|
 The resumption comes after J&J last week slashed its 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.
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.
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, storage and
shipping to remote areas, has seen a relatively slow uptake in
Europe and the United States due to safety concerns and the
production issues.
[to top of second column] |
 Johnson & Johnson and the FDA
did not immediately respond to Reuters requests
for comment.
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, citing a source.
(Reporting by Aishwarya Nair, Maria Ponnezhath
and Manojna Maddipatla in Bengaluru; Editing by
Subhranshu Sahu, Ramakrishnan M. and Shounak
Dasgupta)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content |
