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Moderna Seeks Approval From FDA For COVID-19 Vaccine Booster Shots

Moderna Inc. (MRNA) on Wednesday announced it has submitted documents asking approval from the U.S. Food and Drug Administration (FDA) to allow the use of a third booster dose of its COVID-19 vaccine.

The FDA has currently allowed only people with weakened immune systems to receive third doses of either the Moderna or Pfizer shots. Meanwhile, the health regulator is currently considering Pfizer's vaccine for booster shot. A group of advisers are expected meet to discuss Pfizer's booster shot application on September 17.

Moderna said it submitted initial data for the use of a 50-microgram booster dose of its two-shot vaccine. The original Moderna vaccine contains 100 micrograms of mRNA in each shot.

"We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA. 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 company also said it expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days.

Several countries have started offering booster shots or are considering it as the Delta variant of the coronavirus continues to wreak havoc.

The Biden administration has strongly recommended booster shots for Americans who received the Pfizer-BioNTech and Moderna coronavirus vaccines. Americans will be eligible to take a third dose eight months after receiving their second dose, starting September 20, pending approval from FDA.

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