No restriction of Rotarix and Rotateq
On March 17, 2010, the marketing authorization holder (GlaxoSmithKline Biologicals, GSK) informed the European Medicines Agency (EMA) that the oral vaccine Rotarix is contaminated with DNA of the porcine circovirus (PCV). As an immediate measure, GSK Austria together with BASG/AGES PharmMed has decided to stop the delivery of the Rotarix vaccine as part of the pediatric vaccination concept for approximately six weeks from March 31, 2010 until further clarification.
No risk to public healthAtthe last meeting of the Scientific Committee for Medicinal Products for Human Use (CHMP) from May 17 to May 20, 2010, the statements of GSK, the marketing authorization holder of Rotarix, regarding the impurities were discussed. Porcine circoviruses are not pathogenic to humans. Accordingly, the CHMP sees no need to restrict the use of Rotarix. The impurities were introduced during the manufacturing process and it can be assumed that all doses administered worldwide to date (68 million) were contaminated.
The committee is also currently reviewing information on the second rotavirus vaccine, Rotateq (Sanofi Pasteur MSD SNC). Rotateq is also marginally contaminated with PCV parts. The benefit-risk balance for Rotateq is also positive and the CHMP has not recommended a restriction.
The CHMP expects further information from the marketing authorization holders that will allow conclusions to be drawn about the source of the contamination in the manufacturing process. In addition, the marketing authorization holders must develop measures according to which PCV-free vaccine production can be ensured in the future. The Committee is continuously reviewing the data submitted and will decide on further measures at its next working meeting in July 2010.
About the vaccine
Rotarix is approved for the prevention of gastrointestinal inflammation caused by rotavirus infection in infants six weeks to a maximum of six months of age. Rotarix received its approval in February 2006 in a centralized procedure for all EU member states. Rotarix has been vaccinated to approximately 100,000 infants worldwide in clinical trials and more than 68 million doses have been administered to date.
No unusual safety signals have been detected to date despite the high number of applications. The efficacy of vaccination against rotavirus is very good. Since the introduction of universal vaccination against rotavirus with Rotateq and Rotarix in mid-2007, the number of hospital admissions of infants for rota infections has been reduced by more than 70 percent (from about 2,500 cases before vaccination to about 700 cases in 2009).
BASG / AGES PharmMed
In the view of BASG/AGES PharmMed, Rotarix and Rotateq can therefore be used without hesitation until further notice.
Cost absorption within the framework of the vaccination concept
Further information from the Federal Ministry of Health regarding cost coverage for rotavirus vaccines can be found for download at the bottom of the page.
Further information:
Rotarix background
Queries:
Univ. Prof. Dr. Marcus Müllner
E-mail: pr_pharmmed@ages.at
