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China says hepatitis B vaccines not cause of infant deaths

But suspension on production remains in place

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China has concluded that nine deaths in infants were not caused by the hepatitis B virus inoculations, although a suspension on production for key suppliers remains in place.

On January 1 the country's top three manufacturers suspended manufacturing of their hepatitis B vaccines in the wake of the deaths, sparking concerns that a national shortage may result.

The suspension remains in effect because the three companies - Beijing Tiantan Biological Products, Shenzhen Kangtai Biological Products and Dalian Hissen Bio-Pharm - have not been certified as meeting China's 2011 Good Manufacturing Practice (GMP) standards.

The new GMP rules place greater emphasis on the use of effective quality control system by pharmaceutical companies and introduce new standards on supplier audits, change control, raw material procurement and standard operating procedures.

Certification to the standards became mandatory for facilities manufacturing sterile drug products such as blood products, vaccines and other injectable drug products on December 31, 2013. Other facilities have to reach compliance by the end of 2015.

China launched a probe into the safety of the vaccines late last year after reports of 17 deaths in infants receiving the inoculations. The preliminary findings are that the deaths were unrelated to the shots in nine cases, and look likely to be unrelated in the remaining eight, although the authorities are still waiting for the results of autopsies in these cases.

The three manufacturers account for upwards of 80 per cent of the entire market for hepatitis B vaccines in China, so the threat of shortages remains unless they can quickly gain the required certification or other suppliers such as GlaxoSmithKline (GSK) can step in to plug any gaps.

Any shortage could take a while to emerge as vaccines made before the end of 2013, when the ban was imposed, can still be distributed in the market.

Meanwhile, the authorities in China have insisted that there is no threat of a shortage in the near-term and increased production will be organised if it becomes necessary, according to the Xinhua news agency.

Article by
Phil Taylor

6th January 2014

From: Sales, Regulatory, Healthcare



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