Category: Corona Virus Vaccine

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The 87-year-old doctor who invented the rubella vaccine now working to fight the coronavirus – CNBC

April 10, 2020

Stanley Plotkin, dubbed the "Godfather of Vaccines," has worked on vaccines for anthrax, polio, rabies and rotavirus. In the 1960s, at the Wistar Institute in Philadelphia, Plotkin invented the rubella vaccine, which is credited with eradicating the disease in the United States. Plotkin, a pediatrician and vaccinologist, is consulting for pharmaceutical companies on vaccine development to halt the COVID-19 pandemic.

Rubella, also known as German measles, resulted in mild illness for the adults that contracted it but caused major birth defects for fetuses in utero. The '60s saw "a rubella pandemic swept across the United States and Europe and left some 12,000 infants deaf, blind, or with both impairments," according to Wistar Institute. Plotkin's vaccine is the "R" in the MMR vaccine that children get worldwide.

CNBC interviewed Plotkin at his home outside of Philadelphia. This interview has been edited for length and clarity.

How does the COVID-19 pandemic compare to the rubella pandemic?

Rubella infected all kinds of people, but the danger was mainly to pregnant women. We have the current coronavirus, and it can kill people, so everybody is at risk.

Going back to rubella, there was a lot of panic among women, and I was able to calculate that 1% of all of the pregnancies in Philadelphia during the epidemic were affected by rubella. So women were very upset. Today, of course, everyone is upset because coronavirus can infect anyone and is particularly lethal for the elderly. Is today's effort appropriate? I think so. The question is whether one can stop the spread of the virus the way it has been successful in China. Our societies are not like Chinese society, and so it remains to be seen.

Obviously, the social disruption, the economic disruption, is considerably greater than it was with rubella, so how long can we continue? I'm not the person to judge that, but I think it's appropriate what we're doing today to stop the spread of the coronavirus and therefore to ultimately decrease the number of infected people. If we don't [socially isolate], then probably 70% to 80% of us will get infected.

Everyone is talking about "flattening the curve." What does that mean?

The point is to decrease the number of people who get infected, because obviously it's the infected people who transmit [the disease] to other people. If you decrease the number of people carrying the virus, you decrease the propagation of the [pandemic], and that's what the [social] isolation is attempting to do.

The question is, will there be a reservoir of virus which will cause the virus to return? The results in China suggest that at least, at the moment, you can stop the spread of the virus. Whether that will happen here or not remains to be seen.

What do you think of the US government's response to rubella vs. the coronavirus?

Although there was a lot of anguish in the '60s and research was launched by grants through the government, [the response to rubella] was not nearly the same kind of response as with the coronavirus. It wasn't the same panic. There wasn't the same investment of money. There wasn't isolation. This is a much bigger response than [with] rubella. We're in a big rush to develop vaccines against this coronavirus. In the '60s there were multiple efforts to develop vaccines, including my own, but it wasn't the same all-hands-on-board as it is now.

How do you develop a vaccine?

I had worked a lot on the oral polio vaccine, and so I had learned how to weaken a virus. When I launched the project to develop a rubella vaccine, essentially it was to weaken the virus to make it into something that immunizes people but [doesn't] cause the congenital malformations that the natural virus causes.

This is a much bigger response than [with] rubella. We're in a big rush to develop vaccines against this coronavirus. In the '60s there were multiple efforts to develop vaccines, including my own, but it wasn't the same all-hands-on-board as it is now.

One of the big differences is that today, which is 40 years later, we have many different ways of developing vaccines. Now there's something like 40 different projects to develop vaccines, with about half a dozen being far advanced. In those days, there were relatively few ways to develop vaccines, so there were only three or four projects [tackling rubella].

I have considerable hope for a [coronavirus] vaccine, but people have to understand that it's not something like in the movies where you can develop it overnight that it's safe and effective overnight. It's going to take roughly a year before there's enough vaccine, assuming all goes well.

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How has vaccine-creation technology changed since the '60s?

In the '60s we could kill an agent and use the killed material as a vaccine. But today we have ways of using the nucleic acids the DNA or the RNA constructs of the virus. We can use proteins. We can use "vectors," viruses that carry parts of another virus [to] immunize people. And there are other techniques of making proteins that are not exactly like the natural virus but can still immunize people. So that's why there's something like 40-odd efforts to develop the vaccine, of which I would say about six or 10 are actually on the way to being developed as we speak, and there are two in clinical trials already.

Your rubella vaccine was better than its competitors it produced higher levels of antibodies and had fewer side effects but here in the United States it got sidelined and failed to win government approval for 10 years "because of politics," according to a Science magazine article. Tell me about that.

It happened for a reason, which would not be repeated today. One of the competing vaccines was actually developed at the licensing authority, a branch of the FDA. For a pharmaceutical manufacturer, that was very appealing, because it meant that they would get a license for the vaccine because they'd be working with the licensing authority.

The vaccine that I developed was licensed in Europe at the same time. It was only after the accumulation of information about how the two vaccines worked that it was demonstrated that the vaccine that was being used in Europe was better. Therefore, the company actually dropped the vaccine that they had been making and started to produce the one that was being used in Europe.

The FDA does not develop vaccines [anymore]. [Plus], there are so many more ways to develop vaccines that you have multiple candidates, which is great.

You've been quoted saying that the US should license and produce more than one vaccine. What do you mean?

For two reasons one, because until you have large-scale use of a vaccine, you don't know everything about it; you don't know for sure whether your expectations about the vaccine are right. It may be that something you thought was not as good turns out to be better than the one that you thought was the best. It's only in use that you really can make that judgment.

The second, and perhaps more important point, is if we need a vaccine for the population of the world that's not possible for any one company to make. You need multiple manufacturers, so if you have three or four different types of vaccines and they are roughly equivalent in efficacy, so much the better.

How does politics impact the creation of a vaccine?

The main thing is [funding] for vaccine development. On average, it takes about half a billion dollars to develop and manufacture a vaccine. That includes the basic science; that includes the early clinical trials; it includes the Phase 3 trials, where [they] vaccinate thousands of people [and] follow them [to assess] safety and efficacy. Pharmaceutical companies normally spend that kind of money to develop that kind of vaccine, but it takes years to go through that process. With coronavirus, scientists are trying to speed things up and to do it in a most economical way but, still, to produce a vaccine to immunize everybody, there has to be a major investment.

