Russia approves coronavirus vaccine before completing tests

World
By Editor_1
The first vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology -Handout / Russian Direct Investment Fund / AFP
0

MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir Putin announced Tuesday (11), though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.

Putin, who said at a Cabinet meeting Tuesday morning that the vaccine “works effectively enough”, said his own daughter had taken it.

Russia’s minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in the fall, and said Tuesday that it would start with teachers and medical workers this month.

But by skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps in order to score global propaganda points. Russia’s vaccine sped through early monkey and human trials with apparent success. But Moscow was cautioned just last week by the World Health Organization (WHO) not to stray from the usual methods of testing a vaccine for safety and efficacy.

Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest.

Vaccines generally go through three stages of human testing before being approved for widespread use. The last phase, known as phase 3, compares the vaccine to a placebo in tens of thousands of people.

The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct phase 3 trials.

That final phase, however, is the only way to know with statistical certainty whether a vaccine can prevent an infection, and how effective it is.

The Russian Ministry of Health did not respond to detailed written questions sent last week about human trials and research into potentially harmful side effects.

Kirill Dmitriev, the head of a government-controlled fund that invested in the vaccine, denied in a conference call with journalists Tuesday that Russia had cut corners on testing.

Russia has already received orders for 1 billion doses from 20 countries and plans to manufacture the vaccine in Brazil, India, South Korea, Saudi Arabia and Cuba, according to the Gamaleya Institute.

-New York Times

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