A vaccine which works with a single dose is important for health organizations dealing with shortages as the fall flu season approaches.
The World Health Organization requires a company manufacturing vaccines to go through a thorough inspection ensuring quality before the WHO buys and distributes their vaccines globally. No Chinese companies have yet applied to pass inspection for manufacturing vaccines.
Unfortunately, there have been safety concerns about Chinese drug makers and regulators in the past. Some people are questioning if the quality of this season’s batch will be up to WHO standards. However, it is more likely that the local Chinese market is so vast that local companies are not even considering the export market and have no inclination to deal with outside inspections.
Since the H1N1 swine flu is a problem in poor and developing countries, the WHO is counting on other manufacturers to step up to the plate and provide them with the vaccines they need.
About 25 companies are making H1N1 pandemic vaccines, including Sanofi Aventis SA, GlaxoSmithKline PLC and Novartis AG. The WHO is concerned that poor countries are particularly vulnerable to the new flu because their health-care systems are weak and their populations already suffer a high burden of disease. So far, though, only two companies have agreed to donate doses for developing nations, according to the WHO: Sanofi with 100 million doses, and GlaxoSmithKline with 50 million.
Although the Chinese are ahead of the curve, companies are currently testing their own version of a single dose vaccine in trials taking place in America. If a single dose version of the vaccine becomes widely available, there will be twice the number of doses to go around.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing clinical trials of vaccines in the U.S., said the Chinese data appeared promising, showing that one standard dose produced the response needed to offer protection. “The data look quite reasonable,” he said. The Chinese vaccine used the same form of killed virus that is being used in the vaccines undergoing U.S. clinical trials, he said. “I hope our data will also show that,” he said. Initial results from the U.S. trials will be ready within two weeks, he said.