There are some preliminary reports that there's more than one strain of COVID-19, just like there's more than one strain of the flu. Do you think this could become a seasonal problem?

That information is still controversial not everyone accepts the idea that there are different strains of the virus. That remains to be seen. There are four respiratory coronaviruses that were discovered years ago, which do cause common colds and come back each winter whether that's going to happen with [COVID-19] or not, nobody really knows for sure.

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The 87-year-old doctor who invented the rubella vaccine now working to fight the coronavirus - CNBC

Pfizer aims to create coronavirus vaccine by end of 2020 – MLive.com

April 10, 2020

The global pharmaceutical manufacturing company Pfizer is working towards supplying millions of doses of a COVID-19 vaccine by the end of the year, according to the company.

In partnership with German company BioNTech, known for its cancer treatments, the two health tech giants aim to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing, according to a press release from Pfizer.

With BioNTechs head start in mRNA vaccines, which have seen results in animals with influenza, Zika and rabies virus, the two companies hope to supply millions of vaccine doses by the end of 2020.

The companies plan to rapidly scale up capacity to produce hundreds of millions of doses in 2021, according to the press release.

These developments will hinge on technical success of the development program and approval by regulatory authorities, according to the release.

BioNTech will contribute multiple vaccine candidates as part of its vaccine program, which are expected to enter human testing this month, according to the release.

The collaboration is unprecedented, Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical at Pfizer said in the release.

Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before, Dolsten said . I am proud of Pfizers collaboration with BioNTech and have every confidence in our ability to harness the power of science together to bring forth a potential vaccine that the world needs as quickly as possible.

On March 3, Pfizer announced it identified compounds that could potentially be used in a treatment for the coronavirus.

The company completed a preliminary assessment of certain antiviral compounds that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells, according to a press release.

The company is now investing in materials that will accelerate the start of a potential clinical study of the lead molecule three or more months in advance of earlier estimates due to positive pre-clinic results, according to a press release.

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MORE MICHIGAN CORONAVIRUS COVERAGE HERE.

Below is a county-by-county map of Michigan tracking confirmed COVID-19 cases, followed by a map of possible exposure sites and a chart based on the states daily reports. The maps will be updated as more reports are released.

If you are reading this story on mobile and cant see the map, click here to view it on the web.

Reported coronavirus cases:

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Pfizer aims to create coronavirus vaccine by end of 2020 - MLive.com

A New Front for Nationalism: The Global Battle Against a Virus – The New York Times

April 10, 2020

As they battle a pandemic that has no regard for borders, the leaders of many of the worlds largest economies are in the thrall of unabashedly nationalist principles, undermining collective efforts to tame the novel coronavirus.

The United States, an unrivaled scientific power, is led by a president who openly scoffs at international cooperation while pursuing a global trade war. India, which produces staggering amounts of drugs, is ruled by a Hindu nationalist who has ratcheted up confrontation with neighbors. China, a dominant source of protective gear and medicines, is bent on a mission to restore its former imperial glory.

Now, just as the world requires collaboration to defeat the coronavirus scientists joining forces across borders to create vaccines, and manufacturers coordinating to deliver critical supplies national interests are winning out. This time, the contest is over far more than which countries will make iPads or even advanced jets. This is a battle for supremacy over products that may determine who lives and who dies.

At least 69 countries have banned or restricted the export of protective equipment, medical devices or medicines, according to the Global Trade Alert project at the University of St. Gallen in Switzerland. The World Health Organization is warning that protectionism could limit the global availability of vaccines.

With every country on the planet in need of the same lifesaving tools at once, national rivalries are jeopardizing access for all.

The parties with the deepest pockets will secure these vaccines and medicines, and essentially, much of the developing world will be entirely out of the picture, said Simon J. Evenett, an expert on international trade who started the University of St. Gallen project. We will have rationing by price. It will be brutal.

Some point to the tragedy playing out around the world as an argument for greater self sufficiency, so that hospitals are less reliant on China and India for medicines and protective gear.

China alone makes the vast majority of the core chemicals used to make raw materials for a range of generic medicines used to treat people now hospitalized with Covid-19, said Rosemary Gibson, a health care expert at the Hastings Center, an independent research institution in New York. These include antibiotics, blood pressure treatments and sedatives. Everyone is competing for a supply located in a single country, Ms. Gibson said.

But if the laudable goal of diversification inspires every nation to look inward and dismantle global production, that will leave the world even more vulnerable, said Chad P. Bown, an international trade expert at the Peterson Institute for International Economics in Washington.

President Trump and his leading trade adviser, Peter Navarro, have exploited the pandemic as an opportunity to redouble efforts to force multinational companies to abandon China and shift production to the United States. Mr. Navarro has proposed rules that would force American health care providers to buy protective gear and medicines from U.S. suppliers.

We just dont have the production capacity, Mr. Bown said, noting that Chinese industry is restarting, while American factories remain disrupted. Just as you dont want to be too dependent on China, you dont want to be too dependent on yourself. You have now walled yourself off from the only way you can potentially deal with this, in your time of greatest need, which is relying on the rest of the world.

For seven decades after World War II, the notion that global trade enhances security and prosperity prevailed across major economies. When people exchange goods across borders, the logic goes, they become less likely to take up arms. Consumers gain better and cheaper products. Competition and collaboration spur innovation.

But in many countries especially the United States a stark failure by governments to equitably distribute the bounty has undermined faith in trade, giving way to a protectionist mentality in which goods and resources are viewed as zero-sum.

Now, the zero-sum perspective is a guiding force just as the sum in question is alarmingly limited: Potentially vital supplies of medicine are in short supply, exacerbating antagonism and distrust.

Last week, the Trump administration cited a Korean War-era law to justify banning exports of protective masks made in the United States, while ordering American companies that produce such wares overseas to redirect orders to their home market. One American company, 3M, said halting planned shipments of masks overseas would imperil health workers in Canada and Latin America. On Monday, 3M said it struck a compromise with the government that will send some masks to the United States and some overseas.

