J&J Takes Over Contractor's Covid-19 Vaccine Manufacturing Plant
April 04 2021 - 2:05PM
Dow Jones News
By Peter Loftus and Alex Leary
Johnson & Johnson is taking over manufacturing of its
Covid-19 vaccine at a contract manufacturer's plant that makes the
main ingredient, after a production problem ruined a batch.
In order to give J&J full control, production of AstraZeneca
PLC's vaccine at the Emergent BioSolutions Inc. plant in Baltimore
will move elsewhere, according to a person familiar with the
matter.
The moves, which the person said were facilitated by the Biden
administration and which were confirmed by the companies, mark a
rapid response to the recent discovery of the contaminated
batch.
The Emergent plant hadn't yet been cleared by regulators when
J&J discovered the quality problem during a routine inspection,
and none of the batch had been shipped for use to make
vaccines.
Yet J&J and U.S. health authorities have looked forward to
the plant coming online and producing the key ingredient to bolster
the overall supply of vaccine doses.
Under the changes, J&J is assuming full responsibility for
operations and manufacturing of its vaccine's key ingredient at the
Emergent plant, including installing a new leadership team and
boosting the number of technical, quality and other workers.
J&J continues to work through manufacturing issues with the
U.S. Food and Drug Administration, and no product will come out of
the Baltimore facility without authorization by FDA, the person
said.
J&J said it is working with the FDA to secure authorization
of the plant, which would clear the way for doses containing the
ingredient made at the plant to be distributed.
The federal government worked with AstraZeneca to move
production of its vaccine out of the plant so it could focus
exclusively on making J&J's vaccine, the person familiar with
the matter said.
AstraZeneca said it is working with the U.S. government to find
another plant to make the main ingredient for the company's
vaccine.
Emergent is committed to supporting production of the Covid-19
vaccines, and it will still control the facility and work with
J&J to add its personnel to the plant's staff, an Emergent
spokesman said.
The Emergent plant was supposed to play an important role in
Covid-19 vaccine production, making the main ingredients for the
J&J and AstraZeneca shots.
AstraZeneca's vaccine hasn't been authorized for U.S. use,
though the company said it is preparing a submission.
The FDA has been investigating what caused the quality lapse at
the Baltimore plant.
J&J has said the failed batch of the vaccine's main
ingredient at the Emergent plant never advanced to the vial-filling
stage, and no doses were distributed from the batch.
J&J has said the problem didn't affect doses distributed
since the vaccine was authorized for U.S. use in late February.
For doses already distributed, J&J has made the main
ingredient at its own plant in the Netherlands. J&J also said
it expects to distribute to the U.S. government, as planned, 100
million doses of its vaccine by the end of May.
Write to Peter Loftus at peter.loftus@wsj.com and Alex Leary at
alex.leary@wsj.com
(END) Dow Jones Newswires
April 04, 2021 13:50 ET (17:50 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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