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Russia aims COVID vaccine at Asian buyers beyond Philippines

Vietnam and others eye Sputnik V doses as scientists spar over safety

Vaccine development in a Russian lab: While Moscow sees limited sales prospects in Western markets, it views Asia as "promising."   © Reuters

MOSCOW -- Asia figures prominently in Russia's multibillion-dollar plans for its new coronavirus vaccine -- one that has prompted international experts and even some Russian scientists to raise concerns about its safety.

Others insist the skepticism voiced by the likes of top U.S. doctor Anthony Fauci and others is unwarranted, and that Russia is taking a responsible path.

On Tuesday, President Vladimir Putin said that Russia had registered the world's first vaccine against COVID-19, and that one of his own daughters had already been inoculated. The vaccine has been named Sputnik V, after the 1957 Soviet satellite that was the first human-made object to orbit Earth.

Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF) -- which financed the development -- revealed that 20 countries had already submitted preorders for 1 billion doses of Sputnik V. "So far, countries in Latin America, the Middle East and Asia have displayed the greatest interest in the vaccine," he said, "and we are about to finalize a number of contracts for the purchase of the vaccine."

Dmitriev added that Russia would partner with five other countries to produce 500 million doses of vaccine per year, with plans to scale up output over time. By the end of 2021, Russian vaccine developers hope to corner a quarter of the global coronavirus vaccine market, estimated to be worth over $75 billion, the Russian business daily Vedomosti reported earlier this week.

On Friday, reports emerged that Vietnam's Drug Administration, under the Ministry of Health, is looking to procure Sputnik V. The ministry is seeking approval and guidance from the government, however, given concerns over the limited availability of information on the development process.

Moscow has particularly high hopes for supplying the vaccine in Asia, according to Sergey Shulyak, CEO of DSM Group, a Moscow-based pharmaceutical market research agency.

"The European market will not buy Russia's vaccine because of geopolitical reasons. Not to mention Europe has its own producer which it will support. Same case with the United States and Canada," Shulyak said.

"On the other hand, Russia has traditionally been geopolitically close to both Asia and Africa. So these markets are more promising for us."

Already, Philippine President Rodrigo Duterte has emerged as an early and enthusiastic champion of Russia's vaccine. The Southeast Asian nation plans on beginning Phase 3 trials in October. Duterte himself has pledged to be vaccinated with Sputnik V as early as May 2021.

The RDIF says India and Indonesia are also among the countries that have expressed interest in obtaining the vaccine. The fund has revealed plans to begin mass production of Sputnik V in India and South Korea in partnership with local sovereign wealth funds.

Russian President Vladimir Putin chairs a teleconference with government members on Aug. 11.    © Reuters

Developed by the Gamaleya Research Institute in Moscow, Sputnik V is an adenoviral vector-based vaccine, which combines a coronavirus spike protein with a human adenovirus -- a type of common virus that causes an array of ailments. The Gamaleya Institute had previously used adenoviruses to develop vaccines for Ebola and Middle East respiratory syndrome.

So far, Sputnik V has been tested on animals and 76 people in two early stage trials. Crucially, however, Russia has yet to complete a Phase 3 trial, which entails testing it on thousands of people. This is considered an integral part of the vetting process for any vaccine.

"No one knows the long-term effects of this vaccine," said Yevgeny Timakov, chief physician of the Lider-Medicina medical center in Moscow. "We don't know yet how it will impact a person's immune status, oncology, or reproductive functions."

This is why the decision to approve Sputnik V in its current stage has sparked concern. Russia's own Association of Clinical Trials Organizations, a nongovernmental group representing major drug companies, urged the Kremlin to postpone registering the vaccine until a Phase 3 trial was completed.

In the U.S., Fauci, the director of the National Institute for Allergy and Infectious Diseases, has said he "seriously doubts" Russia has definitive evidence that Sputnik V is safe and effective. Meanwhile, German Health Minister Jens Spahn has warned that Russia's vaccine could be "dangerous" and accused Moscow of not being "transparent."

Yet, some Russian scientists are pushing back against criticism that their country is being too hasty.

Dr. Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases, has said he "seriously doubts" Russia has definitive evidence that Sputnik V is safe and effective.   © Reuters

Sergey Voznesenskiy, an epidemiologist at the Peoples' Friendship University of Russia, told the Nikkei Asian Review that Russia has no intention of making its vaccine widely available before conducting Phase 3 trials.

He explained that the main purpose of registering the vaccine now is to get started on the bureaucratic procedures needed to clear it for mass production, a process which he said would take at least two months. Russia's current plan, Voznesenskiy stated, is to simultaneously carry out Phase 3 trials and begin preparing for mass production of Sputnik V.

"Registering the vaccine does not mean that mass vaccinations will begin anytime soon. We will wait several months for the results of Phase 3 trials," he said. "But once those trials are complete by the start of 2021, we will definitely have a registered vaccine and a certain supply of it. That means in the event of a second wave of the virus, we will have the necessary weapons to combat it."

This approach is not necessarily problematic, said Paul Offit, chief of the division of infectious diseases at the Children's Hospital of Philadelphia and a co-inventor of a rotavirus vaccine.

"As long as Russian researchers perform a large, prospective, placebo-controlled trial proving that their vaccine is safe and effective before releasing it to the public, I have no problem with their premature announcement," he wrote in an email.

The Russian Ministry of Health's registration certificate for Sputnik V states that the vaccine cannot be released for widespread use before Jan. 1, 2021.

This appears to contradict an earlier statement by Health Minister Mikhail Murashko that "extensive vaccinations" could begin as soon as October. Murashko has also been quoted in the media as saying that the first batch could be ready in about two weeks.

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