China prepares for big entry into vaccine market

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BEIJING (AP) - The world should get ready for a new Made in China product _ vaccines.

China’s vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the world’s poor and provide major new competition for the big Western pharmaceutical companies.

However, it may take some time before some parts of the world are ready to embrace Chinese products when safety is as sensitive an issue as it is with vaccines _ especially given the food, drug and other scandals the country has seen.

Still, China’s entry into this market will be a “game changer,” said Nina Schwalbe, head of policy at the GAVI Alliance, which buys vaccines for 50 million children a year worldwide.

“We are really enthusiastic about the potential entry of Chinese vaccine manufacturers,” she said.

China’s vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu _ in just 87 days _ as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe.

Then, this past March the World Health Organization announced that China’s drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.

China is a vaccine-producing power” with more than 30 companies that have an annual production capacity of nearly 1 billion doses _ the largest in the world, the country’s State Food and Drug Administration told The Associated Press.

But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sinovac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine. “We think the main obstacle is that we have the name of ‘made in China‘ still. That is an issue.”

China’s food and drug safety record in recent years hardly inspires confidence: in 2007, Chinese cough syrup killed 93 people in Central America; one year later, contaminated blood thinner led to dozens of deaths in the United States while tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six.

The government has since imposed more regulations, stricter inspections and heavier punishments for violators. Perhaps because of that, regulators routinely crack down on counterfeit and substandard drugmaking.

While welcoming WHO’s approval of China’s drug safety authority, one expert said it takes more than a regulatory agency to keep drugmakers from cutting corners or producing fakes.

“In the U.S., we have supporting institutions such as the market economy, democracy, media monitoring, civil society, as well as a well-developed business ethics code, but these are all still pretty much absent in China,” said Yanzhong Huang, a China health expert at the Council on Foreign Relations. “For China, the challenge is much greater in building a strong, robust regulative capacity.”

Last year, a Chinese newspaper report linked improperly stored vaccines to four children’s deaths in northern Shanxi province, raising nationwide concern. The Health Ministry said the vaccines did not cause the deaths, but some remained skeptical.

Meanwhile, Chinese researchers reported in the New England Journal of Medicine earlier this year that a pandemic flu vaccine given to 90 million people in 2009 was safe.

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