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2016-07-18 10:38:46

A decade after the world’s first human papillomavirus (HPV) vaccine was approved by nearly 50 countries around the world, authorities in China have given the green light for one of the vaccines to be sold domestically.

Pharmaceutical giant GlaxoSmithKline (GSK) announced on Monday that their HPV vaccine Cervarix has been approved by the China Food and Drug Administration (CFDA) for use in China. The vaccine will be available on the Chinese market starting next year.

HPV infection is the leading cause of cervical cancer, the fourth most common cancer in women worldwide according to the World Health Organization. HPV is sexually transmissible and has also been linked with cancers of the anus, vulva, vagina, and penis.

More than a quarter of cervical cancer patients worldwide are in China. According to GSK, it is the second most common cancer among Chinese women between the ages of 15 and 44, with an estimated 130,000 new cases every year. Research shows that early treatment can prevent up to 80 percent of cervical cancers.

As an HPV vaccine has never been available on the mainland, many Chinese women have in recent years visited places like Hong Kong to get vaccinated. Taobao, the country’s biggest e-commerce platform, even offers package deals for HPV vaccination in Hong Kong, which include three injections for prices starting at 2,000 yuan (nearly $300).

Jin Gaowa, a 26-year-old woman working for the power supply bureau of Wenzhou in the eastern Chinese province of Zhejiang, went to Hong Kong in May with a friend to get vaccinated. She told Sixth Tone that the three shots cost her 3,700 Hong Kong dollars ($470).

“A lot of my friends have been to Hong Kong to get the HPV vaccine,” Jin said. “My aunt also took her daughter there.” Jin first heard about the vaccine three years ago, after she gave birth to her baby.

HPV vaccines were first approved in the U.S. in June 2006. By the end of 2006, another 48 countries had green-lighted the drug. Now, more than 130 countries have approved the drug for sale in their markets. By 2014, at least 58 countries around the world had instituted national immunization programs for girls — and some for boys, too.

But controversies persist, as some scientists argue that children are vaccinated at too young an age for the drug to be effective once they become sexually active. GSK announced that their Cervarix vaccine was registered for use by females aged 9 to 25.

Cervarix, which protects against two strains of HPV, is the only HPV vaccine to be approved in China. Two other HPV vaccines — Gardasil and Gardasil 9, produced by Merck & Co. — are available overseas and protect against four and nine strains, respectively, though they have not been approved by the CFDA.

Current regulations require manufacturers of vaccines to conduct clinical trials in China before they can be granted a license there. Sometimes the criteria for approval in China can be stricter than what the WHO requires. Chinese media reported in 2014 that Merck had given their clinical trial data to the CFDA for review by 2013, and that GSK had finished their clinical trials by 2013. Merck and GSK both conducted large-scale trials in other Asian countries from 2002 to 2005, but the Chinese government did not accept those results.

According to GSK, the company conducted a clinical trial in China involving over 6,000 subjects who were followed for up to six years before the vaccine was approved by the CFDA.

With contributions from Qian Jinghua and Yin Yijun.

(Header image: Peter Dazeley/Photographer’s Choice/VCG)