Beginning March 2024, pharma major Sanofi India will discontinue the manufacture of polio vaccine ShanIPV (inactivated). The announcement was made in a public notice on September 2. Observers said this could create havoc as Sanofi is one of the largest suppliers of ShanIPV. Meanwhile, the company has made necessary regulatory submission for the approval of a product with similar composition.
In response to an email query by the Free Press Journal, a Sanofi India spokesperson said, “We are currently in discussions with the Government of India on this subject. As long-term partners for over 20 years, we remain committed to supporting all efforts towards the polio eradication programme.” However, the firm refrained from mentioning the exact reason for a step that could actually hamper the programme.
ShanIPV was launched in 2015 and as per a press statement issued at the time, it was approved for use in the Indian market. It was manufactured at the pharma’s Hyderabad manufacturing site. ShanIPV TM is a trivalent inactivated, injectable vaccine. Under the Central Government’s Universal Immunisation Programme, IPV is to be injected in two stages – at six weeks and 14 weeks.
Though India is not endemic to polio and received its polio free certification from WHO in 2014, endemic wild poliovirus type 1 (as of 2022) remains in Pakistan and Afghanistan, both of which are neighbours of India. To mitigate the risk associated with trivalent oral polio vaccine (tOPV) to bivalent oral vaccine switch, IPV was introduced as part of the global end-game strategy.
In November 2015, IPV was introduced in six states and later expanded to all states by April 2016. With Sanofi now discontinuing its manufacture, the government must look at alternatives immediately.