The leading group of scientists advising the Federal Government says there is still no clear frontrunner in the global race to develop a COVID-19 vaccine, and picking a winner after six months is like "betting on a horse race".

Key points:

• The advice comes from 15 of Australia's most prominent researchers and scientists
• The Federal Government is understood to be moving swiftly to lock in agreements across the world

• Australia is particularly interested in a vaccine being developed by Oxford University

As pressure grows across the world to lock in a supply of a COVID-19 vaccine, the Australian Academy of Science's latest update to the Federal Government advises it is still "too early" and backs Australia's current wait-and-see approach.

The yet-to-be-published advice from 15 of Australia's most prominent researchers and scientists — which is currently being peer-reviewed — has been passed on to Australia's chief scientist Alan Finkel. 

The scientists are part of Australia's COVID-19 Rapid Research Information Forum, which is helping guide decisions by Health Minister Greg Hunt and Prime Minister Scott Morrison on which vaccines to prioritise. 

It is understood the latest review, the third so far since the pandemic began, will advise the Federal Government that no clear victor has yet emerged.

Read more:

https://www.abc.net.au/news/2020-08-13/coronavirus-covid19-vaccine-race-in-australia-too-early/12551620

Forbidden Op-Ed: The Sputnik Vaccine as a Lifesaving Global Partnership

by Kirill Dmitriev

This opinion piece, which tells the story behind the creation of the Russian vaccine against COVID-19 and emphasizes the willingness of Russia to cooperate with the international community, has been rejected by all leading Western media.

We therefore decided to publish it as is in order to share our views with an international audience and to lift the blockade imposed on positive information about the Russian COVID-19 vaccine. We believe that this information is crucial for the international effort to fight the world’s biggest challenge and would like readers to decide for themselves why this op-ed has been rejected.

The “Sputnik moment” has happened. The Russian vaccine “Sputnik V” has been launched becoming the world’s first registered COVID-19 vaccine and evoking memories of the 1957 shock launch of a Soviet satellite, which opened space to exploration by humans. This new era led not only to competition but also to many collaborative efforts, including the joint Apollo-Soyuz mission by the United States and the Soviet Union.

A COVID-19 vaccine is the world’s number one priority and many countries, organizations and companies claim they are close to developing one. By the end of this year some other countries may have their own vaccines. It is important that political barriers do not prevent the best available technologies from being used for the benefit of all people in the face of the most serious challenge humankind has faced in decades.

Unfortunately, instead of looking into the science behind the proven adenoviral vector-based vaccine platform Russia has developed, some international politicians and media chose to focus on politics and attempts to undermine the credibility of the Russian vaccine. We believe that such an approach is counter-productive and call for a political “ceasefire” on vaccines in the face of COVID-19 pandemic.

It is not broadly known worldwide that Russia has been one of the global leaders in vaccine research for centuries. Russian Empress Catherine the Great set an example in 1768 when she received the country’s first smallpox vaccination, 30 years before the first vaccination was done in the United States.

In 1892 Russian scientist Dmitri Ivanovsky observed an unusual effect while studying tobacco leaves infected with a mosaic disease. The leaves remained infectious even after the scientist filtered out the bacteria. Although it was still almost half a century before the first virus could be seen through a microscope, Ivanovsky’s research gave birth to a new science called virology.

Since Ivanovsky’s discovery, Russia has been one of the global leaders in virology and vaccine research, producing scores of talented scientists such as researcher Nikolay Gamaleya, who studied at the laboratory of French biologist Louis Pasteur in Paris and opened the world’s second vaccination station for rabies in Russia in 1886.

The Soviet Union continued to support research into viruses and vaccines. Everyone born after the Second World War received mandatory vaccinations against polio, tuberculosis and diphtheria. In a rare example of Cold War era cooperation, three leading Soviet virologists went to the United States in 1955 to offer testing opportunities in the Soviet Union for a U.S. vaccine against polio, a deadly disease which claimed millions of lives. If we were able to cooperate then, we can and must do it again now.

