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Post by Admin on Aug 11, 2020 20:18:43 GMT
Russian President Vladimir Putin has said a locally developed vaccine for Covid-19 has been given regulatory approval after less than two months of testing on humans.
Mr Putin said the vaccine had passed all the required checks, adding that his daughter had already been given it.
Officials have said they plan to start mass vaccination in October.
Experts have raised concerns about the speed of Russia's work, suggesting that researchers might be cutting corners.
Amid fears that safety could have been compromised, the World Health Organization (WHO) urged Russia last week to follow international guidelines for producing a vaccine against Covid-19.
On Tuesday, the WHO said it had been in talks with Russian authorities about undertaking a review of the vaccine, which has been named Sputnik-V.
Currently, the Russian vaccine is not among the WHO's list of six vaccines that have reached phase three clinical trials, which involve more widespread testing in humans.
Calling it a world first, President Putin said the vaccine, developed by Moscow's Gamaleya Institute, offered "sustainable immunity" against the coronavirus.
He said he knew the vaccine was "quite effective", without giving further details, and stressed that it had passed "all needed checks".
Mr Putin also said the vaccine had been given to one of his daughters, who was feeling fine despite a brief temperature increase.
"I think in this sense she took part in the experiment," Mr Putin said, without specifying which of his two daughters had received the vaccine.
"After the first injection her temperature was 38 degrees, the next day 37.5, and that was it. After the second injection her temperature went up slightly, then back to normal."
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Post by Admin on Aug 11, 2020 23:51:38 GMT
Russia has extended a hand to the Philippines, offering to work closely with that southeast Asian country to supply Russian COVID-19 vaccine candidates. Reports are that Igor Khovaev, Ambassador to the Philippines, introduced during a virtual presser the vaccine developed at Gamaleya National Research Institute of Epidemiology and Microbiology, part of the Ministry of Health of the Russian Federation; he suggested that Russia would make the experimental product available to the Philippines. Apparently, a proposal is on the table. TrialSite urges the Philippines to proceed with caution. Russian Vaccine Update TrialSite and others have questions the speed by which the Gamaleya vaccine candidate has gone through clinical trials, including what appears to be aggressive human challenge trials. Recently, the Russian Direct Investment Fund (RDIF), again the sovereign wealth fund that has contributed financing and deal-making, most recently joined an alliance with R-Pharm Group “to combat coronavirus infection and produce the first Russian vaccine with high export potential.” According to rumblings in the Philippines press, Russia invested 4 billion Rubles, or $54 million US. Production Now that RDIF forged a partnership with R-Pharm Group, the latter will produce the vaccine at a new plant in Yaroslavl, reported Alexey Repik, chairman of the board of the R-Pharm Group. On the topic of production, Kirill Dmitriev, a high-powered player leading RDIF—and who joined the human challenge taking the vaccine before approvals were in place—reports the country is in the works to make 30 million doses in Russia and 200 million to be made globally should tests conclude successfully in 2020. Seeking Distribution Partners for the Gamaleya Vaccine Now the Russians are sending signals that they want to do deals with third parties, e.g., other nations. Although Ambassador Khovaev suggests they are “ready to share” this vaccine and this can be triggered in one of three ways including 1) initiate clinical trials in the Philippines if it is deemed necessary, 2) directly supply the vaccine to the Philippines, or 3) license the vaccine to the Philippines for production locally. According to local Philippines press Sunstar, the Russians have already submitted a proposal to the Philippines, which is now under consideration. Vaccine Approval Imminent? More press now is covering the rapidly compressed Russian vaccine timelines. TrialSite has expressed concerns given SARS-CoV-2 just emerged on the world scene, and the most advanced Western life science companies (the most advanced in the world) can’t even more at the speed Russia now operates. But there are political and nationalistic aspirations as Russia harkens back to a Soviet-era momentum in Sputnik and an associated propaganda victory: the Soviet Union did launch the first satellite in 1957. Now, the Gamaleya vaccine commenced formal human trials just a couple of months ago. However, as TrialSite has uncovered through the various press in Russia and beyond early state and what many would consider highly unethical early state testing started a couple of months before that—possibly as early as March or April. Recently, Lawrence Gostin, Georgetown University global public health expert, suggested, “I’m worried that Russia is cutting corners so that the vaccine that will come out maybe not just ineffective, but also unsafe. Perhaps Russia can change the rules of the clinical trials order, but it’s playing a risky game. Russia appears to have undertaken extensive human testing before or in parallel while they ramped up their Phase 1 clinical trial. From the first scientists at Gamaleya to military personnel to a “VIP” program for the rich and famous, the culture is different from that of the West. A different history, heritage, and sense of connection to the State. Will that translate to a superior or inferior COVID-19 vaccine? It can’t be certain. But if corners from the established global clinical trials ICH, GcP standards, the risks for trouble certainly could rise.
