Mumbai: The Drug Controller General of India (DCGI) has approved the first Indian HPV vaccine to prevent cervical cancer. The vaccine Cervavac will be manufactured by the Serum Institute of India (SII) and is the nation’s first quadrivalent human papillomavirus vaccine (qHPV) vaccine.
Cervical cancer is a common sexually transmitted infection. Long-lasting infection with certain types of HPV is the main cause of cervical cancer. It is the second most common cancer among Indian women constituting almost 1/5th of their cancer burden. Over 95 per cent of cervical cancer cases are caused by a virus known as Human papillomavirus (HPV). As per the US data, there has been a significant decrease in HPV-related pre-cancers and cancers in vaccinated women since 2006, when the HPV vaccine was first introduced there – the percentage of cervical pre-cancers caused by HPV types most often linked to cervical cancer decreased by 40 per cent. Pertinent to note that HPV not only causes cervical cancer but is also responsible for many other cancers including vaginal and vulval cancers, penile cancer, anal cancer, and head-neck cancers. Accordingly, not only girls but boys should also be vaccinated against HPV. Unfortunately, HPV vaccination is still not a part of the national immunisation programme in India.
Scientists from the International Agency for Research on Cancer (IARC) were part of a unique collaboration between the Department of Biotechnology of the Government of India, the United States National Institutes of Health, and the Bill & Melinda Gates Foundation (BMGF) to support the evaluation of a quadrivalent human papillomavirus (HPV) vaccine manufactured by SII in females and males aged 9–26 years.
This unique model of public-private partnership resulted in the successful and timely completion of phase II and phase III vaccine efficacy trials, despite the threat posed by the COVID-19 pandemic. On June 15, 2022, after reviewing the study outcomes, the Subject Expert Committee (SEC) on vaccines to advise the DCGI recommended granting marketing authorisation for the new vaccine for females and males aged 9–26 years.
The approval by the Drugs Controller General will permit the Government of India (GoI) to procure enough HPV vaccines produced by SII 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.
Adar Poonawalla, CEO, Serum Institute of India tweeted on the approval, “For the first time there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible. We look forward to launching it later this year and we thank the #DCGI @MoHFW_INDIA for granting approval today.”
Commending the approval Soumya Swaminathan, Chief Scientist, World Health Organisation (WHO) tweeted, “Good news. #Cervicalcancer can be eliminated if all prepubertal girls are given #HPV vaccination globally.”
“In #India #cervicalcancer is the second-most common cancer, esp among #women between 15 & 44 yrs of age. Making this vaccine affordable & accessible is a huge step toward Universal #healthcare,” tweeted Dr Sangita Reddy, Joint Managing Director, Apollo Hospitals Group.
How will HPV vaccine prevent cervical cancer?
The new HPV vaccine will be able to control cervical cancer in the majority of the cases and more than 80 per cent of the cases and the vaccine. The HPV vaccine prevents cervical cancer by providing immunity to HPV infection. The vaccine is not used in the treatment of cervical cancer when it has already occurred, oncologists inform.
HPV vaccines have been in use for many years and are very effective (more than 90 per cent) in preventing the occurrence of carcinoma cervix. For the first time, India has its own vaccine for cervical cancer prevention.
“The new HPV vaccine will be able to control cervical cancer in the majority of the cases and more than 80 per cent of the cases and the vaccine has to be taken before the first sexual encounter ideally in the younger age group vaccine is given to both boys and girls because HPV infection can also lead to head and neck cancer,” shared Dr PK Jhulka, Sr Director, Medical Oncology and BMT, Max Institute of Cancer Care, Lajpat Nagar, New Delhi.
He further added, “These vaccines are not meant for treating cancer, for treatment of cancer vaccines are being developed but at present, we have the vaccines to prevent cancer they can be given at an early age to prevent cervical cancer.”