Decades of efforts by Russian and Soviet scientists led to the creation of an excellent research infrastructure, such as the National Center of Epidemiology and Microbiology named after Nikolai Gamaleya. This infrastructure ranges from one of the richest “virus libraries” in the world, created using a unique preservation technique, to experimental animal breeding centers. We are proud of this legacy, which allowed us to create the first approved COVID-19 vaccine in the world. We already received international requests for 1 bln doses of our vaccine and reached international agreements to produce 500 mln doses annually with the intention to ramp it up.

Today, many Western media and politicians question the speed of the COVID-19 vaccine creation in Russia, raising doubts about its efficacy and authenticity. The secret behind this speed is Russia’s expertise in vaccine research. Since the 1980s, the Gamaleya Center has led the effort to develop a technological platform using adenoviruses, found in human adenoids and normally transmitting the common cold, as “vectors” or vehicles, which can induce a genetic material from another virus into a cell.

The gene from adenovirus, which causes the infection, is removed while a gene with the code of a protein from another virus is inserted. This inserted element is small, not a dangerous part of a virus and is safe for the body but still helps the immune system to react and produce antibodies, which protect us from the infection.

The technological platform of adenovirus-based vectors makes it easier and faster to create new vaccines through modifying the initial carrier vector with genetic material from new emerging viruses. Such vaccines provoke a strong response from a human body in order to build immunity while the overall process of vector modification and pilot-scale manufacturing takes only a few months.

Human adenoviruses are considered some of the easiest to engineer in this way and therefore they have become very popular as vectors. Since the start of the COVID-19 pandemic all Russian researchers had to do was to extract a coding gene from the spike of the novel coronavirus and implant it into a familiar adenovirus vector for delivery into a human cell. They decided to use this already proven and available technology instead of going into uncharted territory.

The most recent studies also indicate that two shots of the vaccine are needed to create a long-lasting immunity. Since 2015 Russian researchers have been working on a two-vector approach hence the idea to use two types of adenoviral vectors, Ad5 and Ad26, in the COVID-19 vaccine. In this way, they trick the body, which has developed immunity against the first type of vector, and boost the effect of the vaccine with the second shot using a different vector.

It is like two trains trying to deliver an important cargo to a fortress of a human body which needs the delivery in order to start producing antibodies. You need the second train to make sure the cargo reaches its destination. The second train should be different from the first one, which already came under attack from the body’s immune system and is already familiar to it. So, while other vaccine makers have only one train, we have two.

With its two-vector approach the Gamaleya Center also developed and registered a vaccine against Ebola fever. This vaccine has been used on several thousand people over the last few years creating a proven vaccine platform that was used for the COVID-19 vaccine. Аbout 2,000 people in Guinea received injections of Gamaleya vaccines in 2017-18 and the Gamaleya Center has an international patent for its Ebola vaccine.

The Gamaleya Center used adenoviral vectors to develop vaccines against influenza and against Middle East Respiratory Syndrome (MERS). Both vaccines are currently in advanced stages of clinical trials. These achievements show that Russian labs did not waste their time in the last few decades while the international pharmaceutical industry often underestimated the importance of new vaccines research in the absence of global health threats prior to the COVID-19 pandemic.

Other countries follow in our footsteps developing adenoviral vector-based vaccines. Oxford University is using an adenovirus from a monkey, which has neither been used in an approved vaccine before unlike human adenoviruses. U.S. company Johnson & Johnson is using adenovirus Ad26 and China’s CanSino - adenovirus Ad5, the same vectors the Gamaleya Center is using, but they are yet to master the two-vector approach. Both companies already received large orders for vaccines from their governments.

The use of two vectors is the unique technology, developed by the Gamaleya Center scientists, which differentiates the Russian vaccine from other adenoviral vector-based vaccines under development around the world. Vaccines based on adenoviral vectors also have clear advantages over other technologies such as mRNA vaccines.

Prospective mRNA vaccines, undergoing clinical trials in the United States and other countries, do not use vectors for delivery and represent an RNA molecule with coronavirus protein code wrapped in a lipid membrane. This technology is promising but its side effects, especially an impact on fertility, have not yet been studied in depth. No mRNA vaccine has yet received regulatory approval in the world. We believe that in the global vaccine race to fight coronavirus adenoviral vector-based vaccines will be the winners but even in this category the Gamaleya vaccine has the edge.

