were also not impressed with this committee’s recommendation on RSV vaccines and believe that the target market for RSV vaccinations in the country has been narrowed.
This new data, which was shared with the CDC’s Advisory Committee on Immunization Practices (ACIP), showed that the vaccine efficacy of mResvia 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 49.9% effective in preventing RSV-LRTD. This is significantly lower compared with the 80.9% vaccine efficacy achieved by the vaccine at a follow-up period of 3.7 months.
This efficacy rate was also significantly lower 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’s Advisory Committee on Immunization Practices (ACIP)
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 does raise 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.
Investors were not impressed with the ACIP’s recommendation on RSV vaccines. Unlike last year, when the committee members recommended vaccine shots for individuals aged 60 years and older, this time the members unanimously voted to recommend that adults aged 75 years and above get an RSV shot. For individuals aged between 60 and 74, the ACIP has recommended vaccinations for those at higher risk of severe disease due to underlying medical conditions.
Up until last year, there were no approved vaccines against RSV infections anywhere in the world. 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.
This restriction for the 60-74 age group is a major setback to RSV vaccine makers as their target market has been narrowed down as a result of this recommendation. This advice also negatively impacted GSK and Pfizer stock prices, which fell about 3.6% and 2%, respectively, as investors were concerned that these two pharma big-wigs would unlikely generate the same level of sales they did in the last year.
Year to date, Moderna’s shares have risen 23.1% against the industry’s 8.8% fall.
Image Source: Zacks Investment Research
mResvia was approved by the FDA last month to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults aged 60 years and above. Post this approval, the vaccine is Moderna’s second marketed product.
Before mResvia’s approval, the only marketed product in Moderna’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.
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 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
Moderna (MRNA) Shares Decline on RSV Vaccine Efficacy Data
Shares of Moderna (MRNA - Free Report) lost 11% on Wednesday after it presented new data on its RSV vaccine, mResvia, at a CDC advisory committee meeting. Investors were also not impressed with this committee’s recommendation on RSV vaccines and believe that the target market for RSV vaccinations in the country has been narrowed.
This new data, which was shared with the CDC’s Advisory Committee on Immunization Practices (ACIP), showed that the vaccine efficacy of mResvia 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 49.9% effective in preventing RSV-LRTD. This is significantly lower compared with the 80.9% vaccine efficacy achieved by the vaccine at a follow-up period of 3.7 months.
This efficacy rate was also significantly lower 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’s Advisory Committee on Immunization Practices (ACIP)
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 does raise 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.
Investors were not impressed with the ACIP’s recommendation on RSV vaccines. Unlike last year, when the committee members recommended vaccine shots for individuals aged 60 years and older, this time the members unanimously voted to recommend that adults aged 75 years and above get an RSV shot. For individuals aged between 60 and 74, the ACIP has recommended vaccinations for those at higher risk of severe disease due to underlying medical conditions.
Up until last year, there were no approved vaccines against RSV infections anywhere in the world. 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.
This restriction for the 60-74 age group is a major setback to RSV vaccine makers as their target market has been narrowed down as a result of this recommendation. This advice also negatively impacted GSK and Pfizer stock prices, which fell about 3.6% and 2%, respectively, as investors were concerned that these two pharma big-wigs would unlikely generate the same level of sales they did in the last year.
Year to date, Moderna’s shares have risen 23.1% against the industry’s 8.8% fall.
Image Source: Zacks Investment Research
mResvia was approved by the FDA last month to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults aged 60 years and above. Post this approval, the vaccine is Moderna’s second marketed product.
Before mResvia’s approval, the only marketed product in Moderna’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.
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 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.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.