AstraZeneca-Oxford Trial Halted After Reports Of Side Effects: What’s Next?

The entire study assessing the safety of AstraZeneca’s COVID-19 vaccine has been put on hold after a participant suddenly became ill.

The Bay Area was prepared to initiate the Stage 3 clinical trials of AstraZeneca’s coronavirus vaccine, which has been developed in associated with Oxford University.

After the reports of illness in a participant, the company must stop the ongoing study to investigate whether the illness is due to serious side effects of the shot or it is completely unrelated to it.

The San Francisco Department of Public Health, which has been preparing the Bay Area for Phase 3 clinical trials, is surprised as well as disappointed.

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” said AstraZeneca’s official statement released to media.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

The company further explained that illnesses may appear in large trials, however, it needs to be carefully examined. AstraZeneca also plans to expedite the review of the single case that has reported illness to ensure that the timeline of testing is not impacted.

It included the statement by saying that “We are committed to the safety of our participants and the highest standards of conduct in our trials."

According to some sources, the patient who reported illness is located in the U.K. There is a possibility that the illness is not related to the vaccine and therefore, the trials will continue as usual in that case.

According to Stanford epidemiologist Dr. Yvonne Maldonado, as a next step, the product sponsor is expected to the investigation into the illness, what went wrong, and also assess the details of the patient. The details related to the serious illness need to be verified and the timing and location need to be checked as well.

After thorough verification, a meeting with the data safety monitoring board as well as the governmental regulatory agencies is expected.