The Russian vaccine is now ready and registered. The first two phases of clinical trials are over and their results will be published this month in line with international requirements. These documents will provide detailed information about the vaccine, including the exact levels of antibodies as shown by several third-party tests as well as by Gamaleya’s proprietary test, which identifies the most efficient antibodies attacking the spike of coronavirus.

They will also show that all the participants of the clinical trials developed a 100 percent immunity to COVID-19. Studies on Syrian hamsters, animals which usually die from COVID-19, showed 100% protection and an absence of lung-damage after they received a lethal infection dose. After the registration we will conduct international clinical trials in 3 other countries. Mass production of the vaccine is expected to start by September and we already see strong global interest in the vaccine.

Skepticism among international media and politicians has surfaced just as Russia announced its plans for mass COVID-19 vaccine production. When I spoke with Western media many refused to include key facts about the Russian COVID-19 vaccine research in their stories. We view this skepticism as an attempt to undermine our efforts to develop a working vaccine, which will stop the pandemic and help to re-open the global economy.

It is not the first time Russia has faced international mistrust over its leadership in science when politics stand in the way of scientific breakthroughs and put public health at risk. During the polio outbreak in Japan in the 1950s Japanese mothers whose children were dying from polio, went to demonstrate against their own government, which banned imports of Soviet polio vaccine for political reasons. The protesters achieved their goal and the ban was lifted saving the lives of more than 20 million Japanese children.

Today politics again stand in the way of the Russian technology, which can save lives around the world. Russia is open to international cooperation in fighting this and future pandemics. In the words of a Soviet delegate at the international conference on polio vaccines in Washington in 1960 who said in response to questions from the audience about the vaccine’s safety that we in Russia “love our children and are concerned for their wellbeing as much as people in the United States, or any other part of the world are for their children”.

After these words the Soviet delegation received a standing ovation from the audience and joint work on vaccines continued. The wellbeing and prosperity for future generations is what we need to think about now. All countries in the world need to leave politics behind and focus on finding the best solutions and technologies in order to protect lives and resume economic activity.

Our fund has already secured manufacturing partnerships in 5 countries to jointly produce the Russian vaccine. Maybe at some point thanks to this partnership in fighting COVID-19 we can also review and abandon the politically motivated restrictions on international relations, which have become obsolete and represent an obstacle to coordinated efforts in dealing with global challenges.

Kirill Dmitriev is chief executive officer of the Russian Direct Investment Fund, a sovereign wealth fund with $50 billion under management. 

The views and opinions expressed in the article do not necessarily reflect those of Sputnik.

Russia has registered the world's first vaccine against COVID-19, dubbed Sputnik V, in reference to the Soviet satellite that triggered global space research. Scientists believe the vaccine, developed by the Gamaleya Research Centre, will similarly create a so-called "Sputnik effect" for the rest of the world fighting against the pandemic.

Sputnik has spoken to Denis Logunov, deputy research director at the Gamaleya Centre, to learn more about the scientific research into the Russian coronavirus vaccine, which will be published shortly in international scientific journals.

Logunov revealed how they managed to create the vaccine so quickly, although it usually takes at least 1.5 years, and explained the vaccine is unique because it uses two adenoviruses, the 5th and 26th.

Sputnik: Last Sunday you submitted the results of clinical trials to the Russian Ministry of Health. The results haven't been published yet. What are the main findings of these studies?

Denis Logunov: We have conducted a full range of preclinical studies on the vaccine's safety and efficacy, which were followed by two clinical studies that examined the vaccine in terms of safety and immunogenicity involving healthy volunteers. Based on the results of these studies, the vaccine showed a good safety profile and high immunogenicity. Speaking about specific indicators and numbers achieved, the volunteers' average geometric titer of antibodies reached more than 1 in 14,000, nearly 1 in 15,000. One hundred percent of the volunteers had seroconversion.

