WASHINGTON — The Biden administration on Saturday put
Johnson & Johnson in charge of a troubled Baltimore manufacturing plant
that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine
and moved to stop the plant from making another vaccine by AstraZeneca, senior
federal health officials said.
اضافة اعلان
The extraordinary move by the Department of Health and Human
Services came just days after officials had learned that Emergent BioSolutions,
a contract manufacturer that has been making both the Johnson & Johnson and
the AstraZeneca vaccines, mixed up ingredients from the two, which led regulators
to delay authorization of the plant’s production lines.
By moving the AstraZeneca vaccine out, two senior federal
health officials said, the plant can be solely devoted to the Johnson &
Johnson single-dose vaccine and avoid future mishaps.
The Department of Health and Human Services directed Johnson
& Johnson to install a new leadership team to oversee all aspects of
production and manufacturing at the Emergent Baltimore plant, the officials
said. The company said in a statement that it was “assuming full
responsibility” for the vaccine made at the facility.
With President Joe Biden making an aggressive push to have
enough doses to cover every American adult by the end of May, federal officials
are worried that the mix-up will erode public confidence in COVID-19 vaccines. The AstraZeneca vaccine in particular has generated safety concerns; Germany,
France and other European nations briefly suspended its use after reports of
rare brain blood clots in some vaccine recipients.
The ingredient mix-up, and Saturday’s move by the
administration, is a significant setback and a public relations debacle for
Emergent, a Maryland-based biotech company that has built a profitable business
by teaming up with the federal government — primarily by selling its anthrax vaccines
to the Strategic National Stockpile.
A spokesman for Emergent declined to comment, except to say
that the company would continue making AstraZeneca doses until it received a
contract modification from the federal government.
Unlike Johnson & Johnson, AstraZeneca does not yet have
emergency authorization from the Food and Drug Administration for its vaccine.
With three federally authorized vaccines (the other two are by Pfizer-BioNTech
and Moderna), it is not clear whether the AstraZeneca vaccine, which has had a
troubled history with regulators, could even be cleared in time to meet US
needs.
However, one of the federal officials said the Department of
Health and Human Services was discussing working with AstraZeneca to adapt its
vaccine to combat new coronavirus variants. AstraZeneca said in a statement
that it would work with the Biden administration to find a new site to
manufacture its vaccine.
So far, none of the Johnson & Johnson doses made by
Emergent have been released by the FDA for distribution. Officials have said it
may take weeks to sort out whether other batches of vaccine were contaminated
and for FDA inspectors to determine whether the Emergent plant can be cleared
to release any doses that it has made.
The acting FDA commissioner, Dr. Janet Woodcock, said in a
statement Saturday that the agency “takes its responsibility for helping to
ensure the quality of manufacturing of vaccines and other medical products for
use during this pandemic very seriously.”
But she made it clear that the ultimate responsibility would
rest with Johnson & Johnson, saying: “It is important to note that even
when companies use contract manufacturing organizations, it is ultimately the
responsibility of the company that holds the emergency use authorization to ensure
that the quality standards of the FDA are met.”
In another arrangement brokered by the Biden administration
last month, Johnson & Johnson is now working with Merck, one of the world’s
biggest vaccine manufacturers. Officials said Merck would help with management
of the Baltimore plant.
Emergent’s Baltimore plant is one of two that are federally
designated as “Centers for Innovation in Advanced Development and
Manufacturing” and were built with taxpayer support. Last June, the government
paid Emergent $628 million to reserve space there as part of Operation Warp
Speed, the Trump administration’s fast-track initiative to develop coronavirus
vaccines.
Johnson & Johnson and AstraZeneca both contracted with
Emergent to use the space. Both vaccines are so-called live viral-vector
vaccines, meaning they use a modified, harmless version of a different virus as
a vector, or carrier, to deliver instructions to the body’s immune system. The
Johnson & Johnson vaccine is administered in one dose, AstraZeneca’s in two
doses.
Experts in vaccine manufacturing said that in the past, the
FDA had a rule to prevent such mishaps by not allowing a plant to make two live
viral vector vaccines, because of the potential for mix-ups and contamination.
Last month, Biden canceled a visit to Emergent’s Baltimore
plant, and his spokeswoman announced that the administration would conduct an
audit of the Strategic National Stockpile, the nation’s emergency medical
reserve. Both actions came after a New York Times investigation into how the
company had gained outsize influence over the repository.
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