Reading the AstraZeneca-Oxford Trial. What’s at stake?

Given the scientific, economic, political, commercial and moral compulsions around vaccines for the pandemic, the adverse event in a clinical trial of a leading vaccine candidate has been a humbling moment for citizens, governments, companies and hopefully, politicians.

The goal of this expert interview is to help us read the recent pause in a leading clinical trial (AZD1222) following a suspected adverse event and the subsequent news of the resumption of the trial in the UK. A lot has been published already on this trial, already in phase III, but a few aspects worth underscoring.

First, that Pascal Soriot, CEO of AstraZeneca reportedly told investors that the trial was also halted previously in July “after a participant experienced neurological symptoms”. Experts have raised questions on the lack of transparency not only among trial participants, but also within the scientific community.

Also note, the recent “historic pledge” by industry leaders to uphold the integrity of the scientific process as they work on potential global regulatory filings and approvals for the first vaccines for the pandemic. This New York Times story, cites researchers’ concerns that this pledge did not offer “a promise to share more critical details about their research with the public and the scientific community.”

Second, when this edition went to print, the U.S. FDA was still investigating the safety of the vaccine candidate and had halted the trials in the U.S. It is important to note that UK’s Medicines and Healthcare products Regulatory Agency (MHRA), had already confirmed that it was safe to resume the trials in the UK. (It has been subsequently reported that BrazilSouth Africa and India had regulatory approvals to resume trials.)

For geeks tracking regulatory intelligence, this is significant. Regulatory divergences offer clues on how different countries view risks for their populations. It also helps us understand the stakes better.

Q&A with Dr Rebecca Chandler, Senior Pharmacovigilance Expert, Uppsala Monitoring Centre

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