Safety Highest Priority in Any Clinical Trial – COVID – 19: WHO Update (10 September 2020)

United Nations published this video item, entitled “Safety Highest Priority in Any Clinical Trial – COVID – 19: WHO Update (10 September 2020)” – below is their description.

(Excerpts) WHO’s chief, Dr Tedros Adhanom Ghebreyesus said the Access to COVID-19 Tools (ACT) Accelerator “will not be able to deliver on its goals without a significant increase in funding,” adding that it still faces “a funding gap of 35 billion US dollars.” Speaking to reporters in Geneva today (10 Sep), Dr Tedros said, “between now and the end of the year we have a limited window of opportunity to scale-up the ACT Accelerator and fully enable the equitable allocation framework.” He explained, “currently, the ACT Accelerator is supporting research into promising vaccines, therapeutics and diagnostics. But we need to rapidly scale up our clinical trials, manufacturing, licensing and regulation capacity so that these products can get to people and start saving lives.” Speaking about suspension of AstraZeneca COVID-19 vaccine trial, WHO Chief Scientist Dr Soumya Swaminathan told reporters, “there is a protocol for what you do when something happens. If it’s a mild side effect that there are things to be done. If it is major, as it was in this case, it was a severe side event and therefore the trial was halted.” She continued, “this is normal procedure and this is good clinical practice because safety is of the utmost… is the highest priority in any clinical trial. And so, the trial has been halted, the data safety monitoring board is going to look into the details of this individual with the reported side effect. There will be, obviously, discussions and then a decision made on how to proceed.” On the same topic, Dr Soumya Swaminathan also said “I think this is a good, perhaps a wake up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those.” She continued, “It’s not always a fast and a straight road but we don’t need to be overly discouraged because these things happen and we have to wait for the determination by the data safety monitoring board on this particular case and then what the next steps are going to be for this vaccine trial.” Also briefing the reporters was WHO’s Dr Mike Ryan. He said, “just to remind you that Dr Tedros declared a Public Health Emergency of International Concern (PHEIC) on January the 30th of 2020. And six months ago, as part of one of his press statements, characterized the multi-country epidemic as having reached pandemic levels. But WHO had issued its highest level of alert under international law on January the 30th.” Ryan also said, “I think from a WHO perspective, we can only commit to do what is humanly possible from where we sit to work with our Member States to work with everyone around the world to bring this pandemic to an end. The end will not come soon, we are all, all of us, every citizen of this planet is tired and we wish this virus were not with us but we must work to the end of this.” Watch full briefing:

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