COVID-19 Russian vaccine Phase III trial in UAE: What we know so far

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The vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology, has been named Sputnik V, in reference to the successful Soviet Union space programme that launched the world’s first satellite
Image Credit: For illustrative purpose

Abu Dhabi: On Monday, Abu Dhabi announced it would soon be hosting Phase III trials for another COVID-19 vaccine. This is the second Phase III trial in the UAE for a COVID-19 vaccine. While the first was developed in China, the second has been developed in Russia.

With residents soon expected to be invited for the trials, here is what we know about this vaccine, and trials in the UAE thus far.

Who developed this vaccine?

This particular COVID-19 vaccine has been developed in Russia. It was created by the Gamaleya National Research Institute of Epidemiology and Microbiology of the Russian Ministry of Health. Gamaleya, a medical research institute is headquartered in Moscow, is named after Russian scientist, Nikolay Gamaleya, a pioneer in microbiology and vaccine research.

Does the vaccine have a name?

According to the official website, the Russian vaccine has been named Sputnik V, in reference to the successful Soviet Union space programme that launched the world’s first satellite. Sputnik 1 was the first artificial Earth satellite, and it was successfully launched into the Earth’s orbit in 1957.

What is the make up of the Sputnik V vaccine?

The vaccine uses adenoviral vectors – human adenoviruses that have had their genetic material removed. This tricks the recipient’s immune system into producing an immune response, hopefully against the COVID-19 genes carried by the inactivated adenovirus. The first dose of Sputnik V uses the rAd26 adenoviral vector, while the second dose uses the rAd5 adenoviral vector.

According to the developers, a gene with the code of a coronavirus S (spike) protein is inserted into an adenoviral vector during the vaccine creation process. The inserted component is safe for the human body, but still helps the immune system to react and produce the antibodies that protect us from infection.

According to the official website, three adenoviral vector vaccines have previously been approved for the Ebola, and used to vaccinate 60,000 people in Russia, China and other nations. China also reportedly has two adenoviral vector-based cancer drugs.

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On August 1, Russia completed the first two phases of testing, and the country approved Sputnik V as a COVID-19 vaccine on August 11.
Image Credit: For illustrative purpose

Other vaccine developers are also considering human adenoviral vectors for their COVID-19 vaccine candidates, including the University of Oxford and Johnson & Johnson.

The official vaccine website also states that “the use of human adenoviruses as vectors is safe because these viruses, which cause the common cold, are not novel and have been around for thousands of years”.

Has the vaccine been tested so far? Is it safe?

Pre-clinical trials on animals, including two types of primatres were initially conducted.

On August 1, Russia completed the first two phases of testing, and the country approved Sputnik V as a COVID-19 vaccine on August 11.

Alexander Gintsburg, director at Gamaleya, has told international media that staff at the research institute had already received the vaccine, in addition to Russian soldiers, other volunteers, and famously, the Russian president’s daughter.

Results from these first human tests of Sputnik V were published in renowned medical journal, The Lancet, in September. A total of 76 people were involved in the trials, and the vaccine had produced a strong immune response in all. In addition, only mild adverse effects were reported.

The Lancet also reported that large-scale clinical trials of the vaccine, involving over 40 000 people, were scheduled to begin in Russia in the last week of August.

“A number of countries, such as UAE, Saudi Arabia, the Philippines, and possibly India or Brazil, will join the clinical trials of Sputnik V”, the vaccine developer announced on its official website.

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Interim testing results for the Russian vaccine are expected to be released before the end of November
Image Credit: For illustrative purpose

Who will operate the trials in the UAE?

The Russian Direct Investment Fund, RDIF, Russia’s sovereign wealth fund, has partnered with Aurugulf Health Investment, a newly-formed investment outfit in the UAE, for the vaccine trials.

The trials will be conducted by the Department of Health – Abu Dhabi (DoH), the emirate’s health regulator, under the supervision of the UAE Ministry of Health and Prevention (MoHAP). All medical protocols will be handled by Abu Dhabi’s public health provider, the Abu Dhabi Health Services Company (Seha).

How many people will be required for these Phase III trials in the UAE?

Details on these particulars are expected to be announced by the DoH and MoHAP over the coming days. However, Phase III trials typically involve a few thousand people.

Interim testing results for the Russian vaccine are also are expected to be released before the end of November.

How many doses of the Russian vaccine will volunteers have to get?

Most viral vector vaccines require more than one dose to generate the desired effect. In the case of the Sputnik V vaccine, Gamaleya says that vaccines get two doses 21 days apart.

Why was the UAE chosen for vaccine trials?

Sheikh Abdulla bin Mohamed Al Hamed, DoH chairman, said “hosting a second Phase III COVID-19 vaccine trial in Abu Dhabi reaffirms our enduring commitment to collaborating on global solutions to the challenges this pandemic has presented”.

“Thanks to our world-class healthcare infrastructure, the strength of our research ecosystem, and the community’s spirit of volunteerism, Abu Dhabi is an attractive prospect for those seeking to advance scientific discovery.

Similarly, in the case of the first Phase III trials for a COVID-19 vaccine in the UAE, developers had cited the UAE’s diverse demographic base as one of the main reasons why it had been chosen for testing.

How does this trial compare to the first COVID-19 vaccine Phase III trials in the UAE?

The first Phase III trials in the UAE were for an inactivated vaccine developed by Chinese pharmaceutical giant, Sinopharm China National Biotec Group.

These trials were also supervised by the DoH and MoHAP, with medical protocols handled by Seha. They were led by the healthcare wing of Abu Dhabi-based firm, Group 42, which boasts a supercomputer that can be used to analyse trial results.

The trials were kicked off on July 16, and they initially targeted 15,000 volunteers. Within six weeks however, more than 31,000 volunteers had signed up, and registration in the UAE was closed on August 31.

Like Sputnik V, the Chinese COVID-19 vaccine tested in the UAE also required volunteers to get two doses 21 days apart.

What were the results of the first Phase III trials in the UAE?

On September 15, the vaccine was given emergency regulatory approval for use with frontline workers. A number of top officials and frontline workers have already received the two doses of the vaccine. Even though official trial results are pending, officials announced last month that the Chinese vaccine had been tested on 1,000 volunteers suffering from chronic diseases and that no adverse effects or complications had been noted.

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