The government plans to monitor potential adverse reactions to a Covid-19 vaccine, but that doesn’t mean it won’t be safe

23 November 2020
What was claimed

A contract from the UK government says the MHRA is seeking an AI software tool to process the expected high volume of Covid-19 vaccine adverse drugs reactions to ensure no details from the adverse drugs reactions’ text are missed.

Our verdict

This is correct, but monitoring any adverse reactions is a standard part of monitoring an approved drug or vaccine. Reported adverse reactions are not necessarily the same as side effects, and may have no connection to the vaccine.

We’ve been asked by our readers to check claims on whether the government has awarded a contract to create an AI software tool to “process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs)”.

This is correct—the government’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded this contract to a company called Genpact UK.

But this does not mean that any vaccine is expected to be dangerous or have serious side effects. 

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Adverse drug reaction reports are not the same thing as side effects

It’s important to remember that reports of “adverse drug reactions”, sometimes referred to as “adverse events”, are not quite the same thing as side effects. As the University of Oxford’s Vaccine Knowledge Project says, “reporting an adverse event after vaccination does not prove a link with the vaccine.”

It goes on to say: “When a vaccine is given to a very large number of people in a population, it is likely just by chance that a few of them will develop some kind of medical problem around the time of vaccination, but this does not prove ‘cause and effect’.”

Because any Covid-19 vaccine is expected to be rolled out so widely, it’s likely there will be people who get ill at the same time as having the injection, which may or may not be side effects of the vaccine itself. It’s important that such incidents are recorded, even if they are mild, short term, or don’t happen as a result of the vaccine. 

Tracking adverse events is standard practice

This contract does not affect the fact that a Covid-19 vaccine will not be rolled out until it has been judged effective and safe in many rounds of testing and evaluation. The MHRA told us that a “COVID-19 vaccine will only be approved once it has met robust standards on safety, quality and effectiveness through clinical trials and approved for use by the MHRA.” 

This software will be part of an ongoing process to monitor any vaccine’s safety, and not part of approving it in the first place. It won’t be used to assess the data, but according to the MHRA will work by “reducing the amount of manual coding for each report, thereby saving resource in processing cases and ensuring they are rapidly available for scientific analysis.”

The MHRA told Full Fact that “With any major new vaccine campaign we always develop a proactive vigilance strategy, and COVID vaccines are no exception.”

“This is not because we think they will be unsafe. Based on the available published reports from the Phase One and Two clinical trials, we don’t currently anticipate any specific safety concerns with COVID-19 vaccines.”

The agency added that it expected to receive “around 1 Yellow Card report per 1,000 doses administered”. The yellow card scheme is the UK’s system for collecting and monitoring information on potential safety concerns involving medicines or medical products, so these can be evaluated. This is one way that the safety of a vaccine is continually monitored even after the trials are finished, and the vaccine is administered to the public.

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