Moderna, Pfizer, BioNTech Up After FDA Extends EUAs of Covid-19 Vaccines
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
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
Write to Michael Dabaie at firstname.lastname@example.org
(END) Dow Jones Newswires
November 19, 2021 09:28 ET (14:28 GMT)
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