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Post by Admin on Aug 12, 2020 7:17:57 GMT
Covid-19 vaccine being developed by Oxford University and the drug giant AstraZeneca generated an immune response in a study of roughly 1,000 patients, according to interim results published Monday. The data, published in the medical journal the Lancet, also show that the vaccine caused side effects, including fever, headaches, muscle aches, and injection site reactions, in about 60% of patients. All of the side effects were deemed mild or moderate, and all resolved themselves over the course of the study. While the Oxford-AstraZeneca vaccine, known as AZD1222, has moved most rapidly into larger-scale studies of any major contender — and AstraZeneca has said that billions of doses could be manufactured — the new data represent the first glimpse researchers have gotten at its efficacy. They show a relatively safe vaccine — though side effects were greater than for a meningitis vaccine, to which it was compared — that engages the immune system to fight the virus. AstraZeneca said that, because of the results, it is likely that future studies will test giving patients two doses of the vaccine. “At the end of the day, you have to prioritize efficacy and then resolve the challenges around the logistics of the trial or logistics of manufacturing large quantities of vaccine,” said Pascal Soriot, AstraZeneca’s CEO, in a briefing with reporters. Related: Moderna’s skyrocketing market value is an indictment of the U.S. Covid-19 response The Lancet also published results of another vaccine, from the Chinese biotech CanSino, that had been previously released. The Phase 2 results showed that, as was seen in the Phase 1 data, the vaccine induced neutralizing antibody responses — which could be vital to preventing the disease’s dangerous symptoms — in most subjects. But further study continues to show that this vaccine works better in some people than others. And among those it didn’t work as well in were people aged 55 and older, a key target for Covid-19 vaccination. “The results of both studies augur well for phase 3 trials, where the vaccines must be tested on much larger populations of participants to assess their efficacy and safety,” wrote two vaccine researchers from Johns Hopkins University, Naor Bar-Zeev and William Moss, in an accompanying editorial. Added Michael Ryan, the World Health Organization’s health emergencies chief: “We now need to move into larger scale, real-world trials, but it is good to see more data, more products moving in to this very important phase of vaccine discovery.” The data on the Oxford-AstraZeneca vaccine do not provide enough information to predict whether it will be more effective than other vaccines that are also entering clinical trials. AZD1222 is one of 23 potential Covid-19 vaccines that are being tested in clinical trials, according to the World Health Organization. Studies in which thousands of volunteers are given either a vaccine or placebo are necessary to know for sure if any vaccine prevents infection with SARS-Cov-2, and how well that vaccine works. No such studies have been completed. All of the volunteers who received the vaccine developed neutralizing antibodies against Covid-19. However, participants who got a single injection of the vaccine did not produce significantly more antibodies than those who had recovered from Covid-19. The vaccine also produced a response in T cells, a type of white blood cell that attacks cells infected with viruses, according to the paper. In a statement, Andrew Pollard of the University of Oxford, the study’s lead author, said that the vaccine is intended to induce both types of responses. “We hope this means the immune system will remember the virus, so that our vaccine will protect people for an extended period,” he said. In the Oxford trial, participants were between the ages of 18 and 55 and split roughly 50-50 between male and female. Ninety-one percent of volunteers were white, while roughly 5% were Asian, and fewer than 1% were Black. The vaccine has already entered large-scale tests, known as Phase 3 trials, aimed at proving its efficacy. It will also be part of the large trials being conducted in the U.S. as part of the government-run program known as Operation Warp Speed. Researchers at the National Institutes of Health2 found that AstraZeneca/Oxford vaccine protected monkeys against SARS-CoV-2, although the protection did not completely prevent the virus from being detected living in the animals’ respiratory tracts. Those results led to the April 23 start of the clinical trial in people that is being released on Monday. 1. www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext2. www.nih.gov/news-events/news-releases/investigational-chadox1-ncov-19-vaccine-protects-monkeys-against-covid-19-pneumonia
