Oxford, CanSino coronavirus vaccine trials show promising early results

Non-replicating viral vector vaccines induce immune response, show minor side effects, studies report

COVID-19 vaccine shows positive results in first phase of human trials 4 hours ago 8:42
Pharmaceutical company Astra Zeneca and scientists at Oxford University in the U.K. are seeing early signs of success in the first human trial for a COVID-19 vaccine. Phase 1 of the trial had more than 1,000 participants between the ages of 18 and 55. 8:42

Early results from human clinical trials of COVID-19 vaccines from the U.K. and China using similar technology suggest they are safe and induce an immune response in most patients, report two studies published Monday.

The two vaccines are being developed separately, one by AstraZeneca and Oxford University, the other by CanSino Biologics Inc. and China's military research unit.

The vaccine from AstraZeneca and Britain's University of Oxford, called AZD1222, has been described by the World Health Organization's chief scientist as the leading candidate in a global race to halt a pandemic that has claimed more than 600,000 lives.

It did not prompt any serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal, with the strongest response seen in people who received two doses.

U.K. Prime Minister Boris Johnson, whose government has helped to fund the project, hailed the results as "very positive news."

However, the researchers cautioned the project was still at an early stage.

Vaccine trial results good news but there's a long way to go: WHO 5 hours ago 1:52
Dr. Michael Ryan, executive director of the World Health Organization's emergencies program, is encouraged by the most recent coronavirus vaccine data and says large-scale, real world trials will come next. 1:52 "There is still much work to be done before we can confirm if our vaccine will help manage the COVID-19 pandemic," vaccine developer Sarah Gilbert said.

"We still do not know how strong an immune response we need to provoke to effectively protect against SARS-CoV-2 infection," she said, adding researchers needed to learn more about COVID-19 and continue late stage trials, which have already commenced.

AstraZeneca shares surged 10 per cent, but then gave up most of those gains, to trade 1.2 per cent stronger on the day.

INTERACTIVE How close are we to a vaccine for COVID-19? AstraZeneca has signed agreements with governments around the world to supply the vaccine should it prove effective and gain regulatory approval. The company has said it will not seek to profit from the vaccine during the pandemic.

Adrian Hill, the director of Oxford University's Jenner Institute, said early projections that a million doses of the vaccine could be made by September could be an under-estimate, depending on how quickly late-stage trials can be completed. He added it remained possible that the vaccine could be in use by the end of the year.

Researchers said the vaccine caused minor side effects more frequently than a control group, but some of these could be reduced by taking paracetamol.

ONE million doses of potential COVID-19 vaccine by U.K. scientists to be made before proof it works
AZD1222 was developed by Oxford University and licensed to AstraZeneca, which has put it into large-scale, late-stage trials to test its efficacy. It has also already signed deals to produce and supply over 2 billion doses of the shot.

The new trial included 1,077 healthy adults aged 18-55 years with no history of COVID-19.

CanSino vaccine also shows promise, More than 150 possible vaccines are in various stages of development, with U.S. drug-maker Pfizer and China's CanSino Biologics also reporting positive responses for their candidates on Monday.

The COVID-19 vaccine developed by CanSino and China's military research unit was also shown to be safe and induced immune response in most of the recipients, researchers said on Monday.

The National Research Council of Canada announced in May that it would work with CanSino to try to develop its potential vaccine more quickly and to scale up the technology needed to produce enough of the candidate vaccine to protect Canadians.

China approves COVID-19 vaccine for military use, skips final phase of testing. The CanSino candidate, named Ad5-nCOV, is one of a handful of vaccines that have shown some promise in human testing and are gearing up for late-stage trials, along with projects involving Moderna Inc, BioNTech SE and Inovio Pharmaceuticals Inc.

While CanSino's vaccine has yet to start late-stage large-scale clinical trials to assess how well it works to prevent people from becoming infected, it has received the green light to be used in China's military.

The results from the mid-stage study, also published in the medical journal Lancet, supports the testing of the vaccine candidate in a large trial, the study authors said.

