The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”
The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.
The company is a subsidiary of US group GenPact, which already offers an AI and machine learning based tool called Cora PharmacoVigilance that can be used to identify patterns in data to foresee potential side effects.
The contract from the Medicines and Healthcare products Regulatory Agency (MHRA) recognises that the timelines for the development of coronavirus vaccines has been accelerated so fast that a complete picture of their safety may not be available when they start to be used in widespread immunisation campaigns.
Former UK Prime Minister Tony Blair said this morning that the AstraZeneca/Oxford University adenovirus-based vaccine AZD1222 should be rolled as soon as possible – ideally in the month of November – as “it is essentially safe.”
He also called for experimental drugs being tested in the UK RECOVERY trial to be used in any hospitalised patients at risk of serious illness from COVID-19, in a foreword to a report on the pandemic published by the Tony Blair Institute for Global Change.
The MHRA told the Financial Times that based on historical vaccination data, it is expecting between 50,000 and 100,000 ADR reports for every 100 million doses delivered to patients over a six to 12 month period
The regulator also stressed that an ADR does not necessarily mean a true side effect has been observed, and AI would help spot any emerging safety signals.
The coronavirus vaccination programme would be larger than any adult campaign carried out to date, and the MHRA is concerned it could be derailed by “anti-vaccine social media activity and lobbying.”
The GenPact UK contract bypasses the usual “call for competition” tender process required by EU regulations, according to the MHRA, because if “reasons of extreme urgency”, and because it would not be feasible to “retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine.”
The agency also says in the contract announcement that its proposed SafetyConnect programme, for pharmacovigilance and medical device safety monitoring would not be ready by the expected coronavirus vaccine launch.