A BILLION DOSES OF RUSSIA’S VACCINE ORDERED

Clinical trials of Sputnik V to start as many countries show interest

Interest in Russia’s coronovirus vaccine has reached a billion doses even before the medication goes into production.

The vaccine was officially registered in Russia yesterday and the intention is to produce 500 million doses over the coming 12 months, the head of its sovereign wealth fund said.

“We already received tentative interest and preliminary requests for one billion doses of the Russian vaccine ... from more than 20 countries,” said Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, which is financing the vaccine research.

Countries in Latin America, the Middle East and Asia have expressed the greatest interest in the vaccine, known as Sputnik V, he said. The RDIF is “about to finalise a number of contracts for the purchase of the vaccine”, Mr Dmitriev said.

“We believe today is a very positive day in the fight of humanity against coronavirus. It’s a major step not only by our scientists, not only by Russia, not only by our leadership, but also for the world because we have one common enemy and that’s the coronavirus,” Mr Dmitriev said.

The RDIF is backing the production of the vaccine developed by the Gamaleya Institute and has invested four billion roubles (Dh202 million) with its portfolio companies Alium and R-Pharm.

“We have also built a partnership to produce the vaccine in five countries and now have a production capability of 500 million vaccines that can be produced in the next 12 months,” Mr Dmitriev said.

The plan is to increase production, he said.

“We will not be producing the vaccine only in Russia, we will be producing the vaccine with other countries.”

More than 20 million people have been infected with the coronavirus and about 740,000 have died, according to Worldometer, which is tracking the pandemic.

The US has had more than 5.2 million infections. Phase 3 of vaccine clinical trials will start tomorrow and data will be published as it becomes available, Mr Dmitriev said.

“We expect clinical trials to start in the UAE, Saudi Arabia and the Philippines very soon,” he said. People taking part will be monitored and their antibodies measured over the next couple of months, he said.

Mr Dmitriev said the Russian vaccine is an important milestone given the resurgence of the pandemic in countries battling second waves.

“Many predicted the coronavirus would just disappear … and a vaccine is a major step in the way forward,” he said. “This is really about protecting people. It is also about enabling our economies to open and to work well. We need people to be healthy, to be working and the vaccine is really the solution,” he said.

The Gamaleya Institute developed a test that can measure specific antibodies that attack the spike of the coronavirus, he said. The test takes several hours, and will be administered to all of the people who receive the vaccine. Russia’s vaccine will now be offered to volunteers, doctors and teachers.

“We expect tens of thousands of volunteers to be vaccinated in the next months and then, starting from October, there will be mass vaccination in Russia on a voluntary basis,” he said.

Russia gave regulatory approval to the world’s first Covid-19 vaccine, two months after the developer’s Phase-3 clinical testing began.

The plan was to produce 500 million batches over the next year. Industrial production of Sputnik V will start next month, and officials claimed 20 countries have expressed interest in ordering a billion doses.

World Health Organisation spokesman Tarik Jasarevic said yesterday that the WHO would be working closely with Russia regarding the vaccine, including “the rigorous review and assessment of all required safety and efficacy data” that the global body oversees.

The speed at which Russia’s vaccine has been approved confounds all previous benchmarks. The standard length of a Phase-3 vaccine trial is typically one to four years.

The move to production paved the way for mass inoculation while clinical trials to test safety and efficacy continued. The lightning-quick ratification led to consternation among the global science community who fear that it is dangerously premature.

The unparalleled approval time highlights countries’ determination to win what has been called a vaccine space race. Russia named its vaccine Sputnik V after the first satellite placed in orbit during the Cold War space race.

The vaccine is based on the DNA of a Sars-CoV-2 type adenovirus – more commonly known as the common cold, the same method adopted by another Phase-3 trial run by scientists at the University of Oxford.

Before Russia’s push to production, the most prominent research product was the Oxford trial, which is backed by British-Swedish pharmaceutical giant AstraZeneca.

In July, chairwoman of the UK government’s task force, Kate Bingham, told parliament that the Oxford vaccine was “well ahead of the world” and the “most advanced vaccine anywhere”.

Alexander Gintsburg, director of the Gamalweya National Research Centre that developed the vaccine, said that the coronavirus particles in the vaccine had been effectively deactivated so that they cannot multiply and harm the body.

More than 100 possible vaccines are being developed around the world to try to stop the Covid-19 pandemic. At least four are in final Phase 3 human trials, according to WHO data.

The US leads the vaccine race overall, with 39 research projects in the pipeline.

The US biotech company Moderna is pioneering work on an mRNA vaccine. This approach delivers genetic material to human cells that provide a spike protein seen on the surface of the coronavirus. This should trigger an antibody response that allows the body to fight Covid-19.

Moderna hopes to have data from latest trials on 30,000 participants available by November. US drugmaker Pfizer and German biotech company BioNTech are also conducting promising research along the same lines.

China ranks second on the WHO list with 20 projects. The

Lancet in May said the Phase-1 trial of a potential Covid-19 vaccine developed by Chinese military virologists showed promising results.

CanSino is poised to launch a Phase-3 trial of its vaccine candidate, which also uses a harmless cold virus to carry genetic material from the coronavirus into the body. Meanwhile SinoPharm launched its Phase 3 trial among 15,000 volunteers – aged 18 to 60, with no serious underlying conditions – in the UAE.

A WHO overview published last week said 165 candidate vaccines were being worked on, with six reaching Phase 3.

Yesterday, Russian President Vladimir Putin said the vaccine “works quite effectively, forms strong immunity and has passed all the needed checks”. Mr Putin said the vaccine had been administered to one of his daughters.

Scientists in the UK have voiced scepticism. Professor Keith Neil, epidemiologist at the University of Nottingham, believed the cloak of secrecy around the vaccine’s development made it impossible to know if it will be effective.

And he cautioned that even if scientific papers had been made available for analysis, then there may still have been “problems on data quality”.

Philippine President Rodrigo Duterte, 75, said that he has “huge trust” in the Russian vaccine and that he was happy to be the “first they experiment on”.