New York City and India-based Genpact secured a £1.5 million (US $1.9m) strategic contact with the UK Medicines and Healthcare Regulatory Authority (MHRA) to develop an artificial intelligence (AI) -based software tool to sift through the “high volume” of reports of adverse reactions expected as a result of COVID-19 vaccines forthcoming; a major inoculation initiative is just around the corner. Why this deal? Because MHRA expects a high volume of COVID-19-related vaccine adverse drug reactions known as ADRs, and the agency wants to be certain they do not miss key data points. Moreover, their existing legacy systems aren’t up to the task. As reported recently by the Financial Times’ (FT) Anna Gross in London, the UK regulator sought a tool that can help the agency truly get on top of the myriad data connections in association with the mass allocation of novel vaccines. Apparently, the Americans at least publicly don’t have any comparable plans on the books according to FT.
What are the Expected Numbers?
Ms. Gross reports that the MHRA informed FT that they are expecting between 50,000 and 100,000 reports of suspected side effects for every 100 million doses over a period of 6 to 12 months. They do suspect that most vaccines reactions will be on the mild side of the spectrum as they have been rigorously tested.
Part of ‘Yellow Card’ Scheme
The UK’s Yellow Card initiative represents the UK system for collecting and monitoring information on suspended safety concerns or incidents involving medicines and medical devices. The scheme is actually run by MHRA and dependent on voluntary reporting of suspected ADRs by health professionals and patients.
MHRA Legacy Systems
Well they just aren’t good enough to handle the anticipated volume of data collection, management and aggregation not to mention reporting and use of AI for ongoing intelligence. FT referred to a quote form the MHRA contract: “It is not possible to retrofit the MHRA legacy systems to handle the volume of ADRs that will be generated by a COVID-19 vaccine.” Moreover, the absence of an AI tool would “hinder its ability to rapidly identify any potential safety issues.”
“Holding the Breath”
A famous vaccine developer named Maurice Hilleman once told Gary Nabel, chief scientific officer of Sanofi that “every time I launch a new vaccine, I hold my breath for the first 30 million doses.” Nabel was interviewed by Ms. Gross in the FT article declaring that these novel vaccines, even when approved by the relevant health authorities…[H]ave potential liabilities, it’s an unknown unknown.” His company, Sanofi, is working on two of the COVID-19 vaccine products.
Just What the Dr. Ordered
Kate Bingham chairs the UK’s vaccine task force and suggests that this kind of effort is exactly what MHRA needs to be doing to get this pandemic ultimately under control. Truly understanding the safety data associated with the imminent vaccines will be key.
According to the FT piece, the U.S. has no such comparable activity occurring.
New York, NY-based Genpact is a IT and business process consultancy producing about $3.2 billion per year. With 90,000 employees, the firm’s business operations expand over 30 countries.
Call to Action: Interested in learning more: contact Kate Bingham a key contact.