China, which has demonstrated its vaccine manufacturing prowess globally, is poised to enter the international vaccine market in a big way in the coming years. However, more may be required than just the stern regulatory steps that the Chinese authorities have fashioned.
When the World Health Organisation attested last March to the efficacy of the Chinese drug regulatory authorities in ensuring international standards, a window of opportunity opened up for China’s vaccine manufacturers, who now stand poised to enter the international market for vaccines in a big way over the coming few years. This augurs well for the new competition that Western pharmaceutical companies will have to face, and consequently, for lower costs of life saving immunisations that can benefit the world’s poor. Once WHO gives the thumbs up, a given vaccine can be cleared for sale to big buyers like UNICEF, the United Nations, or the GAVI alliance – an alliance that purchases fifty million vaccine doses for children annually. Nina Schwalbe, GAVI’s head of policy, says China’s entry into the international market for vaccines can be a “game changer”, and UNICEF’s supply director, Shanelle Hall, says her organization has been in touch with Chinese companies.
Indeed, China’s clout as a vaccine manufacturer is enormous. 30 plus companies in the country have what it takes to manufacture some one billion vaccine doses, according to China’s State Food and Drug Administration.The country had already demonstrated its arrival on the scene as a vaccine maker in 2009 when, within the short space of eighty-seven days, a Chinese concern became the first to manufacture a vaccine against the swine flu raging across the world. China now has its sights set on entering the international market with, among other products, its vaccine for Japanese encephalitis, which the State-owned China National Biotec Group (CNBG) has been manufacturing since 1989. CNBG, which will be investing $ 1.5 billion by 2015 in a bid to bring its facilities and systems up to WHO standards, also plans to seek WHO approval for its vaccines for polio. Another CNBG product that will be submitted for WHO approval is a vaccine for a disease called rotavirus, which is responsible for half a million child deaths annually. Private players in China, operating on a smaller scale, too are getting ready to join the fray with their products. On the anvil is a new vaccine for enterovirus 71, which the company Sinovac is testing. (Enterovirus 71 causes acute hand, foot and mouth disease among children in China and elsewhere in Asia). Sinovac is also carrying out clinical trials on a vaccine for pneumococcal disease, which causes meningitis, pneumonia and ear infection.
Alas, notwithstanding all the favourable signs, it appears that “Made in China” is still a stumbling block, given the country’s murky track record in standards enforcement. An effective regulatory agency by itself will not do the trick, either; also crucial, according to one analyst, are supporting institutions such as those present in the US but lacking in China - the market economy, democracy, media monitoring, civil society and a business code of ethics.