Moderna Seeks FDA Approval For COVID-19 Booster Shot

Moderna Inc MRNA is pushing ahead for authorization of a third shot of its COVID-19 vaccine as a booster.

What Happened: The Massachusetts-based company said in a statement Wednesday that it had initiated its submission to the U.S. Food and Drug Administration for evaluation of a booster dose of its vaccine at the 50 microgram dose level.

“Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant,” said Stéphane Bancel, Chief Executive Officer of Moderna.

The usual dose for Moderna’s vaccine contains 100 micrograms of mRNA per shot.

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Why It Matters: Moderna said it expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities globally in the “coming days.”

In April, Moderna posted an update to its vaccine program, which included an examination of the vaccine’s effectiveness at the six-month mark. 

At the time, the company said that its COVID-19 vaccine provided over 90% effectiveness against all cases after the second dose.

Moderna said on Wednesday that the Phase 2 study of mRNA-1273 was amended to offer a booster dose at the 50 microgram dose to interested participants 6 months after their second dose.

“Neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months. A booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark,” the company said.

Last month, the FDA approved a booster dose of mRNA COVID-19 vaccines for immunocompromised individuals who have already received two shots citing the need for extra protection.

On Monday, U.S. Centers for Disease Control and Prevention scientist Sara Oliver said at an advisory group meeting that data required to evaluate booster shots for the general population is limited.
Price Action: On Wednesday, Moderna shares closed nearly 3.5% higher at $389.94 in the regular session and rose 0.81% higher to $393.10 in the after-hours trading.

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