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Moderna (MRNA) Seeks Authorization for Booster Dose in Europe

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Moderna, Inc. MRNA announced that it has submitted a regulatory application with the European Medicines Agency (EMA) seeking conditional marketing approval for the third or booster dose (50 microgram) of its COVID-19 vaccine, mRNA-1273. The vaccine uses the tradename of Spikevax in Europe and a two-dose regimen is authorized for conditional use in individuals 12 years or older in the region.

The regulatory application for the booster dose was based on data from an ongoing phase II study. Data from the study showed that the booster dose induced robust antibody responses following inoculation in study participants.

The company had amended the design of its previous phase II study that evaluated the initial two-dose regimen of mRNA-1273 to include a booster dose of mRNA-1273 at the 50 microgram-dose level to interested participants. The booster or third dose was administered six months after the second dose. Initial data from the study demonstrated that the booster dose boosted neutralizing titers significantly compared with the level achieved in the phase III COVE study. The boost in neutralizing titers was seen across all age groups, notably in the age group of 65 and above (older adults).

Data from an additional analysis showed that the booster dose significantly increased geometric mean titers for all the variants of concern. These titers increased 32-fold for Beta (B.1.351), 43.6-fold for Gamma (P.1), and 42.3-fold for the Delta (B.1.617.2) variant.

Please note that the company submitted initial data from the phase II study to the FDA earlier this month to support a potential approval/authorization to its third or booster dose.

Shares of Moderna have skyrocketed 298.9% so far this year compared with the industry’s rise of 3.2%.

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Moderna’s COVID-19 vaccine is authorized for emergency use in adults in the United States. Moderna is seeking authorization for use of the vaccine in adolescents in the country. The company has also filed a biologics license application seeking full approval for mRNA-1273 for the inoculation of adults.

The vaccine’s key competitor, another mRNA-based COVID-19 vaccine — Pfizer PFE/BioNTech’s BNTX Comirnaty (previously BNT162b) — became the first vaccine to get a “full” approval from the FDA last month.

The third dose of both, mRNA-1273 and Comirnaty, are authorized for use in immunocompromised individuals after six months of the second dose of the initial two-dose regimen. Along with Moderna, Pfizer is also seeking authorization/approval for the third dose of its COVID-19 vaccine. J&J JNJ is also developing a booster dose of its single-shot, adenovirus-based COVID-19 vaccine. However, it is yet to file for authorization or approval with any regulatory authority. The U.S. health officials decided last month to start providing booster doses to the country’s citizens in September. However, some experts are actively opposing any authorization to a third dose now.

Moderna, Inc. Price

Moderna, Inc. Price
Moderna, Inc. Price

Moderna, Inc. price | Moderna, Inc. Quote

Zacks Rank

Moderna currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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