Public health officials around the world are waiting for at least a vaccine that will help them battle COVID-19.  But given the speed with which tentative vaccines are being developed, officials are looking for ways of monitoring and responding to potential adverse reactions once any vaccine is being given to the general public.

In the UK, for example, the Medicines and Healthcare Regulatory Authority (MHRA) has paid a software company to develop an AI tool to “process the expected high volume of Covid-19 vaccine adverse drug reaction (ADRs) and ensure that no details . . . are missed”.

As the UK’s Financial Times puts it, “the need for a powerful tool to sort through what are forecast to be a huge numbers of adverse reactions, speaks to the scale of the vaccination program in the months ahead.”

In addition to the scale, many of the vaccinations being developed are new, which means that even after clinical trials there will be plenty of questions about the reactions of potentially millions of people.

“You’re talking about vaccines that have potential liabilities, it’s an unknown unknown,” said Gary Nabel, chief scientific officer at pharmaceutical company Sanofi, which is currently working on two Covid-19 vaccine candidates. “As big as a 30,000-person trial is, when these go out into the world of millions of people, things will happen.”

Indeed, Nabel cited one famous vaccine developer, Maurice Hilleman, telling him, “every time I launch a new vaccine, I hold my breath for the first 30m doses”.

According to the MHRA, based on previous vaccination campaigns, they expect between 50,000 and 100,000 reports of suspected side effects for every 100m doses over a 6-12 month period.

“The AI tool will be employed as part of the MHRA’s yellow card scheme for coronavirus, through which patients and healthcare professionals report suspected side effects and negative reactions. These are then evaluated to identify where updated advice or regulatory interventions are needed to protect the public.”

Noting that the scale of its Covid-19 vaccination campaign wiill be much larger than any past adult program, the MHRA said the absence of an AI tool would “hinder its ability to rapidly identify any potential safety issues . . . and represents a direct threat to patient life and public health”.

According to FT, Mr Nabel and other experts consider the move by the MHRA a positive sign of proactivity by the UK’s regulator.