CanSino vaccine candidate to be used by Chinese military: China approves COVID-19 vaccine for military use. 20 days ago 8:43 .... A vaccine developed by a Chinese company in collaboration with the Canadian government will skip a final phase of testing and will be used on Chinese soldiers. "I really, really hope they're collecting detailed data," says infectious disease expert Dr. Isaac Bogoch. The vaccine by CanSino has been approved for human testing in Canada. 8:43

The vaccine candidate uses a virus called adenovirus to carry genetic material from the novel coronavirus' protein into the human body, a method also used by researchers at the University of Oxford and AstraZeneca for their vaccine candidate.

The immune responses elicited by the vaccine might be undermined if the inoculated person has already developed high-level adenovirus immunity from a previous infection, Chinese researchers said in a peer-reviewed paper.

Caution over early results. In an accompanying editorial, Naor Bar-Zeev and William Moss of the Johns Hopkins Bloomberg School of Public Health called both the Oxford and Chinese results "encouraging," but said further judgment should wait until the vaccine is tested on much bigger populations.

Bar-Zeev and Moss also called for any effective COVID-19 vaccine to be distributed equitably around the world.

"Global planning is underway, but should be underpinned and informed by specific local realities," they wrote. "Only this way can these very encouraging first early phase randomized trial results yield the global remedy for which we all yearn."

THE LATEST NEWS on Coronavirus: What's happening around the world: on Monday, 20th July 2020

Last week, American researchers announced that the first COVID-19 vaccine tested in the United States, boosted people's immune systems just as scientists had hoped and the shots will now enter the final phase of testing.

That vaccine, developed by the National Institutes of Health and Moderna, produced the molecules key to blocking infection in volunteers who got it, at levels comparable to people who survived a COVID-19 infection.

Federal government orders supplies to give two doses of COVID-19 vaccine when it's ready. The vaccine being developed by Pfizer also works to trigger a similar dual immune response as the Oxford shot.

Nearly two dozen potential vaccines are in various stages of human testing worldwide, with a handful entering necessary late-stage testing to prove effectiveness.

That is the best news that is in the making and as it happens.

Now we all will have to wait to get our immune system SHOT. Hope it will be soon. Sooner the better.

FH.

EDIT: 21st July 2020.

https://www.canadianmanufacturing.com/procurement/feds-order-supplies-to-give-two-doses-of-covid-19-vaccine-when-its-ready-257481/?oly_enc_id=0806C7458478B6T

HOW THEY GOT STARTED AND MOVED SO FAST TO PROVIDE US WITH A VACCINE.

Health ‘A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast

By Andrew Joseph. July 30, 2020. Yisheng Biopharma company.

Researchers work in a lab at Yisheng Biopharma, one of a number of Chinese companies racing to create a Covid-19 vaccine. Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19.

Just six months ago, when the death toll from the corona virus stood at one and neither it nor the disease it caused had a name, a team of Chinese scientists uploaded its genetic sequence to a public site. That kicked off the record-breaking rush to develop vaccines — the salve that experts say could ultimately quell the pandemic.

The colossal impact of the corona virus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ tool kits.

“Once we got the sequence, we pulled the trigger to ask how fast we could go,” said Barney Graham, the deputy director of the National Institutes of Health’s Vaccine Research Center. “And because it was a corona virus, we could get into a Phase 3 trial in six months instead of two years.”

Of course, progress so far remains just that. The vaccines are now facing their real tests: the many month long, Phase 3 trials that will demonstrate whether or not they protect people from the virus.

“This is a huge experiment and no one knows how it’s going to turn out,” said James Le Duc, the director of the University of Texas Medical Branch’s Galveston National Laboratory. Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far.

It’s difficult to associate anything with this pandemic with good fortune, but the fact that the culprit was a corona virus — one that was strikingly similar to others that had previously leapt from animals to people — meant scientists could quickly rejigger vaccine projects in the works for those. It was almost like swapping a blue Lego for a red one in their assemblies.

