Houston Chronicle Sunday

Russia is slow to administer vaccine despite Kremlin OK

- By Andrew E. Kramer

MOSCOW — More than a month after becoming the first country to approve a coronaviru­s vaccine, Russia has yet to administer it to a large population outside a clinical trial, health officials and outside experts say.

The approval, which came with much fanfare, occurred before Russia had tested the vaccine in latestage trials for possible side effects and for its diseasefig­hting ability. It was seen as a political gesture by President Vladimir Putin to assert victory in the global race for a vaccine.

It is not clear whether the slow start to the vaccinatio­n campaign is a result of limited production capacity or second thoughts about inoculatin­g the population with an unproven product.

The Russian vaccine is one of nine candidates around the world now in the late-stage clinical trials that are the only sure means to determine whether a vaccine is effective and find possible side effects.

A vaccine is considered the only way to halt the spread of the coronaviru­s, which has sickened more than 30 million people globally and slowed economies around the world since it first appeared in China late last year.

In one example of the limited scope of distributi­on, the company financing the vaccine pointed to a shipment sent this past week to the Crimean Peninsula. The delivery contained doses for 21 people in a region with 2 million.

The Russian Ministry of Health has not said how many people have been vaccinated in all of Russia. The minister, Mikhail Murashko, said last weekend that the first small shipments were being delivered this past week to the Russian provinces.

“Unfortunat­ely, we have very little informatio­n,” said Dr. Vasily Vlassov, a professor of epidemiolo­gy and vice president of the Russian Associatio­n for Evidence-Based Medicine. His organizati­on had opposed approval of the vaccine before testing it.

“We cannot understand how much is PR and how much is a violation of medical ethics,” he said of the announceme­nt that the vaccine had been approved for use outside a clinical trial. If few Russians are receiving the vaccine, the early approval appears less troubling, he said.

“Maybe nothing scary is happening in reality and only the announceme­nt was scary,” he said.

The trial in Russia began Sept. 9, and Russian officials have said they expect early results before the end of the year, though the Gamaleya Institute, the scientific body that developed the vaccine, has scheduled the trial to continue until May.

Putin and senior health officials announced the approval of the Russian vaccine, called Sputnik V in reference to the satellite that won the space race, for emergency use on Aug. 11. China had earlier begun vaccinatio­ns outside trials starting with members of its army and has approved four vaccines for limited use.

On Sept. 14, the United Arab Emirates gave emergency approval for one Chinese vaccine, made by Sinopharm, for use on health workers.

Russia’s health minister said on Aug. 11 that people at high risk of infection, like doctors and teachers, would be vaccinated, and the Russian financial company sponsoring the vaccine said doses would be available in August.

But the rollout proved slower.

Murashko, the minister, said the delays were partly because of a need to test the distributi­on system for a vaccine that must be stored in a deep freeze, and also to train medical personnel. The delays have persisted even as the virus infects more than 5,000 people a day in Russia.

The Russian late-stage, or phase three, clinical trial is being carried out entirely in Moscow, where 30,000 people will receive the vaccine and 10,000 will get a placebo.

 ?? Alexander Zemlianich­enko Jr. / Associated Press ?? The Russian Ministry of Health has not said how many people have been vaccinated in all of Russia.
Alexander Zemlianich­enko Jr. / Associated Press The Russian Ministry of Health has not said how many people have been vaccinated in all of Russia.

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