COVID-19 Vaccine Drug Substance Manufactured by Emergent BioSolutions Authorized as Part of Johnson & Johnson’s Emergency U...
12 June 2021 - 6:35AM
Emergent BioSolutions Inc. (NYSE:EBS) today announced that
two batches of COVID-19 vaccine manufactured by Emergent
BioSolutions at its Baltimore Bayview facility were determined to
be suitable for use by the U.S. Food & Drug Administration
(FDA) and have been authorized as part of Johnson & Johnson’s
Emergency Use Authorization (EUA).
“We are pleased that these initial doses of the Johnson &
Johnson COVID-19 vaccine will be available to protect millions of
people from this deadly disease,” said Robert G. Kramer, president
and chief executive officer of Emergent. “We look forward to
working with the FDA and Johnson & Johnson toward the release
of additional batches and resuming production at our Bayview
facility.”
Emergent is actively addressing issues identified by the FDA at
its Bayview facility and plans to resume manufacturing of the
Johnson & Johnson COVID-19 vaccine drug substance after
Emergent, Johnson & Johnson, and FDA are confident that the
steps taken have remedied shortcomings.
For nearly a decade, Emergent has been working closely with the
U.S. government to ensure that manufacturing capacity stands at the
ready to address public health emergencies. This foresight of the
U.S. government led to the designation of Emergent’s Baltimore
Bayview facility as a Center for Innovation in Advanced Development
and Manufacturing (CIADM) in 2012. This agreement was first
established as a public-private partnership for influenza pandemic
preparedness. Since mid-2020, Emergent has harnessed its
capabilities to rapidly build and scale up capacity to manufacture
bulk drug substance for Johnson & Johnson’s COVID-19
vaccine.
About Emergent BioSolutionsEmergent
BioSolutions is a global life sciences company whose mission is to
protect and enhance life. Through Emergent’s specialty products and
contract development and manufacturing services, Emergent is
dedicated to providing solutions that address public health
threats. Through social responsibility, Emergent aims to build
healthier and safer communities. Emergent aspires to deliver peace
of mind to its patients and customers so they can focus on what’s
most important in their lives. In working together, Emergent
envisions protecting or enhancing 1 billion lives by 2030. For
additional information, visit Emergent’s website and follow
Emergent on LinkedIn, Twitter and Instagram.
Safe Harbor Statement This press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, including statements
regarding manufacturing capacity and supply and vaccination goals
and any other statements containing the words “believes,”
“expects,” “anticipates,” “intends,” “plans,” “estimates,” and
similar expressions, are forward-looking statements. These
forward-looking statements are based on our current intentions,
beliefs, and expectations regarding future events. We cannot
guarantee that any forward-looking statement will be accurate.
Investors should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could differ materially from our expectations. Investors
are, therefore, cautioned not to place undue reliance on any
forward-looking statement. Any forward-looking statement speaks
only as of the date of this press release, and, except as required
by law, we do not undertake to update any forward-looking statement
to reflect new information, events, or circumstances.
There are a number of important factors that could cause the
company's actual results to differ materially from those indicated
by such forward-looking statements, including our ability to
produce vaccine bulk drug substance on a timely basis and in
sufficient quantities to meet demand. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from our expectations in any forward-looking statement.
Investors should consider this cautionary statement, as well as the
risk factors identified in our periodic reports filed with the SEC,
when evaluating our forward-looking statements.
Media Contact:Matt HartwigDirector, Media
Relationsmediarelations@ebsi.com
Investor Contact:Robert G. BurrowsVice
President, Investor Relationsburrowsr@ebsi.com
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Apr 2024 to May 2024
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From May 2023 to May 2024