Research & Development
AstraZeneca's COVID-19 vaccine trial in US continues on hold until at least midweek until regulatory clearance
15 September 2020 -

Reuters news agency reported on Tuesday that according to sources, the enrolment of new patients and other trial procedures for the pivotal US trial of AstraZeneca's COVID-19 vaccine were being rescheduled until at least midweek and that it was not clear how long it would take for the US FDA to complete its probe into a serious side effect in Britain, even as other trials of the vaccine resume.

The British adverse event involved a study patient thought to be suffering a rare spinal inflammatory disorder called transverse myelitis. AstraZeneca had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

This was the first indication that the US trial will remain on hold until the US Food and Drug Administration and a safety panel investigate the case.

Enrolment in the company's global trials of the vaccine, which it is developing with researchers at Oxford University, was paused on 6 September 2020.

According to Reuters, governments around the world are desperate for a vaccine to help end the pandemic, a prolonged delay in the US trial could slow access to the vaccine in the US.

Reuters added that an AstraZeneca spokeswoman declined to comment on when the US trial would resume stating in an email the company "will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume."

Also, the status of the South African and Indian trials remains unknown, but the trial in Brazil has restarted. AstraZeneca has not commented on timing of resumption in other parts of the world besides Britain.

Login
Username:

Password: