Therese Raphael, Columnist

Pfizer Vaccine's Safety Milestone Is Just the Beginning

Tracking adverse reactions will be crucial to keeping public trust in Covid vaccination drives and provide an important defense against anti-vaxxers.

Transforming the body’s own cells into vaccine making factories.

Photographer: Joel Saget/Getty Images
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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 as vaccines like the one from Pfizer Inc. and BioNTech SE reach safety milestones and look set for regulatory approval, 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.)