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GlaxoSmithKline (GSK) today confirmed that the European Medicines Agency (EMA) has maintained its position that it "sees no safety concerns with the Rotarix oral vaccine" and healthcare practitioners in the European Union should continue to use Rotarix as indicated.  This follows a meeting of the Committee for Medicinal Products for Human Use (CHMP) held on 25^th March 2010 to further review all available data relating to the presence of material from PCV-1 in the vaccine. Having done so, the CHMP has reconfirmed its position which is in line with previous communications by WHO, FDA, other national regulatory agencies as well as GSK that the presence of the material does not present a safety risk.

PCV-1 does not multiply in humans and is not known to cause any illness in humans. It is found in everyday meat products and is eaten with no resulting disease. CHMP also confirmed that after reviewing the documentation from the company that material from PCV-1 has not been found in GSK Biologicals other live attenuated vaccines.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals stated: "We remain confident in the safety profile of Rotarix. GSK has over fifty years experience of research & development in producing high quality vaccines and is committed to patient safety and to the highest manufacturing standards for all our vaccines. We are committed to reviewing our manufacturing process and in particular to replacing, in a timely manner, the source material used in production of Rotarix."

In the meantime, the company will continue to manufacture Rotarix in accordance with the approved production methods and quality standards agreed with regulatory authorities worldwide in order to help meet public health needs in fighting against rotavirus infection.

Notes to Editors 

Rotarix

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.

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.

Rotavirus

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.

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

Press Release from GlaxoSmithKline – 26 March 2010

Zu dem Thema empfehle ich Euch auch die folgenden Artikel:

26. März 2010 – European Medicines Agency statement on new information on Rotarix oral vaccine

26. März 2010 – Paul-Ehrlich-Institut (PEI): Informationen zum Lebendvirusimpfstoff Rotarix

26. März 2010 – Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk

The European Medicines Agency is aware of new information reported by the manufacturer of Rotarix, GlaxoSmithKline Biologicals, relating to the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine. Through its own tests, the company has confirmed the finding of DNA originating from porcine circovirus type 1. This virus is commonly found in certain meat and other food products, and is not known to cause disease in either animals or humans.

An initial review by the Agency's Committee for Medicinal Products for Human Use (CHMP) considered these findings on 17 March 2010 and concluded that no action was necessary at this point. The Committee stresses that the findings do not present a public health threat. It also noted that there have been no safety signals reported with the vaccine that suggest otherwise.

It is nonetheless clear that viral DNA should not be present in the vaccine and that its source is unclear. The Committee has therefore requested the manufacturer to provide further information as a matter of urgency.

The Agency is working closely on this matter with its international counterparts. A meeting of the CHMP Vaccine Working Party has been called for 23-24 March 2010, with the participation of the WHO, and international regulators including from Canada and the USA. The next steps will be considered at an extraordinary meeting of the CHMP to be held on 25 March 2010.

Rotarix is a vaccine given by mouth to children of 6 weeks old and older, to protect against gastroenteritis (diarrhoea and vomiting) due to rotavirus infection. The World Health Organization (WHO) estimates that rotaviruses are responsible for approximately 527,000 deaths each year, with more than 85% of these deaths occurring in low-income countries in Africa and Asia.

Rotarix was approved in the European Union in February 2006. It is not usually part of Member States childhood vaccination schedules, but is available in all Member States. The vaccine is widely used outside of the European Union and is part of the WHO pre-qualification programme for vaccines. Some 100,000 children received the vaccine during clinical trials and about 68 million doses have been distributed worldwide to date.

1. More information on Rotarix is available in the European public assessment report (EPAR) at http://www.ema.europa.eu/humandocs/Humans/EPAR/rotarix/rotarix.htm 
2. Rotarix contains a live attenuated ("weakened") virus. It is prepared from live human rotavirus strains that are manipulated to make them unable to cause the disease, while keeping their ability to trigger an immune response.
3. This press release, together with other information on the work of the European Medicines Agency, can be found on the Agency's website: www.ema.europa.eu

EMA (European Medicines Agency) Press Release – 22 March 2010 

Zu dem Thema empfehle ich Euch auch die folgenden Artikel:

26. März 2010 - Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine)

26. März 2010 - Paul-Ehrlich-Institut (PEI): Informationen zum Lebendvirusimpfstoff Rotarix

26. März 2010 - Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk