Russia's Covid-19 vaccine could actually protect people from the disease, as early studies show as the country finally releases data on the controversial sting.
The vaccine was the first in the world to be approved for mass use last month. Vladimir Putin had his eye on injections across the country in October.
The move sparked turmoil in the scientific community as there was no evidence that the vaccine – called Sputnik V – worked or was safe.
However, the results of two early clinical studies carried out in Moscow and published today in the prestigious UK journal The Lancet show that the vaccine is safe and effective.
The Russian scientists behind the studies said the shock stimulated an immune response in all vaccinated participants and did not cause serious health problems.
The production of antibodies seen in the patients suggests that the vaccine was able to prepare the body to fight off Covid-19.
Independent Western scientists said the results were "somewhat reassuring," but warned that the studies were too small and narrow to warrant injecting millions of Russians.
Only 76 people were involved in the study, only half of whom were actually poked, and the volunteers were all healthy and mostly between 20 and 30 years old.
Vaccines can be more dangerous and at risk in older people because their immune systems are too weak to fight off the tiny amounts of virus in the vaccine.
And just because the shock does no harm doesn't mean it can actually prevent infection in real-world situations. To prove this, more rigorous research must be carried out.
Russia's controversial coronavirus vaccine could actually protect people from the disease, early clinical data suggests
The vaccine was the first in the world to be approved for mass use last month. Vladimir Putin had his eye on mass injections in October
Scientists in the US and UK who were not involved in the work said the results were "encouraging" and the vaccine was "showing promise".
However, they were still concerned about the quality of the research and about jumping the gun and pumping the thrust into people too soon.
The research wasn't randomized or placebo-controlled, which means it wasn't up to the highest scientific standard and the effects of the sting couldn't be compared to the health of people who didn't receive it.
Randomized controlled trials ensure that participants do not know whether they are actually receiving the vaccine or a dud and that this is considered critical in eliminating bias.
The trials took place in two hospitals in Moscow, Burdenko Hospital and Sechenov University Hospital.
WHAT DO WE KNOW ABOUT RUSSIA'S VACCINE?
The Russian sting is a type known as a vector viral vaccine. This means he uses a different virus to transport the immunagent – damaged parts of the real coronavirus that can trigger a response but not cause infection – into human cells.
Putin's vaccine uses an adenovirus, a type of virus best known for causing the common cold, which has been weakened so that it cannot cause disease.
The Oxford University vaccine candidate uses the same method.
Russia claims the shock was accelerated by early experiments on monkeys and humans known as Phase I and II trials, and was safe and effective in making antibodies to Covid-19.
However, the scientists behind the vaccine haven't published any scientific data from the studies, which means the results likely haven't been verified by independent experts.
The Russian sting has also not undergone rigorous phase 3 studies, which are believed to be the only way to ensure vaccines are safe and actually work.
During these tests, sometimes referred to as efficacy studies, scientists give the vaccine to tens of thousands of people and wait to see how many become infected.
They then compare their results with volunteers who contracted the infection after receiving a placebo.
Scientists say this final phase is the only way to statistically prove that a vaccine prevents infection.
And because the test group is much larger, the studies can also detect subtle side effects that may only affect a small percentage of people.
These rare side effects can become dangerous as vaccines increase to populations of tens of millions of people.
Professor Peter Openshaw, an expert in experimental medicine at Imperial College London, said today: “It is important to emphasize that this vaccine has not been approved or even fully tested. The Russian health authorities are discussing the procedure for a possible prequalification of the WHO as an approved vaccine.
There are currently 19 vaccines that have been tested for their ability to generate antibodies (Phase I), another 11 that have passed this phase and underwent advanced testing (Phase II), eight in Phase III and one vaccine that is limited to Use is permitted.
So far, it has been reported that the Russian vaccine has undergone human testing in a total of 38 people for less than two months. It seems to be in phase I or II. According to news sources, a Phase III study with 1,600 people is planned. This is not very large for a vaccine study and would require a high infection rate among the volunteers. & # 39;
Professor Openshaw suggested that the type of vaccine the Russians made was likely to cause mild side effects such as fever, headache, and fatigue.