In recent weeks, Turkey, Ukraine, Thailand, Taiwan, Indonesia, Bangladesh, Pakistan, South Africa and Ecuador have all banned the export of protective masks. France and Germany imposed bans on masks and other protective gear, lifting them only after the European Union barred exports outside the bloc. India banned exports of respirators and disinfectants.

Britain has prohibited exports of hydroxychloroquine, an anti-malarial drug now being tested for potential benefits against the virus. Hungary has banned exports of the raw material for that drug and medicines that contain it.

The export bans are not helpful, said Mariangela Simao, assistant director general for medicines and health products at the World Health Organization in Geneva. It can disrupt supply chains of some products that are actually needed everywhere.

President Trump has been especially aggressive in securing an American stockpile of hydroxychloroquine, disregarding the counsel of federal scientists who have warned that testing remains minimal, with scant evidence of benefits.

India is the worlds largest producer of hydroxychloroquine. Last month, the government banned exports of the drug, though it stipulated that shipments could continue under limited circumstances.

In this situation, each country has to take care of itself, said Satish Kumar, an adjunct professor at the International Institute of Health Management Research in New Delhi. If we are not able to take care of our population, it will be a very critical situation.

After Mr. Trump demanded that India lift the export restrictions on Monday night while threatening retaliation, the government appeared to soften its position.

In view of the humanitarian aspects of the pandemic, said Indias foreign ministry spokesman Anurag Srivastava, the government would allow exports to some nations who have been particularly badly affected an apparent nod to the United States.

Arithmetic suggested that a policy of stockpiling for national needs might leave other countries short. India is likely to require 56 metric tons, but now has only 38 metric tons, said Udaya Bhaskar, director general of the Pharmaceuticals Export Promotion Council of India, an industry body set up by the government to promote exports of Indian medicines.

One manufacturer, Watson Pharma, owned by Teva Pharmaceuticals and based in the western Indian state of Goa, was seeking to triple its production of hydroxychloroquine over the next two weeks.

As global pharmaceutical companies explore new forms of treatment for the coronavirus a complex undertaking even under ideal laboratory conditions they are having to navigate an additional layer of real-world intricacy: geopolitics.

Companies steeped in genomics and the rigorous demands of manufacturing must find a way to develop new drugs, begin commercial production and also anticipate how the predilections of nationalists running major economies may limit supplies.

One of the most closely watched drugs, remdesivir, is made by Gilead, an American company. Though clinical trials have not yet been completed, the company has been ramping up manufacturing to meet global demand in advance of the drugs approval.

Like many newer drugs, remdesivirs formula includes novel substances with limited global availability, according to a statement on the companys website.

Gilead is increasing production in part by expanding beyond its own facilities in the United States, contracting with plants in Europe and Asia, in a move that appeared to hedge its bets against trouble in any one place. The international nature of the supply chain for remdesivir reminds us that it is essential for countries to work together to create enough supply for the world, said Daniel ODay, Gileads chairman and chief executive, in an April 4 statement.

Gilead says it has enough of the drug to treat 30,000 patients, while aiming to amass enough to treat one million by the end of the year. But outside experts questioned whether that would be sufficient.

There is going to be a real fight over the allocation of the remdesivir supply if indeed it proves effective, said Geoffrey Porges, an analyst for SVB Leerink, an investment bank in Boston.

Another drugmaker, the New York-based Regeneron, is preparing a U.S. plant to produce a cocktail of antibodies developed in genetically engineered mice, with tests planned for hospitalized patients and as a preventative treatment. A similar antibody cocktail proved effective against Ebola.

The company is planning the extraordinary action of shifting the production of some of its most profitable drugs one that treats eczema, another for eyes to a factory in Ireland to make room for the experimental treatment.

Regenerons chief executive, Dr. Leonard Schleifer, said the decision to make the new drug cocktail in the United States was both geopolitical and practical.

You want to make it close to where the need is, and we anticipate there will be great need in the United States, he said.

He acknowledged that making products overseas now posed risks that they could be subject to export bans in that country. In addition, Regeneron is receiving federal funds to expand its manufacturing of the vaccine, which carries the expectation that the company will prioritize the American market.

It just made good sense to us to do this in the United States, Dr. Schleifer said.

China has seized on the pandemic as an opportunity to present itself as a responsible world citizen, in contrast to Western democracies that failed to reckon with the threat not least the United States, now the epicenter of the outbreak.

Ever since President Trump took office, unleashing tariffs on friends and foes alike, Chinas paramount leader, Xi Jinping, has sought to exploit the American abdication of global leadership as a chance to crown himself champion of the rules-based trading system.

Given that China is ruled by an unelected Communist Party that subsidizes state-owned companies and tolerates the widespread theft of intellectual property, those claims have strained credulity.

Chinas reputation has also suffered as it pursues its Belt and Road Initiative, a $1 trillion collection of infrastructure projects stretching from East Asia to Europe and Africa that has been engineered to spread Beijings influence and generate business for Chinese companies. Some recipients of Chinese credit have come to see the terms as predatory, prompting accusations that China is an ascendant colonial power.

China has dispatched doctors and ventilators to Italy while offering aid to France, Germany and Spain. Last month, as the European Union banned exports of protective gear, Serbias president, Aleksandar Vucic, embraced Chinas largess, even kissing the Chinese flag.

European solidarity does not exist, Mr. Vucic declared. I believe in my brother, my friend, Xi Jinping, and I believe in help from China. The only country that can help us now is China.

Chinese factories make 80 percent of the worlds antibiotics and the building blocks for a huge range of drugs. Chinese officials have pledged to continue to make these wares available to the world. Such moves may bolster Chinas standing, yet appear unlikely to pacify the Trump administration.

Certainly, it would help in projecting Chinas soft power, said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations. But I dont know whether this would ease concerns in the West, particularly the United States, on the need to diversify the supply of the manufacturing of active pharmaceutical ingredients.

President Trump has long obsessed over the trade deficit with China as a supposed scorecard of American victimization. But given Chinas role as a dominant supplier of hospital gear and medicines, American health effectively depends on being able to buy more from Chinese factories.

Right now, the brightest shiny hope that we have is imports of this stuff, said Mr. Bown, the trade expert. Wed like to run the biggest trade deficit we could possibly find.

Its not that we are buying this stuff from China thats made us vulnerable, he added. Its that we are buying this stuff from China, and we decided to start a trade war with them.

China aims to become the first nation to crack the code for a vaccine, a milestone that could cement its status as a world superpower, resonating not unlike the United States putting a person on the moon.

Its importance lies in being able to display our scientific and technological prowess to other countries, said Yang Zhanqiu, a virologist at Wuhan University, in the central Chinese city where the coronavirus first emerged.

About 1,000 Chinese scientists are now engaged in creating vaccines for the virus, with nine potential versions in development, according to the government. The government is considering bypassing some phases of planned clinical trials to rush potential vaccines into emergency use as soon as this month.

But one element appears in conspicuously short supply international collaboration.

In 2003, when another coronavirus, known as SARS, spread through China with deadly impact, officials from the American Centers for Disease Control and Prevention deployed to Beijing to help the government forge a containment strategy. In the years that followed, Chinese and American authorities collaborated on epidemics in Africa.

But in recent years, American public health authorities have sharply diminished their presence in Beijing at the direction of the Trump administration, said Jennifer Huang Bouey, an epidemiologist and China expert at the RAND Corporation.

Given the overall sentiment that any scientific research will be helping China, the United States is really trying to reduce any collaboration with China, said Ms. Bouey. That really hurts global health.

Theres a lack of trust, said Mr. Huang at the Council on Foreign Relations. Nationalism remains very strong among the Chinese public.

Some international collaboration is taking place. Dr. Seth Berkley, the chief executive of the Gavi Alliance, a nonprofit group started by Bill and Melinda Gates that works to get vaccines to the worlds poor, noted that one of the best Ebola vaccines was discovered by a Canadian public health lab that was transferred to an American drug maker and then manufactured in Germany.

Thats how science is done, and we really ought to follow that paradigm, he said. Nothing illustrates the global nature of this problem better than Covid-19, which started off in Wuhan and spread to 180 countries within three months. This is a global challenge that requires a global response.

But even before a vaccine is confirmed, national governments are already seeking to lock up future supply.

In Belgium, a company called Univercells is preparing to manufacture two vaccines that are under development even before clinical trials are completed, according to its co-founder, Jos Castillo. Univercells expects to begin production by September, with the eventual aim of making as many as 200 million doses a year at a pair of plants south of Brussels.

One country Mr. Castillo declined to disclose it has already ordered half of the supply of vaccines that his company will initially make, a share that would decline to 10 percent as production increases.

Some countries will most likely fail to secure enough vaccine. Its really a matter of scarcity, Mr. Castillo said.

More than overwhelming demand explains the anticipated shortfall. Though the science behind developing vaccines has advanced substantially, making them often involves labor-intensive techniques that are not designed to quickly produce billions of doses.

The bottleneck is to produce it, to make it in very large quantities, Mr. Castillo said.

The sense of urgency appears to have inspired President Trump to try to persuade a German company that is developing a possible vaccine to relocate to the United States. The company, CureVac, has denied it was approached by the United States, and said it had no plans to move.

The president has other weapons. He could cite the Defense Production Act to force American companies to give the United States government priority over other buyers for potential vaccines.

A little-known unit within the Department of Health and Human Services, whose mission is to protect American residents from bioterrorism and pandemics, gives grants to companies to speed their vaccine development. It also often comes with the requirement that recipients supply the government with a stockpile, said James Robinson, a vaccine manufacturing expert who sits on the scientific advisory board of the Coalition for Epidemic Preparedness Innovations, an international consortium dedicated to making vaccines available worldwide.

That division, the Biomedical Advanced Research and Development Authority, recently gave nearly $500 million to Johnson & Johnson to help it develop a coronavirus vaccine and set up a U.S. manufacturing facility.

Johnson & Johnson declined to say whether its arrangement with the government would require it to set aside vaccines for American use. It said it currently had the ability to produce as many as 300 million doses a year at its facility in the Netherlands, was preparing to manufacture a similar number in the United States, and was working with outside partners to add capacity elsewhere.

If the current administration is still in place when the vaccines are available, they are going to be really merciless in terms of privileging the U.S. for supply versus the rest of the world, said Michel De Wilde, a vaccine research consultant, and a former executive at Sanofi, a French vaccine manufacturer.

Around the world, 50 potential vaccines are now in the early stages of development, according to the W.H.O. If history is any guide, scientists will eventually produce an effective version.

What is less certain is whether the benefits will be shared.

Im worried about every country that has the potential to manufacture the vaccine, said Dr. Richard Hatchett, the chief executive of the vaccine consortium. They all have the ability to impose export controls. They all have the ability to nationalize their vaccine industry.

If that is what happens, the dangers proliferate.

If there are epidemics out of control in parts of the world, said Dr. Berkley, of the Gavi Alliance, we will never get control of this because the virus will come back and continue to spread.

Reporting was contributed by Hari Kumar, Karan Deep Singh, Kai Schultz, Javier Hernandez and Andrew Jacobs.

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A New Front for Nationalism: The Global Battle Against a Virus - The New York Times

Here’s how your body gains immunity to coronavirus – The Guardian

April 10, 2020

As the daughter of an air force officer and a nurse, I am fascinated by defence systems. There is none more impressive than the human immune system, equipped as it is with a rich arsenal to defend against different types of pathogen. Viruses have evolved to trick, bypass and evade these defences. Our immune systems have, in turn, learned to recognise and deter these virus stealth tactics. In Covid-19, the enemy is a tiny piece of genetic material wearing a lipid coat and a protein crown.

So how is our immune system able to defend against viral infections, and how does this apply to Covid-19? The virus that causes Covid-19 is called severe acute respiratory syndrome coronavirus 2 (Sars-Cov-2), and was first detected in humans around five months ago. It is a coronavirus. Corona, in Latin, means crown. The virus is adorned with an outer layer of protein covered in spikes, like a crown. These spikes help the virus attach itself to target cells. The research community is fast learning about immunity to Covid-19, and we are also applying our knowledge of similar respiratory viruses to predict what to expect in this infection.

