Vaccine side effects are the next big challenge

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Regulatory authorities are gearing up for a deluge in people reporting side effects when the new Covid-19 vaccines go into use. Even if the vaccines prove safe — a reasonable assumption based on current information — managing the reporting and follow-up of what are known as adverse drug reactions will be critical to keeping to the high levels of public participation needed for a vaccination program to be successful.

The U.S. Centers for Disease Control and Prevention plans to send daily texts to those who are vaccinated for the first week and then weekly texts for six weeks, while the Food and Drug Administration will also be monitoring side effects in real time.

It’s not clear if the U.K.’s monitoring system will have similar capabilities by the time the vaccine is rolled out. The country’s Medicines & Healthcare Products Regulatory Agency issued an urgent tender notice (recorded last month in a European Union public procurement journal) for an artificial-intelligence software tool to help deal with the expected high volume of reported effects. (The roughly $2 million contract went to outsourcing firm Genpact.)

The agency didn’t mince words in explaining the reasons for the urgency: Its legacy system would be overwhelmed by the volume of reports and could not be retrofitted to cope with the new vaccine. The absence of a new tool would “hinder its ability to rapidly identify any potential safety issues within the Covid-19 vaccine.” That in turn would represent a “direct threat to patient life and public health.”

Even if the language may have been partly crafted to exempt it from normal EU tender requirements, it underscores what’s at stake for governments around the world as these brand new vaccines are rolled out with unprecedented speed to a far wider public than ever before. As with any new drug, the range of these adverse drug reactions — unintended, harmful events linked to the medication — will only be known when a very large number of people have been vaccinated.❐

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