Hepatitis B vaccines from BioKangtai safe: officials

The hepatitis B vaccines produced by Shenzhen-based BioKangtai were safe, authorities said on Friday, following an initial investigation that found the vaccinations were not linked to the deaths of 17 babies.

Around the nation, 18 infants have been reported ill in the wake of BioKangtai vaccinations between December 13 and 31. Only one of them survived and has recovered.

All of the cases have nothing to do with the vaccines, China Central Television reported, citing a press conference held by the National Health and Family Planning Commission and China Food and Drug Administration.

The 18 cases from different districts and counties used different batches of vaccines except for two babies in central Hunan Province. Also, they showed different symptoms, CCTV reported.

But the cause of the 17 deaths will be confirmed only after autopsies, said Yu Jingjin, director of the disease control bureau with NHFPC.

At the press conference, officials also confirmed no problems had been found with BioKangtai vaccines in production practices, product quality and transportation.

The company has sent 2,271 samples from eight batches to authorities. Two batches have been tested as safe and the results for the other six batches will be released soon, CCTV reported.

China now has seven hepatitis B vaccine manufacturers. The three biggest makers — BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm — shared 80 percent of the domestic market over the first 11 months last year.

But CDFA confirmed yesterday that the three companies have suspended production. They failed to meet the 2010 good manufacturing practice (GMP) code for all pharmaceutical manufacturers by the deadline at the end of 2013.

A CDFA statement said that companies may resume production after certification.

Shanghai used hepatitis B vaccines produced by Hissen. The city's disease control and prevention center said the city is still using vaccine it had stored.