It will be the first vaccine achieving this status and potentially opening the doors to lucrative regional and global markets.
The vaccine is against Japanese encephalitis, a debilitating mosquito-borne disease prevalent in Southeast Asia and the Far East that can be fatal, especially in children.
Made by Chengdu Institute, part of China’s top vaccine maker China National Biotech Group (CNBG), the vaccine is likely to win so-called prequalification status from the World Health Organization (WHO), Seth Berkley, chief executive of the Global Alliance for Vaccines and Immunization (GAVI), said.
Prequalification means a product is eligible for quick procurement by aid agencies, including the U.N. Children’s Fund (UNICEF), which buys vaccines for GAVI and its current market of 70 million children born each year in 73 poor countries.
Seth Berkley also referred to the double benefits this pre-qualification approval will entail for the global vaccine industry as well as general public health:
"If China is able to do that, it has two benefits. One, it has benefits potentially as another supplier for the world of vaccines of regional or global interest. But also it may, through economies of scale or technology transfers, allow China to launch some of these life-saving vaccines in its own country,” he said.
Opening up the Chinese market brings a lot of opportunities, but also a lot of concerns that the industry needs to look into. 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.
Effective regulatory oversight is essential since vaccines are used on a population wide basis and are usually given to healthy infants. By deeming China's State Food and Drug Administration (SFDA) functional, the WHO recognise it to be a competent regulatory agency.
What are your thoughts on China entering the market? What are the opportunities, but also the shortcomings that the industry should be preparing for? Share your thoughts in our comments box below.