PFE Pfizer Inc

By Michael Dabaie

Shares of Moderna Inc., Pfizer Inc. and BioNTech SE were all higher in premarket trading after the U.S. Food and Drug Administration extended the emergency-use authorizations of boosters of their Covid-19 vaccines to all adults.

Moderna shares rose 5%, to $264.70, in premarket trade, while Pfizer was up 1.5%, to $52.17, and BioNTech American depositary receipts were up 1.7%, to $278.59.

The FDA said Friday it amended the emergency-use authorizations for both the Moderna and Pfizer-BioNTech Covid-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved Covid-19 vaccine.

FDA said the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet later Friday to discuss further clinical recommendations.

Moderna said the FDA extended the EUA of a booster dose of its vaccine at the 50 microgram dose level to all adults 18 and older.

In October, the FDA authorized for emergency use a booster dose of Moderna's vaccine at the 50 ug dose level 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 follows the earlier approval of the 100 ug mRNA 1273 third dose in immunocompromised individuals, Moderna said.

Pfizer and BioNTech in October unveiled topline results from a trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% compared to those who didn't receive a booster.

A booster dose of the Pfizer-BioNTech vaccine was also previously authorized in individuals 65 and older, 18 through 64 at high risk of severe Covid-19, and 18 through 64 years with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.

Pfizer and BioNTech said they continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies said they don't expect Friday's news would affect the existing supply agreements in place with governments and international health organizations around the world.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

November 19, 2021 09:28 ET (14:28 GMT)

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