Why has the beneficial HPV vaccine not been included in national immunisation programme?

Up to 25% of cervical cancer-related deaths in the world occur in India, with over 1 lakh women diagnosed with it every year.
Why has the beneficial HPV vaccine not been included in national immunisation programme?
Why has the beneficial HPV vaccine not been included in national immunisation programme?

In 2009, an American NGO, along with the governments of Andhra Pradesh and Gujarat, decided to conduct clinical trials for the Human Papillomavirus (HPV) vaccine, which was introduced to prevent the onset of cervical cancer.

As the trials were underway, 8 girls who were part of the trial died, setting off a debate about the safety and viability of the vaccine. A probe into the clinical trials revealed that the girls did not die as a result of the vaccines administered, yet the damage had been done. In a nation which was already apprehensive about the vaccine, the news added fuel to fire and prolonged the conjecture surrounding the vaccine which could potentially save many lives.

India has some of the highest rates of cervical cancer, with over 1 lakh women being diagnosed with it every year. Furthermore, up to 25% of cervical cancer-related deaths in the world occur in India. Though the HPV vaccine has been determined to be effective in preventing cervical cancer, a large amount of speculation around it has kept it from being integrated into the Universal Immunisation Programme.

Cancer of the cervix

The cervix is a part in the female reproductive system that opens to the uterus; it’s also called the mouth of the uterus.

“Many women we counsel don’t even know that such a part exists in their bodies,” Dr Chethana, Medical Officer at the Indian Cancer Society in Bengaluru, tells TNM.

“Considering that cervical cancer is one of the highest prevailing cancers in Indian women, this is quite alarming,” she adds.

HPV has been determined to be one of the main causes of cervical cancer, though other etiologies have been noted.

The National Technical Advisory Group on Immunisation (NTAGI) has also advised the inclusion of the vaccine into the universal schedule, yet there still appears to be some resistance to the same.

“The vaccine has been included in the immunisation schedule for the paediatric age group,” explains Dr Sapna Lulla, an obstetrician and gynaecologist at Motherhood Hospital in Bengaluru. “Right now, it is listed as an optional vaccine which people can opt to have administered to their child. I recommend that the vaccine be indeed given, though there are many parents who do not wish to vaccinate their children for a variety of reasons. The resistance is because they are not sure what the vaccine does as it was not administered to mothers back in the day.”

The Indian Academy of Pediatrics (IAP) has included the HPV vaccine in its Universal Immunisation Schedule for children. It has been listed as an optional vaccine that can be given to children between the ages of 10 and 12. For girls older than 15 years of age, the IAP guidelines suggest that 2 doses be given, which can be increased to 3 doses for those with weaker immunity.

In adults, while it has been recommended that women get the vaccine before the initiation of sexual activity, most doctors comply with the CDC guidelines which state that women can get the vaccine up to 26 years of age. “The vaccine is generally recommended for women in this age group, although in some cases we do give the vaccine to older women. We take a call according to each individual’s history,” says Dr Tejeswini Potluri, an obstetrician and gynaecologist from Hyderabad.

Forms of vaccine

Dr Hema Divakar is an obstetrician and gynaecologist from Divakars Hospital in Bengaluru. She has been at the forefront of the battle lobbying for the inclusion of the vaccine into the immunisation programme for adults.

“Generally we recommend that the vaccine is given long before the initiation of sexual activity,” she says. “However, the idea is to get it done as early as possible, which is why there is nothing wrong with including it in the immunisation schedule of a paediatric age group.”

There are currently two forms of the HPV vaccine available in India – Cervarix and Gardasil. “Cervarix is a bivalent vaccine, which covers two strains of the virus, while the form of Gardasil present in India is a quadrivalent vaccine which covers four strains of the virus,” explains Dr Chethana. “In the US and a few other countries, there are variations of the vaccine that cover up to 9 strains.”

To this day, it is not clear how the virus spreads.

“Yes, sexual activity has been noted to be a transmission method for the virus, but that is not to say that a person cannot be exposed to the virus in some other way. This is merely the most commonly seen form of transmission. It could also be caused because of smoking or lifestyle choices,” explains Dr Hema. “It comes down to how you explain this to people and make them understand that this vaccine is being administered for good reason.”

Opposition to the vaccine

Most obstetricians and gynaecologists recommend that their patients get the vaccine. “Have you ever heard of a vaccine for cancer?” Dr Hema Divakar asks. “If there are preventive measures available for the dreaded ‘C’ word, then shouldn’t we be taking it?”

But, in spite of the repeated reassurances from doctors, there are several factors which also prove to be a hindrance to including the vaccine into the immunisation schedule. One such reason is its cost. The vaccine is usually administered over 2 to 3 sittings, depending on which one is given, and each time the price can range from Rs 2,000 to 3,000, which is steep for many people, automatically pushing it out of their reach.

Additionally, certain right-wing groups have been opposing the virus citing ‘moral reasons,’ claiming that if young girls are given the vaccine, it would encourage them to be sexually active, whether married or not. The Swadeshi Jagran Manch, an affiliate of the RSS, had even written to Prime Minister Narendra Modi claiming that including the vaccine in the Universal Immunisation Programme would be an ‘unmitigated disaster’.

Doctors rubbish these claims and state that it is wrong to view the vaccine and virus only from a platform of sexual activity. “This is a tested, proven way to prevent the onset of cervical cancer. We should look at it as a method of tackling the menace that is cervical cancer rather than anything else,” says Dr Tejeswini.

Pap smears and screening

Dr Tejeswini further explains that while the vaccine is the only method to prevent the onset of HPV-related cervical cancer, screening must be undertaken frequently to ensure that the woman is healthy.

“I recommend my patients to come in for regular check-ups, and we encourage them to do pap smears at least every 2 to 3 years,” she says.

The Papanicolaou test, or ‘pap test/smear’, is a simple screening test for cervical cancer. Using a pap smear kit, the doctor will collect cells from a woman’s cervix, which are then spread on a microscope slide, fixed with a fixing agent and sent to the pathology lab for testing. Pathologists examine the slide under a microscope to determine whether there is any abnormality. 

“If the cells look normal and healthy, then there is nothing to worry about, but if we catch any odd or unhealthy looking cells, we have to stage them and determine what they are, then we inform the clinician and further tests may be ordered,” explains pathologist Dr K Akshaya from Chennai.

Should the pap smear test come back with an abnormal result, further work is done. Dr Sapna tells TNM how a colposcopy is undertaken in such an event. “It is similar to the pap smear, but we use a type of magnifying glass to see if there are any obvious abnormalities. If needed, during the colposcopy, we can also send a sample of the biopsy to the lab, which will give us a better idea about what we are dealing with.”

If the biopsy returns positive for cervical cancer, or premalignant lesions of the same, doctors will have to determine what the best choice of treatment is, given the woman’s general condition.

“When we know that cervical cancer is predominantly caused by HPV and we know that there is a vaccine available for it, which is an effective tool against the disease, it should definitely be made available for all to access. Today we might think that it’s Rs 2,000 per injection, but long term, if someone is diagnosed with cervical cancer, the treatment costs would definitely be a lot more,” says Dr Hema.

“This is an important breakthrough in science and we must take advantage of it,” she adds. “India was one of the last countries in the world to eradicate polio. Many countries are undertaking mass vaccination programmes to fight cervical cancer and you can see a drop in the incidence of the disease there. India shouldn’t be left behind.” 

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