China enters vaccine Premier League; A Chinese vaccine company has for the first time won international regulatory approval for one of its products, paving the way for its widespread distribution in other parts of the world

China enters vaccine Premier League

Oct 9, 2013 7:53pm by Peter Vanham

It’s a good day for global health – and a good day for China National Biotec group, a leading Chinese vaccine manufacturer. One of CNBG’s vaccines on Wednesday got “pre-qualified” by the World Health Organization for use all around the world, a first for a Chinese company. But more remarkable than the news itself was the way this was achieved. First, some background. The newly approved vaccine prevents Japanese encephalitis. That is a disease which can be found in vast parts of Asia, including India, Southeast Asia and China, and is a major cause of death there, especially among children. In all, about 4bn people live in JE affected areas.The WHO pre-qualification stamp means it will be easier to convince governments that follow WHO guidelines to purchase the vaccine. It also opens the door to large scale use of the vaccine by organizations such as Unicef and GAVI, the global alliance for vaccines and immunization.

The consequences in terms of money and impact are substantial.

The CNBG vaccine costs about 30 cents per dose, which is very inexpensive for a vaccine of this kind. And now that the vaccine got the WHO stamp, countries such as Laos, Cambodia, and Bangladesh are likely to purchase the inexpensive vaccine on a large scale. (200m people in China and India, countries that did not await WHO approval, already used the vaccine.)

But CNBG was not without help. PATH, a Seattle-based NGO, played a crucial role in bringing about the pre-qualification. It received a $39m grant from the Bill and Melinda Gates Foundation to find a more cost-effective solution for the disease in question, and partnered with CNBG to make it happen.

PATH “de-risked” a crucial part of the product development by CNBG, said Dr Kathy Neuzil, who headed PATH’s efforts to bring about the Chinese JE vaccine. “We were able to support the clinical trials, to help CNBG install a facility up to international standard, and to help them improve their systems and processes.”

As such, the Chinese CNBG was in effect subsidized by an American NGO to come up with a vaccine. And that was a fair trade-off, says PATH’s CEO, Steve Davis. “Our goal was to ensure a global health impact, and to achieve that we were willing to forgo on IP rights or making profits. We’ve enabled a competition in a market that previously lacked such solution.”

According to Neuzil, the project shows that an alliance of Western non-profit organizations and emerging market businesses can bring about major change in global health. She expects more similar game-changing solutions to happen in the future.

“This absolutely opens the door to pre-qualification of other Chinese manufacturers,” Neuzil says. “We also have partnerships with other manufacturers, who are going to go to through the WHO process. And of course, they could also do it on their own. But the most important learning is: now that we have a successful vaccine, Chinese manufacturers can say to themselves: ‘yes, it is achievable, also for us’.”

 

Last updated: October 9, 2013 5:57 pm

Chinese vaccine company wins international regulatory approval

By Andrew Jack in London

A Chinese vaccine company has for the first time won international regulatory approval for one of its products, paving the way for its widespread distribution in other parts of the world.

Chengdu Institute of Biological Products, part of China National Biotec, has received “pre-qualification” from the World Health Organisation for its SA 14-14-2 live attenuated vaccine to protect against Japanese encephalitis (JE).

While several other manufacturers make similar JE vaccines, the new Chinese product is the first to be approved for paediatric use, only requires a single dose and paves the way for cut-price generic competition, boosting the prospects of protection for the 4bn people globally at risk and 15,000 who die from the mosquito-borne infection.

The regulatory decision reflects the growing influence of pharmaceutical producers from emerging economies, with India already producing many drugs and vaccines that have global approval and several Chinese companies expanding their international ambitions.

It came on the day Chi-Med, the China-based drug company quoted in London, received “milestone” payments from its partners Eli Lilly and Johnson & Johnson for progress with its development of two experimental medicines. It also has a joint project withAstraZeneca. Christian Hogg, chief executive, said: “Give it a couple more years and we’ll be bringing compounds to market globally.”

China has received approval through the World Health Organisation for 50 “active pharmaceutical ingredients”, the raw materials bought by others to produce medicines, but has until now not had any vaccine or drug approved to international standards.

WHO approval of the Chengdu Institute’s vaccine allows it to market products more widely rather than seeking individual national regulators’ approvals and to win contracts funded by international donors.

The vaccine now has the prospect of tapping the $42m earmarked by the Global Alliance on Vaccines and Immunisation (Gavi) for treating JE in areas where it is endemic, including Bangladesh, Laos, Cambodia, the Philippines and North Korea.

Lingjiang Yang, manager of international business at the Chengdu Institute, said: “We are very proud of this vaccine completely developed by Chinese scientists.” She said the company already had local approval to sell chickenpox vaccine in some countries in the region, and was planning to seek international approval for polio and rotavirus products.

The vaccine authorisation follows nearly a decade of work on JE vaccines including $39m in funding from Path, a Seattle-based public health charity backed by the Gates Foundation, and a decision by the WHO in 2011 that the Chinese drug regulatory authority had reached international standards.

Kathy Neuzil, programme leader for vaccine access and delivery at Path, who indicated the vaccine would be sold at less than 30 cents a dose, said: “This opens the door for other products for pre-qualification.”

Many Chinese manufacturers have until now been dissuaded from seeking pre-qualification because of the costs – which can include expensive clinical trials – and a preference to focus on easier and lucrative domestic and regional sales.