Did AstraZeneca release faulty test data?

I woke up this morning to a series of disturbing headlines in my inbox. They all dealt with questions that have been raised about the trial testing data submitted by AstraZeneca showing that it was 79% effective with few serious side effects. That would be pretty good news if it turned out that we had a fourth viable option on the way, but now medical authorities are raising questions about the results. NBC News said, “U.S. health officials raise ‘concern’ about data from AstraZeneca’s Covid vaccine trial.” But you’ll note that they put the word concern in scare quotes. Why? Well, that’s the problem. Aside from asking if some of the data was “outdated,” it’s hard to nail down what their problem with the test results actually was. But the Wall Street Journal ran with essentially the same story.

U.S. officials said they were told AstraZeneca may have released outdated information in its disclosure of trial results for its Covid-19 vaccine that could have “provided an incomplete view of the efficacy data.”

The statement from the National Institute of Allergy and Infectious Diseases came a day after AstraZeneca released interim data from large-scale U.S. trials that it said found its Covid-19 vaccine to be 79% effective in preventing symptomatic disease.

The results served as a vote of confidence in the shot, which has been clouded by uncertainty over previous, confusing efficacy results and large-scale production problems. More recently, reported cases of rare blood clotting in Europe raised concerns about the vaccine’s safety, though European regulators have recommended its continued use.

In each story, the issue being raised is that the National Institute of Allergy and Infectious Diseases had been working with AstraZeneca and monitoring the test data they were compiling. They seem to be claiming that the pharmaceutical company released “interim” data as part of the process of applying for emergency approval from the FDA. If they released “interim” data, that at least implies that there was more data that had been developed more recently that they didn’t release.

How big of a problem is that? I’m sure everyone wants the latest and most up-to-date information from the study, but they’ll be getting the rest of it at some point, right? I mean, if their interim data looked very promising but the latest data showed significant issues or danger, do we honestly believe that they would sit on the latest data and release the better-looking numbers from earlier in the study? I just can’t see that happening. If they obtained authorization under false pretenses with even a suspicion that the vaccine could be dangerous and people started getting sick or dropping dead, the lawsuits would bury the company for all eternity and their reputation in the industry would be toast.

It seems far more likely that AstraZeneca is still finishing up the trials and they just haven’t compiled all of the figures from the last sets of test subjects. Everyone is still in a massive rush to get the vaccines out on the market at warp speed, so releasing the preliminary data first was probably seen as a way to get the ball rolling while they finished wrapping up the final figures. You can understand how some health officials might pause when they’re given an incomplete data set, but I’m guessing that’s all we’re really seeing here.

Either way, this was yet another headline that AstraZeneca didn’t need. In Europe, where their vaccine was already being distributed, there were already suspicions being raised about the product even before all of those blood clot stories started flooding the headlines. After that, European confidence in the vaccine completely tanked, even though it’s looking more and more like the blood clots weren’t actually related to the vaccine.

Keep in mind that AstraZeneca was gifted with a huge amount of federal funding to enable them to get this product to market. If that turns out to be a bum investment of taxpayer funds and this vaccine doesn’t perform as expected, we’re going to be rethinking the relationship between the federal government and the pharmaceutical industry. And that relationship was already under plenty of scrutiny even before the pandemic began.