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First word
As promised, I am providing an update on the high-profile Covid-19 vaccines being developed in Russia and China, in which President Rodrigo Duterte has pinned his hopes that the country will acquire a safe and effective Covid vaccine by the end of year.
On August 11, Russian President Vladimir Putin announced to the world that the country had registered the world’s first Covid-19 vaccine.
The vaccine was dubbed Sputnik V to refresh the world’s memory of Sputnik I, the Soviet Union’s pioneering feat in space exploration.
The reaction to the news was electric. While some were skeptical, there were those, like our President Duterte, who put their country on the line for ample supplies of the Russian vaccine.
That was not all. On August 26, Reuters reported that Russia revealed plans to approve a second Covid-19 vaccine in late September or early October, according to Russian Deputy Prime Minister Tatiana Golikova.
In a televised government meeting, Golikova told President Putin that early-stage clinical trials of the vaccine, developed by the Vector virology institute in Siberia, would be completed by the end of September.
“Until today, there have been no complications between those vaccinated in the first and second stages of the trial,” he said.
The second vaccine will complement Russia’s feat of being the first country to grant regulatory approval to a Covid-19 vaccine after less than two months of human testing.
“Sputnik V” has been hailed as safe and effective by the Russian authorities.
But some in the West expressed skepticism about Russia’s approval of Sputnik V, warning against its use until all internationally approved regulatory tests and measures have been taken.
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, said on Aug. 26 that the final phase of Sputnik V clinical trials was beginning.
He said that 40,000 people will participate in the final tests and that similar tests will also be carried out in five other countries.
As if to cap off these prodigious efforts in Russia, the respected British medical journal The Lancet this month published a study showing that the Russian Sputnik V Covid-19 vaccine is 100 percent effective.
According to a report by Jonny Tickle on RT.com, “The world’s first registered Covid-19 vaccine successfully produced antibodies in all 76 participants in early-stage trials.”
The Sputnik V trials, funded by the Russian Ministry of Health, found that all patients who received the vaccine developed antibodies and none showed significant side effects.
Developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, the formula will first be distributed to professors and medical workers before being available to the general public next year.
As the world’s first Covid-19 vaccine, Sputnik V will enter a third phase trial after elderly scientists successfully test it on themselves.
After its registration, scientists and epidemiologists around the world have criticized Russia for the rapid development of the vaccine, questioning its safety due to the small number of test subjects. Although the trial was successful, longer-term trials, including a placebo comparison, are required to establish its true quality, according to The Lancet.
However, RDIF said that the scientific data provided in the article proves the “safety and efficacy of the Russian vaccine.”
Explaining why it took a month to publish the results, the director of the Gamaleya Institute, Alexander Gintsburg, told the Russian news agency Interfax that it took a long time to prepare and that the article was evaluated by five independent reviewers, following all standard international conventions. peer review.
“The scientific community has evaluated it quite objectively,” he said.
Lancet findings labeled unlikely
On September 8, Bloomberg News reported that a group of international scientists questioned the results of the study of Russia’s rapid coronavirus vaccine that were published in The Lancet, saying some of the findings seemed unlikely.
The researchers raised concerns about apparently identical levels of antibodies in several study participants who were inoculated with the experimental vaccine. This and other patterns in the data present “several different points of concern,” according to an open letter written by Temple University professor Enrico Bucci and signed by more than a dozen other scientists.
The Lancet published the results of the early-phase trial last week, offering the first look at the Russian study for peer review by outside experts. A government move to approve the use of the injection based on the initial results generated widespread skepticism, as the vaccines are typically not licensed before extensive evaluations of their efficacy and safety.
The Lancet said it encourages debate about the articles it has published.
“We have shared the letter directly with the authors and encourage them to participate in the scientific discussion,” the journal said in a statement.
The Gamaleya Research Institute of Epidemiology and Microbiology, which is developing the vaccine, told the Meduza news portal that there were no errors in the study.
