May 19 (Reuters) - Emergent BioSolutions Inc told
U.S. regulators it aims as soon as July to correct the problems
at its manufacturing facility that ruined millions of COVID-19
vaccine doses, according to a private correspondence published
by the U.S. House Oversight Committee.
Emergent Executive Chairman Fuad El-Hibri was repeatedly
questioned at a Wednesday Congressional hearing about his ties
to the Trump administration. An official under former President
Donald Trump who oversaw the U.S. government's vaccine deal with
Emergent had previously received consulting fees from the
company, the U.S. House memo said.
El-Hibri said it was "simply not true" that his relationship
with Trump official Robert Kadlec influenced the U.S.
government's contract award.
The U.S. Food and Drug Administration paused production of
Johnson & Johnson vaccines at Emergent's Baltimore plant
in April after an inspection flagged numerous serious quality
control and sanitary issues.
The company contaminated millions of vaccine doses during
multiple incidents in 2020 and 2021, the memo said.
Emergent shares were down nearly 3% to $56.42 in midday
trading, while J&J shares were off less than 1%.
Emergent CEO Robert Kramer said at the hearing that he
"can't specifically comment" on the total number of COVID-19
vaccine doses that were ruined at the Baltimore facility.
However, Kramer said in March that material for 15 million
J&J doses was ruined. He also said "a number" of batches of
AstraZeneca's COVID-19 vaccine were ruined in early
production ramp ups.
The company expects to complete corrective measures such as
retraining its staff and acquiring additional refrigerators by
as early as July, according to the correspondence.
It is unclear whether Emergent can begin manufacturing more
COVID-19 vaccine before correcting all the issues flagged by
'DESTROYING MILLIONS OF VACCINE DOSES'
Emergent had not previously disclosed a timeline for
resuming vaccine production. In a late April investor call,
Kramer said he is "hopeful that we can soon return to producing
tens of millions of doses per month."
Staff working for the government's Operation Warp Speed
program in June 2020 flagged "significant" personnel issues at
Emergent's Maryland plant, including that "the staffing plans
presented seem inadequate" to produce three products, according
to a draft report cited in the memo.
The report said recent audits, including one by the FDA,
"highlighted the need for extensive training of personnel."
The memo also said Emergent executives gave themselves
millions of dollars in bonuses in 2020 despite knowing that
their facilities were ruining batches of COVID-19 vaccines.
J&J's vaccine was contaminated with ingredients from
AstraZeneca's shot, which was also being produced at the plant
at the time. Production of AstraZeneca's vaccine was
subsequently moved elsewhere and manufacture of J&J's one-shot
vaccine was halted there after the FDA inspection.
"At the same time that the company was destroying millions
of vaccine doses... its executives were cashing out," said U.S.
Congresswoman Carolyn Maloney, a Democrat.
Kramer said the U.S. government contracted with Emergent in
2012 to help it prepare for public health emergencies, but
failed to provide the financial support needed to boost capacity
ahead of the pandemic.
U.S. government funding "persistently fell short of what was
needed to reach full operating potential," Kramer said in his
opening remarks to the Congressional committee.
"As a result, at the end of 2019, (the Baltimore plant) had
roughly 100 employees," and was less than a year away from being
charged with making millions of COVID-19 shots, the CEO said.
(Reporting by Carl O'Donnell; Editing by Jonathan Oatis and