Serum Institute likely to launch cervical cancer vaccine in India in Nov

Country now depends on foreign companies and Serum's product is likely to bring down prices.

An India-made cervical cancer vaccine would be available by November when Serum Institute of India (SII) launches its Quadrivalent Human Papillomavirus (qHPV) inoculation.

According to sources, the company is stocking the vaccine as it awaits a clearance from the country's drug regulator. India now has HPV vaccines made by foreign manufacturers: Gardasil, manufactured by Merck, and Cervarix by Glaxo Smithkline. SII’s entry into this space is expected to bring down the prices. HPV vaccines are now available in the range of Rs 2,000-3,000 per dose.

SII will soon seek a marketing authorisation for the vaccine from the regulator. However, since the manufacturing process for qHPV takes around four to five months, the vaccine maker has started to make preparations to make the product from now. “The aim is to launch the qHPV vaccine around November. This of course depends on the drug regulator’s approval,” said a source.

SII’s qHPV vaccine uses virus like particles (VLP) technology against several serotypes of the papilloma virus, and thus the company expects it would give coverage against approximately 90 per cent human papilloma viruses.

After the pneumonia vaccine that SII launched in December 2020, the HPV vaccine will be its first major non-Covid19 vaccine after the pandemic.

SII has already halted production of its Covishield vaccine since December. It has a capacity of 250 million monthly doses of Covishield. It has recently got approval for use in children aged 12-17 years for its Covid-19 vaccine Covovax.

Apart from HPV, SII is also close to launching a malaria vaccine here.

SII is expecting that its malaria vaccine candidate will go into production by the end of this year. "It is now in phase 3 clinical trials in Africa, and licensure of this vaccine is expected by 2023. Therefore, production is expected to start by the end of this year at SII,” a source said.

The University of Oxford has partnered with SII to make the R21/Matrix-M. SII will supply over 200 million doses every year of this vaccine after licensure. SII’s peers Bharat Biotech (through a partnership with GSK) and Zydus Lifesciences, too, are bringing malaria vaccines to the market.

According to the World Health Organisation (WHO), in 2020 there were an estimated 241 million malaria cases worldwide, and 627,000 deaths that year. The African region carries a disproportionately high share of global malaria burden, home to 95 per cent malaria cases and 96 per cent of malaria deaths (in 2020). Thus global demand for this vaccine is expected to be high.