Scientists uneasy as Russia approves first coronavirus vaccine

MOSCOW

Russia on Tuesday became the first country to approve a SARS-CoV-2 coronavirus vaccine, a move that was met with international skepticism and unease because the shots have only been studied in dozens of people.

President Vladimir Putin announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus that causes COVID-19, although Russian authorities have offered no proof to back up claims of safety or effectiveness.

“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”

However, scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial — which involves tens of thousands of people and can take months — is the only way to prove if an experimental vaccine is safe and really works.

By comparison, a vaccine entering final-stage testing in the U.S. requires a study of 30,000 people. Two vaccine candidates already have begun those huge studies, with three more set to get underway by fall.

“Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organizations in urging government officials to postpone approving the vaccine without completed advanced trials.

While Russian officials have said large-scale production of the vaccine wasn’t scheduled until September, Deputy Prime Minister Tatyana Golikova said vaccination of doctors could start this month. Officials say they will be closely monitored after the injections. Mass vaccination might begin in October.

Kirill Dmitriev — chief executive of the Russian Direct Investment Fund, which bankrolled the vaccine — said even as Russian doctors and teachers start getting vaccinated, advanced trials are set to start Wednesday that will involve “several thousand people” and span several countries, including the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil.

The U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs. Russia has denied involvement.

Russia has so far registered 897,599 coronavirus cases, including 15,131 deaths.