Doubts about vaccine safety re-emerged as a three-month-old baby died after being given an oral vaccine that is still under clinical trials in one of the nation's leading hospitals, the Center for Disease (CDC) reported yesterday.
The baby was given an oral rotavirus to prevent severe diarrhea and vomiting and a licensed combo vaccine at around 5pm on Tuesday at National Taiwan University Hospital, according to Huang Li-min (
At 7pm, the mother put her baby to sleep, placing the child chest down, local media reported. Around midnight yesterday, the mother found that the baby was not breathing, and rushed back to the hospital -- but in vain.
"Doctors only told me the vaccine may bring on a fever as a side-effect. I didn't know she would die of it," the mother said.
Doctors at the hospital said that the unlicensed rotavirus vaccine should be safe, despite the fact that it is still undergoing clinical trials.
"We have recruited 2,000 subjects since last year to undergo the trials. So far we have found no vaccine-related injuries," Huang said.
The hospital is still waiting for the results of an autopsy to confirm the cause of the infant's death.
According to the hospital's research, about 5 percent of infants who take rotavirus vaccine develop a mild fever, whereas 60 to 90 percent of infant subjects are successfully treated for gastrointestinal infection. Thus far, no one has died as a result of the vaccine.
But in 1999, the US Center for Disease Control recommended suspension of the rotavirus vaccine for infants based on a review of scientific data.
Taiwan's Center for Disease Control said that if the unlicensed rotavirus vaccine leads to an infant's death, the bereaved families can appeal for insurance compensation from the hospital.