AstraZeneca used inaccurate data in trials – US officials

The credibility of data in a world of Big Data Analytics is now becoming a hot topic, even as Covid-19 vaccine manufacturers work tirelessly on several data points to give hope to populations across the globe.

It is now emerging that the AstraZeneca vaccine being suppllied across Africa used outdated data to convince the world that it was very effective in controlling Covid-19 symptoms.

This is after allegations by US health officials that the company may have used “old data” to determine the vaccine’s effectiveness.

Soon after AstraZeneca reported that its Covid-19 vaccine provided strong protection among adults, the National Institute of Allergy and Infectious Diseases (Niaid) said it was worried the trial results have not given the accurate picture of the vaccine, since it doubted the credibility of its data.

US medical data experts raised concern that the vaccine’s 79 percent effectiveness may have been based on “an incomplete view of the efficacy data” from a clinical trial and relied on “outdated information,” throwing another curveball in the saga surrounding the company’s vaccine.

Niaid said it was informed about the data questions by the Data and Safety Monitoring Board (DSMB) auditing the trial.  DSMBs consist of independent medical experts who provide an extra screen of data produced from clinical trials.

According to Jose Almeida, a data consultant in the Middle East and Africa, data preparation is often the biggest of the challenges when companies try to use data to manufacture products, especially those that have to go through scientific testing.

“It is common to hear that 80% of a data scientist’s time is spent on cleansing and classifying data, even being accepted as part of the job, when in fact the quality of the data is a responsibility of everybody in the organization,” he told Afcacia.

Adding to him, the cleansing is often performed autonomously, relying on individual judgment on what are the quality rules and on how to make data compliant with them.

“Finding the right data, scattered across multiple sources, with different and unclear business concepts, various rules and different levels of quality is usually dependent on manual entry of data and time-consuming data searching, leading to errors, repetitions, and redundancy.”

Jose Almeida, data consultant, MEA

Anthony Fauci, the head of Niaid, said the DSMB raised concerns because it felt the results in the AstraZeneca press release looked more favourable than more recent data from the vaccine study had shown.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” Niaid said.

The vaccine has faced some challenges that have eroded confidence in its shots following news of possible rare, serious side effects.

Last week, at least a dozen European countries paused the administration of the vaccine following reports of rare strokes known as cerebral venous sinus thromboses (CVST) and clotting disorders in people who had received it.

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