The deaths of two babies injected with hepatitis B vaccine were caused by the babies' underlying diseases and not by the vaccine, the product's manufacturer said on Monday in a report published in Beijing Times.
Both babies, aged 8 months and 1 month, from Changning and Hengshan, in Hunan province, were given doses of a vaccine made by Shenzhen-based Biokangtai.
The two batches of vaccine involved have now been suspended from use.
Another baby in Hunan reportedly became ill after being injected with the Biokangtai vaccine, but that baby is now out of danger, Beijing Times reported.
In a prepared statement on Monday, Biokangtai said that the production, storage and transportation of its hepatitis B vaccine was all conducted in accordance with State regulations.
Gao Lidong, deputy director of the Hunan Center for Disease Control and Prevention, said autopsy results are needed before anyone can judge whether the infant deaths were related to the vaccine, and it will take about two months to get those results.
Gao also told the newspaper that 108,654 shots of the vaccine had been administered, and no babies other than these three had become ill.
Biokangtai has been producing the vaccine since 1994 and now has more than 50 percent of total market share on the Chinese mainland.