Importantly, Covid-19 cannot gain entry to our homes or bodies by itself we have to let it in

Think of a virus as a robot; it cannot reproduce so it needs a factory of materials proteins, lipids and nucleotides to build copies of itself. The coat allows the virus to attach itself to the target cells membrane. The virus then fuses with the cell and releases a shopping list of instructions on how to build and assemble new viruses. This shopping list, the virus genome, is written in nucleotides (RNA). The first job of a virus that enters our bodies is to invade target cells so that it can comfortably remove its coat and deploy its RNA.

Once inside, the virus commandeers the cell and borrows cellular machinery to build more viruses before immune cells detect the intruders and raise the alarm. Antibody proteins that are able to stick to the virus-spike proteins, and prevent attachment to the target cells, are called neutralising antibodies: generating them is often the goal of protective vaccination.

Our infected cells make the ultimate sacrifice and invite their own destruction by displaying distress signals for T-cells, which swiftly detect and kill them. T-cells are cytotoxic powerful serial killers that can recognise peptide fragments of virus displayed on the infected cell surface. When they do, they release a payload of toxic enzymes that kill the infected cell in a kiss of death. This strategic martyrdom is organised by the immune system to deprive the virus of its replication factories and can lead to the reduction of viral load in the patient. It takes several days for antiviral T-cells to expand and antibodies to be generated. Heres the silver lining: memory cells ensure that if we encounter the same virus again, we can react immediately with pre-existing defences. Sars-Cov-2 is new to humanity so we have no protective immunological memory. Vaccines prepared using harmless parts of the virus can help us build protective memory.

The viruss enemy superpower is spreading. The virus achieves this through shedding from infected patients. Sars-Cov-2 is expert at hopping from person to person, and in some people, it achieves a stealthy existence with mild or no symptoms. Once many copies of the virus are made, it needs to jump to another host. It hitches a ride on droplets that can be coughed or sneezed to a distance of up to two metres. Droplets can survive on surfaces for several hours enabling pick-up by a new host, or they can be directly inhaled if another person is in close proximity. Studies are emerging into animal hosts so far the virus has been detected in a few ferrets, cats, tigers and dogs. No animal deaths have yet been reported, and we dont know if animals can transmit back to humans.

The age differential in fatalities for Covid-19 suggests, with some exceptions, that a healthy immune system is usually able to control infection. Meanwhile, an ageing or weakened immune system may struggle to deploy a protective arsenal. Importantly, Sars-Cov-2 cannot gain entry to our homes or bodies by itself we have to let it in. This is why official advice has centred around cleaning our hands and avoiding touching our faces.

We know that a healthy immune system is usually able to eliminate infection in a couple of weeks. However, we have no understanding of the components of our immune arsenal that contribute to this feat: some vaccines work by creating potent neutralising antibodies; other vaccines generate powerful memory T-cells. Antiviral antibodies emerge as early as three to four days after virus detection, but are they protective against future reinfection? We believe that antibodies to other coronaviruses (Sars, Mers) last from one to three years. Because this is a new virus, we dont yet know the answer to this question. Public Health England is recruiting 16,000 to 20,000 volunteers to monitor antibodies once a month for six to 12 months to confirm whether we can generate long-lasting antibody responses to Sars-Cov-2. Determining the quality of these antibodies will be important to understanding long-term protection.

What is our most potent immune weapon against Covid-19? Cytotoxic T-cells may play an important role. Immunologists and virologists are working together to discover the correlates of protection, to design vaccines that offer long-term defences against Covid-19. Years of investment in research means that we can use existing approaches to respond to this new threat, and early mobilisation of research funders, philanthropists and academics are diverting resources to bolster these efforts on an unprecedented scale. Experience has taught us that vaccines are able to eradicate infections from this planet (for instance, smallpox), and medicines against viruses that dont embed their genetic material to our own (for example, hepatitis C) can also achieve this.

Our secret weapon is research. Scientists are working hard on understanding Covid-19, and collaboration is key to this effort. But until a vaccine or treatment is available, we ought to work hard to protect ourselves and our families: isolate and prevent transmission by using physical distancing, face masks and sensible hygiene. If we all do our part, this little virus holding the world to ransom wont stand a chance.

Zania Stamataki is a senior lecturer and researcher in viral immunology at the University of Birmingham

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Here's how your body gains immunity to coronavirus - The Guardian

More Coronavirus Vaccine Efforts Move Toward Human Trials – The New York Times

April 8, 2020

As the coronavirus pandemic spreads at unprecedented rates, invading the lungs of people of all ages, ethnicities and medical histories, more companies are ratcheting up their efforts to fight the disease with accelerated schedules for creating new vaccines.

In normal circumstances, vaccine development would take around 10 years. But the pharmaceutical industry is racing to compress this timeline with the support of nonprofit organizations, government agencies and regulatory authorities. In just a few months, more than two dozen companies have announced promising vaccine programs, speeding through the early stages of testing unlike ever before.

On Wednesday, Novavax, a Maryland-based biotech company, said its vaccine candidate had stimulated a powerful immune response in lab and animal experiments, producing antibodies that could fight off the coronavirus. The vaccine, called NVX-CoV2373, is set to begin human trials in Australia in mid-May.

While a final product that would be widely available is still a year or more away, the Novavax effort is one of many ready to test in people.

A vaccine made by the biotech company Moderna is already in a clinical trial, which started March 15. Another one, developed by Inovio Pharmaceuticals, was injected into the first adult volunteers on Monday. The health care giant Johnson & Johnson expects to start clinical trials in September, and has received a nearly $500 million partnership via a division of the U.S. Department of Health and Human Services. And experimental vaccines developed by researchers at the University of Pittsburgh and Baylor College of Medicine are also waiting for permission from the Food and Drug Administration to begin testing in people.

Were all trying to do something which we have almost no precedents for, which is accelerating a vaccine in the middle of a pandemic, said Dr. Peter Hotez, who is a co-director of the Texas Childrens Hospital Center for Vaccine Development at Baylor College of Medicine.

There is no proven treatment or vaccine yet against Covid-19, the illness caused by the coronavirus. A vaccine would be the best way to stop further spread of the coronavirus because it enhances the immune systems natural defenses. Of course, many companies are also struggling with ways to partner with manufacturing ventures to produce enough vaccine so that it would be widely available.

White blood cells that act like scouts for the immune system are constantly looking for things that shouldnt be there. Vaccines train these cells to recognize invading viruses before an infection actually occurs. That way, when coronavirus particles do enter the body, the system is prepared to produce antibodies to neutralize the virus.

