Russia sets mass vaccination for October after shortened trial

Andrew E. Kramer, The New York Times

Posted at Aug 03 2020 08:54 AM

MOSCOW — Russia plans to launch a nationwide vaccination campaign in October with a coronavirus vaccine that has yet to complete clinical trials, raising international concern about the methods the country is using to compete in the global race to inoculate the public.

The minister of health, Mikhail Murashko, said Saturday that the plan was to begin by vaccinating teachers and health care workers. He also told the RIA state news agency that amid accelerated testing, the laboratory that developed the vaccine was already seeking regulatory approval for it.

Russia is one of a number of countries rushing to develop and administer a vaccine. Not only would such a vaccine help alleviate a worldwide health crisis that has killed more than 680,000 people and badly wounded the global economy, it would also become a symbol of national pride. And Russia has used the race as a propaganda tool, even in the absence of published scientific evidence to support its claim as a front-runner.

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States, warned a congressional hearing Friday.

State television in Russia has for several months promoted the idea of Russia leading the competition. In May, a government report claimed that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself with a vaccine early in the development process.

Russia will start Phase III trials of the vaccine in early August, said Kirill Dmitriev, a senior official with Russia Direct Investment Fund, a government-controlled investor in the country’s vaccination effort. A Phase III trial is the only way to determine if a vaccine is effective.

The World Health Organization maintains a comprehensive list of worldwide vaccine trials. But there is no Russian Phase III trial on the list.

Still, a Russian regulatory agency is expected to approve the vaccine this month, Dmitriev said. That is far earlier than timelines suggested by Western regulators, who have often said a vaccine would become available no sooner than the end of the year.

“We believe it will be one of the first vaccines with regulatory approval,” Dmitriev said.

But with limited transparency in the Russian program, separating the science from the politics and propaganda could prove impossible. Critics have drawn attention to Russia’s tradition of cutting corners in research on other pharmaceutical products and accusations of intellectual property theft.

The U.S., Canadian and British governments have all accused Russian state hackers of attempting to steal vaccine research, casting a shadow over Russia’s claim to have achieved a medical breakthrough. Russian officials have denied the accusation and say their leading vaccine is based on a design developed by Russian scientists to counter Ebola years ago.

Russia was once at the forefront in virology and vaccinations. In the Soviet era, its doctors led the world in some areas of research, but spending has shriveled in recent decades. Medicines are sometimes approved with limited or no testing.

Russian researchers have continued to advance a range of vaccines since the beginning of the pandemic. The candidate to be given in October is similar to a vaccine developed by Oxford University and AstraZeneca.

The Russian vaccine was developed by the Gamaleya Institute in Moscow. It uses two strains of adenovirus that typically cause mild colds in humans. Adenovirus vaccines are in trials in various countries. They are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus.

The Gamaleya Institute tested its vaccine on soldiers, raising ethical questions about consent, although the Defense Ministry said all of the soldiers had volunteered. The institute’s director, Alexander Gintsberg, went on television in May to say he tried the vaccine on himself before announcing the completion of trials in monkeys.

“There is an escalation in the geopolitics of vaccine research,” said Cliff Kupchan, chairman of Eurasia Group, a risk consulting firm. But “what remains of the vast scientific complex of the Soviet period is a shadow of what it was,” he said.

Countries with vaccine production capacity — abundant in Russia and India — could wind up inoculating their populations by copying a successful vaccine, even if they did not in fact develop it. In April, the Serum Institute in India announced that it had plans to mass-produce a vaccine, with permission from the developer, before clinical trials had ended.

“In all likelihood, the country producing on their soil will be the first to get it, even if they don’t own it,” Kupchan said. “I don’t know how much international law and patent protection will apply here. People are pretty desperate.”

Dmitriev, of the Russia Direct Investment Fund, has attributed Russia’s research success to the Soviet Union’s once-formidable scientific study of viruses.

“We have this very significant legacy of Russia being a leader of vaccines in the Soviet time and today,” he said. “We don’t have to create many things from scratch.”

He contrasted that history with Trump administration’s Operation Warp Speed program, which is financing experimental research by Pfizer and Moderna for a genetic vaccine.

“In the last 20 years, the world took a turn toward molecular biology,” said Aydar A. Ishmukhametov, director of the Chumakov Institute, a Russian vaccine-maker. “The Russian school has preserved virology.”

Russia also has an advantage, Ishmukhametov said, in its vast, Soviet-era industrial base for growing viruses for vaccines. In the pandemic, the country has turned to a secretive laboratory in Siberia with roots in the Soviet Union’s biological weapons program, which included the study of anthrax to target humans and plant pathogens that would destroy U.S. crops.

The laboratory, Vektor, is now testing whether viruses that cause influenza, measles or vascular stomatitis — a livestock disease — can be put to use for a coronavirus vaccine.