While their US counterparts have called for a suspension of GlaxoSmithKline’s Rotarix, regulators in Europe say they have no safety concerns about the oral vaccine.

A week ago, the US Food and Drug Administration advised doctors to temporarily suspend use of the rotavirus vaccine after impurities were discovered in some batches of Rotarix, namely fragments of porcine circovirus type 1 (PCV1). However, the European Medicines Agency says it has concluded that the “unexpected presence of DNA of a non-disease causing viral strain” in batches of Rotarix “does not present a risk to public health”.

The agency’s Committee for Medicinal Products for Human Use (CHMP) has held an extraordinary meeting and endorsed earlier recommendations from its Vaccines Working Party, agreeing and agreed that “there was no need to restrict the use of Rotarix”. PCV1 is commonly found in meat products, and is not known to cause disease in either animals or humans.

Nevertheless, the EMA said that “viral DNA should not be present in the Rotarix vaccine and its source is unclear”. As such, the CHMP has asked GSK to identify “the root cause of the finding and introduce measures to manufacture the vaccine free of PCV1 DNA”, saying it will consider the need for further recommendations in its meetings in April and May “as further data emerges”.

Thomas Breuer, chief medical officer at GSK Biologicals said the firm “remains confident in the safety profile of Rotarix”, stating that it is “committed to reviewing our manufacturing process and in particular to replacing, in a timely manner, the source material used”.