Many of the teams pursuing vaccines for SARS-CoV-2 (the scientific name of the new corona virus) have previously worked on vaccines for the original SARS virus, which caused a 2003 outbreak that killed some 800 people, and MERS, which has caused 2,500 cases since it started spreading in 2012.

The earlier projects had pointed to a component of the corona viruses called the spike protein as a ripe target for a vaccine, which gave scientists a head start for crafting their candidates. Work on SARS also illuminated stumbling blocks in designing corona virus vaccines that Covid-19 immunizations have so far avoided.

“What really helped was the knowledge gained from the SARS-1 infection,” said Rama Rao Amara, an immunologist and vaccine researcher at Emory University. “SARS-2 is quite similar to SARS-1, especially in that spike protein. People could take a very educated guess that this is the protein that we need to be going after.” An acute, not chronic infection.

SARS-CoV-2 causes an acute disease, Covid-19. It’s an infection that most people will clear on their own, which means there’s a vanquishing immune response that a vaccine can aim to induce in order to protect people.

That’s not true for something like HIV, a virus for which there is no vaccine despite decades of research. HIV causes a chronic infection and integrates itself into people’s genomes; there’s no natural immune response that eliminates the virus that a vaccine can mimic. HIV also mutates much faster than corona viruses do, meaning it’s more difficult to rally a lasting defense.

It’s possible, then, that a pathogen that’s harder to design a vaccine for than the corona virus could ignite the next pandemic.

“We were more prepared for a corona virus than for any other family,” NIH’s Graham said. “To me, this is a wake-up call that we need to have a more systematic universal approach to developing vaccines and other countermeasures for virus families ahead of time.”

Vaccines train the immune system to recognize a pathogen it hasn’t yet encountered.

Normally, our immune system builds that memory by battling an infection, so that it can halt a virus in its tracks should it try to invade a second time. A vaccine acts like that first exposure, but without making people sick.

With SARS-CoV-2, researchers are working with new ways of providing that first look, building vaccines on adaptable platforms engineered to easily pivot from pathogen to pathogen.

Older strategies for developing vaccines, such as obtaining the virus and weakening or inactivating it, are lengthy processes. But the cutting-edge approaches require scientists only to know the virus’ genetic sequence. With that, they can string together the right pieces of code to synthesize vaccines.

School closures in spring linked to drastic decrease in Covid-19 cases and deaths

That’s allowed scientists to move with record speed. Less than 10 weeks after the Chinese scientists published the SARS-CoV-2 sequence, a team from the National Institute of Allergy and Infectious Diseases and the biotech company Moderna had a candidate ready for a Phase 1 trial.

The Moderna/NIAID vaccine was built with mRNA, a piece of genetic code containing the instructions for the corona virus’ spike protein. The vaccine shuttles the mRNA into cells, which “read” those instructions and churn out the protein — providing the immune system with that first peek to the spike, like giving a hound a scent.

A team from Pfizer and the German company BioNTech is also working on an mRNA vaccine, while a company called Inovio is pursuing a vaccine based on a different genetic material, DNA. Neither an mRNA nor a DNA vaccine has been approved before.

Knowing the sequence of the corona virus has also spurred other approaches. Some groups — including Johnson & Johnson, the Chinese firm CanSino, and a collaboration between Oxford University and AstraZeneca — are attaching the gene for the spike protein to another, harmless virus that ferries it into cells. There, it gets expressed into the spike, allowing the immune system to mount its forces. Another company, Novavax, is producing versions of the spike from the gene and using them directly in its vaccine.

Better than the rest or behind the competition? Moderna’s future hinges on how its Covid-19 vaccine fares in their trials.

The spike protein is a strategic choice. The proteins, which give SARS-CoV-2 the crown-like appearance that’s characteristic of corona viruses, attach to receptors on people’s cells, allowing the virus to enter and replicate. By blocking spike proteins, then, vaccines could prevent infection. The spikes are also the “immuno-dominant” piece of the virus, meaning they elicit the strongest immune response. (Some vaccines are based on the whole spike, while some include select portions.)

