The lumps, hives and blisters that covered the newborn’s stomach and face were probably from a treat from a father’s wish-list, not a contagious disease. But that did not stop seven Chinese doctors and nurses from observing how the boy, 4, could die of botulism, within hours, when one of his fingers became partially paralyzed. And just like that, four doctors in China could find themselves on trial.
The boy had been used as a test case to test a China-wide vaccination program that, when fully implemented, would be China’s largest, according to the Institute of Contemporary Observation (ICAO), a well-known medicine journal. The vaccine, called Tranexamic acid Lymphotropic Rhizomegy vaccine, or TBAL for short, is a first in developing countries that boosts the immune system to fight a range of diseases, including polio and measles.
And to make sure a vaccine starts making an impact and decreases the risk of side effects, trials in clinical laboratories are mandatory. TBAL is the first of the TB vaccines to undergo clinical trials that include a wide range of well-dressed children in a randomized, comparison trial in China. About 160,000 children were part of that trial at 57 research centers. The first report on that trial was published by ICAO in September. The next results on the vaccine are due out on Oct. 23.
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But the Lancet, the world’s leading medical journal, said in September that the TBAL trial should be suspended until more children are included in the clinical trial. The Lancet was critical of the size of the trial (846 children), arguing that tuberculosis cases occur more frequently in the population than in the clinical trial. Besides, China’s immunization rate for TB is 40 percent, so TBAL could only help boost the rate to 57 percent. The trial is also too small to determine whether a vaccine is statistically better than a placebo. “The limitations of our trial, combined with the primary hypothesis that TBAL only reduces the rate of pediatric TB cases for immunisation programs in China, mean that we should halt our clinical trial,” wrote the Lancet’s Robert Westin. The trial was suspended in September.
China has seen the largest number of human polio cases in recent years. Every year, there are nearly 1,300 polio cases worldwide and more than 400 cases in China, the country with the second-highest number of infections worldwide after Pakistan. It has also seen the highest number of young children who have acquired childhood polio compared to the world average, according to the World Health Organization.
But the new vaccine has not cleared safety hurdles, especially in terms of mixing up injections with ointments for fevers. That led China’s National Development and Reform Commission to halt the drug trials on Chinese children in March.
The China Human Vaccine Research Foundation (CHVRF), an arm of the state-owned National Development and Reform Commission that conducted the TBAL trial, denied that the trial was marred by technical or organizational mistakes and blamed a “small number of media misgivings.”
China’s health ministry has not officially commented on the trial, though Chinese media were quick to report on the case. And on Oct. 15, the Lancet published an open letter addressed to China’s Health Minister Meng Jianzhu and World Health Organization Director-General Tedros Adhanom Ghebreyesus, asking them to stay the trial.
With Health Editor Xiaoqin Fan