The European Medicines Agency (EMEA) has asked British drugs manufacturer GlaxoSmithKline to look urgently into how the DNA of a foreign viral strain got into the company’s Rotarix vaccine.
GSK’s Biologicals division reported the contamination to the medicines regulator after it found DNA from porcine circovirus type 1 in batches of the oral vaccine, used to protect children against diarrhoea and vomiting brought on by rotavirus infection.
The EMEA emphasised that the viral strain, commonly found in meat and other foods, was not disease causing and did not pose a public health threat.
“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,” it said.
The vaccine is approved for use in the EU, though is more commonly used in the developing world.
The US Food and Drug Administration also said it is advising doctors to stop administering the vaccine until the matter is cleared up. The health body will hold an advisory panel meeting within weeks to determine policy on using the injection.
City A.M. Reporter