TB vaccine safety doubts

Oxford University is embroiled in an ethics row - scientists there have been accused of questionable conduct over the controversial trial of a new vaccine on South African babies.

Peter Beverley, a former senior academic at the university, claims scientists tested a new tuberculosis vaccine on more than a thousand infants without sharing data that suggested that monkeys given the immunisation appeared to "die rapidly".

"Certainly in this experiment there was no evidence whatsoever that this is an effective booster vaccine," Beverley said.

In the monkey study, five of the six animals infected with TB and given the experimental vaccine had become "very unwell" and had to euthanised.

A fact sheet given to the South African families participating in the trial said the vaccine had been tested on animals and humans, and was "safe and effective" in animals.

Jimmy Volmink, dean of the faculty of medicine and health sciences at Stellenbosch University, said the fact sheet did not appear to reflect the results of the monkey study, which was "not right".

Almost 1500 babies in this country received the new jab and parents were paid about £10 (about R160) to take part.

The scientists at Oxford maintain the jab is safe for children and their experiment was approved by several regulators in advance. They said they followed the infants' development for two years - a duration approved by the regulators.

The monkey study began in November 2006 and the application to test the vaccine in the Western Cape was submitted 18 months later. Around this time, Beverley heard that the animals in the study had to be euthanised "rather rapidly".

The baby trial began in July 2009.

In 2013 the results indicated that the new vaccine offered no extra protection.

- additional reporting by Katharine Child