Seroconversion is when a person's antibody titer increases more than 4 times compared to the initial, background values. Humoral immunity parameters were also assessed via a virus neutralisation reaction, that is, the virus's direct inactivation by antibodies.

Virus neutralising antibodies have been found in all the volunteers immunised with our vaccine, both when using the dry and the liquid forms of the vaccine. Various cellular immune response indicators were also analysed, in particular, cytotoxic lymphocytes, which is a very important antiviral immunity parameter.

Cytotoxic lymphocytes, which remove virus-infected cells from the body, have been found in all the vaccinated volunteers. Thus, the vaccine has shown very good results in terms of immunogenicity. As for safety, the expected adverse events in the form of temperature and pain at the injection site weren't observed in all the volunteers. These specific numbers will be published shortly.

Sputnik: How many people were involved in the first and second phases of testing?

Denis Logunov: The first and second phases involved 38 people each, a total of 76. The two protocols differed in that the vaccine’s active substance was the same, but its physical state was different. One form was freeze-dried, the other was frozen. There was one active substance but two forms of the vaccine. That is why there were 76 people.

Sputnik: What was the age range of the participants?

Denis Logunov: Volunteers for the first and second phases were recruited from the 18-60 age group.

Sputnik: Media outlets have repeatedly said that it takes at least a year and a half to develop a safe and reliable vaccine. Could you explain how the scientists at the Gamaleya Research Centre managed to create a vaccine so quickly, literally in 5-6 months?

Denis Logunov: It would be wrong to say that we've managed to create a vaccine from scratch in a short time. Four decades have passed since adenoviral vector technology was introduced into practice. Over these four decades, a technological platform was created that has been tested on tens of thousands of people, both on the basis of the 5th and the 26th serotype vector. Since 2015, more than 3,000 people have been vaccinated with adenoviral vector-based vaccines developed at the Gamaleya Centre. Therefore, it was not a 5-month effort in any way, but work over several decades.

Adenoviral vector-based vaccines were not only created in Russia. China, CanSino, and Johnson & Johnson are also working with adenoviral vectors. First of all, it’s about developing vaccines against Ebola. These platforms are well-known and well-studied in clinical trials. Apart from clinical trial results, what can be said in favour of these adenoviral vector-based platforms' safety is that we all suffer from adenoviruses, and no one ever has any consequences in the form of somatic diseases.

The Americans have done quite a lot of work on immunising people with the 4th and 7th serotype of adenoviruses. All US Army recruits are vaccinated with adenoviruses. A large retrospective correlation study on more than 100,000 vaccinated people didn't reveal any abnormalities. Moreover, we’ve been living with adenovirus for millions of years, and there are no associations with somatic pathologies after adenovirus infections. We are not working with live adenoviruses, but with adenovirus vectors.

These are viruses, which have parts of their genomes removed, and they can’t reproduce in human cells. It turns out that living with adenoviruses is not that scary, while living with vectors that are not able to reproduce is completely safe. And my words are supported by tens of thousands of studies of these vectors, including many clinical studies.

Read more:

https://sputniknews.com/interviews/202008171080192137-russias-covid-19-vaccine-is-work-of-several-decades-gamaleya-deputy-research-director-reveals/

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On 11 August, Russia announced the world's first vaccine for COVID-19, named 'Sputnik V', in a bid to curb the pandemic that has currently killed over 737,000 globally. International observers detail why the breakthrough development has been met with either silence or rejection from the Western press.

Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, the Russian anti-coronavirus vaccine has undergone a series of trials launched on 18 June 2020, and has proved to be efficient.

Instead of a sense of relief, the announcement - made by President Vladimir Putin on Tuesday - prompted annoyance and skepticism in the Western mainstream media: "Moscow is cutting corners on testing to score political and propaganda points", The New York Times claims. The Wall Street Journal expressed concern over the "safety" and "efficacy" of the Russian vaccine, while The Guardian alleged that "Sputnik V’s development has been marked by worrying opacity and ethical issues".

According to Doctorow, many of the skeptics are more generally Russia-bashers and detractors, as they know little about the country and have no idea about Russia's scientific community and its achievements over the past decade, precisely in the area of immunology and combating infectious diseases.