Participants were between 18 and 60 years old and were all rated healthy with no underlying health conditions.
In Phase 1 of the study, the volunteers received part of the vaccine to see if they had any negative side effects.
Nearly 60 percent of participants experienced injection site pain, while half experienced high temperatures – these are generally considered mild, acceptable effects.
Four in ten reported headaches, while a quarter felt weak or low on energy and 24 percent had muscle and joint pain.
All of these symptoms were mild and quite common with many other adenovirus vaccines, so the Sputnik V was considered safe and well tolerated.
An adenovirus is a pathogen best known to cause colds and that can be engineered to match the genetic sequence of SARS-CoV-2, the coronavirus that causes Covid-19.
This technique is also used in prototype vaccines developed by Oxford University and the Chinese company CanSino.
In Phase 2, volunteers were given the full two-dose vaccine so the scientists could monitor their body's immune response.
All 40 subjects who were given the sting produced high levels of antibodies against Covid-19 within 28 days, which theoretically would be enough to fight off the infection.
To analyze the level of immunity each person developed, the scientists compared their antibody levels with blood samples from patients previously infected with the disease.
The authors say that antibody responses appear to be higher in vaccinated individuals than in individuals with natural immunity.
The scientists admit that their studies were limited, including a short follow-up period (42 days), it was a small study, some parts included male volunteers only, and there was no placebo or control vaccine to compare them to.
They say more research is needed to evaluate the vaccine in different populations, including older age groups, people with underlying conditions, and people in risk groups.
The vaccine will now move into phase 3 trials, where tens of thousands of people will be injected with the vaccine and sent back to the community.
You will be monitored regularly to see if the sting can actually prevent you from becoming infected with Covid-19 in real life situations, which is still prevalent in Russia.
However, rigorous phase 3 trials typically last many months – as was the case with the Oxford University vaccine candidate.
Oxford's Sting has been in Phase 3 studies for more than three months and has not yet provided any preliminary results.
But Vladimir Putin has vowed to deliver his country's vaccine by next month, making the vaccine race a matter of national prestige for Russia.
There are growing concerns about the speeding up of studies and fears that the Kremlin will not admit defeat if it does not work in the end.
The lead author of the early studies, Professor Alexander Gintsburg of the Gamaleya National Research Center for Epidemiology and Microbiology in Russia, said, “Preclinical and clinical studies have been conducted that allowed the vaccine to be provisionally approved in accordance with the current decree of the Government of the Russian Federation of April 3, 2020 No. 441.
“This preliminary approval requires a large-scale study, enables vaccination of an approved general population in a phase 3 study, enables use of the vaccine in a population under strict pharmacovigilance, and enables vaccination of high-risk groups. ”
"The Phase 3 clinical trial of our vaccine was approved on August 26, 2020. It is planned to include 40,000 volunteers from various age and risk groups and will be conducted through an online application under constant surveillance of the volunteers."
Putin said one of his daughters Maria (left) and Katerina (right) had been injected with a coronavirus vaccine. According to reports in Russia, the younger Katerina was vaccinated
Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health's International Vaccine Access Center wrote in a linked editorial in the Lancet that the studies were "encouraging but small."
He added: & # 39;Immunogenicity (the fact that it elicits an antibody response) is a good sign, although nothing can be inferred about immunogenicity in older age groups and clinical efficacy for a COVID-19 vaccine has not yet been demonstrated.
“With COVID-19 vaccines, evidence of safety will be critical, not only to vaccine acceptance but also to confidence in vaccination in general.
AstraZeneca begins definitive studies of Oxford University's coronavirus vaccine, enrolling 50,000 people worldwide
The world could get one step closer to receiving a coronavirus sting after Oxford University's vaccine candidate entered final testing phase in the US.
British drug giant AstraZeneca, which owns the rights to the vaccine, said it did so 30,000 American volunteers participated in the phase 3 clinical trial.
