China is nearly ready to produce vaccines for developing worldBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6290 (Published 18 September 2012) Cite this as: BMJ 2012;345:e6290
The Chinese drug industry is on the verge of getting the green light to manufacture the Japanese encephalitis vaccine for the developing world, an event that will signal the emergence of a major new player in global vaccines.
Seth Berkley, chief executive of the Global Alliance for Vaccines and Immunisation (GAVI), said that by the beginning of next year Chinese drug firms will be ready for World Health Organization representatives to carry out pre-qualification inspections of production of the vaccine. Once those inspections are carried out, United Nations agencies and other non-governmental organisations will be able to purchase the vaccine for countries that do not have their own regulatory systems.
Berkley was speaking to the BMJ after returning from China, where he met the Chinese health minister and drug companies to discuss collaboration on vaccine production. The Chinese health minister told GAVI that he was confident that China would soon be able to meet large scale demand for a range of vaccines, such as pneumococcal vaccine and human papillomavirus vaccine to protect against cervical cancer.
Berkley said that he believed that the manufacturers of Japanese encephalitis vaccine will pass inspections. “It’s a new game. There may be some glitches, but from a [Chinese] government perspective they would be very concerned if the first pre-qualification application went up in smoke,” he said.
China has been using the vaccine for the domestic market for many years and has exported it to countries in Asia, including India. However, this will be the first time that Chinese manufacturers will have had a vaccine given the green light by WHO, thus enabling use of the vaccine in developing countries.
Berkley hopes that the emergence of China as a supplier of vaccine to developing countries will strengthen the vaccine market by reducing the cost of vaccines, ensuring a greater range of suppliers, and widening choice.
He said that competition was healthy in the vaccine market. “With the pneumococcal vaccine, initially we had a seven strain vaccine, but we thought key strains were being missed. Another manufacturer came out with a 10 strain [vaccine], another came out with a 13 strain, and there’s a 15 strain vaccine being worked on. That’s a result of competition,” he said.
China’s regulatory body, the State Food and Drug Administration, said that China has 36 vaccine manufacturers, producing 49 different vaccines for 27 diseases, with annual capacity of nearly a billion doses.
In March 2011 WHO certified the regulatory body as meeting international standards, an important prerequisite for the pre-qualification of Chinese vaccines. At the time of the announcement WHO said that the ability of UN agencies and other non-governmental organisations to source vaccines from Chinese manufacturers was “expected to have a significant, beneficial impact on global supply of vaccines of assured quality.” WHO predicted that it would take between one and two years for the first vaccines to get to the pre-qualification stage.
Chinese firms are currently working on a hepatitis C vaccine, an example of a “vaccine that the world needs,” said Berkley.
Berkley acknowledged that there had been problems with safety in Chinese manufacturing in the past, such as the infant formula scandal in 2008.1
“China understands that these have been a real problem for its image. There’s an attempt to do things better and better. In the past things were done with much less rigour, but China’s changing,” he said.
Cite this as: BMJ 2012;345:e6290