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 late-stage trials for possible side effects and for its disease-fighting 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.
He did not say how many doses were shipped, describing the shipments only as “small amounts,” and also did not say when they would become 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, 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.
Svetlana Zavidova, director of a pharmaceutical trade group, the Association of Clinical Trial Organizations, which also opposed the hasty approval, said the limited use was encouraging news, even as its reasons are unclear.
“Is it a question of limited production or more of a political decision?” she said. Either way, “of course, from my point of view, it is better they limit their activity to only clinical trials, as we said from the beginning.”
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.
That timeline is similar to the testing schedules announced by the three pharmaceutical companies testing potential vaccines in the United States: AstraZeneca, Moderna and Pfizer.
AstraZeneca paused its trial this month after a test subject experienced symptoms of a neurological disease, transverse myelitis, as a possible side effect. The trial has since resumed in Britain but not 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 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.
Yevgenia Zubova, a spokesperson for the Moscow city health department, said in an interview that the vaccine was available only to trial participants. The Health Ministry did not reply to written questions about the use of the Sputnik V vaccine outside clinical trials.
Nonetheless, Kirill Dmitriev, director of the Russian Direct Investment Fund, the company sponsoring the vaccine, has been cheering on officials in other countries who advocate early vaccine approvals.
“It has now been accepted that Russia’s approach is the correct one,” he said in a statement after reports emerged that the U.S. Food and Drug Administration might provide an emergency use approval for a vaccine, an idea promoted by President Donald Trump.
Russia’s health authorities have a history of approving medicines after limited testing. It is a legacy of the Soviet-era regulatory system, in which an oversight committee often deferred to the judgment of drug researchers, who were not motivated by profit, said Vlassov.
Regulators have, for example, approved a bestselling cold medicine in Russia, Arbidol, though the clinical trial to prove its efficacy was canceled.
But when medicines are tested, Russia has an exceptionally good track record on managing clinical trials, according to a database of U.S. Food and Drug Administration inspections of clinical trials 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.
Andrew E. Kramer. c.2020 The New York Times Company
source https://www.firstpost.com/world/russia-slow-to-administer-kremlin-approved-sputnik-v-vaccine-even-a-month-after-launch-8839081.html
