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China gives hep B vaccine a clean bill of health but suspicions remain

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The start of 2014 has been a tumultuous period for Chinese manufacturers of hepatitis B vaccines, with three leading producers failing to gain quality certificates and authorities investigating 17 baby deaths. This week, China reassured its population there is no link between the vaccine and the deaths, but a history of cover-ups mean people are still suspicious.

Chinese authorities gained a reputation for playing down serious health incidents during the 2003 SARS outbreak. And while its handling of recent potential pandemics has improved its reputation on the world stage, local people still doubt the truthfulness of health authority statements. The deaths of 17 babies are the latest incidents to test people's faith in the regulatory system. Having fully investigated 9 of the deaths, health authorities concluded the vaccine played no role in the events, Reuters reports.

Reuters' article was based on reporting by the Chinese state news agency, Xinhua. The publication also reported that preliminary investigations of the other 8 deaths have failed to find a link to the vaccine, but the health authority is waiting until after the autopsies to conclude what killed the babies. The deaths occurred after the babies were vaccinated with a product manufactured by Shenzhen-based BioKangtai. Chinese regulators have reportedly found no problem with its manufacturing practices or product quality.

BioKangtai is one of three leading hepatitis B vaccine producers that failed to comply with new good manufacturing practices (GMP) ahead of the December 31 deadline, though. As such, it is currently unable to produce its hepatitis B vaccine for sale in China. The loss of three producers that reportedly supplied 80% of hepatitis B vaccines sold in China has raised fears of a shortage. GlaxoSmithKline ($GSK) and Merck ($MRK) produce hepatitis B vaccines for the U.S., but local producers dominate in China.

- here's Reuters' article
- read FiercePharma's take

Related Articles:
China probes its largest hep B vaccine maker after child deaths
New Chinese quality standards raise the risk of a hep B vaccine shortage
National action plans needed to stop hepatitis B, WHO says

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