Russia Approves First Coronavirus Prescription Drug as Distribution of Its Vaccine Hits ‘Inexplicable’ Lull

Russia says it has approved a new drug that treats patients with moderate to severe symptoms of COVID-19. Coronavir is based on favipiravir, which was developed in Japan and has been used to treat patients there since May.

The company that developed the drug, R-Pharm, says that favipiravir, which is also the key component in Fujifilm Holdings Corp’s antiviral drug Avigan, was approved in Japan as an emergency influenza treatment in 2014.

Reuters:

Coronavir’s trial was comparatively small. The European health regulator on Friday endorsed the use of the steroid dexamethasone in the treatment of COVID-19 patients after a study by UK researchers on several thousand patients.

Russia apparently isn’t waiting for extensive human trials to release Coronavir. The country didn’t wait for extensive testing of its new vaccine, Sputnik 5, either. After Russia approved the vaccine with much fanfare last month, there has been an “inexplicable” lull in distributing it to the general population.

The Economist:

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.

I doubt whether people are dropping dead from having been vaccinated by Sputnik 5, but it could be proving less effective than most nations would hope.

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.

The Russian scientific community is breathing a sigh of relief. Scientists opposed the early rollout, largely because Moscow was talking about 100 million doses being distributed. But with such small numbers of vaccine doses being made available, they are hoping that Putin’s braggadocio about the vaccine was a PR move.

“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.

Meanwhile, U.S. vaccine maker AstraZeneca has still paused its trials of a vaccine in the United States after one patient developed serious neurological side effects. It may delay the release of the vaccine for use in the U.S., although there are other vaccines racing to market.

‘Incomplete Data’ and ‘Unlikely Patterns’ in Russian Coronavirus Vaccine Study