Researchers are not only relying on advances in vaccine platforms. Innovations in basic genetics, immunology, and structural biology have also fueled the pace at which Covid-19 vaccines are moving. One way scientists have discovered so much about the spike protein, for example, is by applying methods honed over years to research the proteins on HIV.

Money, money, money. Getting a vaccine approved is not just a scientific expedition. It’s about money.

One reason vaccine development is so slow normally is because companies want to see candidates successfully pass through each sequence in the development process before sinking funding into the next phase.

But that playbook doesn’t fly in a pandemic. “This is the biggest emergency we’ve had in our lifetime,” said Kawsar Talaat, a Johns Hopkins infectious disease physician and vaccine researcher. “Money is kind of no object. We don’t have time to wait.”

To rally companies, funding agencies, including governments and foundations like the Coalition for Epidemic Preparedness Innovations, or CEPI, are throwing millions — and in some cases, billions — into the hunt for vaccines. On Sunday, for example, Moderna said it had received $472 million from the U.S. Biomedical Advanced Research and Development Authority, on top of the $483 million it got in April.

Boosting the promise — and reining in the peril — of Covid-19 pre-prints

The money isn’t just to cover the research and trials; it’s also to get companies to start manufacturing their products — even though their vaccines might not prove to be effective. It’s a strategy called manufacturing “at risk,” and public health experts say it’s necessary to ensure that any authorized vaccine can be rolled out to as many people as quickly as possible.

The U.S. government is also striking deals with companies to purchase their vaccines even before clinical trials are completed, including a $1.6 billion agreement with Novavax that includes 100 million doses and a $1.95 billion compact with Pfizer and BioNTech, also for 100 million doses.

“The fact that industry is able to hedge their bets like this and to make these investments is because the government has put up the money,” said UTMB’s Le Duc, who formerly led the Centers for Disease Control and Prevention’s viral diseases division. “The government has recognized that this is an incredibly important issue and we need to be going full blast knowing full well that not all these vaccines will work. Some are going to be duds, and will lose money.”

‘It’s like you injected adrenaline into them’: Facebook’s vaccine misinformation problem faces a new test with Covid-19. Regulatory nimbleness.

In-the-weeds regulatory decisions don’t get much public attention, but they are helping expedite clinical trials and the ultimate evaluation of how effective a vaccine is.

Many of these lessons were first learned during the West African Ebola crisis, when regulators embraced a new dexterity in green-lighting vaccine trials and took a more proactive approach to communicating with companies about the efficacy thresholds products needed to meet. That’s continuing with Covid-19: the Food and Drug Administration, for example, has outlined that vaccines need to prevent infections or reduce the severity of Covid-19 in 50% of recipients to be approved.

The Ebola crisis “really did give the regulators greater experience and more comfort with the idea that they could have greater flexibility than they normally would have,” said Mark Feinberg, the president of the International AIDS Vaccine Initiative and a former executive at Merck Vaccines. “They could make decisions more quickly and really be true partners in the development process.”

Textbook clinical trials include three increasingly large phases that establish how safe and effective a drug or vaccine is. But with the Covid-19 pandemic, some of the trials have been collapsed into Phase 1/2 or Phase 2/3 trials. It’s a wonky distinction, but it can shave weeks or months off the process by saving research teams from having to write new protocols or get additional clearances.

The first U.S. Covid-19 case was found in her district. A congresswoman reflects on the last six months

The speed of vaccine development can also have an adverse effect. Some people have questioned how such a fast-moving process can ensure safety and might abstain from a vaccine. An Associated Press poll in May found that Black and Latinx Americans, who have been disproportionately harmed by the pandemic and have a history of mistreatment by the medical field, are more skeptical about Covid-19 vaccines than white Americans — showing the importance of outreach campaigns that public health experts say are required to increase the uptake of immunizations.

