Russian health officials have approved drugs after limited testing in the past – the Sputnik V vaccine is likely no different.
More than a month after Russia became the first country to approve a coronavirus vaccine, it has yet to be given to a large population outside of a clinical trial, health officials and outside experts say.
The approval, which came with a lot of fanfare, came before Russia tested the vaccine in late-stage studies for possible side effects and its ability to fight disease. It was seen as a political gesture by President Vladimir Putin to win the global race for a vaccine.
It is not clear whether the slow start of the vaccination campaign was due to limited production capacity or due to considerations of vaccinating the population with an undetected product.
The Russian vaccine is one of nine candidates around the world currently in late-stage clinical trials. This is the only surefire way to determine if a vaccine is effective and possible side effects.
A vaccine is believed to be the only way to stop the spread of the coronavirus, which has made more than 30 million people sick around the world and slowed the economy worldwide since it first appeared in China late last year.
In an example of limited sales, the company funding the vaccine pointed to a shipment that was sent to the Crimean Peninsula last week. The shipment contained cans for 21
The Russian Ministry of Health did not say how many people were vaccinated across Russia. The minister, Mikhail Muraschko, said last weekend that the first small shipments were delivered to the Russian provinces last week.
He did not say how many cans were being shipped, just described the shipments as “small quantities” or when they would be available. He said the St. Petersburg area, Leningrad Region, will be among the first to receive so-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 refused to approve the vaccine before testing.
“We cannot understand how much PR costs and how much is a violation of medical ethics,” he said of the announcement that the vaccine was approved for use outside of a clinical trial. If few Russians get the vaccine, early approval seems less of a problem, he said.
“Maybe nothing scary is happening in reality and just the announcement was scary,” he said.
Svetlana Zavidova, director of a pharmaceutical trading group, the Association of Clinical Trial Organizations, which also opposed the rash approval, said the restricted use was encouraging news, although the reasons were unclear.
“Is it a question of limited production or is it a political choice?” She said. In any case, from my point of view, it is better to limit their activity to clinical studies, as we said from the start.
The trial in Russia began on September 9, and Russian officials have said they expect initial results before the end of the year, although the Gamaleya Institute, the scientific institution that developed the vaccine, has planned to continue the trial until May .
This schedule is similar to the testing plans announced by the three drug companies testing potential vaccines in the US: AstraZeneca, Moderna, and Pfizer.
AstraZeneca discontinued its study this month after a test person experienced symptoms of a neurological disease called transverse myelitis as a possible side effect. The trial has since resumed in the UK, but not in the United States.
Putin and senior health officials announced the approval of the Russian vaccine Sputnik V in relation to the satellite that won the space race in an emergency on August 11th. China had previously started off-trial vaccination, starting with members of its army, and has approved four vaccines for limited use.
On September 14, the United Arab Emirates issued an emergency permit for a Chinese vaccine manufactured by Sinopharm for use by health 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 firm that sponsors the vaccine said the doses would be available in August.
However, the rollout turned out to be slower.
Minister Murashko said the delays were partly due to the need to test the distribution system for a vaccine that needs to be stored in a freezer and also to train medical staff. The delays have continued despite the virus infecting more than 5,000 people daily in Russia.
The Russian late-stage or third-stage clinical trial will be carried out entirely in Moscow, where 30,000 people will receive the vaccine and 10,000 a placebo.
Yevgenia Zubova, a spokeswoman for the Moscow Health Department, said in an interview that the vaccine was only available to study participants. The Ministry of Health did not respond to written questions about the use of the Sputnik V vaccine outside of clinical trials.
Still, Kirill Dmitriev, director of the Russian Direct Investment Fund, the company that sponsors the vaccine, has encouraged officials in other countries to advocate early vaccine approval.
“It has now been accepted that Russia’s approach is the right one,” he said in a statement after reports surfaced that the US Food and Drug Administration might approve the emergency use of a vaccine, an idea which was sponsored by President Donald Trump.
Russia’s health authorities have historically approved drugs after limited testing. It’s a legacy of the Soviet-era regulatory system, with a supervisory committee often resorting to the judgment of drug researchers who weren’t motivated for profit, Vlassov said.
For example, regulators have approved a top-selling cold drug in Russia, Arbidol, even though the clinical trial to prove its effectiveness was halted.
According to a database of clinical trial inspections by the United States Food and Drug Administration, Russia has an exceptional track record of clinical trial auditing. The FDA has found a lower percentage of studies with problems in Russia than in any other European country or the US.
Andrew E. Kramer. c.2020 The New York Times Company
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