Russia Seeks to Register First Covid-19 Vaccine in August

The Wall Street Journal, 29.07.2020

Country has tested soldiers, shortened trial times to be first to create a vaccine

MOSCOW—Russia seeks to become the first country to produce a vaccine for widespread use against the novel coronavirus, as a Moscow-based research institute plans to register its candidate within the first two weeks of August.

The vaccine, which has gone through two phases of testing, is expected to be registered with the Health Ministry by August 14, said Kirill Dmitriev, head of Russia’s Direct Investment Fund, or RDIF.

RDIF is developing and producing the vaccine with the state-owned Gamaleya Institute for Epidemiology and Microbiology and Russian conglomerate Sistema.

"We have very strict procedures and they will follow all of them," said Mr. Dmitriev. "I am so confident in the vaccine I injected it myself."

The vaccine, developed through tests on volunteer soldiers, is one of two vaccines undergoing late-stage trials in Russia.

In Russia, registration of a drug is the most important step with the Health Ministry to verify its safety and make it available for medical use, similar to approval from the Food and Drug Administration in the U.S.

Evidence of how protective the vaccine is wasn't immediately available.

Officials at the Gamaleya institute weren't available for comment. Sistema said in a statement it would be involved in manufacturing of the vaccine once it was registered and ready for mass production.

Hardhit by the pandemic, Russia has employed the armed forces, shortened trial approval times and sped up clinical evaluations in an attempt to assert itself in a race for a vaccine.

"Our trust in the vaccine should be absolute," said President Vladimir Putin Wednesday, speaking to members of the government on the country's health-care system. Earlier this year, the Russian leader insisted that the first vaccine be registered by September, a timeline public-health experts said was extremely short and could pose health risks if a vaccine's potential side effects aren't studied extensively.

Moscow has faced international criticism in its efforts to develop the vaccine, and the Kremlin denied allegations last month from the U.K., U.S. and Canada thatit had hacked into international institutionsto steal Covid-19 vaccine information.

Russia, which briefly registered the second-highest number of coronavirus cases in the world earlier this year, has struggled with the disease, straining hospital workers and bed capacity. Currently, it has the fourth highest number of total infections in the world, with more than 820,000 cases.

World-wide there are more than 100 potential vaccines and more than 10 actively in trials, some of which have entered a third testing phase. Large testing programs in the U.S. and U.K. have been rolled out to develop a vaccine, but none have yet proven safe or effective.

Scientists and officials, including Anthony Fauci, the U.S. government's top infectious-disease expert, have given a timeline of a year to 18 months to safely develop a vaccine.

Mr. Dmitriev said RDIF was in advanced talks with a handful of countries in South America, Africa, the Middle East and Asia to transfer the technology of the vaccine so it can be replicated elsewhere. He said clinical data will be made open to the public in early August.

After the vaccine is registered with the Health Ministry, a third test phase would be carried out in tandem with the voluntary vaccination of Russian health workers. Production of the vaccine for public use is expected in September, said Deputy Prime Minister Tatiana Golikova.

The vaccine will be conditionally registered, which means it can be recalled if subsequent tests show it poses any health hazards, said Mr. Dmitriev.

"If you include all the health workers who will receive the vaccine, you are talking about tens of thousands of people," said Mr. Dmitriev.

The second vaccine undergoing late-stage trials in Russia, being developed by Moscow-based Vector Research Center, is on track for mass production by October, Ms. Golikova said.

Alexander Gintsburg, director of the Gamaleya institute, said that no side effects of the vaccine were observed in the first round of testing apart from cold symptoms and redness at the injections site, according to Moscow's official Russian Gazeta.

The European Union has backed a more multilateral approach, saying the intellectual property behind any vaccine should be shared globally. The Trump administration, meanwhile, has pushed for Americans to have priority access by the fall, channeling more than $2 billion to pharmaceutical companies in both the U.S. and Europe to make sure even breakthroughs abroad benefit the U.S.

Moscow, by contrast, has largely gone it alone so far, counting on Russian state and private companies to develop and manufacture a vaccine within months.