The Medicines and Healthcare Regulatory Authority (MHRA) has paid Genpact UK a tender of £1.5m to develop an AI tool to sift through the high volume of reports of adverse reactions to COVID-19 vaccines.

The government contract states that the AI tool will “process the expected high volume of Covid-19 vaccine adverse drug reaction (ADRs) and ensure that no details . . . are missed.”

WHY IT MATTERS

As the UK prepares for a widespread inoculation programme of monumental scale in the months ahead, the need for an effective and powerful tool to process a large number of reports is critical in managing the high volume of reports.

The types of vaccine being developed, such as the MRNA and chimpanzee adenovirus are relatively new, making it hard to predict how they will interact with millions of people's immune systems.

The contract from MHRA also concedes that the timelines of the coronavirus vaccine has been accelerated so fast that an accurate analysis of their safety may not be available when they start to be trialled in national immunisation campaigns.

THE LARGER CONTEXT

As the global race for a COVID-19 vaccine gains steam, Abu Dhabi's G42 Healthcare announced a volunteer healthcare management programme with US wearable technology firm WHOOP to monitor the health and fitness of those taking part in the company’s COVID-19 vaccine trials. 

The UK government is currently in talks with Palantir Technologies to strengthen its test-and-trace programme, according to the Financial Times [paywall].

ON THE RECORD

An MHRA spokesperson told Healthcare IT News: “Based on the available published reports from the Phase I/II trials, we do not currently anticipate any specific safety concerns with COVID-19 vaccines, and we expect the general safety profile to be similar to other types of vaccine.

“Our past experience with other new immunisation campaigns is that we tend to receive around 1 Yellow Card report per 1,000 doses administered and we are preparing our surveillance systems on that basis.

“The purpose of the AI tool we are introducing as part of our Yellow Card system is to help us rapidly evaluate such reports after approval, and not as part of the approval process.

“A COVID-19 vaccine will only be deployed once it has been proven to be safe and effective through robust clinical trials and approved for use by the appropriate licensing authority. 

“It is also important to note that a report of a suspected ADR is not proof of a side effect occurring due to the vaccine but a suspicion by the reporter that the vaccine may have caused the side effect.”

Visit Yellow Card website for more information on Yellow Card reporting in general, including what actions the MHRA can take.