Another vaccine under question- Nationwide launch to safeguard girls from cervical cancer halted

KUENSEL ONLINE

Bhutan’s Daily Newspaper

By Sonam Pelden

15 April, 2010 – The drug regulatory authority (DRA) has written to the department of public health (DoPH) to halt the launch of the human papillomavirus (HPV), which was scheduled to go nationwide on May 5.

It comes at a time, when the vaccine known to protect women against cervical cancer, has allegedly caused the death of four tribal girls in Khammam, Andhra Pradesh, India, after they received three doses of the HPV vaccine.

HPV vaccine protects against two types of HPV (16 and 18), which causes 70 percent of cervical cancer in women.

According to Indian media reports, about 14,000 girls between 10-14 years in Andhra Pradesh were vaccinated with three doses of the HPV vaccine, of which 120 reported adverse side-effects.

Following the alleged deaths, civil society groups, public health organisations, medical professionals, human rights organisations and women’s groups have voiced their opposition to the nature of the HPV vaccination programme carried out in Andhra Pradesh and Gujarat.

“The vaccine is being pushed, when the reality is that even basic health care to many isn’t available,” said an expert on health issues in India, Dr Mira Shiva, who has 30 years of experience with issues of right to health, prevention of misuse of medicines and medical technology. “Health groups and women health groups are all questioning this.”

Dr Shiva, who is also the coordinator of initiative for health equity and society and all India drug action network, told Kuensel that the vaccination of HPV has been stalled and a committee formed to investigate the deaths.

Even though the HPV vaccine’s nationwide launch is being halted, more than 3,000 girls in Paro between 12 to 18 years have already received the first two doses of the HPV vaccine, said public health officials. Except for one case of giddiness reported, there were no other serious complaints from any girls, who received the vaccine said health officials.

About 9,600 doses of the HPV vaccine, called Gardasil, were given to Bhutan by Merck and company, the DoPH director, Dr Ugen Dophu said. “Paro was chosen because the number of vaccines we received was enough for girls in Paro,” he said.

The first dose was given in October last year to 3,080 girls and the second dose in December to 2,981 girls. Many girls had left for winter holidays at the time of the December vaccination, public health officials said.

For their third and final dose, which is being given today in 22 schools in Paro, the health ministry is expecting about 3,000 girls. There are 51,473 girls between the ages of 12 to 18 in Bhutan, according to statistics maintained by the national statistical bureau.

In response to the letter from DRA, Dr Ugen Dophu said that the DoPH would now have to prove that the vaccine is not harmful. “The vaccine technical committee will discuss this very soon,” he sad.

DRA’s head and drug controller, Sonam Dorji, said that they are keeping a close watch on the happenings in India. “We wrote to them, based on the reports in India,” he said. “The reports could be malicious, but we need to scrutinise the vaccine and keep updating any information on the vaccine.”

Sonam Dorji said that they would soon meet and inform the medicine board and the national committee on immunisation practices. “What actions we take next depends entirely on the chairman, our health minister,” Sonam Dorji said.

Cervical cancer is a silent disease that develops in the lining of the cervix, the lower part of the uterus that enters the birth canal. The vaccine, which is given in three shots, is most effective when taken before a girl is introduced to sexual activity, said health officials.

Records with DoPH show that the highest incidence of cervical cancer was seen between 2000 and 2004 with 42 cases. In 2008, JDWNRH saw 22 new cases in women between 30 to 40 years.

According to a memorandum of understanding, signed in August last year between the Australian cervical cancer foundation (ACCF), Merck and company, which will supply the vaccine, and the Bhutanese government, the vaccines will be provided free until 2014. Bhutan will receive in the next five years a total of 369,849 doses of HPV vaccine, worth about USD 40M.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.