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(Adds expert comment, Emergent statement, background)
By Carl O'Donnell and Julie Steenhuysen
April 21 (Reuters) - A U.S. plant that was making Johnson &
Johnson's COVID-19 vaccine must fix a long list of
problems including peeling paint and unsanitary conditions and
practices to resume operation, according to a highly critical
report by the Food and Drug Administration.
Experts said addressing the issues raised in the scathing
FDA inspection report could take months.
Neither J&J nor the FDA has said when they expect vaccine
production to restart at the Baltimore plant owned by Emergent
Biosolutions Inc. Only two other plants are currently
equipped to supply the world with the key drug substance for
J&J's vaccine.
"It may take many months to make these changes," said
Prashant Yadav, a global healthcare supply-chain expert at the
Center for Global Development. He described some of the issues
raised by the FDA as "quite significant."
J&J said it will exercise its oversight authority to ensure
that all of the FDA observations are addressed promptly and
comprehensively.
The healthcare conglomerate has drawn scrutiny for months
over its halting process to scale up production of a vaccine
that is easier to handle and, by virtue of being a single shot,
easier to use than other authorized vaccines.
Its use in the United States has been paused since last week
as health officials study a possible link to a very rare but
serious blood clot condition.
Emergent has been seeking regulatory authorization to make
the J&J vaccine in the United States. It stopped production at
the plant recently, saying the FDA had asked it to do so after
an inspection.
J&J's plant in Leiden, the Netherlands, is still producing
doses for the world. It has another facility in India, which is
currently curtailing exports of the shot as it struggles to
vaccinate its own population.
Johnson & Johnson reiterated on Wednesday that it was
working to establish a global supply chain in which 10
manufacturing sites would be involved in production of its
COVID-19 vaccine, in addition the Leiden plant.
The company has a U.S. government-brokered agreement with
rival drugmaker Merck & Co, which is preparing to make
doses of J&J's vaccine.
FAILURE TO TRAIN PERSONNEL
The FDA in its final 12-page inspection report said it had
reviewed security camera footage in addition to an in-person
site visit to the Emergent plant.
It found failure to train personnel to avoid cross
contamination of COVID-19 vaccines from Johnson & Johnson
and AstraZeneca, which had also been produced at
the site. The agency also cited staff carrying unsealed bags of
medical waste in the facility, bringing it in contact with
containers of material used in manufacturing.
Earlier this week, the U.S. House Representatives launched
an investigation into whether Emergent used its relationship
with a Trump administration official to get a vaccine
manufacturing contract despite a record of not delivering on
contracts.
Emergent said in a statement that it is working with the FDA
and J&J to quickly resolve the issues outlined in the report.
Production of the AstraZeneca vaccine, which is not yet
authorized for use in the United States, was previously stopped
at the Emergent plant after ingredients from that shot
contaminated a batch J&J vaccine, ruining millions of doses.
The FDA also noted that Emergent did not produce adequate
reports showing that the vaccines it was producing met quality
standards.
The inspection, carried out between April 12 and April 20,
also found the building not of suitable size or design to
facilitate cleaning, maintenance or proper operations.
J&J said it was redoubling its efforts to get authorization
for the facility as quickly as possible.
No vaccine manufactured at this plant has been distributed
for use in the United States.
(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru;
Carl O'Donnell in New York and Julie Steenhuysen in Chicago;
Editing by Caroline Humer, Peter Henderson and Bill Berkrot)