“If the Lancet editorial board asks for clarification, we are ready to respond,” Deputy Editor Denis Logunov told Meduza.
Doubts about the vaccines of Russia and China
This is not the first time Western scientists have expressed doubts about Russian vaccines.
Previously, some scientists mentioned the disadvantages of Covid vaccines that were being developed in both Russia and China.
Reuters released the following report on August 31:
“The high-profile Covid-19 vaccines developed in Russia and China share a potential shortcoming: They are based on a common cold virus that many people have been exposed to, potentially limiting their effectiveness, say some experts.
CanSino Biologics’ 6185.HK vaccine, approved for military use in China, is a modified form of adenovirus type 5 or Ad5. The company is in talks to gain emergency approval in several countries before completing large-scale tests, the Wall Street Journal reported last week.
“A vaccine developed by the Gamaleya Institute in Moscow, approved in Russia earlier this month despite limited testing, is based on Ad5 and a second less common adenovirus.
“‘Ad5 worries me just because a lot of people have immunity,’ said Anna Durbin, a vaccine researcher at Johns Hopkins University. ‘I’m not sure what your strategy is … it may not be 70 percent effective. It could be 40 percent effective, and that’s better than nothing, until something else comes along. ‘
“Vaccines are considered essential to end the pandemic that has claimed more than 845,000 lives around the world. Gamaleya has said that her two-virus approach will address Ad5 immunity issues.
“Both developers have years of experience and approved Ad5-based Ebola vaccines. Neither CanSino nor Gamaleya responded to requests for comment.
“Researchers have experimented with Ad5-based vaccines against a variety of infections for decades, but none are widely used. They use harmless viruses as “vectors” to transport genes from the target virus, in this case the new coronavirus, into human cells, triggering an immune response to fight the real virus.
But many people already have antibodies against Ad5, which could cause the immune system to attack the vector instead of responding to the coronavirus, making these vaccines less effective.
“Several investigators have chosen adenovirus or alternative delivery mechanisms. The University of Oxford and AstraZeneca AZN.L based their Covid-19 vaccine on a chimpanzee adenovirus, avoiding the Ad5 problem. Johnson & Johnson’s JNJ.N candidate uses Ad26, a relatively rare strain.
“Dr. Zhou Xing, from Canada’s McMaster University, worked with CanSino on their first Ad5-based vaccine, for tuberculosis, in 2011. His team is developing an inhaled Ad5 Covid-19 vaccine, theorizing that it could circumvent immunity problems pre-existing.
“‘The Oxford vaccine candidate has a huge advantage’ over the injected CanSino vaccine,” he said.
Xing is also concerned that high doses of the Ad5 vector in the CanSino vaccine could induce fever, fueling skepticism about the vaccine.
“‘I think they’ll get good immunity in people who don’t have vaccine antibodies, but a lot of people do,’ said Dr. Hildegund Ertl, founding director of the Vaccine Center at the Wistar Institute in Philadelphia.
“In China and the US, about 40 percent of people have high levels of antibodies from previous exposure to Ad5. In Africa, it could be as high as 80 percent, experts said.
“The Gamaleya vaccine will be administered in two doses: the first based on Ad26, similar to the J&J candidate, and the second on Ad5.
“Alexander Gintsburg, director of Gamaleya, has said that the two-vector approach addresses the problem of immunity. Ertl said it could work quite well in people who have been exposed to one of the two adenoviruses.
“Many experts expressed skepticism about the Russian vaccine after the government declared its intention to administer it to high-risk groups in October without data from large pivotal trials.
“’It is very important to demonstrate the safety and efficacy of a vaccine,’ said Dr. Dan Barouch, a Harvard vaccine researcher who helped design J & J’s Covid-19 vaccine. Often, he noted, large-scale trials “do not give the expected or required result.”
The path ahead is still unclear for vaccines from Russia and China. The world has yet to wait for American vaccines to be approved.
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