New Delhi: The Union Health Ministry has held a meeting with domestic and international pharmaceutical companies for the introduction of human papillomavirus (HPV) vaccine against cervical cancer among children in the national immunisation programme next year, official sources said.
Representatives of the Pune-based Serum Institute of India and American multinational pharmaceutical company Merck were present in the meeting held on Thursday and deliberated on their manufacturing capacity as well as pricing of their vaccines, they said.
“The ministry is likely to float a global tender in early 2023 for 16.02 crore doses of HPV vaccine which will be supplied by 2026. Global vaccine manufacturer Merck is likely to participate in the tender apart from domestic manufacturer Serum Institute of India,” one of the official sources stated.
In July 2022, India’s drug regulator granted market authorisation to the Serum Institute’s indigenously developed HPV vaccine. However, the vaccine has not been launched yet.
Recently, on the sidelines of the South Asia Meeting on HPV Prevention and Control Landscape and the Way Forward, Serum Institute Director Prakash Kumar Singh confirmed that their HPV vaccine with brand name CERVAVAC will be launched in the first quarter of 2023 at an affordable price compared to international HPV vaccines available in India.
The government advisory panel NTAGI has also given its go-ahead for the inclusion of CERVAVAC in the public immunisation programme.
Currently, the country is fully dependent on foreign manufacturers for HPV vaccine.
Three foreign companies manufacture HPV vaccines, of which two firms sell their vaccines in India. A dose of the jab available in the market cost over Rs 4,000, sources said.
In September 2022, Serum Institute CEO Adar C Poonawalla had said that its HPV vaccine would be available in India at an affordable price of Rs 200-400 per dose.
India is likely to roll out the HPV vaccine against cervical cancer in nine to 14 year-olds in the national immunisation programme by mid-2023, Dr N K Arora, the chairperson of the National Technical Advisory Group on Immunisation (NTAGI), had said recently.
India, which is home to about 16 per cent of the world’s women, 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 per cent cumulative death risk from cervical cancer, Dr Arora had stated.
According to some recent estimates, every year almost 80,000 women develop cervical cancer and 35,000 die due to it in India.
On what prevented India from introducing the HPV vaccine till now, Dr Arora had stated that the vaccine supply has been a limiting factor globally. Fortunately, over the last five years, the global supply of HPV vaccines is gradually improving.
India has taken a lead in this direction. The Serum Institute – one of the major Indian vaccine manufacturers – with the support from the Department of Biotechnology has developed four valent HPV vaccines.
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 HPV vaccines,” he said.
Dr Arora said vaccines to prevent HPV infection have been available since 2006 and these can prevent more than 90 per cent of HPV cancers when given at the recommended ages.
“The WHO has recommended two doses of vaccine for the young and adolescent boys and girls between 9 and 14 years to be fully protected. Studies done in India have indicated that efficacy of a single dose of the HPV vaccine is more than 95 per cent. Based on studies, the WHO has now recommended that even a single dose of the vaccine for 9-14-year-olds is effective,” he had said.