AstraZeneca COVID-19 vaccine trial remains on hold in the United States. Also, there is a U.S. investigation pending into a serious side effect in Britain even as other trials of the vaccine resumes.
AstraZeneca on September 12 stated that they had restarted their trial in Britain. This was done after regulators completed their review of a serious side effect in one of their trial participants. This was the first indication that the U.S. trial will remain on hold. This will be until the U.S. Food and Drug Administration and a safety panel investigate the case.
The company’s global trials of the vaccine were put on hold on September 6. They were developing the vaccine with researchers at Oxford University.
Enrollment of new patients and other trial procedures for the pivotal U.S. trial was rescheduled until at least midweek. However, it is not clear how long it will take for the FDA to complete its probe.
Governments around the world are desperate for a vaccine to help end the pandemic. The COVID-19 pandemic has caused more than 900,000 deaths. It has also responsible for global economic turmoil. Earlier, the World Health Organization (WHO) had flagged AstraZeneca’s vaccine as the most promising. The delay in the U.S. trial could slow access to the vaccine in the United States.
The British adverse event involves a study patient who is suffering a rare spinal inflammatory disorder.
The AstraZeneca spokeswoman, however, was not available to comment on when the U.S. trial will resume. In an email, she stated that the company will continue to work with health authorities across the world. The FDA will guide as to when other clinical trials can resume.
The status of the South African and Indian trials still remains unknown.
Also Read: AstraZeneca Vaccine Trails Paused After Unknown Illness