Others have raised suspicions that President Trump — whose vaccine initiative is dubbed Operation Warp Speed — might force an emergency authorization of a vaccine before the election, even if it hasn’t cleared efficacy and safety standards. Presumptive Democratic presidential nominee Joe Biden on Monday raised the specter of politics interfering in the quest for a vaccine.

Scientists and regulators are already stressing that safeguards aren’t being jettisoned. Public health experts say vaccine makers need to be transparent that while manufacturing and regulatory steps are being streamlined, safety checks aren’t being sacrificed.

In a call with reporters Monday, NIH Director Francis Collins, whom former President Obama first tapped for the position, defended the integrity of the decisions regulators will make. “Nothing is being done here to compromise the safety” of Covid-19 vaccine trials, he said, “nor will we compromise on an ultimate conclusion about whether the vaccine is effective. Those issues are going to be tested in the most rigorous way.”

Covid-19 vaccines may cause mild side effects, experts say, stressing need for education, not alarm
The challenges ahead

Exactly what all this speed will translate into remains to be seen. The many month long, final-stage clinical trials starting now will settle that.

The Moderna and Pfizer/BioNTech candidates respectively launched Phase 3 and Phase 2/3 trials this week, and the Oxford/Astra Zeneca vaccine is in a Phase 2/3 trial. Others are entering pivotal studies soon. These involve enrolling thousands of people, injecting half with the candidate and half with a placebo or control, and then comparing whether people who received the vaccine are less likely to be infected than their counterparts.

Oxford phase 3 A doctor injects a study volunteer with a Covid-19 vaccine candidate as part of a clinical trial. Some vaccine candidates could very well fail — a normal part of the scientific pursuit, experts say. “I hope that doesn’t happen, but people need to accept when things don’t pan out the way they hope,” said Maria Elena Bottazzi, the co-director of Texas Children’s Hospital Center for Vaccine Development at Baylor.

It’s also not clear yet what a vaccine “working” will look like. A Covid-19 vaccine might be like the flu vaccine — only preventing infections in some people, or staving off serious disease but still leaving people contagious.

Exclusive analysis of biopharma, health policy, and the life sciences.

A vaccine that prevents even 50% of infections would be a massive lifeline. But experts worry there’s a disconnect between a public expecting vaccines to instantly reset their lives and what the first vaccines may actually allow. Successful vaccines will likely be restricted to front line workers and vulnerable populations at first. It could take some time for enough vaccine to be made for everyone who wants a shot. Some vaccines might require two doses to confer protection.

“It might not be some magic bullet that’s going to stop the pandemic in its tracks, and people need to be prepared for that possibility,” said Columbia University virologist Angela Rasmussen about the first vaccines that reach people. “I really hate the term vaccine race. Because that implies there’s going to be a medal ceremony, and the pandemic is over.”

We now know a lot about how they went about developing and testing. Hopefully we will get our SHOTS soon enough to heave a sigh of relief and go about with our daily lives as before. (The start of the PANDEMIC)


FH.

NEWS. : https://www.nytimes.com/2020/08/02/world/europe/russia-trials-vaccine-October.html

HOW THEY ARE CONTOLLING COVID 19 INSIDE DHARAVI.

FH.

https://www.youtube.com/watch?v=YnYqp-o8a1w

Surprise!! Surprise.!! The RUSSIANS beat us all to it. It is called SPUTNIK 'V'. Yes it is the Vaccine for .. COVID 19 and they are vaccinating their whole population with it.

Russia’s fast-track corona virus vaccine draws outrage over safety.: Their immunization is the first approved for widespread use but could be dangerous because it hasn’t been tested in large trials, say all researchers.

Russian President Vladimir Putin receives a video report about registration of the tested and registered corona virus vaccine. Russia’s president Vladimir Putin announced on 11 August that the country’s health regulator had become the world’s first to approve a corona virus vaccine for widespread use — but scientists worldwide have condemned the decision as dangerously rushed. Russia hasn’t completed large trials to test its safety and efficacy, and rolling out an inadequately vetted vaccine could put at risk people who receive it, researchers say. It could also impede global efforts to develop quality COVID-19 immunizations, they suggest.

