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Moderna's (MRNA) Flu Vaccine Data Fails to Impress Investors
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Moderna (MRNA - Free Report) announced positive interim data from an ongoing phase I study evaluating its quadrivalent seasonal flu vaccine candidate, mRNA-1010. Data from the study demonstrated that immunization with mRNA-1010 boosted immune response against all four strains of flu tested in the study in both younger and older adults.
However, investors were underwhelmed by the study data as it reportedly failed to show superiority compared to a popular flu vaccine — Sanofi’s (SNY - Free Report) Fluzone HD — and flu vaccines in pipeline including Novavax’s (NVAX - Free Report) NanoFlu vaccine. A robust immune-response from Moderna’s mRNA-based COVID-19 vaccine, which was developed within a short span of time, has likely raised efficacy expectations for the company’s mRNA-based programs under development.
Shares of Moderna declined 5.6% on Dec 10, following the flu study data readout, reflecting investors’ disappointment. However, Moderna’s shares have gained 146.1% so far this year against the industry’s decrease of 22.7%.
Image Source: Zacks Investment Research
Moderna’s early-stage study evaluated three dose levels — 50 µg, 100 µg and 200 µg — of mRNA-1010 in younger adults aged between 18 and 49 years and older adults aged 50 or above. The vaccine candidate is designed to provide protection against four seasonal influenza viruses — influenza A/H1N1, A/H3N2 and influenza B/Yamagata- and B/Victoria-lineages.
Interim data from the study demonstrated that vaccination with mRNA-1010 boosted geometric mean titers (GMT) by 10 and 8 folds from the baseline against influenza A strains — H1N1 and H3N2 — respectively at the lowest dose level in younger adults. The increase in GMT was 3 and 2 folds against Yamagata and Victoria lineages, respectively.
For older adults, the increase in GMT from baseline was six fold against influenza A strains while the rise in GMT from baseline against influenza B strains were similar to the younger adult population.
Moderna has initiated a phase II study to evaluate three dose levels — 25 µg, 50 µg and 100 µg — of mRNA-1010 in November. The company plans to start a late-stage study next year. Apart from mRNA-1010, the company is also developing three other flu vaccine candidates designed to provide protection against more influenza virus types.
Reportedly, the data from the study demonstrated that immune response was not as robust as Sanofi’s Fluzone HD in older patients.
Sanofi’s Fluzone HD is approved for use in persons aged 6 months and older for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses. Sanofi has multiple vaccines in its influenza vaccine portfolio. These vaccines generated more than $1.8 billion in sales in the first nine months of 2021, rising almost 24% year over year.
In September, Novavax announced data from a phase III study evaluating its NanoFlu vaccine candidate in participants aged 65 years or older. Data from Novavax’s study demonstrated that GMT responses were 24%-66% higher than Sanofi’s FluZone. Novavax plans to seek approval in the United States under the accelerated approval pathway soon.
Image: Bigstock
Moderna's (MRNA) Flu Vaccine Data Fails to Impress Investors
Moderna (MRNA - Free Report) announced positive interim data from an ongoing phase I study evaluating its quadrivalent seasonal flu vaccine candidate, mRNA-1010. Data from the study demonstrated that immunization with mRNA-1010 boosted immune response against all four strains of flu tested in the study in both younger and older adults.
However, investors were underwhelmed by the study data as it reportedly failed to show superiority compared to a popular flu vaccine — Sanofi’s (SNY - Free Report) Fluzone HD — and flu vaccines in pipeline including Novavax’s (NVAX - Free Report) NanoFlu vaccine. A robust immune-response from Moderna’s mRNA-based COVID-19 vaccine, which was developed within a short span of time, has likely raised efficacy expectations for the company’s mRNA-based programs under development.
Shares of Moderna declined 5.6% on Dec 10, following the flu study data readout, reflecting investors’ disappointment. However, Moderna’s shares have gained 146.1% so far this year against the industry’s decrease of 22.7%.
Moderna’s early-stage study evaluated three dose levels — 50 µg, 100 µg and 200 µg — of mRNA-1010 in younger adults aged between 18 and 49 years and older adults aged 50 or above. The vaccine candidate is designed to provide protection against four seasonal influenza viruses — influenza A/H1N1, A/H3N2 and influenza B/Yamagata- and B/Victoria-lineages.
Interim data from the study demonstrated that vaccination with mRNA-1010 boosted geometric mean titers (GMT) by 10 and 8 folds from the baseline against influenza A strains — H1N1 and H3N2 — respectively at the lowest dose level in younger adults. The increase in GMT was 3 and 2 folds against Yamagata and Victoria lineages, respectively.
For older adults, the increase in GMT from baseline was six fold against influenza A strains while the rise in GMT from baseline against influenza B strains were similar to the younger adult population.
Moderna has initiated a phase II study to evaluate three dose levels — 25 µg, 50 µg and 100 µg — of mRNA-1010 in November. The company plans to start a late-stage study next year. Apart from mRNA-1010, the company is also developing three other flu vaccine candidates designed to provide protection against more influenza virus types.
Reportedly, the data from the study demonstrated that immune response was not as robust as Sanofi’s Fluzone HD in older patients.
Sanofi’s Fluzone HD is approved for use in persons aged 6 months and older for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses. Sanofi has multiple vaccines in its influenza vaccine portfolio. These vaccines generated more than $1.8 billion in sales in the first nine months of 2021, rising almost 24% year over year.
In September, Novavax announced data from a phase III study evaluating its NanoFlu vaccine candidate in participants aged 65 years or older. Data from Novavax’s study demonstrated that GMT responses were 24%-66% higher than Sanofi’s FluZone. Novavax plans to seek approval in the United States under the accelerated approval pathway soon.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold).
Sarepta Therapeutics (SRPT - Free Report) is a better-ranked stock from the pharma/biotech sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022.
Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.