GSK has confirmed that material from the PCV1 virus has been detected in Rotarix and, although there is no evidence of a safety risk, the FDA has recommended use is temporarily suspended.
Retrospective testing of the Rotarix vaccine has established that DNA from porcine circovirus 1 (PCV1) has been present since the treatment was in clinical trials. GlaxoSmithKline (GSK) is now reviewing how to replace the cell bank and virus seeds used as base production materials.
Thomas Breuer, chief medical officer of GSK Biologicals, added: “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 US Food and Drug Administration (FDA), GSK and the European Medicines Agency (EMA) have all stated there is no evidence that the vaccine poses a safety risk. GSK added that post-marketing surveillance data for more than 69m Rotarix doses show an excellent safety profile.
Despite this the FDA has recommended clinicians temporarily suspend use until it can learn more about the situation. During this period the FDA will research whether intact virus, as opposed to DNA fragments, is present and assess current vaccine testing methods.
In contrast, the EMA has concluded that no action is necessary at this point. Discussions between the EMA’s Committee for Medicinal Products for Human Use (CHMP), US and Canadian regulators and the World Health Organization (WHO) take place today and tomorrow.
Following this the EMA will consider its next steps at an extraordinary meeting of the CHMP. The FDA will consider further recommendations at a meeting of an expert advisory committee in four to six weeks. PCV1 has not been detected by the FDA in RotaTeq, another rotavirus vaccine.
Detection of PCV1
PCV1 DNA was first detected by an independent US academic research team using a novel technique. Since then follow-up tests by the FDA and GSK have confirmed the researchers’ findings and also established that PCV1 has been present in Rotarix since early development.
The PCV1 virus is commonly found in certain meat and other food products. It is not known to cause disease or multiply in humans. Rotarix has been licensed by the FDA since 2008 to vaccinate against rotavirus, which causes 50,000 hospitalisations each year in the US.
“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine”, added Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC).