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Moderna (MRNA) Reveals New Data on Bivalent COVID Booster
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Moderna, Inc. (MRNA - Free Report) reported new clinical data on its bivalent COVID-19 vaccine booster candidate mRNA-1273.214, targeting the Omicron variant.
The clinical data showed that following one month of administration of a 50 µg dose of mRNA-1273.214, a 5.4-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 was seen in all study participants, regardless of prior infection. In a subset of seronegative participants, the candidate generated a 6.3-fold increase in neutralizing titers against both the Omicron subvariants.
This data is an extension of Moderna’s ongoing phase II/III study, evaluating mRNA-1273.214. Earlier this month, Moderna announced that this 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 participants generated a superior antibody against the Omicron variant in comparison to those who received Moderna’s currently marketed COVID-19 vaccine (mRNA-1273).
However, Moderna also revealed that the neutralizing titers generated on dosing with mRNA-1273.214 against the BA.4 and BA.5 subvariants were three-fold lower than the previously reported neutralizing titers against the BA.1 variant.
Based on these results, Moderna intends to complete the regulatory filing for mRNA-1273.214 in the coming weeks with a request to update the composition of the booster vaccine to mRNA-1273.214 for the fall 2022 season.
Shares of Moderna have lost 46.4% in the year so far compared with the industry’s 25.6% decline.
Image Source: Zacks Investment Research
Per a Reuters article, the BA.4 and BA.5 subvariants of Omicron accounted for more than one-third of COVID infections in the United States last week. Considering a potential rise in COVID infections due to the Omicron variant in the early fall 2022 season, Moderna is actively preparing to commence the supply of mRNA-1273.214, starting this August.
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 and BioNTech are currently the only jabs that have 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.
Additionally, in March 2022, the FDA authorized the use of a second booster dose of Moderna and Pfizer and BioNTech vaccines in older individuals (aged 50 years and above) as well as in certain immunocompromised individuals, aged 18 years and above.
Pfizer and BioNTech are also working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
Estimates for Alkermes’ 2022 bottom line have narrowed from a loss of 10 cents to 3 cents in the past 60 days. Shares of Alkermes have risen 16.1% year to date.
Earnings of Alkermes beat estimates in each of the trailing four quarters, with the average surprise being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
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Moderna (MRNA) Reveals New Data on Bivalent COVID Booster
Moderna, Inc. (MRNA - Free Report) reported new clinical data on its bivalent COVID-19 vaccine booster candidate mRNA-1273.214, targeting the Omicron variant.
The clinical data showed that following one month of administration of a 50 µg dose of mRNA-1273.214, a 5.4-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 was seen in all study participants, regardless of prior infection. In a subset of seronegative participants, the candidate generated a 6.3-fold increase in neutralizing titers against both the Omicron subvariants.
This data is an extension of Moderna’s ongoing phase II/III study, evaluating mRNA-1273.214. Earlier this month, Moderna announced that this 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 participants generated a superior antibody against the Omicron variant in comparison to those who received Moderna’s currently marketed COVID-19 vaccine (mRNA-1273).
However, Moderna also revealed that the neutralizing titers generated on dosing with mRNA-1273.214 against the BA.4 and BA.5 subvariants were three-fold lower than the previously reported neutralizing titers against the BA.1 variant.
Based on these results, Moderna intends to complete the regulatory filing for mRNA-1273.214 in the coming weeks with a request to update the composition of the booster vaccine to mRNA-1273.214 for the fall 2022 season.
Shares of Moderna have lost 46.4% in the year so far compared with the industry’s 25.6% decline.
Image Source: Zacks Investment Research
Per a Reuters article, the BA.4 and BA.5 subvariants of Omicron accounted for more than one-third of COVID infections in the United States last week. Considering a potential rise in COVID infections due to the Omicron variant in the early fall 2022 season, Moderna is actively preparing to commence the supply of mRNA-1273.214, starting this August.
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 and BioNTech are currently the only jabs that have 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.
Additionally, in March 2022, the FDA authorized the use of a second booster dose of Moderna and Pfizer and BioNTech vaccines in older individuals (aged 50 years and above) as well as in certain immunocompromised individuals, aged 18 years and above.
Pfizer and BioNTech are also working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
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.
Estimates for Alkermes’ 2022 bottom line have narrowed from a loss of 10 cents to 3 cents in the past 60 days. Shares of Alkermes have risen 16.1% year to date.
Earnings of Alkermes beat estimates in each of the trailing four quarters, with the average surprise being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.