The deaths of four young girls in Andhra Pradesh have stirred up a debate on a vaccine for a cancer that kills more than 74,000 women every year in India. The question being asked is: are these shots safe?

Four girls, aged between 10 and 14, died recently after they were administered the human papilloma virus (HPV) vaccine — being marketed aggressively in India to prevent cervical cancer among women — in Khammam district of Andhra Pradesh. They were among 14,000 girls in the state who were administered HPV vaccines during a “demonstration project” carried out by the health department of the state government in association with a US-based NGO called Path Internat- ional.

Doctors across the country have been urging parents to get their young daughters — even eight-year-olds — vaccinated against the cancer. Global guidelines state that HPV vaccines need to be administered to a girl before she becomes sexually active. The vaccines are designed to protect against some strains of HPV that account for at least 70 per cent of cervical cancer cases around the world.

The importance of the vaccines is being highlighted in anti-cervical cancer camps in the country. Apart from Andhra Pradesh, a “demonstration project” was also being carried out in Gujarat. Cervarix and Gardasil — the only two HPV vaccines available in the world market — were reportedly donated free of cost by their respective manufacturers GlaxoSmithKline and Merck Sharp Dohme for the Gujarat and Andhra projects. Around 23,500 girls have so far been vaccinated in the two states.

Civil rights groups and members of the medical fraternity seem to be divided on the issue. Women’s groups such as the All-India Democratic Women’s Association contend that “clinical trials” of HPV vaccines have crossed ethical lines and that the Indian government is imposing the vaccines on unsuspecting women without verifying its efficacy.

The HPV vaccines have been available in India for over a year now. The manufacturers have been liaising with gynaecologists and paediatricians to raise awareness about cervical cancer. But the deaths in Andhra have stoked an old debate all over again.

“The uproar over the deaths can be regarded as a setback to cervical cancer awareness programmes that are being carried out in India,” says Partha Basu, head, department of gynaecological oncology, Chittaranjan National Cancer Institute, Calcutta.

While the central health ministry has started an inquiry into the deaths and halted all vaccination programmes for the present, health authorities caution against panic.

“As far as we know, there is no correlation between the HPV vaccine and the four deaths in AP. The government is looking into the issue,” says Sanjay Gupte, president-elect, The Federation of Obstetrics and Gynaecological Societies of India, which collaborates with the Indian government on national policies related to women’s health.

But many health experts in India believe the vaccine is targeting the wrong section of people in India. Multiple sexual partners, unprotected sex and unhygienic conditions are some of the factors that lead to the cancer, which is mostly prevalent in the poorer sections of Indian society. But since the vaccine is expensive (costing Rs 8,400-Rs 10,500), the poor can’t afford it.

Some experts also believe that the vaccine does not necessarily prevent cervical cancer. Gagandeep Kang, a medical scientist at the Christian Medical College, Vellore, points out that the vaccinations are only effective for some strains of HPV, and ineffective against other strains. In an article in the latest issue of Indian Journal of Medical Ethics, Kang points out that the risk of cervical cancer is associated not only with HPV infection but also with a person’s socio-economic status and other risk factors.

On top of all these questions, a new dimension has been added to the debate on whether the vaccines are safe. Gupte points out that the vaccines are a part of school programmes in countries such as Britain. “If it’s part of school programmes, then the government concerned has cleared it with due responsibility. The safety of the vaccines has been proved beyond doubt in other countries too.” He stresses that vaccination is the primary prevention strategy for cervical cancer.

On the other hand, sporadic outbursts in several countries over deaths among girls who were administered HPV vaccines have been reported from time to time in the media. According to the US Centers for Disease Control and Prevention, as of January 31, 2010, there had been 49 reports of deaths of women who received Gardasil. But it also said that there was nothing to suggest that the deaths had been “caused” by the vaccine. “No deaths have been causally associated with HPV vaccination in India or elsewhere,” stresses Path International.

Rahul Roy Chowdhury, consultant gynaecological oncologist at the Cancer Centre Welfare Home and Research Institute, Thakurpukur, Calcutta, says that there have been “controversies” across the world relating to the safety of vaccines. “But all reports of adverse effects have been investigated by the respective governments and no causal link between the vaccines and the deaths has been established,” he says.

But can people in India report any adverse effect of HPV vaccine? “They should consult their paediatrician or gynaecologist who in turn should report to the vaccine manufacturer,” says Roy Chowdhury. In the US, people can report the adverse effect of any vaccine to a national public health alert system called Vaccine Adverse Event Reporting System. “We don’t have any such system here,” says Gupte.

Others point out that the Indian government needs to ensure a continuous surveillance system for all vaccines. “The Andhra Pradesh deaths have revealed a flaw in our system. Our regulatory bodies are not prompt in reacting to reports of adverse effects or make any conclusive statement in this regard within a reasonable timeframe,” says Basu.

Merck officials in India say 55 million doses of Gardasil have so far been distributed all over the world, that it is the outcome of over 10 years of research and development, that clinical trials evaluating the efficacy and safety of the vaccine have included more than 25,000 women from 33 countries, that Merck has a surveillance programme to monitor the safety, efficacy and duration of protection of people who are vaccinated with Gardasil and that leading international health organisations have reviewed all of the safety information available to them about Gardasil and continue to recommend its use.

A Glaxo spokesperson says that over 10 million doses of Cervarix have been distributed worldwide. The Glaxo spokesperson points out that to be granted a licence, its vaccine had to meet rigorous safety and efficacy standards. “GSK is confident of the safety profile and efficacy of Cervarix.”

Adds Basu, “A few deaths in a sample size of millions do not prove that the vaccine is not safe.” Some, however, would say that “a few deaths” is a few deaths too many.