* Vaccine shipments waiting for regulatory approval
* WHO to release final report by end of Jan
* Crucell shares up 1.7 pct
(Recasts with Crucell confirmation, adds details)
By Aaron Gray-Block
AMSTERDAM, Jan 13 Dutch biotech Crucell
CRCL.AS said on Thursday it has resumed making its paediatric
vaccines at a South Korean plant after it was forced to stop
production last year because of contamination.
Crucell, the target of a takeover by U.S. healthcare group
Johnson & Johnson (JNJ.N), halted shipments from the facility in
October because of microbiological contamination, sparking
concerns that J&J might withdraw or lower its 1.75 billion euros
bid for the company.
"We have restarted production but...we are not shipping new
product until we receive formal approval from the Korean FDA,"
Crucell spokeswoman Oya Yavuz said, confirming earlier comments
from the World Health Organisation (WHO).
Alison Brunier, a WHO spokeswoman, also said Crucell's
vaccines cannot be supplied to international agencies such as
UNICEF until the WHO gives its final assessment of the
manufacturing setback and the steps Crucell has taken to resolve
Shares in Crucell were up 1.7 percent at 24.43 euros at 1435
GMT, just under J&J's offer price of 24.75 euros in a negative
The WHO previously said it had received Crucell's final
report about the incident in December and it is now being
reviewed by internal and external experts. The WHO expects to
publish its conclusions before the end of this month.
Crucell has already started distributing unaffected doses
which were produced before the contamination.
Crucell's childhood vaccines product Quinvaxem treats five
deadly diseases and had been a strong driver of growth before
later coming under pressure from new rivals Panacea Biotech
(PNCA.BO) and Sanofi-Aventis's (SASY.PA) Shantha Biotechnics.
UNICEF spokeswoman Joan Howe has said the supply shortfall
created by the temporary suspension of production at Crucell was
covered by adjusting vaccine shipments to a number of countries
and UNICEF does not expect to award new contracts in 2011.
"WHO pre-qualified manufacturers of pentavalent are
producing to the best of their ability and awarding new
quantities is therefore not an option during this period of
decreased availability," Howe added.
(Reporting by Aaron Gray-Block; Editing by Sara Webb)