MOSCOW: More than a month after becoming the first country to approve a coronavirus vaccine, Russia has yet to deliver it to a large population outside of a clinical trial, health officials and outside experts say.
The approval, which came with much fanfare, came before Russia tested the vaccine in late-stage trials for potential side effects and its ability to fight disease. President Vladimir Putin saw it as a political gesture to claim victory in the global race for a vaccine.
It is not clear whether the slow start of the vaccination campaign is the result of limited production capacity or doubts about inoculating the population with an untested product.
The Russian vaccine is one of nine candidates worldwide that are now in late-stage clinical trials that are the only sure way to determine whether a vaccine is effective and to find possible side effects.
A vaccine is seen as the only way to stop the spread of the coronavirus, which has sickened more than 30 million people around the world and slowed economies around the world since it first appeared in China in late 1990. last year.
In an example of the limited scope of distribution, the company that finances the vaccine pointed to a shipment sent last week to the Crimean peninsula. The delivery contained doses for 21 people in a region with 2 million.
The Russian Health Ministry has not said how many people have been vaccinated across Russia. Minister Mikhail Murashko said last weekend that the first small shipments were delivered last week to the Russian provinces.
It did not say how many doses were shipped, described the shipments only as “small amounts” and did not say when they would be available. He said the area around St. Petersburg, the Leningrad region, would be among the first to receive what he called “samples” of the vaccine.
Putin has said that one of his two adult daughters took the vaccine.
“Unfortunately, we have very little information,” said Dr. Vasily Vlassov, 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 PR is and how much is a violation of medical ethics,” he said of the announcement that the vaccine had been approved for use outside of a clinical trial. If few Russians are getting the vaccine, early approval seems less of a concern, he said.
“Maybe nothing scary is happening in reality and just the announcement was terrifying,” he said.
Svetlana Zavidova, director of a pharmaceutical trade group, the Association of Clinical Trials Organizations, who also opposed the hasty approval, said the limited use was encouraging news, though her reasons are unclear.
“Is it a matter of limited production or more of a political decision?” she said. Either way, “of course, from my point of view, it is better that they limit their activity to only clinical trials, as we said from the beginning.”
The trial in Russia began on September 9, and Russian officials have said they expect first results before the end of the year, although the Gamaleya Institute, the scientific body that developed the vaccine, has scheduled the trial to continue through May.
That schedule is similar to the testing programs announced by the three drug companies testing potential vaccines in the United States: AstraZeneca, Moderna, and Pfizer.
AstraZeneca stopped its trial this month after a test subject experienced symptoms of a neurological disease, transverse myelitis, as a possible side effect. Since then, the trial has been resumed in Great Britain, but not in the United States.
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 August 11. China had previously started off-trial vaccinations starting with members of its military and has approved four vaccines for limited use.
On September 14, the United Arab Emirates gave emergency approval for a Chinese vaccine, manufactured by Sinopharm, for use in healthcare workers.
Russia’s health minister said on Aug. 11 that people at high risk of infection, such as doctors and teachers, would be vaccinated, and the Russian financial company sponsoring the vaccine said doses will be available in August.
But the launch was slower.
Murashko, the minister, said the delays were partly due to the need to test the delivery system for a vaccine that must be stored in a freezer, and also to train medical staff. Delays have persisted even as the virus infects more than 5,000 people a day in Russia.
The last-stage Russian clinical trial, or phase three, is being carried out entirely in Moscow, where 30,000 people will receive the vaccine and 10,000 will receive a placebo.
Yevgenia Zubova, a spokeswoman for the Moscow city health department, said in an interview that the vaccine was available only to trial participants. The Health Ministry did not respond to written questions about the use of the Sputnik V vaccine outside of clinical trials.
Nonetheless, Kirill Dmitriev, head of Russia’s Direct Investment Fund, the company that sponsors the vaccine, has been encouraging officials in other countries who advocate for early approval of the vaccine.
“It has now been accepted that Russia’s approach is the right one,” he said in a statement after reports emerged that the US Food and Drug Administration could provide emergency use approval for a vaccine, an idea promoted. by President Donald Trump.
Russia’s health authorities have a history of approving drugs after limited testing. It’s a legacy of the Soviet-era regulatory system, in which an oversight committee often came up against the judgment of drug investigators, who weren’t motivated by profits, Vlassov said.
Regulators, for example, approved a top-selling cold medicine in Russia, Arbidol, although the clinical trial was canceled to demonstrate its effectiveness.
But when drugs are tested, Russia has an exceptionally good track record in managing clinical trials, according to a database of U.S. Food and Drug Administration clinical trial inspections around the world. The FDA found a lower percentage of trials with problems in Russia than in any other European country or the United States.
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