Moderna Gets FDA Authorization of Booster Dose of Covid-19 Vaccine

By Michael Dabaie

Moderna Inc. said the U.S. Food and Drug Administration extended the emergency use authorization of a booster dose of its Covid-19 vaccine at the 50-microgram level to all adults aged 18 and older, sending shares higher in premarket trade.

This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved Covid-19 vaccine, the company said.

Moderna shares rose 6% to $267.43 in premarket trade.

The booster dose is to be administered at least six months after completion of any primary series Covid-19 vaccination.

In October, the FDA authorized for emergency use a booster dose of Moderna's vaccine for people aged 65 and older, as well as adults 18 to 64 at high risk of severe Covid-19 and people 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

"This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country," said Chief Executive Stephane Bancel.

In addition, Pfizer Inc. and BioNTech SE said Friday the FDA expanded the emergency use authorization of a booster dose of the their Covid-19 Vaccine to include individuals 18 years of age and older.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

November 19, 2021 08:49 ET (13:49 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.