AstraZeneca’s data missteps shows that drug regulation actually works

After more than a dozen countries in the EU suspended the use of AstraZeneca’s Covid-19 vaccine over precautionary safety concerns, it finally looked like things were improving for the pharmaceutical company. A secondary review by the European Medicines Agency on March 18 found AstraZeneca’s shots to be safe and effective. And the US Food and Drug Administration (FDA) was set to consider original data from another late-stage clinical trial conducted in the US, Chile, and Peru. If these results were promising, they could potentially deliver a huge win for the Swedish vaccine maker.

Unfortunately for AstraZeneca, that’s not what happened.

AstraZeneca submitted interim data to the FDA about its vaccine on Monday (March 22) showing that the inoculation was 79% effective. But just after midnight on Tuesday (March 23) morning local time, an independent data safety monitoring board organized by the US National Institutes of Health flagged a major problem with the data: It appeared that the company had submitted only the data that supported its vaccine, and not the trials most complete data. In a brief statement issued later in the day, AstraZeneca said it would work with the data safety monitoring board to release newer data based on a later statistical analysis later in the week.

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