Guy Mettan, a Swiss politician and the executive director of the Geneva Press Club, is not confused by the outburst from the Western mainstream press:

Earlier, Russia came on US and European mainstream media radar due to a relatively modest number of COVID-related deaths, despite that a number of countries around the world boasted even lower fatality rates from the coronavirus.

Given the current climate in Western views of Russia, it's not surprising that the vaccine is immediately rejected before its results are known, admits Joe Lauria, editor-in-chief of Consortiumnews. "It's a knee-jerk reaction, though there is reason for measured scientific skepticism as vaccines usually take years to develop", he opines.

Russian scientists provide a clear explanation for the mind-boggling speed of the new vaccine development: the crux of the matter is that it was made on the base of previous research. 

Since the 1980s, the Gamaleya Centre has been developing a technological platform using adenoviruses found in human adenoids and normally transmitting the common cold, as vehicles, or 'vectors', which could carry a genetic material from another virus into a cell.

This method was used to create the vaccine against the deadly Ebola virus in 2015. Russian researchers carried out a great deal of study on the selection of required doses as well as on the side effects of the two-vector vaccine. The anti-Ebola preventive has been used on several thousand people over the last few years, creating a proven platform that was instrumentalised for the development of the COVID-19 vaccine.

Read more:

https://sputniknews.com/analysis/202008111080137681-why-sputnik-moment-of-russias-first-covid-vaccine-triggered-sour-grapes-reaction-in-western-msm/

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I am surprise that the Western media (MSM, MMMMM) has not said that this "success" is in relation to the Russians' ability to manufacture nasty poisons such as Novichok (similar to VX)... I am awaiting for some development, beyond a silly TV series about killing someone in Salisbury with a perfume bottle, coming to your box in your loungeroom... We haven't seen not heard from the Skripals for a long time now... The media owes us some more "evidence", via MI5 and MI6, that Russia did it...

The trials of ‘Sputnik V,’ funded by the Russian Ministry of Health, discovered that every single patient who received the vaccine developed antibodies, and none showed any significant side effects.

On August 11, Russian President Vladimir Putin announced that the country had registered the world’s first Covid-19 vaccine. Developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, the formula will first be distributed to teachers and medical workers before being made available to the general public next year.

Following its registration, scientists and epidemiologists worldwide criticized Russia for the vaccine’s rapid development, questioning its safety due to the small number of trial subjects. Although the testing was successful, longer-term trials, including a placebo comparison, are required to establish its actual quality, according to The Lancet.

However, according to the Russian Direct Investment Fund (RDIF), the scientific data provided in the article proves the “safety and effectiveness of the Russian vaccine.”

Explaining why it took a month to publish the results, Gamaleya Institute head, Alexander Gintsburg, told Russian news agency Interfax that it took a long time to prepare, and the article was evaluated by five independent reviewers, following all standard international peer-review conventions.

“The scientific community has assessed it quite objectively,” he explained.

Read more:

https://www.rt.com/russia/499876-the-lancet-russian-sputnik-vaccine-effectiveness/

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By Marcello Ferrada de Noli, Swedish professor emeritus of public health sciences esp. epidemiology, former Research Fellow at Harvard Medical School.

Above all, there are two essential principles that regulate the survival of mankind. One is the ontogenetic, related to the survival of the individual, the other is the phylogenetic – connected to the survival of the species. The supreme dialectic of it being that, for the human race to survive, we the individuals have to secure our existence, to strive to keep healthy, to be. The only possible way for future generations to be born and exist is to carry on with that atavism.

A nuclear war using the current nuclear weapons can obliterate most of the human populations. And there are still 35 million tons of uranium left to mine – the equivalent to ten billion Hiroshima bombs. More than enough to wipe Earth clean of human life.

But the same may, theoretically, very well be accomplished by a smart deadly virus.

