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Moderna Asks FDA to Approve Covid Booster Shot

Moderna shares rose Thursday after the company asked the FDA to approve use of a third, or booster, shot of its Covid-19 vaccine.
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Moderna  (MRNA) - Get Moderna, Inc. Report shares rose Thursday after the company asked the FDA to approve use of a third shot (booster shot) of its Covid-19 vaccine.

Cambridge-Mass.-based Moderna said it “has initiated its submission to the U.S. Food and Drug Administration for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level.”

In addition, the company said it expects in coming days to submit data to the European Medicines Agency and other regulatory authorities around the world.

Moderna recently traded at $397, up 2%. The stock has more than doubled (up 152%) over the past six months amid optimism over its vaccine.

The Phase 2 study of its vaccine produced positive results, Moderna said.

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A study comparing the Covid vaccines of Pfizer  (PFE) - Get Pfizer Inc. Report/BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report and Moderna showed that Moderna’s produced more than twice the antibodies of Pfizer/BioNTech’s.

The trial included 2,499 Belgian health-care workers who were vaccinated with two doses of either vaccine. It was published Monday in the Journal of the American Medical Association.

“Higher antibody titers were observed in participants vaccinated with 2 doses of mRNA-1273 [the Moderna vaccine] compared with those vaccinated with BNT162b2 [the Pfizer/BioNTech] vaccine,” the JAMA article read.

“Previously infected participants had higher antibody titers compared with previously uninfected participants.”

Further, “Antibody levels negatively correlated with age in previously uninfected participants, being highest among those younger than 35 years,” the article said.

“Across all age categories, previously uninfected participants vaccinated with mRNA-1273 had higher antibody titers compared with those vaccinated with BNT162b2.”