More than one million people around the world have already been sickened by the coronavirus. For public health experts and those on the front lines, a vaccine cant come soon enough.

If you could only have a vaccine, just imagine you could walk out your door confident that you were not going to get sick, said Dr. Gregory Glenn, the president for research and development at Novavax. Because of that, everyone is very motivated and working to move things quickly.

The team at Novavax is no stranger to the effort that goes into making vaccines. It had worked on experimental vaccines for both SARS and MERS, which are closely related to the new coronavirus. The company also has vaccines for the seasonal flu and respiratory syncytial virus, which causes colds, in the last stages of clinical trials.

When Chinese scientists posted the genetic sequence of the new coronavirus in January, researchers at Novavax immediately started working on recombinant technology to make a synthetic version of the virus. Researchers used a baculovirus to carry bits of genetic material from the coronavirus into cells. Baculoviruses typically infect insects, so they cannot replicate and cause illness in humans.

We never use the real virus, Dr. Glenn said. But we can fool the immune system to think its been attacked.

By combining the recombinant vaccine with an adjuvant, or substance that increases immune stimulation, Novavax was able to achieve a high neutralization titer in preclinical tests a measure of the protective antibodies that can block the virus.

The company hopes to see a similar effect after giving more than 130 healthy adults two doses of the vaccine. Results of the trial, which will be conducted in Australia, are expected around July.

Moderna and Inovio are pioneering a different approach to their vaccines.

Moderna uses RNA technology, while Inovio has developed DNA technology to package the genetic code of coronavirus spike proteins, which make up the crown around the virus and help it latch on to cells. This approach has the advantage of being able to move to trials faster than vaccines that require the production of viral proteins or a weakened version of the actual virus to induce an immune response. But the technology is still unproven. There are no approved RNA or DNA vaccines for any disease.

Dr. Hotezs team and Johnson & Johnson, on the other hand, are relying on technology that is more similar to Novavaxs approach because it has been used successfully to create other vaccines in the past, including one for Ebola that has been registered in Europe and used in the recent epidemic in the Democratic Republic of Congo.

Some countries already have the manufacturing capabilities that will be needed to scale up vaccine production and keep costs low if everything goes well.

Its not very sexy, but its a reliable approach. We know that it works, Dr. Hotez said.

For now, the first stage of clinical trials for each potential coronavirus vaccine must focus on how safe or toxic the vaccine may be at different dose levels. Researchers will carefully collect the medical histories of volunteers participating in the trials and track their antibody levels, liver enzymes and other indicators of emerging side effects.

One concern is that the vaccines may inadvertently cause a phenomenon known as disease enhancement, in which vaccinated people develop more severe inflammation and disease than those who have never been vaccinated. Studies of early SARS and MERS vaccines noted this troublesome complication in some animal models.

If everything looks good and the vaccine appears to be safe, then well go on to trials with much bigger numbers and look at the vaccine efficacy, said Dr. John Ervin, who is leading the Inovio clinical trial in Kansas City, Mo.

In parallel, companies are planning to continue further animal testing, as well as investing in manufacturing capacity both in the United States and abroad. They will need millions of doses for additional clinical trials and even more if a vaccine eventually goes to market.

Companies also have to be prepared for the possibility that some candidates will fizzle out or that demand for a vaccine will decrease by the time one is ready for widespread use. But industry experts are not waiting for this to happen.

The virus is racing through crowded urban areas and slums in certain countries. How do you do social distancing in those places? You dont, Dr. Hotez said.

We are building out a road map for how we how we work as a country for the next two or three years. Thats roughly the time frame that we saw for the 1918 flu pandemic and thats probably likely for Covid-19.

Link:

More Coronavirus Vaccine Efforts Move Toward Human Trials - The New York Times

A coronavirus vaccine is being developed in record time. But don’t expect that technology to speed up flu vaccines yet. – USA TODAY

April 8, 2020

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

Imagine generating a vaccine for the novel coronavirus from your immune system.

The virus that causes COVID-19 has swept the globe with about 1.3 million infections and 70,000 deaths through Sunday evening.Development of a widely available vaccine can take a year or more while a virus continues its rampage.

Key to the race to develop a vaccine for the new coronavirus is a technology that uses the virus' genetic code to essentially persuade your body to make its own vaccine.

This techniqueis faster than egg-based manufacturing, which produces the majority of annual flu vaccines and led to delays in distributing a vaccine forH1N1 during the 2009 pandemic.

And it's enablingapossible vaccine for the new coronavirus to be developed in record time.

Coronavirus updates:Get the latest in USA TODAY's live blog

Its quicker to get started, said Clem Lewin, who is working onvaccine candidates for the manufacturer Sanofi Pasteur. All you need is the blueprint for the protein."

Testing still will take time. Scientists must determine whether any of several vaccine candidates fight the virus effectively. If so, they need to determine the proper dose. This tinkering is what could take a year or more.

When the first potential vaccine from the manufacturer Moderna was injected into people on March 16, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he believed the coronavirus vaccine was being developed at a record pace. It took 63 days to go from identifying a viruss genetic sequence to testing a vaccine in people.

Panic, then neglect: Prior pandemics gave us lessons to fight the coronavirus. But funding dried up.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, speaks at a press briefing with the coronavirus task force on March 17, 2020.(Photo: Evan Vucci/AP)

Several manufacturers pursuing a vaccine for the latest coronavirus have been aided by a technological innovation.

The method that Moderna, Sanofi and others are pursuing is different from traditional vaccinations, in which a weakened or dead version of the virus is introduced into the body, triggering itto createantibodies that would attack the live virus should the person be exposed to it.

In the new approach, pieces of messenger RNA that hold the chemical template of a spike protein from the SARS-CoV-2 virus are injected into a human, said Mark Slifka, a professor of viral immunology at Oregon Health and Science University in Portland, Oregon.

The spikes are what the virus uses to attach to a human cell the first step in sickening someone.

In response to the injection of those molecules, the cells in the body produce the spike protein encoded by that mRNA. That triggers the body tomountan immune response to that viral protein, just as in traditional vaccines.

Essentially, the patient makes their own vaccine, says the narrator of a Moderna video about the vaccine.This cuts out the middleman.