The Covid-19 pandemic has at present decimated lives and economies in all countries, and its massacre continues unabated. Epidemiology monitors estimate that almost one million (940 thousand) individuals on earth have now perished. Among all European and European-Asian countries, the five with the most deaths per capita are Belgium, Italy, Spain, Sweden, and the UK. Covid-19 deaths in Sweden are about five times the death toll in all its Nordic neighboring countries combined.

So far, the only functioning vaccine against an all-out nuclear holocaust has been human intelligence, brainy diplomacy added to strong deterrence, amidst the strive for peaceful coexistence. In the virus battlefront, to this point, the world's first officially registered (and so far, effective) coronavirus vaccine is the Russian-discovered Sputnik V.

Its closest competitor, the AstraZeneca project AZD1222, has only recently resumed clinical trials in the UK after a patient reported an adverse reaction. However, the US authorities have now put the AstraZeneca clinical trials on hold, including testing among American patients, until an investigation is concluded by the US Food and Drug Administration (FDA).

The article in the prestigious medical journal The Lancet, reporting the results of the Sputnik V vaccine, demonstrated that 100 percent of participants in the clinical trials attained a stable humoral and cellular immune response.

There are many economic interests around the UK/Swedish AstraZeneca corporation and their vaccine project. The European Commission has made a down payment of €336 million to acquire 300 million doses of the vaccine – to start with.

And it is not the only pharmaceutical company related to Swedish interests. Novavax, Inc., a US-based company developing a vaccine project, also has facilities in Uppsala, Sweden.

Not surprisingly, the campaign in Sweden against the Sputnik V vaccine has been as forceful as it has been deceiving. In general, the Swedish state media as well as the corporate media (which partly receives financing with public funds), maintains a clear anti-Russian stance. Amina Manzoor, a medical commentator for news outlet Dagens Nyheter (DN), for instance, maintains that “they [the Russians] have no vaccine. It is only propaganda,” but there are no arguments given on the vaccine itself.

And Anna-Lena Lauren, DN’s correspondent in Russia – and who to the best of my knowledge neither has medical nor epidemiological academic education – says to Swedish TV4: “It is very doubtful how effective this vaccine is, and above all, how safe it can be.” In her interview, she mentions President Putin and “Soviet Union” more times than the actual Russian vaccine. The program’s anchor rounds up: “Questions have emerged about this vaccine in the research world. May the vaccine have been approved in Russia for political reasons, a propaganda instrument?”

But if anything is politically biased, it’s those “questions” relentlessly thrown at the Russian vaccine in political and research circles of the West.

The recent open letter of “criticism” from a number of scientists, who sent their reservations to The Lancet, presents no arguments that would invalidate the results of the vaccine. Their issue is with the “presentation of data.”

The “criticism,” widely reported in Western media, was sent by a group led by a US-based Italian researcher. The authors are also mainly Italian doctors, and some professors. One of them, Swedish professor Anders Björkman, is known in the debate for herd immunity.

And contrary to Sweden’s reaction, there are also positive reviews in Western media about Sputnik V. ‘Russian vaccine holds promise and other findings’ writes Medical News Today. ‘Vaccine shows ‘no serious adverse’ effects and creates antibody response’ quotes CNBC in a headline. And even BBC heads a report with ‘Russian vaccine shows signs of immune response’.

For the corporate world in the West, and the governments that represent them, the vaccine issue is a race, a new “cold war”-like confrontation, not about whose technologies would be more advanced for the sake of the health of all, but for the sake of their profits. They are now doing their best to cast unsubstantiated and speculative doubts on Sputnik V. They do it with no consideration of the vast harm this could cause by limiting public access in the nations under their sphere of influence to a potentially life-saving medical tool.

Countries should instead cooperate to decimate this epidemic, all scientific efforts put together to attack a plague killing individuals on Earth independently of race, faith and status. Some states’ selfish stances could end up self-destructive for those same states.

The fact is that the Russian Sputnik V is the closest the world has to a functioning vaccine against Covid-19. To wait too long for cooperation among governments in the implementation of this at-hand vaccination, is to cynically cooperate with the virus. It is to take a cold war against humanity as a whole.

Read more:

https://www.rt.com/op-ed/500981-sputnik-v-cold-war-covid/

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