AstraZeneca is still waiting for the United States drug regulators to approve of its restart of clinical trials of its potential COVID-19 vaccine in the United States, after being paused for almost three weeks due to safety concerns.
The U.S. trial of AstraZeneca’s COVID-19 vaccine candidate, which was initially developed by the University of Oxford, is still on hold as regulators continue to investigate an illness in one of the participants of the trials, despite other programmes outside of the U.S. resuming, including British trials.
Chief Executive Officer of Astra Zeneca, Pascal Soriot told a virtual World Economic Forum discussion that they “are the sponsor of the U.S. study. We then provided all this information to the FDA (U.S. Food and Drug Administration) and we are waiting to hear their decision”.
U.S. Health and Human Services Society Secretary Alex Azar stated on Wednesday that the continued suspension of the trials indicated how seriously the FDA was taking vaccine safety.
Last week, a document posted online by Oxford University showed that the illness that the British participant contracted may not have been associated with the vaccine, with the document also stating that the pause in trials was triggered on September 6.
Soriot stated that clinical trial regulators and independent supervisors were safeguarding the participants’ privacy by not disclosing the nature of the illness.
However, the company will be looking to increase transparency without compromising the rights of the individual, and also preventing the public and volunteers from drawing wrong conclusions about the safety of their vaccine, which could endanger trial enrolment.
Soriot also said that AstraZeneca is “discussing with other companies as an industry what information we can offer without compromising patient privacy but also without compromising the trial itself”.
Soriot added that the tests of the vaccine candidate on children has not started yet, with this being the next stage of trials after the current ones are completed.