Fauci said volunteers would be given two injections of the potential coronavirus vaccine, the second after 28 days. The doses are 25 milligrams, 100 milligrams and 250 milligrams, he said.

The individuals will be followed for one year both for safety and whether it induces the kind of response that we predict would be protective, Fauci said.

Moderna, the manufacturer conducting the initial tests, projected the first commercially available vaccine in 12 to 18 months. A corporate filing March 23 said CEO Stephane Banceltold Goldman Sachs it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.

US coronavirus map: Tracking the outbreak

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Most flu vaccines are produced from fertilized chicken eggs, a decades-old process that takes four to five months.The mRNA process ismuch faster.

Delays in producing an H1N1 vaccine spurred health officials to urge development of other technologies, according to a Government Accountability Office report.

Its a state-of-the-art technology for the 1950s, Luciana Borio, then director for medical and biodefense preparedness at the National Security Council, said at a 2018 conference on the 100th anniversary of the Spanish flu pandemic.

A New England Journal of Medicine review of the response to H1N1 found that 78 million doses of the vaccine were eventually produced for 70 countries worldwide, but only after two waves of the illness worldwide.

The most serious operational shortcoming ...was the failure to distribute enough influenza vaccine in a timely way, the report said. The cause: distribution problems, "a shortfall in global vaccine-production capacity and technical delays due to reliance on viral egg cultures for production.

Developing a vaccine is laborious, said Harvey Fineberg, a former president of the U.S. Institute of Medicine and former dean of the public-health faculty at Harvard University.

One step is confirmingthat a possible vaccine doesn't causebad reactions in patients. Then scientists examine how much vaccine is required for an antibody response. And they must verify the vaccine actually protects against infection, which is why it's ideal to test during an outbreak.

All those steps come after scientists identifythe genetic sequence to target for a vaccine.

Its like saying,'Ive got my architectural plans my house must be ready to move into,' Fineberg said. There are a lot of things you need to do between now and being ready to open the door.

(Photo: Getty Images)

The manufacturers pursuing coronavirus vaccines are working closely withthe Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Agency.

Moderna is working on 13 potential vaccines. Sanofi is working on two candidates:an mRNA candidate with the company Translate Bio and another option in collaboration with the Biomedical Advanced Research and Development Agency.

Other companies are pursuing other technologies. GlaxoSmithKline is working with China-based Clover Biopharmaceuticals through a different process to produce a cell-based vaccine.

Johnson & Johnson, which is working on several possible vaccines,announced last week it wouldinvest$1 billion for vaccine research, development and testing. The company said it could produce 1 billion doses of a vaccine when the time comes.

Sen. Chris Coons, D-Del., said $3.5 billion in the coronavirus spending packagewill help develop manufacturing technologies to ensure a robust, agile, U.S.-based supply chain of vaccines, therapeutics, and active pharmaceutical ingredients.

The biggest challenge we face in the United States is not developing a vaccine, tricky as that step is, Coons said in a statement. Its that we lack the domestic manufacturing capacity to quickly produce a vaccine once its proven and deliver it to the American people.

Lewin of Sanofi said the global health emergency spurred manufacturers to try different technologies.

We and all the other manufacturers are working as quickly as possible to accelerate these programs while ensuring the vaccine is safe and effective, Lewin said. It isnt business as usual for anybody.

Coronavirus(Photo: USA TODAY)

The technology used todevelop a coronavirus vaccine wont affect the annual flu vaccine because they are different viruses requiring different approaches. But evenbefore the pandemic,steps were underwayto hasten changes to the flu vaccine.

President Donald Trump signed an executive orderin September calling onmanufacturers to move away from egg-based vaccines because of critical shortcomings, including the months they take to produce. The order anticipated a pandemic more lethalthanthe 1918 Spanish flu, which killed 675,000 Americans.

William Schaffner, professor of infectious diseases at Vanderbilt University, said one reason tochange vaccine productionis that growing the vaccine in eggs allows mutationsthat make it less effective.

People were working on this already, Schaffner said. That sort of commitment, a presidential commitment, plus the moneys that go with it, really put the pedal to the metal for future research.

Egg-based vaccine manufacturing has been reliable. Developing another process would require a multimillion-dollar investment in an industry with small profit margins, Schaffner said.

Moving away from egg-based production is not like flipping a switch, he said. Im sure all the manufacturers are all thinking about this, but how and how quickly they do it is another matter.

Other options include cell-based and recombinant processes. A cell-based vaccine is grown in a mammal's cells, such as kidney cells from monkeys or dogs, rather than in a hen's eggs. A recombinant vaccine is created synthetically from the DNA, or genetic instructions, of a protein from the flu virus. The DNA is then combined with a baculovirus, which infects invertebrates.

Other changes could address vaccine delivery, perhaps moving from injections to pills or skin patches, Schaffner said.

A loftier goal is to develop what is called a universal vaccine, which could last five years at a time. Such a vaccine could be administered any time of year during a doctor's visit, rather than just in the fall.

Doing that would require changing how the vaccine attacks the flu virus, whichis shaped like a sphere with lollipops protruding from it. Vaccines so far have targeted the candy at the end ofthe lollipop, which changes every year.

A vaccine that targetsthe stem of the lollipop could offer protection for years, Shaffner said. If you get vaccinated, youre vaccinated against a whole series of different influenza viruses,Schaffner said.

The coronavirus pandemic has come during a severe flu season. This years vaccine is about as effective as usual, according to a Centers for Disease Control and Prevention study of cases through Feb. 8. The study found the severity for people up to 49 years old including hospitalizations was worse than other recent seasons, including the severe year of 2017-2018.

Current influenza vaccines are providing substantial public health benefits,"said the study in CDCs Morbidity and Mortality Weekly Report."However more effective vaccines are needed."

Contributing:Elizabeth Weise

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A coronavirus vaccine is being developed in record time. But don't expect that technology to speed up flu vaccines yet. - USA TODAY

Why a coronavirus vaccine takes over a year to produce and why that is incredibly fast – World Economic Forum

April 8, 2020

As several companies race to develop a coronavirus vaccine, the public is repeatedly reminded that the finish line is at least 12 to 18 months away. This timeline feels excruciatingly long as the coronavirus pandemic continues to ravage the world around us. But it deserves some context. New technologies combined with international cooperation to fight infectious diseases are enabling faster responses to new disease outbreaks, shaving several years from traditional vaccine development timelines. Here are the key steps in the path to developing a vaccine against coronavirus and an outline of what they mean for time saving and for you.

