HONG KONG (Reuters) - French drugmaker Sanofi-Aventis hopes to sell 25 million doses of seasonal flu vaccine annually into China’s largely untapped domestic market once its plant in the southern city of Shenzhen goes onstream in 2012.
Wayne Pisano, head of the company’s vaccines arm Sanofi-Pasteur, said on Monday only two percent of Chinese were vaccinated against seasonal flu each year, a fraction of the coverage in Europe and the United States.
“Immunization is between 20 and 40 percent in Europe and North America, but only 2 percent in China ... by producing the vaccine in China with this new facility, we are going to increase our capacity immediately with an additional 25 million doses and it will allow us to expand that and double it as the needs in China grow,” Pisano told reporters in Hong Kong.
The 70 million euros ($95 million) plant will use China-made antigen, substances in vaccine that stimulate production of antibodies in the human body. It is cultured using chicken eggs.
Asked how the company will ensure quality given China’s problematic food safety records, Pisano said: “We have a single quality standard and so the facility in Shenzhen, the quality of the product will be identical to our vaccines produced in France and the U.S.”
“We’ve identified almost 50 farms that can provide eggs for production and (will) narrow down to two that can meet the quality standards that we set for manufacturing.”
“We work with the farmers to make sure that they can meet the requirements,” Pisano said.
CAN PRODUCE PANDEMIC FLU VACCINE
The plant can switch to producing vaccines to fight a pandemic flu in a matter of weeks if needed, he said.
The company is also working on an adjuvant, or booster, which will be useful during a pandemic when, in all likelihood, there will not be enough antigen to go around.
“We’re working on a novel adjuvant that enhances the immune response of the vaccine ... to use the least amount of antigen so we can produce the most amount of doses,” he said.
While a flu vaccine typically uses 15 micrograms of antigen, Pisano said just 1.9 to 3.8 micrograms of antigen will be needed if adjuvants are added. This means the plant will theoretically be able to produce 400 million vaccine doses in a pandemic.
The world’s flu vaccine factories are concentrated in advanced countries and current production amounts to 350 million doses annually.
According to the World Health Organization, they can churn up to 500 million doses if they work flat out, but that is still hardly enough for a global population of over 6 billion.
This has set off worries among some developing nations that they will be unprotected in the event of a pandemic.
Asked where Sanofi would supply its vaccines in a pandemic, Pisano said: “We don’t believe it should be our decision as a manufacturer to determine where the first doses go, we believe the WHO (World Health Organization) should decide.”
“Our job is to manufacture as much and as fast as we can and governments and the WHO will decide where to use this vaccine.”
Sanofi hopes to carry out clinical trials for its experimental dengue vaccine in Asia at the end of 2008.
“We are in discussions with the Thai government and Singapore ... (we) need places with high incidences of the disease,” Pisano said. They would require a sample size of about 250 people.
Sanofi, which bought vaccines maker Acambis Plc last month, is open to more acquisitions with the global financial downturn.
“We are always open to partnerships or acquisitions that make sense. There are no specific ones we are looking at but we are always open to discussion,” Pisano said.
Editing by Jerry Norton
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