“That the Russians may be skipping such measures and steps is what worries our community of vaccine scientists. If they get it wrong it could undermine the entire global enterprise,” says Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, Texas.

“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” Francois Balloux, a geneticist at University College London, said in a statement distributed by the UK Science Media Centre.

The race for coronavirus vaccines: a graphical guide.. In his announcement, Putin said that the Russian regulator had approved a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, even though phase III trials of the vaccine had yet to be completed. Such trials involve giving thousands of people a vaccine or a placebo injection, and then following them to see if the vaccine prevents disease. They also allow researchers to confirm the vaccine’s safety and look for rarer side effects that may not have been observed in smaller, earlier stage trials. Russian health-care minister Mikhail Murashko said that the vaccine would be gradually introduced to citizens, and given to health workers and teachers first.

More than 200 COVID-19 vaccines are in development worldwide and several are already in phase III trials, with more front--runners slated to begin theirs soon. But researchers think that the earliest one of those vaccines could be approved is still months away.

Lack of data
The Gamaleya vaccine has been given to 76 volunteers as part of two early-stage trials listed on Clinical-Trials.gov, but no results from those trials or other pre-clinical studies have been published, and little else is known about the experimental vaccine.

According to the ClinicalTrials.gov listings, the vaccine, which is given in two doses, is made of two adenoviruses that express the coronavirus spike protein. The first dose is an Ad26 virus — the same strain being used in an experimental vaccine being developed by pharmaceutical company Johnson & Johnson and its subsidiary Janssen — while the second ‘booster’ dose is made of an Ad5 virus, like the one in an experimental jab being developed CanSino Biologics in China.

Corona virus vaccines leap through safety trials — but which will work is anybody’s guess. According to the vaccine’s Russian-language registration certificate, all 38 participants who received one or two doses of the vaccine had produced antibodies against SARS-CoV-2’s spike protein, including potent neutralizing antibodies that inactivate viral particles. These findings are similar to results of early-stage trials of other candidate vaccines. Side effects were also similar, such as fever, headache and skin irritation at the site of injection.

Hotez expects that the Gamaleya vaccine will elicit a decent immune response against SARS-CoV-2. “The technical feat of developing a COVID19 vaccine is not very complicated,” he says. “The hard part is producing these vaccines under quality umbrellas — quality control and quality assurance — and then assuring the vaccines are safe and actually work to protect against COVID19 in large phase III clinical trials.”

But little is known about phase III trial plans for the Gamaleya vaccine. “I simply haven’t managed to find any published details of a protocol,” says Danny Altmann, an immunologist at Imperial College London. He hopes the trial is closely tracking the immune responses of participants and looking out for any side effects.

China’s corona virus vaccines are leaping ahead – but face challenges as virus wanes. The head of a Russian government-supported investment fund said the vaccine would go through phase III testing in the United Arab Emirates, Saudi Arabia and other countries, according to the state-owned TASS Russian News Agency. The official said that purchase requests for 1 billion doses had been received by 20 countries, in Latin America, the Middle East, Asia and elsewhere, and that manufacturing was in place to produce 500 million doses, with more capacity in the works.

‘Ridiculous authorization’
Altmann says he is concerned that the vaccine could cause an exacerbated disease that occurs when antibodies generated by the vaccine carry the virus into cells, after exposure to the virus. Another problem could be an asthma-like immune reaction that became an issue with some experimental vaccines against the SARS (sever acute respiratory syndrome) virus. Picking up these reactions would require comparing thousands of people who received a vaccine or placebo and potentially became exposed to SARS-CoV-2.

“It’s ridiculous, of course, to get authorization on these data,” says Svetlana Zavidova, head of Russia’s Association of Clinical Trials Organizations, which works with international pharmaceutical companies and research organizations. Without a completed phase III trial, Zavidova also worries that it will not be clear whether the vaccine prevents COVID-19 or not — or causes any harmful side effects, because of gaps in how Russia monitor the effects of medicines. “Our system for safety monitoring, I think, is not the best,” she says.

