Cervavac, India's 1st HPV Vaccine for Cervical Cancer: All You Need to Know

Until now there were only two international HPV vaccines: Gardasil vaccine (first ever vaccine approved by the FDA in 2006) which is marketed by Merck & Co and Cervarix, manufactured by GlaxoSmithKline. In India, both these vaccines were imported from international manufacturers at a cost of Rs 3,500 to Rs 6,000 per dose. Cervavac is likely to cost between Rs 200 - Rs 400.

"The price of the vaccine may come down to Rs 350," Dr Rupinder Sekhon, Senior Consultant and Chief Gynaecologic Oncology at Rajiv Gandhi Cancer Institute, New Delhi, told FactChecker.

"We're waiting to see if this vaccine becomes part of the government's immunisation programme Category 1. This means that the government will pay for it. As of now, it's a Category 2 vaccine. Since it is indigenous and the cost is not very high, let us hope that they fully launch the vaccine. The vaccine has not been launched yet, they have only introduced the vaccine," she said.

Cervical cancer develops in a person's cervix. The cervix is the passage that connects the vagina (birth canal) to the upper part of the uterus.

Worldwide, Cervical cancer is the fourth most frequent cancer in women -- with more than six lakh cases in 2020. In India, it remains the second most common cancer in women after breast cancer. Cervical cancer cases and deaths are on the rise in India — a 14% increase in cases and deaths between 2015 and 2020, as per a Lok Sabha response given in December 2021.

In 2020, India reported 75,209 cases and 33,095 deaths. Uttar Pradesh recorded 10,046 cases, making it the state with the highest estimated incidence of cervical cancer. This is followed by Tamil Nadu (7,958). Likewise, Uttar Pradesh (4,420) and Tamil Nadu (3,502) reported the highest deaths related to cervical cancer in 2020.

What is HPV and How Does it Spread?

Human Papillomavirus or HPV is the most common sexually-transmitted viral infection and can affect the genitals, mouth and throat. There are at least eight sexually transmitted infections. Of these, 4 are currently curable: syphilis, gonorrhoea, chlamydia and trichomoniasis. The other 4 cannot be cured. HPV is one of them. The others are hepatitis B, herpes simplex virus (HSV), and Human Immunodeficiency Virus (HIV). There are over 100 different kinds of HPV strains and not all of them cause cancer. Most of these diseases are caused by HPV types 6, 11, 16 or 18.

Most persons with HPV do not develop symptoms but may infect others through sexual contact. In 9 out of 10 cases, HPV goes away on its own within two years without health problems, as per Centers for Disease Control and Prevention. But when HPV does not go away, it can cause genital warts and cancer.

"Type 16 and 18 are mainly the cancer causing variants. For women, it is cervical cancer, for men it could be anal cancer, penile or oral cancer. Earlier research focussed only on sexual transmission with regard to genitals, but recent studies have focussed on oral sex as well," Dr Ishwar Gilada, Consultant in HIV & Infectious Diseases and President of AIDS Society of India told FactChecker.

How effective is Cervavac?

Cervavac is the first Indian HPV vaccine which acts against four different strains 6,11,16 and 18. Hence it is called a quadrivalent vaccine.

SII had started phase 2 and 3 clinical trials in multiple centres across India to study the efficacy of the vaccine in young women in 2018. On July 12, 2022, the Drugs Controller General of India (DCGI) granted market authorisation to (SII) to manufacture the HPV vaccine.

"This vaccine includes L1 VLPs of serotypes 6,11,16,18, which is expected to give a coverage of approximately 90% against the papilloma virus prevalent in the developing world," Dr Kumar Gubbala, Senior Consultant – Gynaecological Oncology, Apollo Proton Cancer Centre, told FactChecker.

"With one dose the efficacy of the vaccine is around 35%, with two doses it will be around 90% if they are above 15 years and almost 100% if they're below 15," said Dr Gilada.

According to Dr Sampada Dessai, Consultant - Gynecologic Cancer surgeon, PD Hinduja Hospital & MRC, Mahim, "HPV vaccines cause the body to develop antibodies against this cancer causing virus. So once infected with the virus, the already-present antibodies in the body will help in viral clearance." Prevention of HPV infection can definitely reduce the burden of cervical cancer, she added.

Who Should and Should Not Get the HPV Vaccine?

The validity of the vaccine is from 9 to 45 years.

But the vaccine is most effective during pre-adolescent years, said Dr Gilada. "The reason for this is because once people start being sexually active during their late teenage years or in their twenties, the chances of infections to develop are high especially if they are sexually active. If the vaccine is administered after the infections develop, it may be less effective, he explained. According to the Rajiv Gandhi Cancer Institute and Research Centre, The most favourable time to take the vaccine is "Before the Sexual Debut".

However, all doctors stressed that the vaccine can be administered up to 45 years of age and that people must not hesitate to get vaccinated.

"If a woman is married and sexually active and believes her husband is monogamous there is no need to take the vaccine but monogamy is not guaranteed all the time. Further, there could also be cases where couples are in an open relationship. Hence, it's better to take the vaccine," advised Dr Gilada.

While administering the vaccine, Dr Gilada pointed out that sex-workers and those belonging to LGBTQIA+ community should also be prioritised.

Further, the vaccine can also be administered to men, said Dr Gilada. "Most women who get these cancers, get it from their husbands. Men also carry the infection and give it to women. But initially this can be offered free of charge or at a subsidised cost to women," he recommended.

All doctors that FactChecker spoke to advised to consult a gynaecologist or any general practitioner before administering the vaccine, especially if:

First, they have ever had a life-threatening allergic reaction to any ingredient of an HPV vaccine, or to a previous dose of HPV vaccine.

Second, if they have an allergy to yeast (Gardasil and Gardasil 9).

Third, if they are pregnant. "Gardasil 9 vaccine of MERCK has not been tried in pregnant women. Hence it should not be used. But Gardasil 4 of Merck and Cervarix of GSK can be used in pregnant women," confirmed Dr Gilada.

How is the Vaccine Administered?

According to Apollo Cancer Centre's Dr Gubbala, the HPV vaccination is administered as:

1. A two-dose series (0, 6-12 months) for most persons who initiate vaccination at ages 9 through 14 years.

2. A three-dose series (0, 1-2, 6 months) for persons who initiate vaccination at ages 15 through 45 years, and for immunocompromised persons.

   No Treatment
   

There is no treatment for the virus itself. However, there are treatments for the health problems that HPV can cause, as per the CDC.

Genital warts can go away with treatment prescribed by a healthcare provider. If left untreated, genital warts may go away, stay the same, or grow in size or number.

"Cervical pre-cancer treatment is available. Women who get routine Pap tests and follow up as needed can find problems before cancer develops. Prevention is always better than treatment," the CDC says.

The HPV vaccine is made to be available at an affordable price range by the manufacturers. Majority of the cervical cancer related deaths occur in low and middle income countries where routine gynaecological screening is minimal or absent, said Dr Gubballa. "This vaccine will be a beacon in winning over cervical cancer," he added.

"Unfortunately, adult vaccinations are not popular in India. It is the duty of the government and health experts to see that people do not get these diseases which can be prevented with vaccines. If expense is the concern, the government should prioritise those who need the vaccine the most," Dr Gilada concluded.