New Delhi: With Covid on the wane and the demand for vaccines slowing down, the Serum Institute of India (SII) is working on launching India’s first domestically manufactured vaccine against cervical cancer by the end of the year.
The vaccine against Human Papilloma Virus (HPV), which is one of the commonest causes of cervical cancer, was approved for inclusion in the Universal Immunisation Programme in 2017 by a technical expert group but has not been adopted nationally.
Company sources told ThePrint that the SII, the world’s largest vaccine-maker, is looking at a November launch date for the vaccine.
Although a formal mail that ThePrint wrote to the company remains unanswered, sources said the vaccine will begin to be available in phases as the company tests the waters rather than entering with a large stockpile.
SII has already announced its decision to slow down Covishield production.
The company’s foray into the space is expected to significantly bring down prices of the vaccine. SII, however, is not ready to divulge pricing details just yet. HPV vaccines currently available in the market are Gardasil, manufactured by Merck, and Cervarix by Glaxo Smithkline.
Cervarix is a three-dose vaccine priced at approximately Rs 2,100 a dose. Gardasil sells for approximately Rs 3,100 a dose and is administered both as a two-dose and three-dose regimen depending on the age of the recipient.
“Cervical cancer is the leading cause of female cancer mortality worldwide. Majority of the cervical cancer related deaths occur in low- and middle-income countries where routine gynaecological screening is minimal or absent,” says the SII website about the vaccine.
“Serum Institute of India is developing a tetravalent HPV vaccine which includes L1 VLPs [virus-like particles] of serotypes 6,11,16,18, which is expected to give a coverage of approximately 90 per cent against papilloma virus prevalent in the developing world. The vaccine is currently under development and will be available in the near future,” it adds.
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Pricing concerns
According to the World Health Organization (WHO), more than 95 per cent of cervical cancer is caused by sexually transmitted HPV. It is the fourth most common type of cancer among women globally, with 90 per cent of these patients believed to be in low- and middle-income countries.
“In India, cervical cancer contributes to approximately 6-29 per cent of all cancers in women. The age-adjusted incidence rate of cervical cancer varies widely among registries; highest is 23.07/100,000 in Mizoram state and the lowest is 4.91/100,000 in Dibrugarh district,” reads a 2016 paper in the Indian Journal of Medical and Paediatric Oncology.
In 2017, National Technical Advisory Group on Immunisation (NTAGI) recommended the vaccine for both boys and girls, but said that girls should be the first targets, given the burden of the disease overwhelmingly affecting them.
However, the recommendation did not lead to the inclusion of the vaccine in the national programme. Officials associated with the issue at the point told ThePrint on condition of anonymity that one of the concerns then was about the pricing of the vaccine. However, some states/UTs like Punjab, Delhi and Sikkim have introduced the vaccine in their vaccination programmes.
“The vaccine is already approved by NTAGI, so the only thing holding up its inclusion in the national programme really is the pricing,” said an industry source. “That would be resolved once a domestic player is introduced into the market and there are hopes that with the acceptability of vaccines on a high post-Covid, we will soon see its inclusion. If that does not happen, then there are multiple international buyers.”
The Swadeshi Jagran Manch, an RSS affiliate, has been opposed to the vaccine and also wrote to the prime minister in 2018, opposing the inclusion of HPV in the national programme.
The letter said, “It is our concern that this programme will divert scarce resources from more worthwhile health initiatives diverting it to this vaccine of doubtful utility and that its adverse effects will erode confidence in the national immunisation programme and thereby expose children unnecessarily to the risk of more serious vaccine-preventable disease”.
(Edited by Uttara Ramaswamy)
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