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Moderna (MRNA) Posts Upbeat Data From Next-Gen COVID Jab Study
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Moderna (MRNA - Free Report) announced positive results from the pivotal phase III NextCOVE study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older.
The study achieved its primary endpoint, showing that individuals who received mRNA-1283 generated a higher immune response against both the Omicron BA.4/BA.5 and original strains of SARS-CoV-2, compared to mRNA-1273.222, Moderna’s previously approved bivalent Omicron BA.4/BA.5-targeting COVID vaccine. Per management, the benefit was primarily seen in older adults aged over 65 years, the population that remains at the highest risk of infection from the virus.
Per Moderna, mRNA-1083 offers the potential for longer shelf life and storage advantages. However, management did not report any numerical data or figures. It intends to provide detailed data from the study at the company’s vaccine day event on Mar 27.
Year to date, Moderna’s shares have increased 8.0% against the industry’s 0.9% fall.
Image Source: Zacks Investment Research
The above results intend to reinforce confidence in Moderna’s combination vaccines. The company is currently evaluating mRNA-1083, which combines mRNA-1283 and its influenza vaccine mRNA-1010. This combination vaccine is currently being evaluated in a late-stage study and a data-readout is expected by year-end. The company intends to launch this vaccine next year.
Last October, Moderna reported positive interim data from a phase I/II study on mRNA-1083 in individuals aged 50 years and older. Data from the study showed strong immunogenicity against influenza and COVID-19 when compared with licensed standalone influenza and COVID-19 vaccines. Per management, mRNA-1083 generated antibodies similar to or greater than the quadrivalent influenza vaccines marketed by GSK and Sanofi. About COVID-19, the vaccine generated neutralizing antibodies similar to mRNA-1273.222.
MRNA intends to initiate a regulatory filing with the FDA for mRNA-1010 as a standalone influenza vaccine later this year. Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating this flu vaccine. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared to the licensed vaccines marketed by GSK and Sanofi.
With the end of the pandemic, demand for COVID-19 vaccines has dropped significantly. This has led to a steep decline in sales and profits of Moderna and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , which benefitted from being the first makers of COVID-19 vaccines. Like Moderna, Pfizer/BioNTech is also evaluating its own COVID/flu combination vaccine in a late-stage study.
Another company working on a combination vaccine for COVID-19 and influenza is Novavax (NVAX - Free Report) . Last year, Novavax reported top-line results from a phase II study evaluating its COVID-19-influenza combination (CIC) candidate. Results from the study showed that the CIC vaccine achieved antibody levels similar to the licensed vaccines marketed by Seqirus and Sanofi. Based on this data, Novavax intends to start a pivotal late-stage study on the CIC vaccine before the end of 2024, with the intent to market the same in 2026 commercially.
Moderna, Pfizer/BioNTech and Novavax believe that COVID-19, like influenza, will require once-in-a-year administration with updated formulations against evolving virus variants. Through a combination vaccine, these companies intend to launch a one-for-all vaccine to actively immunize individuals against respiratory infections with a single vaccine formulation.
Image: Bigstock
Moderna (MRNA) Posts Upbeat Data From Next-Gen COVID Jab Study
Moderna (MRNA - Free Report) announced positive results from the pivotal phase III NextCOVE study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older.
The study achieved its primary endpoint, showing that individuals who received mRNA-1283 generated a higher immune response against both the Omicron BA.4/BA.5 and original strains of SARS-CoV-2, compared to mRNA-1273.222, Moderna’s previously approved bivalent Omicron BA.4/BA.5-targeting COVID vaccine. Per management, the benefit was primarily seen in older adults aged over 65 years, the population that remains at the highest risk of infection from the virus.
Per Moderna, mRNA-1083 offers the potential for longer shelf life and storage advantages. However, management did not report any numerical data or figures. It intends to provide detailed data from the study at the company’s vaccine day event on Mar 27.
Year to date, Moderna’s shares have increased 8.0% against the industry’s 0.9% fall.
Image Source: Zacks Investment Research
The above results intend to reinforce confidence in Moderna’s combination vaccines. The company is currently evaluating mRNA-1083, which combines mRNA-1283 and its influenza vaccine mRNA-1010. This combination vaccine is currently being evaluated in a late-stage study and a data-readout is expected by year-end. The company intends to launch this vaccine next year.
Last October, Moderna reported positive interim data from a phase I/II study on mRNA-1083 in individuals aged 50 years and older. Data from the study showed strong immunogenicity against influenza and COVID-19 when compared with licensed standalone influenza and COVID-19 vaccines. Per management, mRNA-1083 generated antibodies similar to or greater than the quadrivalent influenza vaccines marketed by GSK and Sanofi. About COVID-19, the vaccine generated neutralizing antibodies similar to mRNA-1273.222.
MRNA intends to initiate a regulatory filing with the FDA for mRNA-1010 as a standalone influenza vaccine later this year. Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating this flu vaccine. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared to the licensed vaccines marketed by GSK and Sanofi.
With the end of the pandemic, demand for COVID-19 vaccines has dropped significantly. This has led to a steep decline in sales and profits of Moderna and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , which benefitted from being the first makers of COVID-19 vaccines. Like Moderna, Pfizer/BioNTech is also evaluating its own COVID/flu combination vaccine in a late-stage study.
Another company working on a combination vaccine for COVID-19 and influenza is Novavax (NVAX - Free Report) . Last year, Novavax reported top-line results from a phase II study evaluating its COVID-19-influenza combination (CIC) candidate. Results from the study showed that the CIC vaccine achieved antibody levels similar to the licensed vaccines marketed by Seqirus and Sanofi. Based on this data, Novavax intends to start a pivotal late-stage study on the CIC vaccine before the end of 2024, with the intent to market the same in 2026 commercially.
Moderna, Pfizer/BioNTech and Novavax believe that COVID-19, like influenza, will require once-in-a-year administration with updated formulations against evolving virus variants. Through a combination vaccine, these companies intend to launch a one-for-all vaccine to actively immunize individuals against respiratory infections with a single vaccine formulation.
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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.