HPV vaccine still unavailable in China 8 years on(2)

Some Chinese doctors and officials claim that there are ethnic differences between Chinese people and Americans or Europeans, and clinical trials that target Chinese people are needed to ensure of the vaccines' safety and efficiency on Chinese.

But there is little evidence of such differences affecting vaccinations, especially with China's highly genetically diverse population. Hongkongers and people of Chinese descent in other countries have already received the vaccines without problem.

Controversial standards

Meanwhile, Liu Peng, a deputy professor in the School of Public Administration and Policy with Renmin University of China, said that as high-risk drugs, vaccines should be reviewed stricter before being applied domestically.

"China has a large population, and even low possibility adverse events could affect a large group of people," Liu told the Southern Weekly.

Shi Hui, who works in the pharmaceutical Industry, also said that China's Food and Drug Administration (CFDA) always takes new vaccines more seriously than other new medicines.

The CFDA's caution may be in part due to public panics after previous scandals involving allegedly sub-standard or out-of-date vaccines being issued, such as in Shanxi between 2006 and 2010, where vaccine storage was allegedly subcontracted to a private entrepreneur with local government connections and improper storage caused several deaths. The then Ministry of Health has denied the reports.

Besides GSK and Merck, another homegrown vaccine developed by experts from Xiamen University has also finished its first two phases of clinical trials and is undergoing the last phase.

Approval for those vaccines in China would bring huge benefits for these companies, Shi believed.

His opinion was echoed by Chen Hao, at the Huazhong University of Science & Technology, who said that protecting the domestic vaccine industry might be another reason for the delay.

The HPV vaccine made by Merck had a sales figure of $1.831 billion globally in 2013, according to Southern Weekly.

Although many believed that the CFDA's standards on vaccines approval are far too strict, Shi said that they won't be easily modified. "If anything goes wrong in the future, the authorities would have to pay the costs for making the change," he said.

CFDA's endpoint criteria for the trials requires a statistical differences in quantity, which requires a certain number of cancers occurring in the research group.

However, since it usually takes a decade for the infection to progress to invasive cancer, most other countries have applied a different criteria, which requires only a consistent infection showing up in the research group. A recent WHO report approved this method.

Current data would be enough if a new endpoint was adopted, Qiao Youlin from Chinese Academy of Medical Sciences & Peking Union Medical College told Southern Weekly.