July 29 (Reuters) - Emergent BioSolutions said it
will resume production of Johnson & Johnson's COVID-19
vaccine at its troubled Baltimore facility, where operations
were stopped in April after millions of doses were found to be
The development was announced late on Wednesday. Last week,
J&J slashed 2021 production target of its single-dose vaccine to
between 500 million and 600 million doses from its original goal
to produce a billion shots.
The resumption follows additional reviews and collaboration
with the FDA and manufacturing partners, Emergent Chief
Executive Officer Robert Kramer said.
The FDA has so far approved five batches from the Emergent
facility since production there was paused, and J&J is working
to clear additional doses for use, the drugmaker said last week.
Emergent expects the FDA to approve additional batches of
J&J shots, Kramer said during Emergent's Thursday investor call.
U.S. health regulators in April halted operations at the
Baltimore plant following a discovery that ingredients from
AstraZeneca's COVID-19 vaccine, also being produced
there at that time, contaminated a batch of J&J's vaccines.
That month, the U.S. government asked Emergent to stop
making AstraZeneca shots after it discovered the cross
"We continue to work collaboratively with AstraZeneca to
complete all documents related to their drug substance so they
and the U.S. government can make decisions regarding the
disposition of this material," Kramer said during the call.
An FDA inspection also turned up a long list of sanitary
problems and bad manufacturing practices.
J&J's vaccine, considered more convenient for use, storing
and shipping to remote areas, has seen a relatively slow uptake
in Europe and the United States due to safety concerns and the
"We will continue to work toward securing Emergency Use
Authorization in the United States for drug substance
manufactured at Emergent Bayview as quickly as possible," J&J
said in an email.
The FDA did not immediately respond to a Reuters request for
The Wall Street Journal, which first reported the news,
cited a letter from the FDA saying the agency had no objections
with the plant resuming manufacturing. (https://on.wsj.com/3iXSAfg)
The facility could make as many as 120 million doses a month
at full capacity, but the finished doses might not be available
until this fall, the Journal reported.
Emergent expects to launch in the near future a late stage
study for a COVID-19 therapeutic it is developing in partnership
with the U.S. government, executives said on the investor call.
(Reporting by Aishwarya Nair, Maria Ponnezhath and Manojna
Maddipatla in Bengaluru; Editing by Subhranshu Sahu,
Ramakrishnan M. and Shounak Dasgupta)