- The Washington Times - Tuesday, August 11, 2020

U.S. Health and Human Services Secretary Alex M. Azar II on Tuesday led a worldwide reaction of skepticism to Russian President Vladimir Putin’s announcement that his country has developed the world’s first COVID-19 vaccine.

Mr. Azar noted that the goal of developing a coronavirus vaccine is to have one that’s safe and effective, and he noted that Russia was skipping the trial phase where that is usually determined, instead distributing the vaccine while performing those Phase 3 trials.

“The point is not to be first with a vaccine — the point is to have a vaccine that is safe and effective for the American people and the people of the world,” Mr. Azar said on ABC’s “Good Morning America.” “We need transparent data, and it’s got to be Phase 3 data that shows that a vaccine is safe and effective.”

Mr. Putin said Tuesday that his country had approved the world’s first coronavirus vaccine and that one of his two adult daughters had been inoculated with only minor side effects like a slight fever.

“I hope our foreign colleagues’ work will move as well, and a lot of products will appear on an international market that could be used,” Mr. Putin said.



Russia is expected to move forward with vaccinating its population while Phase 3 trials, which can involve thousands of people and last for months, continue to progress. The vaccine has only yet been studied in dozens of people for less than two months.

Others were skeptical about the announcement.

“I wouldn’t take it, certainly not outside [a] clinical trial right now,” Dr. Scott Gottlieb, a former head of the Food and Drug Administration, said on CNBC. “It appears that it’s only been tested in several hundred patients at most.”

Last month, American, Canadian and British authorities accused Russian hackers of targeting Western companies that are trying to develop a coronavirus vaccine.

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

“We expect tens of thousands of volunteers to be vaccinated within the next months,” Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that bankrolled the vaccine, told reporters.

Mr. Dmitriev 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 Russian Health Ministry said in a statement Tuesday that the vaccine is expected to provide immunity from the coronavirus for up to two years.

Russia has officially acknowledged more than 895,000 coronavirus cases and more than 15,000 COVID-19-related deaths.

Worldwide, there have been more than 20 million cases and more than 738,000 coronavirus-related deaths.

Mr. Azar said six vaccine candidates are in development in the U.S. through the Trump administration’s “Operation Warp Speed” to facilitate the production and mass distribution of a vaccine by January.

Moderna and Pfizer recently announced the start of Phase 3 or Phase 2/3 trials for their vaccine candidates.

“We could have FDA-authorized or -approved vaccines by December,” Mr. Azar said.

• This article was based in part on wire service reports.

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