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Post by Admin on Aug 16, 2020 7:24:35 GMT
Russia has said that it sees strong global interest in its first coronavirus vaccine dubbed ‘Sputnik V’ being registered for use on Tuesday, adding that the country plans to conduct phase 3 trials in different countries, including India. However, officials at the Union Health Ministry have reportedly denied Moscow’s claim saying no such talk on collaboration had been held.
On Tuesday, August 11, the vaccine developed by the Gamaleya Research Institute and the Russian Defence Ministry was registered by the health ministry for use amid widespread safety concerns raised by various experts from across the world. President Putin announced the approval of the Sputnik V vaccine, claiming it as the world’s first vaccine against the SARS-CoV-2, the virus that causes COVID-19.
A report from the first information website on Sputnik V stated that Russia plans to conduct phase 3 clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and the Philippines. The Russian Direct Investment Fund (RDIF), which finances the production of the Sputnik V in Russia, also claimed that it plans to start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba.
But, a senior official in the Indian Council of Medical Research (ICMR) had denied any information on the matter, reported The New Indian Express.
“As far as our information is concerned, there is no movement on that front yet. Besides, there is also no data from phase 1 and 2 trial of the Russian vaccine yet,” a senior official was quoted as saying by the report.
The report, citing sources, added that Bharat Biotech has been approached by Russia for the production of the Sputnik V vaccine. However, the Hyderabad-based vaccine manufacturer is yet to confirm the claim.
Which countries have shown interest in the Sputnik V vaccine? Russia claimed that at least 20 countries, including UAE, Saudi Arabia, Indonesia, Philippines, Brazil, Mexico and India had expressed interest in obtaining the Sputnik V. Moscow said it plans to start mass production of the vaccine in September and ramp up the production to 200 million doses by the end of 2020, including 30 million doses in Russia.
Despite the scepticism, the Philippines said it has accepted Russia’s offer to participate in clinical trials, vaccine supply and production of the Sputnik V. The Philippines is expected to begin large-scale human trials of Russia's coronavirus vaccine in October. However, Rodrigo Duterte’s spokesman said that the President will not receive the jab until regulators guarantee its safety, AFP reported. Earlier, Duterte had offered himself up as a guinea pig for the first shot. A report from the Manila Bulletin, quoting an official from the Department of Science and Technology (DOST), said that Sputnik V will be registered in the Philippines by conducting a local phase 3 clinical trial, possibly simultaneous with the phase 3 clinical trial in Russia, an official from the Department of Science and Technology (DOST) said.
Similarly, the Brazilian state of Parana had signed a deal to test and produce the Russian COVID-19 vaccine, although officials stressed that they would have to be sure of the vaccine’s safety and effectiveness first. The RDIF is inviting partners to cooperate on international production and clinical trials of the vaccine.
Why is the Sputnik V vaccine under questions? While the phase 1 clinical trials of the Russian vaccine were registered in June 2020, no results have been published in the scientific literature. The vaccine underwent two phases of trials in June and July - with the first phase involving 38 civilians and 38 military volunteers. The second phase included about 100 people, The Moscow Times reported.
