Russia’s Sechenov University says it has completed clinical trials of world’s first COVID-19 vaccine

Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology said that the first group of volunteers who participated in the study will be discharged on Wednesday.

Moscow:

As the world races towards finding an effective and safe vaccine against the novel coronavirus, the clinical trials of the world's first COVID-19 vaccine on volunteers at  Sechenov First Moscow State Medical University has been completed, said  Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology, reported news agency ANI. He also said that the first group of volunteers who participated in the study will be discharged on Wednesday, and the second on July 20th.

The university was conducting trials on the vaccine candidate produced by Gamalei Institute of Epidemiology and Microbiology, Russia. They began trials on June 18. 

"Sechenov University has successfully completed tests on volunteers of the world's first vaccine against coronavirus," Tarasov said.

The objective of this stage of the trials was to test the vaccine's safety for human health, which was successfully done, said  Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical and Vector-Borne Diseases at Sechenov University.

"The safety of the vaccine is confirmed. It corresponds to the safety of those vaccines that are currently on the market," Lukashev told Sputnik, reported ANI.

Further plans on vaccine development are being determined by the developers, including the complexity of the epidemiological situation with the virus and the possibility of scaling up production. 

"Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research centre that is able to participate in the creation of such important and complex products as drugs ... We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway," Tarasov added. 

More than a hundred vaccines against the novel coronavirus are currently under development or trials, globally. The coronavirus has infected more than 12 million people around the world, till now.

WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients:

The World Health Organization (WHO) welcomes the initial clinical trial results from the United Kingdom (UK) that show dexamethasone, a corticosteroid, can be lifesaving for patients who are critically ill with COVID-19. For patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth, according to preliminary findings shared with WHO.

The benefit was only seen in patients seriously ill with COVID-19, and was not observed in patients with milder disease. 

“This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This is great news and I congratulate the Government of the UK, the University of Oxford, and the many hospitals and patients in the UK who have contributed to this lifesaving scientific breakthrough.”

Dexamethasone is a steroid that has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders and certain cancers. It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordably available in most countries.

The researchers shared initial insights about the results of the trial with WHO, and we are looking forward to the full data analysis in the coming days. WHO will coordinate a meta-analysis to increase our overall understanding of this intervention. WHO clinical guidance will be updated to reflect how and when the drug should be used in COVID-19.

Today’s news builds off the WHO Research & Development Blueprint meeting, which took place in Geneva in mid-February to accelerate health technologies for COVID-19, where further research into the use of steroids was highlighted as a priority. The findings reinforce the importance of large randomized control trials that produce actionable evidence. WHO will continue to work together with all partners to further develop lifesaving therapeutics and vaccines to tackle COVID-19 including under the umbrella of the Access to COVID-19 Tools Accelerator.