GSK, a British healthcare company, announced on Monday that its HPV vaccine, Cervarix, has been approved by the China Food and Drug Administration (CFDA), marking the first HPV vaccine to enter the Chinese mainland market.
It took nearly 10 years for the vaccine to get the approval in the mainland since the first HPV vaccine was developed in 2007. Possible reasons may include the lack of unified criteria for the clinical trials of vaccines, concerns about the safety and high prices of the vaccines.
The whole vaccination process requires 3 doses with each costing around 1,000 yuan (around $149 US dollars) in Hong Kong, a hot destination for people from the mainland who seek to get this vaccine.
GSK has claimed that it has conducted a 6-year-long clinical trial of Cervarix in the mainland with over 6,000 people tested. The result shows that the vaccine is effective.
In the Chinese mainland, Cervarix mainly targets females aged between 9 and 25. Although many medical researchers hold that for women above the age of 25, the vaccine is still effective in preventing infection and cervical cancer. Males who take the vaccine can also be prevented from getting anal cancer and penile cancer.
Its efficacy weakens as the vaccinated people grow older.
HPV, short for human papillomavirus, is one of the most common sexually transmitted viruses worldwide. It is a kind of double-stranded circular DNA virus which parasitizes human's squamous epithelium cells.
The virus is connected with many diseases, including venereal diseases such as genital warts and various types of cancers such as cervical cancer.
The WHO in 2004 stated that HPV infection is a necessary factor in causing cervical cancer.
Data show that, among the over 200 types of HPV, HPV 16 and 18 cause 70% of cervical cancer cases while HPV 6 and 11 causes 90% of genital warts worldwide.
Cervical cancer is the second highest incidence of cancer for women between the ages of 15 and 44 in the Chinese mainland. Every year the mainland sees 130,000 new cases, accounting for 28% of the total amount worldwide.
The HPV vaccine has been confirmed to be effective in preventing cervical cancer.
There are now two major HPV vaccines available on the market now: one is Cervarix, a product of GSK, which is against HPV 16 and 18; another, Gardasil, a product of Merck & Co, which is against HPV 6, 11, 16 and 18.
In 2009, the WHO suggested the HPV vaccine should be employed for the primary prevention of cervical cancer.
Over 170 countries so far have introduced these two vaccines which have proven to be effective and safe for most vaccinated people.
The vaccine is expected to hit the Chinese market next year.