Moreover, the candidate is yet to undergo the final stage of testing which requires large numbers of volunteers to assess the safety and efficacy of the vaccine. Registration of volunteers for the phase 3 trials began Tuesday and the studies will also be conducted in other countries, including Saudi Arabia, the United Arab Emirates and the Philippines, according to RDIF head Kirill Dmitriyev.
When will the Sputnik V vaccine be available to the public? Russian Health Minister Mikhail Murashko had said the first batch of the coronavirus vaccine is likely to be released within two weeks, adding that vaccination will be voluntary. Tatyana Golikova, a deputy prime minister in charge of health issues, had said officials hoped that vaccinations of medical workers could start by late August or early September. While mass production of the vaccine is expected to begin in September, Moscow plans to begin a mass vaccination campaign in October.
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Post by Admin on Aug 24, 2020 23:13:14 GMT
A lot of eyebrows were raised when Russia announced it was the first to approve a vaccine for the coronavirus, and even more so when Vietnam said it would buy up to 150 million doses.
Not many were expecting the news, but if it comes to pass, a few factors would explain how Vietnam and Russia got here. The two sides have a long history, from founding father Ho Chi Minh’s revolutionary years in Moscow, to their membership in a modern trade deal. Vietnam has also been more aggressive than most other nations in tackling COVID-19, and it needs an affordable vaccine as the World Health Organization (WHO) warns rich nations against “vaccine nationalism” and hoarding.
The U.S., a key partner of Vietnam, has expressed doubt that Russia developed a vaccine so quickly. Other nations reportedly interested in the vaccine include the Philippines, Indonesia, India and South Korea.
Cold War history
Several nations have already put in pre-orders for other future vaccines, and there are more than 150 programs to research possible vaccines around the world, from silkworm cells in Japan, to new use of RNA instead of DNA in research.
Russia announced this month it is in Phase 2 trial of a vaccine, which involves testing on hundreds of people, as opposed to tens of thousands in Phase 3. Vietnam could buy 50 million to 150 million doses by 2021, according to the state-run newspaper Tuoi Tre.
“A vaccine that has been used in a foreign country may not require any more tests when it's imported to Vietnam,” Dr. Tran Dac Phu, an associate professor at the Vietnam Ministry of Health’s Public Health Emergency Operations Center, said on the national VTV station. “However, its trials must still be applied on humans to test its safety and effectiveness.”
Russia’s relations have frayed elsewhere, from interference in the U.S. presidential election, to its annexation of Ukraine territory which prompted European Union sanctions. By contrast, feathers are mostly unruffled in Asia, especially in Vietnam, one of the world’s last remaining communist nations, which had strong ties to the old Soviet Union. In addition to Ho Chi Minh’s studies of Lenin, many prominent Vietnamese spent their formative years in Cold-War-era Russia before coming home to found companies, such as Vietjet Air.
'Negligent' behavior
The Southeast Asian nation was already conducting its own vaccine research before the Russia announcement, one of many trials globally because scientists need to test on a diverse array of volunteers. However, the first viable vaccine is likely to come from a nation with many resources, leading to fears at the WHO and elsewhere that instead of cooperating, developed nations could put themselves first when a vaccine emerges.
Vietnam was also taking COVID-19 seriously before its peers, but the fight intensified in July when it reported its first ever death from the disease. It has now jumped on the possibility of a vaccine, following a pattern of attacking the pandemic aggressively.
Still people need to keep taking safety measures and not pin all their hopes on a vaccine, said Vu Duc Dam, the Deputy Prime Minister of Vietnam who has been leading the pandemic efforts.
“Because we controlled the disease well for a long time, people have become more negligent,” he said this month. “It’s time to remind ourselves that the pandemic is still going on and the vaccine will only be available to everyone in at least one year. We must strengthen measures to safely live together with the disease.”
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