If an adverse event occurs when the Covid-19 vaccine is administered to people in the UK, it will be captured using software tools developed by coders in Bengaluru and Noida. The UK has recently approved the mRNA vaccine developed by Pfizer and BioNTech for rollout, and it has also put in place a speedy mechanism to track reactions to the vaccine.

Last week, the Medicines and Healthcare Products Regulatory Authority (MHRA) in the UK rolled out an artificial intelligence solution to capture how those who received the vaccine were faring. Called pharmacovigilance AI (PVAI) solution, the software was developed at development centres of the NYSE-listed Genpact at Bengaluru and Noida.

MHRA signed a deal with Genpact for sourcing the PVAI tool for £1.5 million (₹15 crore), thereby becoming one of the world’s first drug regulators to use an AI tool to record and process adverse drug reactions.

“This is an Indian born and bred solution… The key members of the team are there in India. The products are built and architectured in India,” said Eric Sandor, Pharmacovigilence Artificial Intelligence (PVAI) Business Lead, Genpact. He also said the rollout was “tremendously fast”, given that the contract with MHRA was signed only in mid-September. The firm is already in discussions with regulators in other countries, including that in India, Sandor added.

Product safety

Pharmacovigilance, which is all about monitoring the safety of medical products, is an over $2-billion market globally and has been growing at a double digit rate.

A big pharma company invariably receives reports about a million potential adverse events a year. Most of them could be insignificant. But one in a million could turn out to be a real problem. “You are actually trying to discover the needle in the haystack. The faster you find the needle in the haystack, the quicker the pharmaceutical company can take action and that could save lives,” said Tiger Tyagarajan, CEO, Genpact.

As Sandor told BusinessLine : “The idea is that we don’t really fully know the safety profile of a pharma product till it is mass marketed because the trials are constrained to a small number of people. And each person is like an individual laboratory responding differently to the substances given to them.”

The future of the pharmacovigilance discipline is hugely exciting in terms of discovering why certain people have adverse reactions while others don’t. But the process and technology to collect all these outcomes or information resulting from the administration of the vaccine is very important.

As Tyagarajan sums up: “The science of drugs and pharmaceuticals is no longer biological sciences alone. It is biological sciences plus mathematics. Take the mRNA vaccine as an example. It is as much as a biological breakthrough as it is an AI and mathematical breakthrough.”