COVID-19: AstraZeneca, Johnson & Johnson resume clinical trials of vaccine after pause

After having security and safety of trials reviewed by US Food and Drug ministration, AstraZeneca’s and Johnson & Johnson resumed its major clinical trials for experimental COVID-19 vaccines in US on October 23. In an official release, pharmaceutical companies anunced that independent Data Safety and Monitoring Board (DSMB) has approved resumption of clinical trial recruitments. 

While FDA authorized AstraZeneca’s COVID-19 AZD1222 vaccine’s Phase III trials, on or hand, it allowed Johnson & Johnson to restart its pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine. two pharmaceutical firms AstraZeneca PLC and Johnson & Johnson h to pause ir trials after serious verse reaction (SAE) was detected in volunteers.

Meanwhile, USFDA paused trials to review safety data and probe medical occurrence in study subjects. Investigators found that participant’s illness didn’t find a link to shots. However, Janssen COVID-19 vaccine was being investigated by Institutional Review Boards as clinical trial program was given approval to resume. “After a thorough evaluation of a serious medical event experienced by one study participant, clear cause has been identified,” Johnson & Johnson declared in release. 

AstraZeneca Chief Executive Officer, Pascal Soriot said, “ restart of clinical trials across world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.”

He ded, “we should be reassured by care taken by independent regulators to protect public and ensure vaccine is safe before it is approved for use.”

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To publish its late-st trial result

AstraZeneca, meanwhile, anunced that FDA regulators h approved resumption for Oxford coronavirus vaccine in US, UK, Brazil, South Africa, and Japan confirming that it was safe. Last month, on September 6, AstraZeneca h voluntarily paused vaccination across all global trials for monitoring committees to examine vaccine’s safety data.  AstraZeneca plans to publish its late-st trial results later this year 2020 after reopts are submitted to regulators. trial results would be published in peer-reviewed scientific journals. Meanwhile, pharmaceutical firm Pfizer Inc anunced that it could file for authorization of COVID-19 vaccine in US after its safety data arrives in third week of vember for coronavirus vaccine it’s developing with German partner BioNTech. 

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