The vaccine has skipped one phase of testing in people to help accelerate its development.
A coronavirus vaccine developed by Russia’s Gamaleya Research Institute has been approved for use in the country, Russian President Vladimir Putin said, according to the news agency TASS, but there are concerns that it has not yet been properly tested on humans.
Putin said receiving the vaccine will be voluntary, but will first be administered to teachers and health care workers as early as this month, according to the Washington Post.
The Russian president also claimed his daughter has been given the experimental vaccine, according to the Associated Press. And Reuters reported that Philippine President Rodrigo Duterte said he has “huge trust” in the Russian research and is wiling to participate in trials of the vaccine.
The news puts Moscow ahead in the global race to discover a coronavirus vaccine. An official release put out by the Russian Ministry of Health said the Gamaleya vaccine had been tested on “several species of animals (rodents and monkeys)” as well as two groups of human volunteers (38 people each). But it has skipped a crucial phase of large-scale testing on human subjects, meaning there is far less safety and efficacy data available for the product than would normally be the case.
In July, the country said it would complete Phase 2 clinical trials in time to register the vaccine by mid-August. Usually, vaccines go through three stages of testing in humans — the last of which is large-scale testing on thousands of volunteers to prove the vaccine’s efficacy and to bolster safety data.
“The rules for conducting clinical trials are written in blood. They can’t be violated” — Svetlana Zavidova, executive director of the Association of Clinical Trials Organizations (ACTO)
“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” Putin told a Cabinet meeting today, according to the New York Times.
Svetlana Zavidova, the executive director of the Association of Clinical Trials Organizations (ACTO), warned against the move in an interview with Bloomberg.
“The rules for conducting clinical trials are written in blood. They can’t be violated,” Zavidova said. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”
Nikolay Briko, the Russian health ministry’s chief non-resident epidemiologist, told TASS there is no reason to delay the vaccine’s registration.
“The process was sped up due to the fact that the vaccine was not created from scratch,” Briko said. “It is important that all stages [of vaccine research] are followed and that international requirements are adhered to.”
In May, Marco Cavaleri, the head of the European Medicines Agency’s vaccines strategy said vaccines will have to undergo Phase 3 trials before receiving authorization in Europe.
Russia is not alone in speeding up the process. In June, China also said its military will receive an experimental vaccine while it’s still undergoing testing.
There are more than 100 coronavirus vaccines in various stages of development.
Source: POLITICO https://www.politico.eu/article/russia-coronavirus-vaccine-vladimir-putin-given-green-light/?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication