Global firms could enter hepatitis vaccine market

Certification hurdle

However, given local majors' failure to pass the GMP certification process, there will be a major market share shift, analysts said.

China's hepatitis B vaccine market amounted to about 100 million doses in 2013, according to Liu.

"We can foresee a shortage of hepatitis B vaccine in 2014, given the simultaneous absence of the three local majors in the coming months, combined with additional newborns under the newly relaxed one-child policy," said Liu.

Since two domestic makers - North China Pharma Corp and Hualan Biological Engineering Inc. - have obtained GMP certification, they're stepping up to close the supply-demand gap.

United States-based Merck & Co Inc initially provided hepatitis B vaccine to Chinese majors when the company sealed a deal with the Chinese government in 1989.

MSD said in an announcement on Dec 23 that it doesn't make or sell hepatitis B vaccine in China, and it also doesn't supervise production by Chinese vaccine companies.

There were 17 deaths reported following vaccinations using BioKangtai products from Dec 13 to Dec 31.

The China Food and Drug Administration said no problems had been found with BioKangtai vaccines in terms of production practices or product quality earlier this month.

However, just two days before the clarification, China's three biggest hepatitis B vaccine manufacturers - BioKangtai, Beijing Tiantan Biological Products Co and Dalian Hissen BioPharm Co Ltd - were reported to have failed to obtain GMP certification for 2013.

In a bid to further regulate drugmakers, authorities said those who did not conform to the code must suspend production in 2014.

The suspended production of the three major suppliers of free hepatitis B vaccines, which account for more than 90 percent of the market, deepened the sense of crisis among consumers.

Chen, the mother of the 6-month-old, brought her baby to the hospital for a third shot of hepatitis B vaccine.

"I asked for detailed information about the manufacturer of the vaccine. When the nurse told me it was produced by Beijing Tiantan, I felt assured," said Chen.

However, a few days later , reports surfaced about infant deaths allegedly linked to hepatitis B vaccines produced by Beijing Tiantan.

"I'm concerned that the three shots may have a negative impact on my son. I wish I'd known that I can choose a specific vaccine producer," said Chen.

According to the Chinese Center for Disease Control and Prevention, all infants should receive hepatitis B vaccine, as this is the mainstay of hepatitis B prevention.