Covid-19 Vaccine Maker Blames Problems on Producing Two Different Shots -- 2nd Update
May 19 2021 - 2:34PM
Dow Jones News
By Peter Loftus
Emergent BioSolutions Inc. has made enough of a key ingredient
to yield more than 100 million doses of Johnson & Johnson's
Covid-19 vaccine, and federal health regulators are evaluating
whether to release the shots, Emergent's chief executive said.
Emergent CEO Robert Kramer apologized during a congressional
hearing Wednesday for the problems at the company's Baltimore plant
that resulted in the contamination earlier this year of a batch of
the vaccine.
Mr. Kramer said the company, which makes vaccines and drugs
under contract, has been taking corrective steps to fix the
manufacturing problems at the plant.
Emergent has blamed some of the problems on having to produce
two Covid-19 vaccines at large scale, which the company said
strained the capacity of its equipment. The plant also was making
AstraZeneca PLC's Covid-19 vaccine.
Emergent described some of the problems and its plan to fix them
in a letter to the U.S. Food and Drug Administration, responding to
the agency's finding of various deficiencies during an April
inspection.
A subcommittee of the U.S. House Committee on Oversight and
Reform released the April 30 letter ahead of its hearing about
Emergent.
Emergent was producing a bulk key vaccine ingredient for Johnson
& Johnson's Covid-19 vaccine, but a mishap led to the
contamination of material that could have yielded up to 15 million
doses during January and February.
The contamination came from viral material similar to what was
used in the production of the AstraZeneca vaccine at the same
plant, according to a memo from the Democratic staff of the House
committee to members.
The incident ruined the batch of J&J's vaccine ingredient
and led to a halt in production of the J&J vaccine, as well as
a decision to relocate production of AstraZeneca's vaccine
elsewhere. In addition, J&J took over manufacturing at the
Emergent plant.
At the hearing, Mr. Kramer said the company agreed last year
with the federal government to manufacture both J&J's and
AstraZeneca's vaccines, though the plant hadn't previously produced
vaccines at full capacity.
"Ramping up production of two novel vaccines on a very large
scale in the same facility is unprecedented," he said in remote
online testimony.
The FDA's inspection of the Emergent plant found it didn't
maintain clean, sanitary conditions and didn't take proper steps to
prevent contamination. The inspection found the building and
equipment, including refrigerators, weren't big enough to support
large-scale manufacturing in a way that would ensure clean
conditions.
Emergent, in its April 30 response, said: "The sudden scale-up
to full-scale manufacturing activities for two different Covid-19
vaccine drug substances strained the capacity of Emergent's"
refrigerators.
The company said it has cleaned and organized them and will
purchase additional refrigerators.
The company also said its plant "experienced a dramatic increase
in storage and staging demands as the facility operated at full
capacity for the first time." The company said it has changed
procedures to mitigate the risk of contamination.
At the hearing, Democratic members of the committee generally
criticized Emergent for the contamination problem. Rep. James
Clyburn (D., S.C.), who is chair of the House Select Committee on
the Coronavirus Crisis, said the destruction of millions of J&J
vaccine doses was "due to Emergent's failure to properly maintain
its facilities, adequately train its staff and ensure that proper
protocols were followed."
Several Republican members of the committee, however, defended
Emergent. Rep. Mark Green (R., Tenn.) said Emergent had
successfully delivered drugs and vaccines for other diseases
including an overdose treatment. Addressing Mr. Kramer, he said
"you are a reputable company that has done yeoman's work to protect
this nation in biodefense."
Emergent, based in Gaithersburg, Md., said in a statement
Wednesday that its role in responding to the Covid-19 pandemic is
"unlike any we have confronted before." The company said it is
focused on releasing a vaccine ingredient that is currently under
evaluation and on resuming vaccine production.
The House committee also released documents showing that
Emergent has charged the federal government $27 million a month in
reservation fees to be ready to manufacture vaccines.
The government has paid Emergent $271 million of these fees to
date, but has partially stopped payment since learning of the
contamination, the committee's Democratic staff said in the memo to
members.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
May 19, 2021 15:19 ET (19:19 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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