|
 J&J did not say how many vaccine doses the batch would have
produced. The New York Times reported that about 15 million doses
were ruined, without citing a source.
The Times said that workers had conflated ingredients for the J&J
vaccine and a coronavirus vaccine developed by AstraZeneca Plc,
which is produced at the same plant, several weeks ago.
The manufacturing misstep follows manufacturing issues at J&J, which
is seen as one of the most important COVID-19 vaccines globally,
because its vaccine is a single dose and requires relatively little
special handling. J&J said manufacturing was on track.
J&J did not directly respond to a question about the number of doses
ruined, only responding with a statement saying that the batch being
produced at Emergent Biosolutions' site in Baltimore did not meet
quality standards and did not advance to the fill-and-finish stage,
which is handled by another company.
J&J said the problem at the Emergent Biosolutions plant, which is
not yet authorized to produce the drug substance for the vaccine,
was identified and addressed with Emergent and shared with the U.S.
Food and Drug Administration. J&J said it was sending more people to
supervise manufacturing at the plant.
News of the setback comes at a time when the Biden administration
has been trying to accelerate shipments of COVID-19 vaccines to U.S.
states.
Last month, the Biden administration said it was exploring ways to
increase manufacturing of J&J's vaccine, as the expected levels of
early doses were less than it hoped at the time.
[to top of second column] |
 J&J said it has met its
commitment to deliver more than 20 million doses
of its single-shot vaccine by the end of March
in the United States.
In addition to contracting with Emergent
Biosolutions to produce the vaccine drug
substance, J&J tapped Catalent Inc <CTLT.N> to
handle the final stage - called fill and finish.
Johnson & Johnson faced some manufacturing
issues earlier in the year.
A European Union official in early March told
Reuters that Johnson & Johnson told the bloc it
was facing supply issues that might complicate
plans to deliver 55 million doses of its
COVID-19 vaccine in the second quarter of the
year.
Emergent, which is a manufacturing partner to
both J&J and AstraZeneca, referred to J&J's
statement when contacted for comment.
Astrazeneca, whose vaccine is not yet authorized
in the U.S., said: "We are aware of the reports
regarding the facility and we understand
Emergent is investigating the matter."
(Reporting by Dania Nadeem and Radhika Anilkumar
in Bengaluru; Editing by Leslie Adler)
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