Russia aims to approve Covid-19 vaccine in mid-August, but questions remain

Russian authorities told CNN they are working on an August 10 or earlier date for approval of the vaccine, which has been created by the Moscow-based Gamaleya Institute.

It will be approved for public use, and front-line healthcare workers will receive it first, they said.

“This is a Sputnik moment,” said Kirill Dmitriev, director of Russia’s sovereign wealth fund, which funds Russian vaccine research, referring to the successful launch in 1957 of the world’s first satellite by the Soviet Union.

“The Americans were shocked when they heard the Sputnik beeps. It is the same with this vaccine. Russia will have come first.”

But Russia has not released scientific data on its vaccine tests and CNN cannot verify its claimed safety or effectiveness. Critics say the country’s push for a vaccine comes amid political pressure from the Kremlin, which wants to portray Russia as a global scientific force.

There are also widespread concerns that human testing of the vaccine is incomplete.

Dozens of vaccine trials are underway around the world, and a small number are in large-scale efficacy trials, but most developers have warned that much work remains before their vaccines can be approved.
Infecting volunteers with Covid-19 could accelerate the race for a vaccine.  But it could be risky

While some global vaccines are in the third phase of the trials, the Russian vaccine has not yet completed its second phase. The developers plan to complete that phase before August 3 and then carry out the third phase of testing in parallel with the vaccination of medical workers.

Russian scientists say the vaccine has developed rapidly because it is a modified version of one already created to fight other diseases. That is the approach that is being taken in many other countries and by other companies.

In particular, Moderna, whose vaccine is backed by the US government and who began Phase 3 testing on Monday, has built its coronavirus vaccine on the spinal cord of a vaccine it had been developing for a virus. related, MERS. While this has accelerated the development process, American and European regulators require the full complement of the vaccine’s safety and efficacy tests.

Russia’s defense ministry says Russian soldiers volunteered in human trials.

In recorded comments provided to CNN, Alexander Ginsburg, the project director, said the vaccine had already been injected.

Russian authorities say drug approval is accelerating due to the global pandemic and Russia’s serious coronavirus problem. The country now has more than 800,000 confirmed cases.

“Our scientists focused not on being the first but on protecting people,” said Dmitriev.

The vaccine uses human adenovirus vectors that have been weakened so that they do not replicate in the body. Unlike most vaccines in development, it is based on two vectors, not one, and patients would receive a second booster injection.

Russian President Vladimir Putin attends a meeting with health workers at the Novo-Ogaryovo state residence on the outskirts of Moscow on June 20.

Authorities say their scientific data is currently being collected and will be available for peer review and publication in early August.

“Russia brought together its leading position in vaccine development and its proven Ebola vaccine platform and MERS to provide the first safe and efficient solution to the world’s biggest problem,” Dmitriev told CNN earlier.

The World Health Organization says there is no approved vaccine for MERS.

The Russian health ministry, which has not yet confirmed the August approval date, says front-line medical staff will be the first to be vaccinated once the new drug has been approved for public use.

Large-scale vaccine trials in the United Kingdom, the United States and elsewhere are advancing rapidly, but they have not committed to meeting the deadlines for product approval.

Early results from trials of a vaccine developed by Oxford University and AstraZeneca were promising, but Mike Ryan, executive director of the World Health Organization’s Health Emergencies Program, said earlier this month that “there is a long way to go”.

“These are Phase 1 studies. Now we need to move to larger-scale, real-world trials, but it’s good to see more data and more products moving forward in this very important phase of vaccine discovery,” he said.

Earlier this month, the Kremlin denied allegations of hacked Russian spies in American, Canadian, and British research labs stealing vaccine development secrets.

Russian authorities also denied reports that members of the country’s political and business elite, including Russian President Vladimir Putin, had had early access to the vaccine.

CNN’s Rob Picheta contributed to this report.