India’s cervical cancer vaccine found to be safe and effective as Merck’s Gardasil vaccine: Why are the findings of the new Lancet study important? | Health and Wellness News
3 min readTo meet global cervical cancer elimination efforts, a wider range of affordable and accessible vaccines against human papillomavirus (HPV) are needed. A new study in The Lancet Oncology reveals that the newly developed quadrivalent HPV vaccine by the Serum Institute of India, based in Pune, elicits a comparable immune response to Merck’s Gardasil vaccine. The authors of the study suggest that the availability of Serum’s HPV vaccine could play a pivotal role in addressing the worldwide demand for HPV vaccines, enhancing coverage for both girls and boys on a global scale.
What is the new study:
‘Cervavac’, the first indigenous HPV vaccine for prevention of cervical cancer and other HPV-associated cancers developed and manufactured by Pune-based Serum Institute of India (SII) was studied in 9 to 15-year-old girls and boys. The study states that the Cervavac vaccine was found to be safe and as immunogenic as Gardasil, a quadrivalent HPV vaccine marketed by Merck. Immunogenicity is an important metric that measures the ability of a vaccine to trigger an immune response.
The marketing authorization for the first indigenous HPV vaccine had received regulatory approval by the DCGI following a Phase II/III study conducted across 10-12 sites in India. The findings of this Phase II/III HPV vaccine study that compared the safety and immunogenicity of Cervavac with that of Gardasil (a quadrivalent HPV vaccine marketed by Merck) are published in the Lancet Oncology.
Why is it important?
Cervical cancer is the second most common cancer among women in India, accounting for about a fifth of the global burden of cervical cancer. Every year, approximately 1.23 lakh new cases and around 77,000 deaths due to this cancer are reported in India. HPV is a major cause of cervical cancer, with 14 HPV types identified as oncogenic. Among these, HPV types 16 and 18 are responsible for approximately 70% of all cervical cancer cases globally and are considered to be the most oncogenic types.
The Serum Institute of India developed a quadrivalent HPV vaccine (Cervavac) against HPV types 6, 11, 16, and 18, primarily targeting females and males aged 9–26 years. The inclusion of boys is one of the major strengths of this study, as they are at risk of many HPV-associated cancers, including anal cancer, penile cancer, and HPV-related head and neck cancer, as well as genital warts. Furthermore, HPV vaccination in boys could facilitate the rapid reduction in the prevalence of diseases caused by HPV. When contacted, Dr. Smita Joshi, Principal Investigator for Serum Institute of India’s HPV vaccine study at Ruby Hall Clinic, said that HPV vaccination of adolescent girls and cervical cancer screening of adult women using an HPV test are the two tools that we have to prevent cervical cancer. It kills one woman every 8 minutes in the country.
Has the HPV vaccine been included in the national immunization programme?
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The currently available HPV vaccines are quite expensive and not affordable for the national program. However, Serum’s HPV vaccine Cervavac will soon be included in the national program in India. ‘Cervavac’ is set to be rolled out across 7 states in India in early 2024, according to officials. Millions of doses of HPV vaccine are needed worldwide, and there is a huge demand.
What is the cost of HPV serum vaccine vis-à-vis others in the private market?
SII is going to provide the vaccine for the government program at subsidized rates (Rs 200-400/-). For private practitioners, the cost is about 1400-1600/- per dose. Gardasil costs Rs 3500/-.