AstraZeneca Data Snafu’s Fallout may be bigger than it looks

The data flap on AstraZeneca’s vaccine is unlikely to cost the company much, at least in the short term. Wall Street should pay close attention anyway.

U.S. officials said they were told that AstraZeneca may have released outdated information about the study results for the Covid-19 vaccine – a surprising revelation that immediately cast doubt on the company’s claim a day before the results showed that the shot was very was effective. AstraZeneca said in response it would share a new analysis of the data within 48 hours.

This situation is highly unusual, but investors may find reasons not to worry: it will not affect the company’s finances in the short term. The AstraZeneca Covid-19 vaccine has been widely used in places such as the UK, and Dr. Anthony Fauci said on Tuesday that the vaccine is likely still safe and effective. Sales of the vaccine are not included in the company’s full-year financial outlook.

Those reasons make sense, but are ultimately shortsighted. Data that can be trusted is the backbone of the pharmaceutical industry; Physicians, regulators, and the general public need to be confident that clinical results are valid to sell, approve, or take medications. Data integrity concerns are rare, even for small biotech companies. In modern times, problems on this front around a giant like AstraZeneca are unimaginable, and especially worrying during a global pandemic.

Integrity doubts are hard to dispel once they have been sown. And a good working relationship with US drug regulators is essential, even for foreign companies, as it is by far the most lucrative drug market in the world. A slower drug approval process – almost a given for AstraZeneca in the future – makes it more difficult to compete with rivals developing other drugs.

Source