Academic journal article Bulletin of the World Health Organization

China Enters the Global Vaccine Market: China Is Gearing Up to Supply the World with Affordable Vaccines That Fulfil All Efficacy, Safety and Quality Requirements

Academic journal article Bulletin of the World Health Organization

China Enters the Global Vaccine Market: China Is Gearing Up to Supply the World with Affordable Vaccines That Fulfil All Efficacy, Safety and Quality Requirements

Article excerpt

The global vaccine industry has long been dominated by a few multinational companies. But now that companies in China, India and other emerging economies are becoming major vaccine manufacturers and have started selling these vaccines on the international market, competition is set to increase and prices to come down.

For Jiankang Zhang, representative for PATH'S China Programmes, the growth of China's vaccine industry is "a very positive development for global health, as governments and international procurement agencies will be able to afford more life-saving vaccines and thus protect more lives".

Since 1987, vaccine quality for international procurement has been assured through the prequalification system that is managed by the World Health Organization (WHO). The "prequalified" stamp of approval means that these vaccines are consistently safe, effective and of high quality, and thus recommended for bulk purchase by the United Nations Children's Fund (UNICEF) in 152 low and middle-income countries, the GAVI Alliance--which funds vaccines in 73 of these countries--and other agencies.

When WHO pre-qualified a Chinese-made vaccine for the first time last October, the move showed what Chinese vaccine manufacturers could potentially achieve and--in a sense--paved the way for others to follow suit.

"The prequalification of the Japanese encephalitis vaccine in China is a big step forward, and now several other Chinese producers are interested in obtaining prequalification for their vaccines," says Melissa Malhame, whose team at the GAVI Secretariat in Geneva works with vaccine manufacturers around the world to ensure sufficient supply of high quality vaccines at affordable prices.

This and other Chinese vaccines are licensed by the China Food and Drug Administration (CFDA) that is part of China's National Regulatory Authority (CNRA), which received WHO's seal of approval in March 2011, after finding that it met WHO standards for vaccine regulatory oversight.

In July, this status was renewed, after a successful WHO reassessment of the vaccine regulatory part of the CNRA. WHO Director-General Dr Margaret Chan welcomed the news saying: "As a result of this evaluation, WHO is confident in the quality, safety and effectiveness of vaccines that are made in China."

For Dr Lance Rodewald, head of WHO's expanded programme on immunization (EPI) in China, the two WHO programmes--prequalification and national regulatory authority strengthening --"are really terrific, as they have made it possible for the United Nations and other agencies to procure life-saving vaccines for countries without the capacity to make high quality vaccines or the resources to purchase them".

"More Chinese vaccine manufacturers will follow suit and apply for pre-qualification later this year or early next year," Rodewald says.

China has come a long way since 1978 when it introduced EPI and a largely state-run vaccine manufacturing industry grew up to meet the resulting demand.

Initially, the programme offered the country's children vaccines for polio, diphtheria, tetanus, pertussis (whooping cough), measles and tuberculosis. Later vaccines for hepatitis A and B, Japanese encephalitis, mumps, rubella and invasive meningococcal disease were added.

According to the CFDA, China has 34 vaccine manufacturers, of which four are international joint ventures, seven are state run and the rest are private. All 34, it says, have met the most recent (2010) Good Manufacturing Practices requirements.

"China is currently producing nearly all of the commonly-used vaccines for viral diseases such as influenza, measles, rabies (for humans), mumps, rotavirus, hepatitis A and B and for bacterial diseases, including typhoid, tetanus and diphtheria," says Dr Xu Ming, Vice President of the China Chamber of Commerce for Import and Export of Medicines and Health Products. …

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