Russia approves first Covid-19 vaccine, says Putin

MOSCOW, RUSSIA: Russian President Vladimir Putin announced Russia to be the first country in the world to provide the first regulatory approval to Covid-19 vaccine in less than two months of human testing on Tuesday, a move pelted by Moscow as an evidence to it’s scientific dexterity.

The vaccine approved has raised many questions and concerns among some scientific experts across the world with the rate of it’s approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.

Russian health workers treating Covid-19 patients will be given a chance to be the subject and will be vaccinated in the coming few weeks, a source told Reuters last month.

Regulatory approval makes way for the mass immunization of the Russian population and authorities see a light for the economy to return to it’s full capacity, which has been battered by fallout from the virus.

“Sputnik moment”

Kirill Dmitriev, head of Russia’s sovereign wealth fund, hailed the development as a historic “Sputnik moment”, comparable to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite.

The vaccine will be marketed under the name ‘Sputnik V’ on foreign markets, he said.

Russia had already received foreign requests for over 1 billion doses. International agreements had been signed to produce 500 million doses annually. Also, the vaccine is said to be produced in Brazil as well, said Dmitriev.

He said clinical trials were expected to start soon in the United Arab Emirates and the Philippines.

Putting national prestige over safety?

Many scientists are worried with the speed at which Russia has moved to approve the vaccine before it made it to the final trials to test its safety and efficacy, as only about 10 percent of the clinical trials are successful. This rate of approval has raised many questions that maybe Moscow is putting national prestige over safety.

Putin cleared those concerns while speaking at a government meeting on a state television saying, the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

Mass production is expected to start soon, he said.

Phase III trial

The vaccine’s approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.

Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.

The Moscow-based Associations of Clinical Trials Organisation (ACTO), a body representing professional drug makers of Russia had requested the health ministry this week to halt and postpone the approval until the final trial is successfully completed.

In the letter to the ministry, they specified that registering a drug before it has been successfully tested is a great risk.

“It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” it said.

Many international experts are worried with approving a drug with such speed.

“Normally you need a large number of people to be tested before you approve a vaccine,” said Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac’s Covid-19 vaccine in clinical trials.

“In that respect, I think it’s reckless to do that (approve it) if lots of people haven’t already been tested.”

Equally prudent approach as FDA and EMA

A professor of intellectual property law, Duncan Matthew at Queen Mary University of London said, news of the Covid-19 vaccine is warmly welcome “but safety must be the priority.”

“The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach,” Matthews said in an emailed comment.

Nearly more than 100 Covid-19 vaccines have been created globally, but only four could make it to the final phase III human trials, according to a data received by WHO.