Emergent BioSolutions to Resume Manufacturing Covid-19 Vaccine at Bayview Facility
July 29 2021 - 7:24AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S.
Food and Drug Administration (FDA) is allowing Emergent’s Bayview
manufacturing facility to resume production of Johnson &
Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This
resumption of manufacturing follows extensive reviews by FDA, weeks
of diligent work, and close coordination with J&J and FDA to
execute on Emergent’s quality enhancement plan.
“We are proud to be resuming production of bulk Covid-19 vaccine
batches following additional reviews and collaboration with FDA and
our manufacturing partners,” said Emergent chief executive officer,
Robert Kramer. “We are in the unique business of producing
life-saving medications for catastrophes that we hope never occur
like anthrax attacks, opioid overdoses, and Covid-19.”
Since production was paused at Bayview, Emergent has worked
closely with FDA and J&J to address quality concerns including
developing and executing an action plan and committing extensive
resources to bring operations up to FDA’s exacting standards.
Emergent expects to continue to work with FDA throughout the
manufacturing process to help ensure the strength of the J&J
Covid-19 vaccine supply chain.
“The American people should have high expectations of the
partners its government chooses to help prepare them for disaster,
and we have even higher expectations of ourselves,” said Kramer.
“We have fallen short of those lofty ambitions over the past few
months but resumption of manufacturing is a key milestone and we
are grateful for the opportunity to help bring this global pandemic
to an end. We’d like to thank our government partners as well as
Johnson & Johnson for their support.”
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 StatementThis 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 our ability to meet the FDA’s exacting standards,
ensuring the strength of J&J’s supply chain, receipt of EUA
from the FDA for the Bayview facility 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. The reader should
realize that if underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could differ
materially from our expectations. Readers 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
Emergent’s actual results to differ materially from those indicated
by such forward-looking statements, including our ability to
maintain production at FDA standards and receive EUA for our
Bayview facility. 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. The reader should
consider this cautionary statement, as well as the risk factors
identified in our periodic reports filed with the Securities
and Exchange Commission, when evaluating our forward-looking
statements.
Contacts:
Media:Matt HartwigDirector, Media
Relations(240) 760-0551mediarelations@ebsi.com
Investors:Robert G. BurrowsVice President,
Investor Relations(240) 631-3280burrowsr@ebsi.com
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Sep 2023 to Sep 2024