India would be in a position to roll out the indigenously developed Human Papillomavirus Vaccine (HPV) against cervical cancer for girls in the age group of 9–14 under the National Immunisation Programme by mid-2023, NTAGI chairperson Dr N K Arora said.
The CERVAVAC vaccine is likely to be launched by the Serum Institute of India (SII) in April next year and will be available at a much lower price than the international vaccines available in the market, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the SII said on the sidelines of the South Asia meeting on HPV here.
The vaccine has received the DCGI's approval and been cleared by the government advisory panel National Technical Advisory Group on Immunisation (NTAGI) for use in the public health programme, Dr Arora told PTI. At present, the country is fully dependent on foreign manufacturers for the vaccine. Three foreign companies manufacture the HPV vaccine out of which two firms sell their vaccines in India. Each dose of the jab available in the market costs over Rs 4,000.
Serum Institute's vaccine is likely to be available at a much lower rate. In September 2022, SII CEO Adar C Poonawalla had said that HPV vaccine will be available in India at an affordable price of Rs 200-400 per dose. India is home to about 16 per cent of the world's women and accounts for about a quarter of all cervical cancer incidences and nearly a third of global cervical cancer deaths.
Indian women face a 1.6 per cent lifetime cumulative risk of developing cervical cancer and 1.0 per cent cumulative death risk from cervical cancer, Dr Arora said. According to some recent estimates, every year almost 80,000 women develop cervical cancer and 35,000 die due to this cancer in India.
On what has prevented India from introducing the HPV vaccine till now, Dr Arora said vaccine supply has been a limiting factor globally. Fortunately, over last five years, the global supply of the HPV vaccine is gradually improving. India has taken a lead in this direction. SII - one of the major Indian vaccine manufacturers - with the support from Department of Biotechnology, Government of India has developed the four valent HPV vaccine.
The vaccine has received regulatory approval and been cleared by NTAGI for use in the public health programme. "We are given to understand that three other Indian vaccine manufacturers are also in various stages of developing the HPV vaccine," he said.
To a question, Dr Arora said vaccines to prevent HPV infection have been available since 2006. The HPV vaccination can prevent more than 90 per cent of HPV cancers when given at the recommended age. Studies done in India have indicated that efficacy of a single dose of the HPV vaccine is more than 95 per cent. Based on the studies, the WHO has now recommended that even a single dose of the vaccine for 9–14-year-olds is effective.
As of 2021, the global HPV immunisation coverage stood at a meagre 13 per cent. Till 2020, less than a third of low and lower-middle income countries had introduced the HPV vaccine in their national immunisation programmes. This when 85 per cent of high income had already incorporated this in their public health programmes, Dr Arora said.
For comprehensive cervical cancer prevention and control strategy, screening of women after the age of 35 years and need for infrastructure to diagnose and treat cervical lesions are essential. A cervical screening programme has already been included in the national chronic disease (NPCDCS) programme as part of the Ayushman Bharat Scheme.
By 2021, over 900 hospitals had been empanelled for cervical cancer care. In addition, India has established over 150,000 health and wellness centres as part of the outreach, which will be taking the screening facilities closer to community. "The NFHS -5 data shows that only about two per cent of women have ever undergone screening in India. This is unacceptable. The screening of women is to be taken up in a manner which is culturally acceptable and scientifically appropriate," Dr Arora said.
Vaccines alone will take more than a decade to show their impact but early recognition of pre-cancerous and cancerous lesions through mass screening followed up with treatment will save thousands of untimely and avoidable women deaths, he said. Women with cervical cancers lose their lives in 40s and 50s when their families require them the most. Screening of women in their most vulnerable period has to be taken up in a mission mode not only to achieve global targets to prevent families from suffering extreme grief and multi-faceted tragedies.