GlaxoSmithKline Statement on New Information Relating to Manufacture of Rotarix (Rotavirus Vaccine)
LONDON, March 22 /PRNewswire-FirstCall/ -- GlaxoSmithKline
(NYSE:GSK) today confirmed that it has notified
regulatory authorities of the presence of material from a virus
called PCV-1 in its oral rotavirus vaccine, Rotarix(TM). PCV-1 does
not multiply in humans and is not known to cause illness in humans
(1)(2). It is found in everyday meat products and is frequently
eaten with no resulting disease or illness.
The material was first detected following work done by a
research team in the US using a novel technique for looking for
viruses and then confirmed by additional tests conducted by
GlaxoSmithKline.
Having reviewed the information and data submitted by
GlaxoSmithKline, as well as information available regarding PCV-1
from the world's literature, the European Medicines Agency (EMA)
and the World Health Organization (WHO) will also be issuing
statements today confirming the positive balance of benefits and
risks of the vaccine despite the presence of the material from
PCV-1 and have not recommended any change to the way that
healthcare practitioners in Europe and the developing world use
Rotarix.
The US Food and Drug Administration (FDA) similarly has issued a
statement confirming that there is no evidence that this finding
poses a safety risk based on the excellent safety profile of
Rotarix and evidence that PCV-1 is a known virus that does not
multiply in humans and is not known to cause illness in humans.
Rotarix has been produced according to FDA standards as reviewed
and approved for US licensure in 2008. This notwithstanding, the
FDA is recommending that US clinicians and public health
professionals temporarily suspend the use of Rotarix as a
precautionary measure. The FDA have also stated that they intend to
convene an advisory committee, within approximately four to six
weeks, to review the available data and make recommendations on
rotavirus vaccines licensed in the USA. The FDA will also seek
input on the use of new techniques for identifying viruses in
vaccines.
Thomas Breuer, Head of Global Clinical R&D and Chief Medical
Officer of GSK Biologicals stated: "No safety issue has been
identified by external agencies or GSK. GSK is committed to patient
safety and to the highest manufacturing standards for all our
vaccines and medicines. We are already working closely and
discussing this finding with regulatory agencies around the
world."
The safety profile of Rotarix is based on extensive clinical
data from the largest vaccine clinical trial programme conducted by
GSK, enrolling more than 90,000 participants in Europe, Latin
America, Asia, Africa and the US.
Additionally, the post marketing surveillance data represents
more than 69 million doses of Rotarix vaccine distributed globally
and reflects an excellent safety profile.
Retrospective testing of Rotarix, using new molecular detection
techniques, has confirmed that material from PCV-1 has been present
since the initial stages of the vaccine's development in the cell
bank and rotavirus seeds used as base production material.
GSK is now reviewing how best to replace, in a timely way, the
cell bank and virus seeds used as base production material. In the
meantime, and in accordance with the regulators, the company will
continue to manufacture Rotarix to the existing approved production
and quality standards to meet public health needs worldwide.
Rotavirus is the leading cause of severe gastroenteritis among
children below five years of age and it is estimated that more than
half a million children die of rotavirus gastroenteritis each year-
a child a minute worldwide. It is predicted that rotavirus
vaccination could prevent more than 2 million rotavirus deaths over
the next decade. The continued availability of rotavirus vaccines
around the world remains critical from a public health perspective
to protect children from rotavirus disease.
Notes to Editors Rotarix(TM)
Rotarix is a two-dose, orally-administered vaccine that offers
protection against rotavirus to infants. Rotarix is indicated for
the active immunisation of infants from the age of 6 weeks for
prevention of gastro-enteritis due to rotavirus infection.
Worldwide Rotarix sales in 2009 were 282million pounds Sterling
with US representing 76million pounds Sterling.
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the
company' s Annual Report on Form 20-F for 2007.
References 1. Linlin Li, Journal of Virology, Feb. 2010, p. 1674-1682 2. Hattermann, Kim. Xenotransplantation 2004: 11: 284-294
Source: GlaxoSmithKline
CONTACT: UK Media enquiries: Philip Thomson, Claire Brough,
Stephen
Rea, Alexandra Harrison, Jo Revill, (020) 8047-5502; US Media
enquiries:
Nancy Pekarek, Mary Anne Rhyne, Kevin Colgan, Sarah Alspach,
+1-919-483-2839;
European Analyst/Investor enquiries: David Mawdsley, (020)
8047-5564, Sally
Ferguson, (020) 8047-5543, Gary Davies, (020) 8047-5503; US
Analyst/ Investor
enquiries: Tom Curry, +1-215-751 5419, Jen Hill Baxter, +1-215-751
7002
Web Site: http://www.gsk.com/
Posted: March 2010
