Abstract

In a promising advance in its fight against cervical cancer, India has recently launched its first locally produced version of the human papillomavirus (HPV) vaccine. The quadrivalent Cervavac vaccine, which protects against the virus strains most likely to cause cancer of the cervix, vagina, and vulva, among others, was developed jointly by the Serum Institute of India and the Indian Government's Department of Biotechnology. Following positive data from a large phase 2/3 clinical trial, marketing authorisation was granted by the Drugs Controller General of India on July 12, 2022, for female and male individuals aged 9–26 years, with the vaccine officially launched on Sept 1. Cervavac costs 200–400 rupees (€5) per dose, making it much more affordable than existing licensed HPV vaccines. Heralded as a huge step forward, could this be the silver bullet for cervical cancer control, both in India and other low-income and middle-income countries?Cervavac should be welcomed in India, where the incidence of cervical cancer is high, accounting for a fifth of the global burden, with more than 124 000 cases and 75 000 deaths annually. According to WHO, 4·1 million women in India have died from the disease since 2019, and without intervention, as many as 5·7 million will die by 2070. Previous efforts to control or eradicate the disease in India have been woefully inadequate. Although HPV vaccines have been available in the country since 2008, attempts to establish a national vaccination programme have stalled, mainly due to unfounded worries about side-effects, as well as affordability concerns. The new vaccine will be funded by the Indian Government and distributed via state-run services, with enough doses initially produced to vaccinate nearly 50 million girls aged 9–14 years, and plans to extend availability to private providers and eventual export to other nations in need.Since up to 99% of cervical cancer cases are caused by high-risk HPV infection, HPV vaccination programmes have been credited with substantially reducing the disease burden in many countries. However, progress has been slow elsewhere, including in several of India's neighbouring countries in south Asia. A myriad of factors, including poor awareness of cervical cancer, low screening uptake, insufficient availability of and access to vaccines, and screening and vaccine reluctance, all contribute to the high burden of disease in the region, as we highlighted in a 2019 Editorial. Encouragingly, some south Asian countries have launched national HPV vaccination programmes for girls, including Bhutan (in 2010), Thailand (2017), Sri Lanka (2017), and the Maldives (2019), with pilot projects completed in others such as Bangladesh. However, HPV vaccines are not included in the national vaccination schedule in Pakistan, which recorded 741 000 cervical cancer deaths in 2019 (vs around 850 per year in the UK), and this is unlikely to be prioritised for some time in view of the recent devastating floods in the country. Meanwhile, the government of Nepal has cancelled the roll-out of a national HPV vaccination programme due to insufficient funds, even though cervical cancer is the country's second most common cancer. Moreover, although 42 countries worldwide include boys in their HPV vaccination programmes, in many resource-poor countries vaccination efforts target only adolescent girls. Given that up to 25% of men carry at least one high-risk HPV subtype, experts argue that vaccination of boys is key to cervical cancer elimination, including in India, and call for gender-neutral vaccination programmes.As the largest of the Commonwealth nations, India is a key member of this group who have pledged to eliminate cervical cancer by 2030. Although the 54 Commonwealth countries comprise 30% of the global population, they account for 40% of global cervical cancer incidence and 43% of cervical cancer mortality. In 2021, the International Taskforce on Cervical Cancer Elimination in the Commonwealth was launched by the Commonwealth Secretariat and the Union for International Cancer Control to step up efforts towards preventing and treating cervical cancer, to align with WHO's Global Strategy to accelerate the elimination of cervical cancer as a public health problem. The launch of a new, affordable HPV vaccine will hopefully help India, and other nations, to make strides towards this goal. However, vaccine availability must be matched with vaccine accessibility via organised, and ideally school-based, vaccination schemes, and vaccination alone is not sufficient. Screening is the other core pillar of cervical cancer control, and well-organised and accessible national screening programmes are also essential. Given that fewer than one in ten women in India have been screened for cervical cancer in the past 5 years, much remains to be done.For more on gender-neutral HPV vaccination see https://timesofindia.indiatimes.com/blogs/voices/what-india-needs-for-cervical-cancer-elimination-gender-neutral-hpv-vaccination/ In a promising advance in its fight against cervical cancer, India has recently launched its first locally produced version of the human papillomavirus (HPV) vaccine. The quadrivalent Cervavac vaccine, which