EMEA sees no safety concerns with GlaxoSmithKline's Rotarix oral vaccine; emphasises the importance of the European medicines network

The European Medicines Agency (EMEA) says it has concluded that the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine Rotarix, made by UK drug giant GlaxoSmithKline, does not present a risk to public health. At an extraordinary meeting held on March 25, the Committee for Medicinal Products for Human Use (CHMP) endorsed the recommendations from its Vaccines Working Party and agreed that there was no need to restrict the use of Rotarix, which is given to children and infants to protect against rotavirus, which causes severe diarrhea and vomiting and is a leading killer of children in developing countries.

Earlier this month, the safety of Rotarix came under review after the UK Food and Drug Administration said that it had became aware that an independent US academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in GSK's Rotarix (The Pharma Letter March 23). Responding to the US news, the EMEA noted that GSK had confirmed the finding, and the agency said it would look into the matter further.

The CHMP will be reviewing all new data on an ongoing basis. The Committee will consider the need for further recommendations in its meetings in April and May 2010, as further data emerges. The EMEA noted, however, that viral DNA should not be present in the Rotarix vaccine and its source is unclear. The Committee has therefore requested that the manufacturer identifies the root cause of the finding and introduces measures to manufacture the vaccine free of PCV1 DNA.

The drug major's stock dipped 1.5% to £12.75 by mid-afternoon trading in London last Friday, after the news was revealed.