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Moderna's (MRNA) Omicron-Specific Booster Jab Meets Study Goal
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Moderna, Inc. (MRNA - Free Report) announced positive data from a phase II/III study, which evaluated its second bivalent COVID-19 vaccine booster candidate mRNA-1273.214, targeting the Omicron variant.
This phase II/III study achieved all its pre-specified endpoints.
Data from the study showed that following one month of administration of a 50 µg dose of mRNA-1273.214, the study participants generated a superior antibody against the Omicron variant in comparison to those who received Moderna’s currently marketed COVID-19 vaccine (mRNA-1273). A dose of mRNA-1273.214 showed an eight-fold increase in neutralizing geometric mean titers (GMT) against Omicron among baseline seronegative participants.
Results from the study also showed that the binding antibody titers were significantly higher against all other variants of concern for mRNA-1273.214 than mRNA-1273. The study also achieved its primary endpoints of non-inferiority of the bivalent booster candidate against the original SARS-CoV-2 virus.
The safety profile of this bivalent booster candidate was also consistent with the authorized booster dose of mRNA-1273.
Based on the above outcome, Moderna decided to select mRNA-1273.214 as its lead candidate for the Northern Hemisphere fall 2022 booster. Management plans to submit this data with the FDA in the coming weeks to enable the use of the bivalent booster shot.
Shares of Moderna have lost 41.5% in the year so far compared with the industry’s 22.8% decline.
Image Source: Zacks Investment Research
Apart from mRNA-1273.214, MRNA also developed mRNA-1273.211, its first bivalent COVID-19 booster candidate, which includes mutations found in the Beta variant.
In April, Moderna announced clinical data from the study evaluating this candidate. Data from this study showed that a 50 µg dose of the mRNA-1273.211 elicited a superior antibody response compared to the currently authorized COVID-19 vaccine against the Beta and Omicron variants of concern.
The superiority was further maintained against the Beta and Omicron variants in patients even after six months of receiving a dose of the candidate. Additional data from this study is expected later this year.
The COVID-19 vaccine developed by Moderna, including its bivalent booster candidates, is based on mRNA technology. Another vaccine based on mRNA technology is Comirnaty, developed by Pfizer (PFE - Free Report) in collaboration with BioNTech (BNTX - Free Report) .
The COVID-19 vaccines developed by Moderna and Pfizer/BioNTech are currently the only jabs that received full approval from the FDA for use in adults. In fact, the booster doses of these vaccines are also authorized for use in adults. Both PFE and BNTX are also jointly working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
However, Comirnaty has an edge over MRNA’s COVID-19 vaccine. The Pfizer/BioNTech vaccine is currently the only vaccine authorized for emergency use in the United States as a primary two-dose regimen in individuals aged five years and above. A third/booster dose of Comirnaty is also authorized for use in individuals aged five years and above.
Moderna is yet to gain authorization to use its COVID vaccine, either as a primary regimen or as a booster dose, in individuals under 18.
Additionally, in March 2022, the FDA authorized the use of a second booster dose of Moderna and Pfizer/BioNTech vaccines in older individuals (aged 50 years and beyond) as well as in certain immunocompromised individuals, aged 18 years and above.
Alkermes’ loss per share estimates for 2022 have narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 24.6% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, ALKS delivered an earnings surprise of 1,100%.
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Moderna's (MRNA) Omicron-Specific Booster Jab Meets Study Goal
Moderna, Inc. (MRNA - Free Report) announced positive data from a phase II/III study, which evaluated its second bivalent COVID-19 vaccine booster candidate mRNA-1273.214, targeting the Omicron variant.
This phase II/III study achieved all its pre-specified endpoints.
Data from the study showed that following one month of administration of a 50 µg dose of mRNA-1273.214, the study participants generated a superior antibody against the Omicron variant in comparison to those who received Moderna’s currently marketed COVID-19 vaccine (mRNA-1273). A dose of mRNA-1273.214 showed an eight-fold increase in neutralizing geometric mean titers (GMT) against Omicron among baseline seronegative participants.
Results from the study also showed that the binding antibody titers were significantly higher against all other variants of concern for mRNA-1273.214 than mRNA-1273. The study also achieved its primary endpoints of non-inferiority of the bivalent booster candidate against the original SARS-CoV-2 virus.
The safety profile of this bivalent booster candidate was also consistent with the authorized booster dose of mRNA-1273.
Based on the above outcome, Moderna decided to select mRNA-1273.214 as its lead candidate for the Northern Hemisphere fall 2022 booster. Management plans to submit this data with the FDA in the coming weeks to enable the use of the bivalent booster shot.
Shares of Moderna have lost 41.5% in the year so far compared with the industry’s 22.8% decline.
Image Source: Zacks Investment Research
Apart from mRNA-1273.214, MRNA also developed mRNA-1273.211, its first bivalent COVID-19 booster candidate, which includes mutations found in the Beta variant.
In April, Moderna announced clinical data from the study evaluating this candidate. Data from this study showed that a 50 µg dose of the mRNA-1273.211 elicited a superior antibody response compared to the currently authorized COVID-19 vaccine against the Beta and Omicron variants of concern.
The superiority was further maintained against the Beta and Omicron variants in patients even after six months of receiving a dose of the candidate. Additional data from this study is expected later this year.
The COVID-19 vaccine developed by Moderna, including its bivalent booster candidates, is based on mRNA technology. Another vaccine based on mRNA technology is Comirnaty, developed by Pfizer (PFE - Free Report) in collaboration with BioNTech (BNTX - Free Report) .
The COVID-19 vaccines developed by Moderna and Pfizer/BioNTech are currently the only jabs that received full approval from the FDA for use in adults. In fact, the booster doses of these vaccines are also authorized for use in adults. Both PFE and BNTX are also jointly working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
However, Comirnaty has an edge over MRNA’s COVID-19 vaccine. The Pfizer/BioNTech vaccine is currently the only vaccine authorized for emergency use in the United States as a primary two-dose regimen in individuals aged five years and above. A third/booster dose of Comirnaty is also authorized for use in individuals aged five years and above.
Moderna is yet to gain authorization to use its COVID vaccine, either as a primary regimen or as a booster dose, in individuals under 18.
Additionally, in March 2022, the FDA authorized the use of a second booster dose of Moderna and Pfizer/BioNTech vaccines in older individuals (aged 50 years and beyond) as well as in certain immunocompromised individuals, aged 18 years and above.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Alkermes (ALKS - Free Report) , which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alkermes’ loss per share estimates for 2022 have narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 24.6% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, ALKS delivered an earnings surprise of 1,100%.