protects against the virus strains most likely to cause cancer of the cervix, vagina, and vulva, among others, was developed jointly by the Serum Institute of India and the Indian Government's Department of Biotechnology. Following positive data from a large phase 2/3 clinical trial, marketing authorisation was granted by the Drugs Controller General of India on July 12, 2022, for female and male individuals aged 9–26 years, with the vaccine officially launched on Sept 1. Cervavac costs 200–400 rupees (€5) per dose, making it much more affordable than existing licensed HPV vaccines. Heralded as a huge step forward, could this be the silver bullet for cervical cancer control, both in India and other low-income and middle-income countries? Cervavac should be welcomed in India, where the incidence of cervical cancer is high, accounting for a fifth of the global burden, with more than 124 000 cases and 75 000 deaths annually. According to WHO, 4·1 million women in India have died from the disease since 2019, and without intervention, as many as 5·7 million will die by 2070. Previous efforts to control or eradicate the disease in India have been woefully inadequate. Although HPV vaccines have been available in the country since 2008, attempts to establish a national vaccination programme have stalled, mainly due to unfounded worries about side-effects, as well as affordability concerns. The new vaccine will be funded by the Indian Government and distributed via state-run services, with enough doses initially produced to vaccinate nearly 50 million girls aged 9–14 years, and plans to extend availability to private providers and eventual export to other nations in need. Since up to 99% of cervical cancer cases are caused by high-risk HPV infection, HPV vaccination programmes have been credited with substantially reducing the disease burden in many countries. However, progress has been slow elsewhere, including in several of India's neighbouring countries in south Asia. A myriad of factors, including poor awareness of cervical cancer, low screening uptake, insufficient availability of and access to vaccines, and screening and vaccine reluctance, all contribute to the high burden of disease in the region, as we highlighted in a 2019 Editorial. Encouragingly, some south Asian countries have launched national HPV vaccination programmes for girls, including Bhutan (in 2010), Thailand (2017), Sri Lanka (2017), and the Maldives (2019), with pilot projects completed in others such as Bangladesh. However, HPV vaccines are not included in the national vaccination schedule in Pakistan, which recorded 741 000 cervical cancer deaths in 2019 (vs around 850 per year in the UK), and this is unlikely to be prioritised for some time in view of the recent devastating floods in the country. Meanwhile, the government of Nepal has cancelled the roll-out of a national HPV vaccination programme due to insufficient funds, even though cervical cancer is the country's second most common cancer. Moreover, although 42 countries worldwide include boys in their HPV vaccination programmes, in many resource-poor countries vaccination efforts target only adolescent girls. Given that up to 25% of men carry at least one high-risk HPV subtype, experts argue that vaccination of boys is key to cervical cancer elimination, including in India, and call for gender-neutral vaccination programmes. As the largest of the Commonwealth nations, India is a key member of this group who have pledged to eliminate cervical cancer by 2030. Although the 54 Commonwealth countries comprise 30% of the global population, they account for 40% of global cervical cancer incidence and 43% of cervical cancer mortality. In 2021, the International Taskforce on Cervical Cancer Elimination in the Commonwealth was launched by the Commonwealth Secretariat and the Union for International Cancer Control to step up efforts towards preventing and treating cervical cancer, to align with WHO's Global Strategy to accelerate the elimination of cervical cancer as a public health problem. The launch of a new, affordable HPV vaccine will hopefully help India, and other nations, to make strides towards this goal. However, vaccine availability must be matched with vaccine accessibility via organised, and ideally school-based, vaccination schemes, and vaccination alone is not sufficient. Screening is the other core pillar of cervical cancer control, and well-organised and accessible national screening programmes are also essential. Given that fewer than one in ten women in India have been screened for cervical cancer in the past 5 years, much remains to be done. For more on gender-neutral HPV vaccination see https://timesofindia.indiatimes.com/blogs/voices/what-india-needs-for-cervical-cancer-elimination-gender-neutral-hpv-vaccination/ For more on gender-neutral HPV vaccination see https://timesofindia.indiatimes.com/blogs/voices/what-india-needs-for-cervical-cancer-elimination-gender-neutral-hpv-vaccination/ For more on gender-neutral HPV vaccination see https://timesofindia.indiatimes.com/blogs/voices/what-india-needs-for-cervical-cancer-elimination-gender-neutral-hpv-vaccination/

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