China probes its largest hep B vaccine maker after child deaths

China, which has been trying to demonstrate adequate oversight of its growing drug industry, is investigating two of its key vaccinemakers after the deaths of 8 children were tied to their hepatitis B vaccines. One of those, Shenzhen Kangtai Biological Products, has become by far the largest producer of hepatitis B vaccines in China after getting its start two decades ago with the help of Merck & Co.

Chinese authorities put a hold on millions of doses of the vaccines from Shenzhen Kangtai Biological earlier this week, The New York Times reports, after 6 deaths were linked to its products. Since then two more children reportedly died after taking hepatitis B vaccines made by Beijing Tiantan Biological Products. Authorities said other vaccinemakers in the country could make up for the suspended products to maintain its vaccination program.

Shenzhen Kangtai Biological, which now has about 60% of the market, was started in 1992 with government support, The Times reports, as well as a big helping hand from Merck ($MRK). The U.S. drugmaker helped with the expertise for its first manufacturing facility and kicked in, royalty-free, the technology needed to make the hepatitis B vaccine to help the country deal with a condition that was infecting about two million children a year. China now has an early childhood vaccination program for the disease.

China is a key emerging market for Big Pharma, which sees great opportunity there. One example is French drugmaker Sanofi ($SNY), whose vaccine unit Sanofi Pasteur got approval in October to begin manufacturing influenza vaccines at a new plant in Shenzhen. But China has struggled to keep up with oversight on health and food issues. Five years ago, tainted Chinese heparin killed dozens of dialysis patients in the U.S., which made the FDA realize it needed to keep a closer look on production there. The FDA is currently investigating Chinese-made pet treats that have killed hundreds of dogs in the U.S.

To get in a better position to deal with China's growing place in the U.S. drug supply chain, the FDA is significantly adding to its own presence in China, planning to station another 10 drug inspectors and 9 food inspectors there over the next year. China has also been making strides with drug enforcement, sending 7 people to prison this year for their parts in making tainted drug capsules and just this month arresting hundreds of suspects in a crackdown on counterfeit drugs being made there and sold over the internet.  

- read the New York Times story

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