'Delhi belly' vaccine licensed only for cholera, says European agency

A Cholera vaccine that also offers protection against "Delhi belly," the traveller's diarrhoea that ruins thousands of holidays every year, becomes available in pharmacies today.

But the vaccine, which is taken as a drink in two doses at least a week before departure, was granted a licence in Europe last month only for cholera, against which it offers 85 per cent protection. The European Medicines Evaluation Agency (EMEA), based in London, refused to license Dukoral fordiarrhoea, despite 20 countries including Canada and New Zealand already approving.

Drug companies believe the misery caused by an upset stomach on holiday will create a market worth up to US$400m (£224m) a year. Dukoral is the first effective vaccine against traveller's diarrhoea to be brought to market. Rival vaccines are in development, but developers say it could be four or five years before they are on the market.

Jane Zuckerman, the medical director of the travel health centre at the Royal Free Hospital in London, said the EMEA wanted further clinical trials before licensing it because some of the data was 10 years old. "It's bizarre. It means we are not in synchrony with other countries. It is bureaucratic and not a sensible decision by the EMEA," she said.

Dr Zuckerman said she and many of her colleagues in travel medicine were likely to prescribe the vaccine for traveller's diarrhoea, which is permitted at the doctor's discretion, even though it can only be promoted as a vaccine for cholera.

"There are many causes of diarrhoea but Dukoral provides good protection against the most common cause [enterotoxigenic E Coli]. It should be used with prudence depending what the traveller is doing, how long they are away for and what the purpose of the trip is. If they are travelling within Europe it is unlikely to be justified," she said.

Dukoral was developed in Sweden a decade ago by SBL.Dukoral, which costs £23.42 for two doses in the UK, is now the biggest selling vaccine among travellers in Sweden and Norway. British travellers are more likely to have diarrhoea abroad than other Europeans.