杂志汇中国与非洲

Contributing to World Health

作者:By Ge Lijun
Chinese pharmaceutical firms given the green light from WHO to go global

A nurse vaccinates a child in a clinic in Hefei City in Anhui Province Keeping young children healthy can be challenging at the best of times, as Li Haijie, a 34-year-old mother of two knows only too well. For example, to have her first child vaccinated, she had to queue for hours in a crowded, noisy room, in her hometown of Jining, in east China’s Shandong Province.

“But by the time I had my second child vaccinated, services had really improved thanks to new technologies. I can now book my appointment on the Internet. When the doctor scans my children’s vaccination cards, he has access to all of their information, making the whole process clear and fast. It saves parents a lot of time and energy,” she said to Qilu Evening News.

health clinics, a program that should cover all clinics in the city by the end of 2018. Meanwhile, the vaccination rate has reached more than 90 percent, compared to 70 percent in 1978, when the planned childhood vaccination program was expanded nationally.

Better and safer vaccines

This year marks the 40th anniversary of the implementation of national planned vaccination program in China. “Over this long period, services have progressively improved. Today, China has nearly 200,000 inoculation units that carry out vaccination tasks according to the national policies,” said Wang Huaqing, a senior immunization expert of the Chinese Center for Disease Control and Prevention.

New information technologies have proven to be a good tool to improve services. Jining Center for Disease Control and Prevention makes full use of the Internet to facilitate immunization work. Its website offers related information and appointment booking services to avoid long wait time. “In addition to digitalized clinics, medical refrigerators are now used to store vaccines instead of household refrigerators. Moreover, immunization centers now offer a better environment, which was not the case before,” said Zuo Shuyan, an official from the World Health Organization (WHO) China Office.

Increased government funding is an important factor in ensuring the safety of vaccines. According to Chinese Government figures, in 2017, the country invested 3.56 billion yuan ($559 million) in the immunization program. In Jining, the local government invested 3.84 million yuan ($603,000) over the last three years to upgrade storage and refrigerated transport facilities in the city’s inoculation units. In addition, electronic devices have been installed to control the temperature of cold-chain equipment and ensure that vaccines stay safe and effective.

China launched its vaccination program in the 1950s and national planned vaccination program from 1978 to 2001. The expanded vaccination program that has been implemented from 2001 onward sees the vaccination rate continue to increase, reaching 90 percent now. “This high rate has created a safety net to effectively prevent and control a number of contagious diseases, such as hepatitis B among children,” Wang said, adding that China passed WHO’s assessment on its national vaccination regulatory system in 2011 and again in 2014, which not only helps ensuring vaccine safety, but also enables export of made-in-China vaccines.

Serving global health

Parents and children take part in a vacination promotion event in Hefei in Anhui Province Up to 2017, only 43 countries could produce vaccines certified for export. Of these, 25 countries - including China - manufactured 90 percent of the vaccines used worldwide. But for China, making such a contribution has not come easy.

China’s national regulatory authority for vaccines first had to pass the WHO’s assessment, which uses independent tools and expert panels to periodically evaluate each country’s regulatory authority. “A functional national regulatory authority is the prerequisite for the UN agencies to buy vaccines from China for other countries as needed. It’s a very strict process,” explained Zuo.

In 2011 and 2014, WHO twice confirmed that China’s vaccination regulatory authority had met its standards, which means that vaccines produced by Chinese companies are safe and effective. However, for pharmaceutical companies to export vaccines, they still have to undergo the WHO prequalification (PQ) process.

“China has invested a lot in the innovation of its biomedical techniques and medical products. We hope that Chinese innovation can increase our contribution to global health,” said Du Heng, Senior Program Officer at the Bill & Melinda Gates Foundation China Office.

She added that global health still needed investment to deal with contagious diseases, such as tuberculosis, HIV/AIDS, Malaria and neglected tropical diseases. Although contagious tropical diseases are no longer among the priorities of China, she hopes that Chinese companies will nonetheless strengthen their R&D efforts in this area in order to help other countries in need.

The first Chinese vaccine that has passed the WHO PQ assessment was the Japanese Encephalitis vaccine in 2013. This vaccine has been used in the Chinese market since 1988, where it is sold at a much more affordable price than the equivalence produced in other countries. The assessment process of the vaccine started in 2005 and lasted eight years. As of 2017, more than 400 million doses had been shipped outside of China, most of which to Southeast Asian and South Asian countries. In Laos alone, 1.5 million children were vaccinated against Japanese Encephalitis in 2015.

So far, four vaccines made in China have passed PQ assessment, including the bivalent oral poliovirus vaccine in 2017. The United Nations Children’s Fund has purchased 70 million doses of this vaccine, i.e. 20 million for 2018 and 50 million for 2019. This is major step toward eradicating poliovirus globally.

“Through the process of [WHO PQ assessment], China’s production capacity and vaccine quality have improved a lot. Children also benefit. It’s a win-win situation,” said Du.

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