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COVID-19 Vaccines: Development, Diplomacy
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SEOUL — China and Russia have begun a mass rollout of their coronavirus vaccines before clinical tests are complete, in what is emerging as an unexpectedly complex geopolitical challenge for the United States.
China’s Sinopharm announced this week that it would provide emergency doses of one of its two trial vaccines to the United Arab Emirates, prioritizing the U.S. ally over the vast majority of Chinese. China is now the sole supplier of coronavirus vaccine to the Middle East.
Meanwhile, Russia’s sovereign wealth fund signed a deal this week to supply India with 100 million doses of the Sputnik V vaccine.
These moves have thrown Western policymakers off balance. American health-care experts say the United States should not rush out its own vaccine in response. But that leaves China and Russia as the only countries wielding this valuable diplomatic tool for potentially months to come.
The upshot is that by next year, China and Russia may have purchased significant geopolitical power by having bent the rules and rushed out their vaccines. It is also possible their vaccines may fail, at enormous human cost.
“It’s really insane and a terrible idea,” Arthur Caplan, head of the division of medical ethics at New York University’s Grossman School of Medicine, said of China and Russia not waiting for the results of Phase 3 trials. “It’s staggeringly hard to comprehend.”
Kirill Dmitriev, head of the Russian Direct Investment Fund, which bankrolled Russia’s vaccine efforts, said Russia’s decision to roll out Sputnik V before the completion of Phase 3 trials has been validated by other countries now doing the same.
“The criticism was that you cannot register a vaccine before Phase 3,” Dmitriev said. “But after this, China registered a vaccine, the UAE registered a vaccine before completion of Phase 3, and both Britain and the U.S. said publicly they’re considering registering a vaccine before Phase 3. So this part of the criticism is gone.”
In recent days, President Trump has pressed for faster release of an American vaccine, while U.S. pharmaceutical companies have resisted the idea of taking a shortcut around long-established safety protocols.
Hundreds of thousands of people in China, including diplomats, the military, front-line health workers and employees of state-owned enterprises, have received Sinopharm’s vaccines under urgent-use stipulations, according to state media reports last week. But even as the rest of the country awaits access, Beijing has begun deploying vaccines abroad to regions where it is seeking to expand its influence.
Aside from the UAE collaboration, Sinopharm is also running Phase 3 trials in Jordan and Bahrain.
Egypt announced on Sept. 11 that it will also begin trials with Sinopharm, three days after the British-Swedish drugmaker AstraZeneca paused its clinical trial because of a “potentially unexplained illness.” The trial has since resumed, although not in the United States. Egypt signed a deal with AstraZeneca in July to purchase 30 million doses of its vaccine.
Caplan said of these geopolitical dynamics: “Yeah, it’s a problem.”
Officials in Moscow said this week that initial doses of the Sputnik V vaccine have been delivered to all regions of Russia, with health-care workers and teachers the first to receive access.
India, Brazil, Mexico and Kazakhstan have agreed to purchase Sputnik V.
For China, the moves represent an enormous gamble. As the country where the novel coronavirus originated, it has sought to make amends and blunt international fury. But some of its earlier efforts ended up backfiring, such as when batches of masks and other personal protective equipment exported from China were found to be defective.
The stakes are far higher with vaccines. Physicians say there is a risk of rare but severe side effects that do not present in small-scale trials, which is why large-scale Phase 3 trials are usually conducted for months before a vaccine is approved for sale. Safety issues could also emerge because of rushed manufacturing.
But if China’s bet pays off — if its vaccines prove to be safe and effective — it could cement its lead over the West in economic recovery in 2021, while also using the vaccine as a powerful diplomatic tool.
Even as China and Russia speed ahead with vaccine deployment, there will not be enough doses for everyone, necessitating decisions about who gets priority. Both countries estimate they can produce enough vaccine in the first year for a fraction of their populations.
Last week, Zhou Song, a Sinopharm executive, told state radio that the company expected an initial output of 300 million doses a year. At two doses per person, that would cover a tenth of China’s population. The vaccines will be more broadly available in December, he said.
China has a total of four vaccine candidates in Phase 3 testing, and their makers have scattered across the world to run trials. Executives have explained that China has so few coronavirus cases that it is hard to run the trials at home.
But this overseas testing has also been diplomatically expedient for Beijing, as it is essentially an early-access pass to vaccines that China can offer developing nations. Countries that have signed up to run Phase 3 trials of Chinese coronavirus vaccines include Argentina, Bahrain, Brazil, Bangladesh, Egypt, Indonesia, Jordan, Morocco, Peru, Russia, Saudi Arabia and the UAE.
The Russian Direct Investment Fund said it expects to have 30 million doses produced in Russia by the end of the year — enough for roughly 20 percent of the population.
But while the domestically produced doses of Sputnik V will be reserved for Russians, the investment fund plans to manufacture larger quantities of the vaccine abroad for international sale.
Russian Health Minister Mikhail Murashko told the state-run Tass news agency this week that of the announced 40,000 volunteers for Phase 3 trials, more than 300 had been vaccinated so far. That does not include the health-care workers or teachers who volunteered for vaccination, and it was unclear how many have done so.
Murashko added that the vaccine will be more widely available to the general population in late November or December. Russia’s Health Ministry did not respond to a request for comment.
State News Announcement
Rapid progress made in developing vaccine – China
Updated: 2020-09-17 China Daily Global
Expert says it may be available for public use as early as November
Research and development on COVID-19 vaccines in China is progressing rapidly, and they may be available for public use as early as November, a senior virologist said.
Five of the nine COVID-19 vaccines that have entered phase 3 clinical trials globally are being developed in China, and they have produced satisfying trial results, said Wu Guizhen, chief biosafety expert at the Chinese Center for Disease Control and Prevention. A vaccine usually has to complete three phases of trials before gaining market approval.
None of the people who have received candidate COVID-19 vaccines developed by China for emergency use have exhibited serious side effects or contracted the novel coronavirus, Wu said.
“It is expected that ordinary people can receive COVID-19 vaccination in November or December,” she said. “We expect the vaccinations will remain effective for between one and three years.”…
RDIF and Dr. Reddy’s to cooperate on clinical trials and supply of 100 million doses of Sputnik V vaccine to India
Sep 16, 2020 MOSCOW and HYDERABAD, India, Sept. 16, 2020 /PRNewswire/ — The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.
Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “We are very pleased to partner with Dr.Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19.
RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”
GV Prasad, Co-Chairman of Dr. Reddy’s Laboratories stated: “We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.”…