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Published 14 September 2009, doi:10.1136/bmj.b3778
Cite this as: BMJ 2009;339:b3778
Jane Parry
1 Hong Kong
As China rolls out the first phase of its programme to vaccinate 65 million of its 1.3 billion people against A/H1N1 swine flu, the Ministry of Health has confirmed that the disease is spreading inland and into rural areas and may infect tens of millions of Chinese people in the coming months.
Vaccination got under way in Beijing on 9 September, state media have reported, and will also cover Shanghai and Guangdong province in the initial phase. So far two vaccine manufacturers, the Beijing based Sinovac Biotech Ltd and Hualan Biological Engineering in Henan province, have been granted production licences by Chinas State Food and Drug Administration.
Sinovacs vaccine, Panflu 1, has been approved to vaccinate people aged 3 to 60 years and requires only a single shot, while evaluation reports on Hualans vaccine show that it is safe for anyone aged over 3 years, with no upper age limit specified, said Chinas state run news agency, Xinhua.
Chinas Ministry of Industry and Information Technology ordered four million doses from Hualan and 3.3 million from Sinovac. Sinovac and Hualan have claimed they will be able to produce five million and 13 million doses, respectively, by 1 October, Chinas national day.
Chinas vaccination plan "would seem to be in line with the World Health Organizations recommendations to prioritise high risk groups such as healthcare workers, young people, and those with chronic conditions," said Cris Tunon, WHOs acting representative in China.
In addition to these groups, the first batch of vaccines will be given to the 200 000 participants in the 1 October pageant celebrating the 60th anniversary of the founding of the Peoples Republic of China.
The speed with which the two Chinese manufacturers have brought a vaccine to market is not surprising, said Yuen Kwok-yung, head of the Department of Microbiology at the University of Hong Kongs Li Ka Shing Faculty of Medicine, who recently visited the Sinovac plant.
"The speed of production should be achievable by any other multinational vaccine company which is producing seasonal flu vaccine, but this company is only producing a few million doses as the first batch and thus appears to be faster," he said.
The safety and efficacy results for the first two vaccines look good, said Paul Chan Kay-sheung, of the Department of Microbiology at the Faculty of Medicine, Chinese University of Hong Kong. "Making flu vaccines is not that technically demanding," he said.
Two studies recently published in the New England Journal of Medicine of two different vaccines (one from CSL Biotherapies in Australia and one from Novartis in Germany) show that a single dose confers protection from the A/H1N1 virus (New England Journal of Medicine doi:10.1056/NEJMoa0907413; doi:10.1056/NEJMoa0907650).
However, Zhong Nanshan, a leading Chinese expert on respiratory diseases, told Xinhua that the safety of the vaccine has not yet been fully established. "The vaccine should be put into mass use only after it has been proved safe through tests in many pilot places," Xinhua reported him as saying.
The vaccine comes at a time when health authorities in China expect the disease to spread rapidly. China has so far not had any deaths attributed to A/H1N1 swine flu and had approximately 7000 confirmed cases by 10 September, compared with 15 800 in Hong Kong alone by the same day. The number of confirmed cases doubled from 24 August to 10 September, and imported cases have already been outnumbered by new domestic cases.
Cite this as: BMJ 2009;339:b3778
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