High cost and ethical considerations may impede the introduction of the
world's first vaccine to prevent cervical cancer to China, according to Chinese
The new vaccine, Gardasil, was developed by Merck & Co Inc in the United
States, and won approval from the US Food and Drug Administration on Thursday.
After breast cancer, cervical cancer is the second-biggest killer of women in
the world. About 300,000 women die from the cancer worldwide each year. The
latest figures released by the World Health Organization (WHO) suggest that
nearly 500,000 new cases of cervical cancer are detected annually worldwide.
"The vaccine is a significant advance in the protection of women's health,"
Acting Food and Drug Administration Commissioner Andrew von Eschenbach said.
Given in three doses over six months, Gardasil targets four types of human
papillomavirus (HPV), a common sexually transmitted virus that causes genital
warts and most cases of cervical cancer.
Merck said the vaccine would be available within weeks.
China accounts for 20 per cent of cervical cancer victims worldwide, while
early detection and treatment has greatly reduced the incidence and deaths in
industrialized countries, said Dr Qiao Youlin, who is studying HPV types in
collaboration with Merck, WHO's International Agency for Research on Cancer, and
the Cleveland Clinic Foundation.
Chinese women don't know much about the cancer. A 2003 survey conducted in
the high-incidence area of Xiangyuan County in North China's Shanxi Province
found that only 10.3 per cent of the 2,004 surveyed women had heard of a pap
smear. Only 4.4 per cent knew that HPV is the primary risk factor in cervical
As the virus is known to be sexually transmitted, the Gardasil vaccine is to
be given to pre-teens before they become sexually active.
"Experts in America and Australia recommend the vaccine be given to boys and
girls as young as 9-12 years old while they're still at school," said Dr Elaine
Esber, executive director for Merck's Medical Affairs International.
However, some experts are worried the vaccine may trigger an ethical
controversy in China.
"Parents might think the practice of vaccinating with Gardasil encourages
promiscuity among teenagers," said gynaecologist Liu Zhihua of the Shenzhen
Women's and Children's Hospital in South China's Guangdong Province.
Theoretically, Gardasil is effective for women of all ages. "If a woman
contracts one of the four types of HPV, the vaccine is still effective against
the other three," said Esber. "At this point, however, the vaccine targets 16-
to 26-year-old women only. Clinical trials for other age groups between 26-45
The clinical trials for Gardasil involved 27,000 women and men from 33
countries. China was not included.
The cost of Gardasil will be US$300 to US$500 for a complete series of three
shots, estimated Liu, one of many experts who worry the vaccine is out of reach
for ordinary people.
Merck submitted its patent application to China's State Food and Drug
Administration last February. "We really cannot anticipate when it will be
approved for the Chinese market, because each country has its own regulations
and procedures," said Jane Lin, medical director for Merck China in Shanghai.
A doctor with the Chinese Academy of Medical Sciences said he did not believe
Gardasil will be available in China for at least five years.