FDA, J&J Near Deal for Covid-19 Vaccine Production at Baltimore Plant -- Update
May 27 2021 - 8:44PM
Dow Jones News
By Thomas M. Burton
WASHINGTON -- The Food and Drug Administration and vaccine maker
Johnson & Johnson expect to announce as early as next week that
contamination problems at a Covid-19 vaccine plant in Baltimore are
resolved, clearing the way for millions more doses to become
available.
Vaccine production at the plant run by contract manufacturer
Emergent BioSolutions Inc. was halted after unsanitary conditions
led to contamination of J&J vaccines. The facility made vaccine
substance and finished vaccine doses for J&J and AstraZeneca
PLC.
Emergent chief executive Robert Kramer told a House committee
last week that the company had produced enough of a key ingredient
to yield more than 100 million doses of the J&J vaccine.
The company has been taking corrective measures and been in
talks with FDA and J&J over the steps needed to reopen the
facility.
Johnson & Johnson said it is working with Emergent to secure
"as quickly as possible emergency-use-authorization in the U.S. for
Covid-19 drug substance manufactured at Emergent Bayview."
Emergent declined to comment for this article.
The emergency use authorization for the plant to produce
Covid-19 vaccine could be made next week, the U.S. officials said.
That could help toward fulfilling President Biden's pledges to
share 20 million doses from J&J, Pfizer Inc. and Moderna Inc.
with the rest of the world by the end of June.
The Baltimore plant has produced millions of doses that were in
inventory awaiting authorization, but most aren't finished and are
placed in vials, the officials said, adding it could take months
before all those doses are ready for use.
One official said that as part of that arrangement to get the
plant online, the U.S. and J&J have tentatively agreed that
about 60 million doses of J&J vaccine substance made at the
Baltimore plant now will be cleared for use either in the U.S. or
overseas.
AstraZeneca is still doing testing on about 60 million doses,
also manufactured at the Emergent plant in Baltimore, that could be
the subject of another agreement with the FDA in coming weeks or
possibly still part of this one, another official said. AstraZeneca
declined to comment for this article.
The J&J doses, when they are finished, would be enough to
vaccinate about 60 million people with the company's one-shot
regimen. The AstraZeneca doses, if they become available, are a
two-dose regimen and could inoculate about half that many
people.
An accident at the Baltimore plant led to the contamination of
material that could have yielded up to 15 million doses during
January and February.
An FDA inspection of the Emergent plant in April concluded that
the facility failed to maintain clean and sanitary conditions and
didn't take proper measures to avoid cross-contamination between
the two vaccine lines.
Under an agreement with the U.S. government, the U.S. had paid
Emergent $271 million of monthly reservation fees to be prepared to
manufacture vaccines, but the government partially stopped payment
after learning of the contamination, according to a memo from the
Democratic staff of the House Select Subcommittee on the
Coronavirus Crisis.
At a meeting of the subcommittee last week, Emergent executives
blamed some of the problems at its Baltimore vaccine plant on
having to produce the two different vaccines simultaneously in
large quantities.
Mr. Kramer said that "ramping up production of two novel
vaccines on a very large scale in the same facility is
unprecedented."
In an April 30 response to the FDA inspection report, Emergent
said it had decommissioned the AstraZeneca portion of its plant in
the Bayview section of Baltimore and has taken several steps to
avoid any contamination of the J&J vaccine ingredient.
It said it planned to complete several remedial steps, such as
repairing, cleaning and disinfecting the manufacturing plant and
improving training of personnel at the site.
The company pledged to take several corrective actions during
May and June, all of which need to be accomplished before fully
recommencing manufacturing at the site.
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
May 27, 2021 20:39 ET (00:39 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