A second chance for the HPV vaccine

As India’s human papillomavirus vaccination programme gains strength, lessons from an earlier trial must not be forgotten

October 04, 2017 05:57 pm | Updated October 07, 2017 11:36 pm IST

  In a jab  “A key reason given by HPV vaccine manufacturers and experts on the need for HPV vaccine is the near-absence of screening in India.”

In a jab “A key reason given by HPV vaccine manufacturers and experts on the need for HPV vaccine is the near-absence of screening in India.”

After the suspension of the human papillomavirus (HPV) vaccine trial in 2010 carried out on nearly 23,500 girls in Vadodara, Gujarat and Khammam, Andhra Pradesh, Delhi and Punjab governments have started vaccinating girls aged 11 to 13 years from November 2016 onwards. The two States started the vaccination programme for school children on the occasion of the National Cancer Awareness Day.

In 2012, there were 123,000 new cases of cervical cancer and 67,000 deaths in India. About 25% of global cervical cancer deaths take place in India.

While 1,200 doses have been administered in Delhi as of March 2017, nearly 10,000 girls have been covered in two high prevalence districts - Bathinda and Mansa - in Punjab. A total of 261 schools in Bathinda (5,851 girls) and 187 schools in Mansa (4,002 girls) were involved in the program and 5,851 and 4,002 girls were vaccinated in Bathinda and Mansa respectively, says a paper published in September 2017 in the Journal of Global Oncology .

While Delhi intends to expand the vaccination programme to cover 250,000 school-going girls annually, Punjab will be expanding the HPV vaccination to five more high prevalence districts in its second phase. The vaccination will eventually be scaled up to include all girls in class 6 across Punjab. The bivalent vaccine, which contains HPV 16 and HPV 18, is used in Delhi while the quadrivalent vaccine (HPV 16, HPV 18, HPV 6 and HPV 11) is used in Punjab.

“Now other States such as Sikkim, Harayana and Tamil Nadu have shown interest,” says Dr. Ravi Mehrotra, Director of the National Institute of Cancer Prevention and Research, Noida.

As more States decide to introduce HPV vaccination, it is important to bear in mind the lessons learnt from the HPV vaccine trial in Andhra Pradesh and Gujarat. The trial came under scrutiny following the uproar over the death of seven children. Though deaths of the children were found to be unconnected with the vaccination, investigation into the conduct of the trial exposed several ethical violations, including signing of 2,800 consent forms by a hostel warden. The trial was suspended in March 2010.

Following the uproar caused by the deaths and unethical practices during the conduct of the HPV vaccination trial, the Supreme Court in January 2013 expressed serious concerns about clinical trials in India. It said that uncontrolled clinical trials in India by multinational pharmaceutical companies was creating “havoc” and slammed the Centre for failing in its duty to stop the “rackets” that resulted in deaths of people who had participated in clinical trials.

And in September 2013, the Supreme Court stayed the approvals for 162 clinical trials already approved by the Drugs Controller General of India. It then came out with very stringent guidelines for the conduct of clinical trials.

The Indian Council of Medical Research (ICMR) has been the driving force behind the vaccination programme. “We held expert group meetings with many stakeholders, including NGOs, and looked at the scientific evidence from the World Health Organisation, the International Agency for Research on Cancer (IARC), other countries that have introduced HPV vaccine and from within India. We took into account the current global recommendations. We also looked at experiences of other countries in this region such as Nepal, Indonesia and Sri Lanka, which have introduced the vaccine,” says Dr. Soumya Swaminathan, Director-General of ICMR.

“The National Technical Advisory Group on Immunisation is considering the introduction of HPV vaccination as part of the Universal Immunisation Programme,” says Dr. Swaminathan. “The HPV vaccine is offered in the private sector and people who can afford it are getting it. But the poor who are more vulnerable are not getting it.”

Some of the important recommendations by the expert group are to make the uptake of vaccination absolutely voluntary and with prior knowledge and informed consent from the parents of girls to be vaccinated. Also, cervical cancer screening of mothers accompanying the female child at the time of vaccination has been recommended.

While it may take about 25 years to see the benefits of large-scale vaccination of children, screening mothers in the 30-65 years group will have an immediate positive outcome.

There is a lack of effective screening for cervical cancer in developing countries, India included. A 2009 study carried out in about 500 villages in Osmanabad district in Maharashtra found a “single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer”. There were 34 cancer deaths in the HPV-testing group compared with 64 in the control group.

One of the main reasons cited by HPV vaccine manufacturers and other experts on the need for HPV vaccine is the near-absence of screening for cervical cancer. Only about 5% of women in India have been ever screened for cervical cancer. But what is not mentioned is that HPV vaccination does not make screening for cervical cancer unnecessary. “Screening should go hand-in-hand with vaccination. Strengthening cervical cancer screening is part of the ICMR recommendation. Earlier detection of cervical cancer is very important,” says Dr. Swaminathan.

The WHO has made it abundantly clear that despite vaccination, screening for cervical cancer should continue. The reason: besides 16 and 18 HPV serotypes, infection with 11 other serotypes can cause cervical cancer. The HPV serotypes 16 and 18 account for only about 77% of cervical cancer in India. Hence, girls vaccinated with even a quadrivalent vaccine can be infected with other serotypes. The 9-valent HPV vaccine, which was licensed in 2015, offers greater protection against HPV-causing serotypes.

Some oncologists from the Tata Memorial Centre are of the opinion that HPV vaccine to prevent cervical cancer is not needed in India. They cite the sharp fall in the number of cervical cancer cases without any medical intervention. They attribute this fall to increased awareness particularly of personal hygiene in cities such as Mumbai, Bengaluru, Chennai, Kolkata and Delhi. Cancer registries in four rural pockets have not shown any increase in incidence in over two decades.


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