Zavidova also worries the vaccine’s approval will be “very harmful” for efforts to run clinical trials of other COVID-19 vaccines and other medicines in Russia.

“Not sure what Russia is up to, but I certainly would not take a vaccine that hasn’t been tested in Phase III,” said Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York City, in a tweet. “Nobody knows if it’s safe or if it works. They are putting [health-care workers] and their population at risk.”

Would the rest of the world give any credit to the Russian Scientists for getting the Vaccine early and save a few Russians and their families? The Russians must know a thing or two which the others don't. Kudos to you HELGA!!. Drop your thingy down and tell them "POTSELUEY MENYA V ZADNITSU"

FH.

How many of us believe this is true? I believe it might be true. Let's wait couple of weeks to see the outcome. Or wait, how can be get transparent news from Russia?

-----------------------------------------------------------------
A Proud Indian Canadian

That's what they say when you have the first one before the sun comes up over the yard-arm.

All of it is TRUE. Everyone is doing research and have arrived at a level that they know it works. The Vaccine research and its effective cure is also known. It is the side reactions that they all want to minimize or avoid. Here they are testing it on 60,000 volunteers. If Russia saying that they are doing it to the whole population and the first 60K are volunteers, it is just as good as what the rest of the world is doing in the tests. Most of them are giving HALF a SHOT and testing. If it produces good results then they will give the others the FULL SHOT.

It is all a game ROULETTE. Hope they all come up winning. HOW TRUE??... The Vaccine is REAL and I want to know the RESULTS. I guess there are a Million other BIG WIGS do too. But NO ONE will whisper or utter a single word. All of them have sealed their lips and threw away the key. That is what GET SMART team did in their show. It is all done under A DOME OF SILENCE.

BBB..(yes B.S.Baffles Brain!!) Your question is a VALID one. HELGA knows a lot more than any of the others. When I meet with her I will repeat what I said here. She will display everything silently.

NJOY

FH.

HEALTH & MEDICINE. :
Here’s what we know about Russia’s unverified coronavirus vaccine. Despite incomplete testing, Sputnik-V may be the first COVID-19 vaccine for the general public Russia coronavirus vaccine.

This coronavirus vaccine developed in Russia may be the first one available for the general public, but the vaccine hasn’t passed all the tests needed to make sure it is safe and works.

ALEXANDER ZEMLIANICHENKO JR/RUSSIAN DIRECT INVESTMENT FUND VIA AP

AUGUST 11, 2020 AT 7:09 PM

Russia has launched a new Sputnik V — this time, a vaccine to combat the coronavirus.

Russian President Vladimir Putin announced in a televised cabinet meeting August 11 that the country is ready to roll out the world’s first COVID-19 vaccine to the general public. Teachers and doctors may be among the first inoculated.

Dubbed Sputnik-V, after the first artificial satellite, the vaccine has been tested in only a small number of people. The announcement came even though no published information is available about the vaccine’s safety and efficacy, and scientists have yet to complete the final phase of clinical testing to determine whether it works. Nonetheless the vaccine has been submitted to the health ministry for registration, comparable to applying for approval from the U.S. Food and Drug Administration.

It “works quite effectively. It forms a stable immunity,” Putin declared.

Researchers around the world have been racing to create a vaccine (SN: 7/10/20), but none have been thoroughly vetted yet. Russia has tried various tactics to get in front of the competition, with hackers in the country reportedly trying to steal vaccine data from the United States, Great Britain and Canada. Being the first to approve a vaccine may be a matter of national pride, but the declaration of victory may be premature, some vaccine researchers say.

Sign up for e-mail updates on the latest coronavirus news and research. Usually, vaccines go through three phases of clinical tests. The first two phases test the vaccine in small numbers of people for safety and may collect data on whether people make antibodies or have other responses to the vaccine. The third phase tests the vaccine in thousands of people to determine whether it lowers the infection rate. That third phase of testing has not even started for the Russian vaccine.

