President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.
The Moscow-based Association of Clinical Trials Organisations (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 Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “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.
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.