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Moderna (MRNA) Bivalent COVID Booster Effective Against BA.4/5

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Moderna, Inc. MRNA announced new clinical data on its bivalent COVID-19 vaccine booster candidate mRNA-1273.214, which was developed to target the Omicron variant.

The new clinical data showed that study participants who received 50 µg dose of mRNA-1273.214 (irrespective of prior infection or age), generated higher neutralizing antibodies against the Omicron subvariants BA.4 and BA.5, following a month-long administration, when compared to those who received a booster dose of Moderna’s currently marketed COVID-19 vaccine (mRNA-1273).

In participants without any prior infection, the BA.4/5 geometric mean fold rise (GMFR) from pre-booster levels was 6.3-fold in those who were administered mRNA-1273.214 compared to a 3.5-fold increase in those who had received mRNA-1273.

This data is a follow-up of Moderna’s ongoing phase II/III study, evaluating mRNA-1273.214. In June 2022, MRNA announced that this study achieved all its pre-specified endpoints. Data from the study showed that following a month’s administration of a 50-µg dose of mRNA-1273.214, the participants generated a superior antibody against the Omicron BA.1 subvariant in comparison to those who received mRNA-1273.

The above results were already shared by Moderna with the health authorities in Europe and Australia. MRNA intends to complete the remaining filings by this week.

Shares of Moderna have lost 31% in the year so far compared with the industry’s 19% decline.

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Moderna also announced that it is developing a new bivalent candidate mRNA-1273.222, targeting the Omicron variant. This candidate is being specifically developed for the U.S. market. In fact, its development was initiated after the FDA recommended vaccine makers develop bivalent booster vaccines targeting the Omicron BA.4 and BA.5 subvariants.

Though both mRNA-1273.214 and mRNA-1273.222 were developed to target the Omicron variant, the former is based on the Omicron BA.1 subvariant, while the latter was based on the more recent Omicron subvariants, namely BA.4 and BA.5.

Moderna intends to complete the regulatory filings for both Omicron-specific bivalent vaccines in the coming weeks, precisely by the fall of 2022.

Currently, BA.4 and BA.5 are the dominating Omicron subvariants, responsible for more than half of all COVID-19 cases in the United States. Moreover, these two subvariants outdo the BA.1 Omicron subvariant and also showed the potential to evade immune protection. This creates a need for adapted vaccine boosters with improved vaccine effectiveness.

Like Moderna, Pfizer PFE and BioNTech BNTX are also working on new Omicron-based vaccine candidates, namely a monovalent and a bivalent, in a phase II/III study. The bivalent vaccine is a combination of the ancestral strain and the Omicron BA.1 subvariant. Last month, Pfizer/BioNTech announced data from this study, which showed that participants with the booster dose of both the vaccine candidates, generated a substantially higher immune response against the Omicron subvariant BA.1compared to Comirnaty, Pfizer/BioNTech’s currently authorized vaccine.

Last month, Pfizer and BioNTech also announced that they reached an agreement with the United States government to supply 105 million doses of their COVID-19 vaccine by this year. Upon receiving these doses, the U.S. government will pay $3.2 billion to the companies. The deal also includes the supply of Pfizer/BioNTech’s Omicron-based vaccine, provided the FDA granted it an emergency use authorization (EUA).

Moderna, Inc. Price

Moderna, Inc. Price
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 overall healthcare sector is Merck MRK, which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Merck’s 2022 earnings have increased from $7.28 to $7.31 in the past 30 days. Shares of MRK have risen 23% in the year-to-date period.

Earnings of Merck beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 13.4%. In the last reported quarter, MRK delivered an earnings surprise of 18.2%.

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