In an open letter to the minister of health, the Moscow-based Association of Clinical Trial Organizations urged the government to delay approval of the vaccine until after Phase III data is in.

“Without that data, it seems reckless to proceed to approving the vaccine,” says virologist Onyema Ogbuagu of the Yale School of Medicine. He is leading Phase III testing at Yale of a vaccine candidate from the drug company Pfizer.

While information is limited about Russia’s COVID-19 vaccine, here’s what we know so far. How does the vaccine work? Researchers at the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, part of the Russian Health Ministry, developed the two-part vaccine. Both parts start with viruses that cause the common cold. Those viruses, adenovirus 5 and adenovirus 26, were each engineered to make the coronavirus’ spike protein. That protein helps the coronavirus latch on to cells and infect them. Since it is on the surface of the virus, it’s also a target for antibodies against the virus.

This approach is similar to other coronavirus vaccines in the works. The University of Oxford working with AstraZeneca uses a chimpanzee adenovirus. And a vaccine devised by China-based CanSino Biologics Inc. is based on adenovirus 5. Johnson & Johnson uses adenovirus 26 for its vaccine. Those vaccines have gone through initial safety tests where participants made antibodies against the virus and didn’t have any serious side effects (SN: 7/21/20).

According to the latest trial information on Sputnik-V, available at clinicaltrials.gov, a U.S. website that tracks clinical trials, 38 people first got a shot containing the engineered adenovirus 26 component. Three weeks later, they received booster injections of the engineered adenovirus 5 component. Results of the study have not yet been published.

Using two adenoviruses instead of one is unusual, but may help solve a potential problem, says Daniel Kuritzkes, a virologist and infectious diseases doctor at Brigham and Women’s Hospital in Boston. Because the body may develop antibodies to the adenovirus carrying the spike protein, a booster shot with that same virus might be rendered useless. The two-step inoculation with different adenoviruses may sidestep that issue.

How many people have been tested?
It’s unclear. The registered trial tested 38 people. That’s “in the ballpark . . . to make sure it doesn’t kill people, essentially,” Ogbuagu says. “That’s a good number for a Phase I study, but that’s just the beginning of vaccine development,” he says.

Russian business people and politicians, including one of Putin’s daughters, have also been given access to the vaccine, Bloomberg reports. And the Russian military completed Phase II tests of the vaccine in July, First Deputy Defense Minister Ruslan Tsalikov said in an interview published in the Argumenty i Fakty newspaper.

Usually, Phase II studies test a vaccine in hundreds of people. But the letter from the clinical trials association says the vaccine has been tested in fewer than 100 people. By contrast, multiple vaccines around the world are now starting Phase III tests with 30,000 people each.

If you want to get to hear the transparent news from HELGA, you will have to wait. She says Russians always do that and it is as clear as MUD.

"Here is to the 'MUD in your eyes' "!! Cheers. The next one is on me.

FH.
You can take a shot NEAT or with O.J.
https://i.redd.it/h1z11bw8rlg51.jpg

----

Quote:

---

Originally posted by Garvo Gujarati

How many of us believe this is true? I believe it might be true. Let's wait couple of weeks to see the outcome. Or wait, how can be get transparent news from Russia?

---

Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective coronavirus vaccine by next year. Researchers are testing 36 vaccines in clinical trials on humans, and at least 89 preclinical vaccines are under active investigation in animals.

SARS-CoV-2

coronavirus

Work began in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March, but the road ahead remains uncertain. Some trials will fail, and others may end without a clear result. But a few may succeed in stimulating the immune system to produce effective antibodies against the virus.

Here is the status of all the vaccines that have reached trials in humans, along with a selection of promising vaccines still being tested in cells or animals.

For an overview of different Covid-19 treatments, see our Coronavirus Drug and Treatment Tracker.

PLEASE READ ON it is with Pictures and all.

Link.: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html


Keep SAFE.

FH.