The European Medicines Agency (EMA) has ruled that the presence of porcine circovirus (PCV) in GlaxoSmithKline's Rotarix and Merck's Rotateq poses no threat to the public and said that there is no need to confine use of the vaccines within the European Union.
The EMA's conclusion echoes the evaluation made by the US Food and Drug Administration (FDA) earlier this month, during which the FDA claimed that the benefits of Rotarix and Rotateq are substantial and include prevention of hospitalisation and death.
Both GSK and Merck's vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies. Although rotavirus is rarely fatal in the Western world, there are 72,000-77,000 hospitalisations annually in the European Union (EU) due to illness from the virus within the 23 million children under the age of five.
GSK's Rotarix had global sales of $440 million in 2009, with Merck's Rotateq global sales standing at $564.2 million.
Concerns about GSK's Rotarix and Merck's Rotateq were raised when PCV was found in both drugs and led to new clinical trials. The EMA have now noted, however, that the virus is not known to cause disease in humans.
A randomised, double-blind, placebo-controlled study conducted in six European countries (Czech Republic, Finland, France, Germany, Italy and Spain) demonstrated that, during the first year of life, the efficacy of Rotarix against severe rotavirus gastroenteritis (RVGE) was 96 percent (95.8 percent) and against hospitalisation due to RVGE was 100 percent.
Thomas Breuer, head of global development at GSK Biologicals, said: "The announcement by the EMA is further confirmation that the benefit/risk profile of Rotarix remains positive and unchanged. The availability of rotavirus vaccines is critical from a public health perspective and GSK is dedicated to continuing to work with the EMA and other regulatory agencies around the world to help protect to children from rotavirus disease."
The EMA latest statement revealed that the agency is now awaiting further information from manufacturers of these drugs on the measures being taken to eliminate PCV from their vaccines, and will consider the need for further recommendations in its meeting in July, as additional data emerges.
Like this article? Get the RSS feed: