Russia registered world’s first COVID-19 vaccine: Putin

Russian President Vladimir Putin said Tuesday that his country has succeeded to develop a vaccine that “forms stable cell and antibody immunity” against the COVID-19.

Speaking at a government meeting, Putin said: “As far as I know, this morning for the first time in the world a vaccine against the novel coronavirus infection was registered.” 

The Russian Tass news agency reported that the vaccine was developed by Moscow’s Gamaleya institute and its clinical trials were over.

The vaccine was approved by the country’s Health Ministry after less than two months of human testing.

“I know this very well, because one of my daughters got vaccinated, so in this sense, she took part in testing,” Putin said. He noted that after the first vaccine shot, his daughter had a 38°C fever, and on the next day, a fever slightly higher than 37°C. And then, after the second shot, she had a slight fever again, and then everything was fine, she is feeling well and has a high [antibody] count,” Putin said quoted by the Tass.

The vaccine still has to complete final trials but Russia’s move could pave the way for mass vaccination.

Reuters reported that 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 Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.

In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.

“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.

Some international experts have also questioned the speed at which Russia approved its vaccine.

“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.”

Duncan Matthews, a professor of intellectual property law at the Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “but safety must be the priority”.

“The U.S. 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.

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 III human trials, according to WHO data.

(With inputs from Reuters)