India’s first HPV vaccine

Source: By Anuradha Mascarenhas: The Indian Express

The Serum Institute of India (SII)’s vaccine Cervavac recently received the Drugs Controller General of India’s (DGCI) approval for market authorisation. Cervavac is India’s first quadrivalent human papillomavirus vaccine (qHPV) vaccine, and intended to protect women against cervical cancer.

Experts see this as a real opportunity to eliminate cervical cancer, and have expressed the hope that it will be rolled out in national HPV vaccination strategies, and be available at a cost more affordable than existing vaccines.

The disease

Cervical cancer is preventable, but kills one woman every eight minutes in the country, said Dr Smita Joshi, senior scientist with Prayas health group, a public charitable trust working on sexuality, gender, and HIV/AIDS. It is preventable as long as it is detected early and managed effectively.

Cervical cancer is a common sexually transmitted infection. Long-lasting infection with certain types of HPV is the main cause of cervical cancer.

Worldwide, cervical cancer is the second most common cancer type and the second most common cause of cancer death in women of reproductive age (15–44). India accounts for about a fifth of the global burden, with 1.23 lakh cases and around 67,000 deaths per year according to the World Health Organization’s International Agency for Research on Cancer (IARC-WHO).

Screening and vaccination are two powerful tools that are available for preventive cervical cancer. Still there is little awareness among women for prevention of this cancer and less than 10% of Indian women get screened. All women aged 30-49 must get screened for cervical cancer even if they have no symptoms and get their adolescent daughters vaccinated with HPV vaccine,” Dr Joshi said.

Existing vaccines

Two vaccines licensed globally are available in India — a quadrivalent vaccine (Gardasil, from Merck) and a bivalent vaccine (Cervarix, from GlaxoSmithKline). Each dose costs Rs 2,800 per dose (Gradasil) or Rs 3,299 (Cervarix).

Although HPV vaccination was introduced in 2008, it has yet to be included in the national immunisation programme.

According to a report in the Indian Journal of Gynaecologic Oncology (December 2021), a vaccine delivery and demonstration project led by international non-profit organisation PATH was started in 2009 in Andhra Pradesh and Gujarat but had to be suspended in 2010 as a result of public concern allegedly arising from the deaths of seven girls who received the vaccine.

In 2016, a multidisciplinary expert group of the Indian Council of Medical Research (ICMR) reviewed available evidence globally regarding immunogenicity and efficacy, adverse effects and cost effectiveness of HPV vaccines, and recommended that adolescent girls should be vaccinated with two doses.

The new vaccine

The vaccine is based on VLP (virus-like particles), similar to the hepatitis B vaccine, and provides protection by generating antibodies against the HPV virus’s L1 protein.

Experts have expressed hope that the DGCI approval will allow the government to procure enough HPV vaccines at a special price to vaccinate nearly 50 million girls aged 9–14 years in India who are waiting to receive the vaccine. This will be a huge step to accelerate cervical cancer elimination in India and globally, a statement from IARC-WHO has said.

“It will be great to see this vaccine being rolled out in the national HPV vaccination strategies in India and globally. We have a real opportunity to eliminate cervical cancer which causes a lot of death and suffering worldwide among women,” WHO chief scientist Dr Soumya Swaminathan said.

SII received the DCGI’s authorisation in the second week of July. SII plans to launch the vaccine by the end of the year, although officials said it was too early to comment on the quantities. “In particular, this vaccine is very important for adolescent girls as teenagers and upwards to protect them against cervical cancer,” said Adar Poonawalla , CEO of SII Said.

Trial results

Scientists from IARC were part of collaboration between the Department of Biotechnology of the Government of India, US States National Institutes of Health, and the Bill & Melinda Gates Foundation to support the evaluation of the vaccine in females and males aged 9–26. This model of public–private partnership resulted in completion of phase II and phase III trials, despite the pandemic, IARC- WHO said.

Clinical trials commenced in early 2019, involving thousands of participants across 12 sites in the country. Phase III trials show a robust immune response in 100% of the vaccine recipients with excellent safety records, according to SII officials. Vaccination can be started at the relatively young age of nine.

Dr Sanjay Gupte, former President of Federation of Obstetric and Gynaecological Society of India said that vaccination is extremely effective when administered before the first sexual intercourse. Dr Gupte agreed that it was difficult to convince women to get screened for cervical cancer, and hence this development is of immense importance.