New Delhi, March 27
Days after the death of four tribal girls in Andhra Pradesh after the alleged administration of HPV vaccine for prevention of cervical cancer, it turns out that the vaccines are being sold over the counter without comprehensive country-specific safety trials held.

Currently, GlaxoSmithKline is marketing Cervarix, a preventative cervical cancer vaccine (it is not therapeutic) while Merck Sharp and Dohme, an affiliate of Merck and Co, is marketing Gradasil HPV vaccine in India.

Both were introduced last year and are approved by the FDA, with GSK’s Cervarix vaccine already sold in 60 countries, including the US, Australia and the European Union. The vaccine had sales of 125 million pounds last year and was even approved by the UK for its national programme of vaccination for teenage girls.

In India, however, HPV (Human papillomavirus) vaccines are not yet part of the national cancer control programme and their environment specific trials are yet to concluded, with enquiries revealing that the International Agency for Research in Cancer (IARC), World Health Organization branch, is presently conducting safety trials at eight sites.

Being held under IARC’s Dr Shankar Narayan, these trials will help resolve local issues around the vaccine use in India. Dr GK Rath, cancer specialist with AIIMS, today said it was yet not clear how the vaccines would behave in the Indian population which lives in different socio-cultural environment than the westerners.

“We must find out which age group to administer the vaccine to. Like in other countries, we can’t start giving the vaccine to girls of nine years because here we can’t medically examine them at that age. Without examination, we wouldn’t know how the vaccine would behave. Also we need to determine whether to administer the vaccine to those with antibodies. If yes, we need to test girls for antibodies first. These issues are unresolved and we must wait for vaccine use until we put the record straight,” Rath said, putting question marks on mass scale use of HPV vaccines.

The vaccines, however, if proven effective, would help 80 per cent women who get one type of HPV virus or the other (over 100 types exist). Of these, 15 high-risk types cause all cervical cancers. In India (eight women die every hour of cervix cancer), GSK is marketing vaccines to prevent HPV 16 and 18 viruses, which cause 70 per cent cases.

IARC trial report would be submitted to the government in three months after which it can be decided whether India wants the vaccines for its National Cancer Control Programme. “Trials will reveal the side effects, if any and will help us frame guidelines. So far, we have no guidelines for use of HPV vaccines though we have guidelines for Hepatitis B and Oral Polio vaccines,” Rath said. IARC is holding trials in AIIMS, Delhi, Chennai, Trivandrum, Kolkata, Mumbai among other sites.

Meanwhile, Drug Controller General of India Surinder Singh did not respond despite repeated attempts by the Tribune to contact him on the sale of HPV vaccines in India.