GlaxoSmithKline (GSK) 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 March 25, 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, US 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.
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.