The news that we will have a new Indian-made qHPV vaccine is such wonderful news. The DCGI and the NTAGI (National Technical Advisory Group on Immunisation) have reviewed and recognised that the Indian manufactured quadravalent HPV vaccine (CERVAVAC) provides a robust antibody response to all the targeted HPV subtypes across all age groups,” mentioned Dr Mangesh P Kamath, Senior Consultant, Medical Oncology, Hemato-Oncology prevention oncology and Bone Marrow Transplant, Fortis Hospital, Bannerghatta Road, Bangalore.
Side effects of HPV vaccines
There are hardly any side effects with these vaccines, three doses have to be given for the prevention of cancer and there are no side effects. Some people might have body ache, pain, generalised weakness and nausea otherwise no major side effects.
Commenting on the side effects of the vaccines, Dr Kamath said, “Most of the side effects due to the HPV vaccine are local injection site reactions such as redness, pain and swelling. Rarely, mild headaches, giddiness, nausea, fever may occur which are self-limiting and can be usually relieved with OTC drugs.”
Sharing his views on the side effects, Dr Pankaj Kumar Garg, Professor and Head, Department of Surgical Oncology, Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital, Dehradun commented, “Like any other medicine or vaccine, HPV vaccinations may also have some side effects; however, the majority of the side effects are minor and include pain and redness at the injection site, nausea, headache or dizziness, or rarely fainting. We must realise that the benefits of HPV vaccination hugely outweigh the side effects.”
“Usually post-vaccine, dizziness, weakness, nausea, and vomiting are temporary effects. Hence patients are kept for observation post the vaccination for some time,” added Dr Upasna Saxena, Consultant Radiation Oncology- HCG Cancer Centre, Mumbai.
Best time to get vaccinated with the HPV vaccine
It is recommended that the HPV vaccine is best given beginning from the age of 9 years, ideally before boys and girls have their first sexual contact. Once someone is infected with HPV, vaccination might not be as effective since the response is a lot better at younger ages.
“Even if vaccination has been missed at younger ages, ‘catch-up’ vaccination is still better than nothing, up to the age of 26 years. Beyond the age of 27, It is best to discuss with your doctor whether vaccinating is useful or not. Even if you are already sexually active, you could still derive benefit from vaccination as the quadravalent vaccine protects you from the strains other than that has infected you,” further added Dr Kamath.
Affordability of Cervavac vaccine
Preventive vaccines cost about Rs 3500 for one vaccine and three such doses have to be given so it is roughly about Rs 12,000. Making it affordable for the prevention of cervical cancer.
Centre for Disease Control and Prevention (CDC), US recommends two doses of HPV vaccination given six months apart to all persons between the age of 9-26 years. One must remember that early vaccination protects better, so HPV vaccination is recommended earlier than later.
“There are more than 100 different types of HPV, and around 40 affect the genital area in men and women. Out of these, 13-15 are high-risk types responsible for over 90 per cent of HPV-related cancers. Presently, three HPV vaccines are available on the market – Gardasil 9, Gardasil-4, and Cervarix,” commented Dr Garg.
Dr Garg added, “Cervarix prevents infection with types 16 and 18 while Gardasil-4 prevents infection with types 6, 11, 16, and 18. The price of one shot of Cervarix is Rs 2000-3000 thousand while one shot of Gardasil-4 costs Rs 3000-4000 thousand. Gardasil-9, which is the most recent, prevents infection against nine HPV types. It costs Rs 10,000-11,000 thousand for one shot. With the introduction of the HPV vaccine by the Serum Institute of India in near future, the cost of HPV vaccination should come down significantly.”
“The vaccine is much cheaper than the treatment once cervix cancer has developed. This vaccine is a classic example of prevention is better than cure,” stated Dr Saxena.
SII plans to launch the vaccine at the end of 2022. Cervavac is affordable as compared to other HPV vaccines available in the market. The vaccine could help in the fight against cervical cancer as India has one of the highest incidences of cervical cancer. The GoI could also add this to the National Immunisation Programme to make it a nationwide drive to vaccinate boys and girls and reduce the occurrences of preventable cancers.
Cervavac could also boost the fight against cancer prevention not only in India but also globally. The affordability of the vaccine could help eliminate cervical cancer.