There are now 50,000 people around the world taking part in studies to determine whether the bite – known as AZD1222 – can actually prevent people from becoming infected with Covid-19.
In the UK, Brazil and South Africa, thousands of volunteers have already been injected with the experimental drug and are being monitored by scientists.
Oxford professor Sarah Gilbert, the minds behind the bump, said preliminary data from trials in these countries could be expected in the coming weeks.
Cambridge's AstraZeneca said further trials are planned in Japan, where there has been a fatal second wave, and in Russia, where there have been a million cases.
Scientists from AstraZeneca and Oxford have repeatedly promised to deliver the vaccine to the groups most at risk from Covid-19 by the end of the year.
Meanwhile, the UK drug maker today signed a £ 15 million contract with Oxford Biomedica to mass-produce the vaccine if it turns out to be effective.
Gene and cell therapy company Oxford Biomedica will be the only manufacturer of the vaccine in the UK for 18 months.
AstraZeneca has also signed contracts with manufacturers in China, the US and across Europe to supply the Oxford Jab to the whole world.
“A vaccine that reduces disease but does not prevent infection could paradoxically make the situation worse.
& # 39; It could falsely reassure recipients of personal invulnerability and thus reduce transmission mitigation behavior.
"This, in turn, could lead to increased exposure in older adults, who are likely to be less effective, or in other higher-risk groups, who may have lower vaccine acceptance and uptake."
Comment on the results, Professor Ian Jones, a virologist at the University of Reading, said: & # 39; The study confirms what has been observed with adenovirus vectors elsewhere that they are generally safe and have an immune response to the built-in Sars-CoV-2 Make protein.
“While the numbers are relatively low, the dual serotype approach appears to have generated good levels of neutralizing antibodies and T cell activity.
"Everyone wants to know if this translates into on-site protection, and the recently announced Phase 3 trials should provide for that."
Dr. Michael Head, Senior Researcher on Global Health at the University of Southampton, added, “This manuscript confirms some of the public statements made a few weeks ago that this appears to be a very promising vaccine candidate.
& # 39; Phase 1 and Phase 2 studies have been conducted and there is ample reason to expand to much larger Phase 3 studies.
“That would be the right way to develop vaccines. Concerns remain about some of the ambiguous comments previously made about the formal approval and approval of this vaccine.
“At this point in time, we don't know if the vaccine will actually work – that's what the phase 3 studies will tell us.
“Public trust in an approved vaccine is critical, and proposals from Russia and the US that a vaccine can be accelerated without proper research are problematic.
“We need to be open and transparent about the efficacy and safety profiles of all vaccine candidates. Ultimately, we are not allowed to add extra fuel to the fires in the anti-vaccine lobby. & # 39;
Russia claims that 20 countries have already ordered a billion doses of the vaccine, named Sputnik V after the former Soviet space satellite.
Philippine President Rodrigo Duterte has already signed a contract for millions of doses, while India, Brazil and Saudi Arabia have previously expressed interest in the drug, according to Russian officials.
The UK, US and Canada claimed last month that Russia tried to meddle in Western vaccine research to win the race.
Putin announced approval of the vaccine last month, claiming it had been properly tested and proven safe.
"I want to reiterate that it passed all the necessary tests," he said. "The most important thing is to ensure the full safety of the use of the vaccine and its effectiveness."
The Russian leader added that one of his two adult daughters had received two vaccinations and was feeling fine. "She took part in the experiment," said Putin.
Putin said his daughter had a temperature of 38 ° C (100 ° F) on the day of the first vaccine injection, which dropped to 37 ° C (99 ° F) the following day.
After the second shot, the temperature rose again slightly, but then it was all over, Putin said.
He did not reveal whether it was his daughter Maria or Katerina who received the vaccine. However, according to reports in Russia, the younger Katerina was vaccinated.
Additional reports from last month said that part of Russia's business and political elite had been given access to experimental vaccines as early as April.
The Russian President said he hoped the country would start mass producing the vaccine soon.
The Ministry of Health said the vaccine is expected to provide immunity to the coronavirus for up to two years.
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