COVID-19 vaccine: UAE approves Phase 3 clinical trial of Russia's Sputnik V

The UAE has approved human trials of Russia’s COVID-19 vaccine, Sputnik V, in the Arab nation, becoming the second foreign country after Belarus to take part in the programme. The UAE Ministry of Health and Prevention gave the approval for Phase III clinical trials of Sputnik V, the vaccine candidate which first received a license by Russian authorities in August for domestic use.

“The UAE is committed to the global fight against COVID-19 and we are pleased to play our part in enabling promising solutions and progress,” UAE Minister for Health HE Abdul Rahman bin Mohammed Al Owais said in a statement.

Russian Direct Investment Fund (RDIF) stated that the trials of Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology in collaboration with the Russian Health Ministry, will be supervised by the Abu Dhabi Department of Health and the UAE Ministry of Health and Prevention. The medical protocols will be handled by Abu Dhabi’s public health provider, the Abu Dhabi Health Services Company. 

“As part of the Phase III trials of the Sputnik V vaccine, we are planning to expand in several other countries over the coming months, and we are delighted that the UAE will be the first country in which we do so in the Middle East,” RDIF CEO Kirill Dmitriev said in a statement.

Read: Thailand Agrees To Manufacture, Supply AstraZeneca's Experimental COVID-19 Vaccine

Read: Johnson & Johnson Halts COVID-19 Vaccine Trial Due To 'unexplained Illness' In Participant

Preliminary trial results

Preliminary results from two early-phase non-randomised trials of Sputnik V showed no major side effects over 42 days and induce antibody responses within 21 days, said the study published in The Lancet. The leading peer-reviewed medical journal said that the doctors conducted trials for the two-part vaccine which contains a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector.

The primary outcome measures for the trials were safety and immunogenicity of the potential COVID-19 vaccine and the secondary outcome measures were antigen-specific cellular immunity, also known as T-cell responses, and change in neutralising antibodies. The researchers performed two open, non-randomised phase 1/2 studies at two hospitals in Russia and enrolled healthy adult volunteers aged 18–60 years to both studies. 

“The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response,” the study’s authors wrote.

Read: Donald Trump's Son Says ‘My Father Took COVID-19 Vaccine’, Gets Grilled Online

Read: COVID-19: AstraZeneca Begins Late-stage Trials Of Vaccine With 6,000 Participants