Published 12:51 IST, October 24th 2020
COVID-19: AstraZeneca, Johnson & Johnson resume clinical trials of vaccine after pause
FDA authorized AstraZeneca’s COVID-19 AZD1222 vaccine’s Phase III trials, on the other hand, it allowed Johnson & Johnson to restart pivotal Phase 3 ENSEMBLE.
- World News
- 2 min read
After having security and safety of the trials reviewed by the US Food and Drug Administration, AstraZeneca’s and Johnson & Johnson resumed its major clinical trials for experimental COVID-19 vaccines in the US on October 23. In an official release, the pharmaceutical companies announced that the independent Data Safety and Monitoring Board (DSMB) has approved the resumption of the clinical trial recruitments.
While FDA authorized AstraZeneca’s COVID-19 AZD1222 vaccine’s Phase III trials, on the other hand, it allowed Johnson & Johnson to restart its pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine. The two pharmaceutical firms AstraZeneca PLC and Johnson & Johnson had to pause their trials after the serious adverse reaction (SAE) was detected in volunteers.
Meanwhile, the USFDA paused the trials to review safety data and probe the medical occurrence in study subjects. Investigators found that the participant’s illness didn’t find a link to the shots. However, the Janssen COVID-19 vaccine was being investigated by the Institutional Review Boards as the clinical trial program was given the approval to resume. “After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” Johnson & Johnson declared in the release.
AstraZeneca Chief Executive Officer, Pascal Soriot said, “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.”
He added, “we should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
To publish its late-stage trial result
AstraZeneca, meanwhile, announced that the FDA regulators had approved resumption for the Oxford coronavirus vaccine in the US, UK, Brazil, South Africa, and Japan confirming that it was safe. Last month, on September 6, AstraZeneca had voluntarily paused vaccination across all global trials for the monitoring committees to examine the vaccine’s safety data. AstraZeneca plans to publish its late-stage trial results later this year 2020 after readopts are submitted to the regulators. The trial results would be published in peer-reviewed scientific journals. Meanwhile, pharmaceutical firm Pfizer Inc announced that it could file for authorization of the COVID-19 vaccine in the US after its safety data arrives in the third week of November for coronavirus vaccine it’s developing with German partner BioNTech.
Updated 12:49 IST, October 24th 2020