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|Wed, 01-27-2010 - 4:44pm|
In November of 2008, a report was published about a halted vaccine trial in India. Here is an excerpt which can be found on Livemint :
New Delhi: Patient trials of an advanced pneumonia vaccine by the domestic unit of US drug giant Wyeth Inc. have been suspended by India’s drug quality regulator after the death of an infant on whom the vaccine was tested in a trial in Bangalore.
The child had a pre-existing cardiac disorder. Indian drug rules prohibit testing on human subjects with such conditions without the prior approval of the drugs controller general of India (DCGI), the drugs quality regulator.
Indian authorities said that the trial was stopped because:
“The baby was suffering from a cardiac abnormality and should not have been included in the trial at all. It seems that the ‘inclusion-exclusion’ criteria protocol has not been adhered to by the investigator,” said Surinder Singh, drugs controller general. “We have suspended all further trials across the country.”
Inclusion-exclusion criteria exist for two reasons: to protect the participants in the study and to avoid skewing the results of the study. The testers were careless and a baby died; the testers were careless and the results of a study are now questionable. But was there already a problem built into the basic structure of the trial?
Wyeth, the pharmaceutical company which is testing the safety, tolerability and immunogenicity of their advanced pneumonia vaccine, pointed out that the baby who died was in the placebo arm of the study. What was being used as a “placebo”?
Wyeth said the child who died had been administered Prevnar and not the new 13-strain variant.
“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson said in an email. The test was comparing efficacy of Prevnar and the new variant.
Regular readers of Inside Vaccines will know that using a different vaccine as the “placebo” in vaccine safety and effectiveness trials is standard.