Vaccines reduce the risk of disease by preparing the immune system the bodys natural defense network to recognize, fight and destroy certain bacteria and viruses. While there are different types of vaccines, they work by introducing enough identifying information about a bacteria or virus to cause an immune response in the body without causing illness (though they sometimes cause symptoms). In response to a vaccine, the body sends immune cells to fight this foreign invader. The first time the body encounters a new virus or bacteria, it takes time to develop an appropriate immune response but, once the invader is eliminated, certain immune cells remain that will recognize and be prepared to protect the body from this invader in the future.

Developing a Vaccine with New Technology

Around 10 January, Chinese scientists developed and shared a full genetic sequence of SARS-Cov2, the virus that causes COVID-19, colloquially called coronavirus. Several companies are using this information to develop vaccines that will contain a small amount of genetic code. Certain cells in the body will take up this genetic information and produce elements of the virus, not infecting the person but triggering the immune system to respond.

In 2000, Gavi, the Vaccine Alliance was launched at the World Economic Forum's Annual Meeting in Davos, with an initial pledge of $750 million from the Bill and Melinda Gates Foundation.

The aim of Gavi is to make vaccines more accessible and affordable for all - wherever people live in the world.

Along with saving an estimated 10 million lives worldwide in less than 20 years,through the vaccination of nearly 700 million children, - Gavi has most recently ensured a life-saving vaccine for Ebola.

At Davos 2016, we announced Gavi's partnership with Merck to make the life-saving Ebola vaccine a reality.

The Ebola vaccine is the result of years of energy and commitment from Merck; the generosity of Canadas federal government; leadership by WHO; strong support to test the vaccine from both NGOs such as MSF and the countries affected by the West Africa outbreak; and the rapid response and dedication of the DRC Minister of Health. Without these efforts, it is unlikely this vaccine would be available for several years, if at all.

Read more about the Vaccine Alliance, and how you can contribute to the improvement of access to vaccines globally - in our Impact Story.

DNA or RNA based vaccines are not made with a weakened or deactivated virus, nor elements of the virus, so they can be produced in the lab. This approach is faster and more reliable than traditional vaccine processing, which uses virus grown in eggs or cell cultures. For example, Moderna, in collaboration with the National Institute of Allergy and Infectious Disease (USA), developed the first COVID-19 vaccine in clinical trials using a genetic platform called messenger RNA (mRNA). It took only 42 days to move from vaccine design to human testing an industry record.

While genetic platforms are promising and fast, there are currently no such vaccines approved for human use. In addition to the many companies pursuing vaccines on this platform, other companies are exploring different vaccine approaches such as using a deactivated version of the virus. The benefit of developing and trying multiple potential vaccines is the increased chance that one of them will be approved for public use. First, however, they must go through clinical trials.

Safety, Efficacy and Approval

Vaccines are given to healthy people to prevent disease. While a COVID-19 vaccine is very much needed, a rush to market without appropriate testing could put healthy people at risk. One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person.

The clinical trial process is designed to test whether new vaccines are both safe and effective before making them available to the public. The process typically involves several phases and takes approximately ten years, but governments and industry are making efforts to expedite the process, and even intersperse animal testing throughout, while maintaining safety and efficacy standards, as follows:

The first human trial of a COVID-19 vaccine was administered this week.

CEPI, launched at the World Economic Forum, provided funding support for the Phase 1 study. The organization this week announced their seventh COVID-19 vaccine project in the fight against the pandemic.

The Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017 at the Forum's Annual Meeting bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines against emerging infectious diseases and to enable access to these vaccines during outbreaks.

Coalitions like CEPI are made possible through public-private partnerships. The World Economic Forum is the trusted global platform for stakeholder engagement, bringing together a range of multistakeholders from business, government and civil society to improve the state of the world.

Organizations can partner with the Forum to contribute to global health solutions. Contact us to find out how.

The final step in speeding up production of mass quantities of vaccine is early and robust manufacturing.If manufacturing begins during trials, then a vaccine will be available to the public upon approval.However, vaccines that are manufactured before they are approved are done so at risk.A manufacturer loses significant resources if approval does not come or a vaccine is no longer needed in the marketplace.The more vaccines produced, the more risk incurred.

To mitigate this risk and encourage manufacturing, governments, industry and international organizations are working together. CEPI, the Coalition for Epidemic Preparedness Innovations, made an urgent call for $2 billion in funding to support vaccine development, trials and enhanced manufacturing capacity. Gingko Bioworks committed capacity to manufacturing DNA or RNA based vaccines.Government officials are discussing funding support as well.

CEPI calls for $2 billion to develop vaccine against COVID-19.

Image: Statista

What does this mean for you?

The international community is working together like never before to produce a coronavirus vaccine. If a vaccine is developed in the timeline predicted, then people will have a preventative option should COVID-19 recirculate next year. Protection from the virus will save lives and help society return to functioning as normal.

If the virus fizzles out, the innovative and cooperative multistakeholder approaches taken to develop a vaccine will still have a lasting impact. They led to the fastest time from vaccine design to trial, and may lead to the first approvals of vaccines based on genetic platforms. This technology could fundamentally change how scientists are able to develop vaccines that protect people from new diseases making discovery faster, production more reliable and vaccines potentially more cost effective.

Contributors: Professor Gareth Baynam. Clinical Geneticist, Head Western Australian Register of Developmental Anomalies; Program Director, Undiagnosed Diseases Program, Genetic Services of WA; Adjunct Genomic Policy Advisor, Office of Population Health Genomics, WA Health; Ministerial Council for Precision Health

License and Republishing

World Economic Forum articles may be republished in accordance with our Terms of Use.

Written by

Elissa Prichep, Project Lead Precision Medicine, World Economic Forum

The views expressed in this article are those of the author alone and not the World Economic Forum.

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Why a coronavirus vaccine takes over a year to produce and why that is incredibly fast - World Economic Forum

Pandemic expert calls for manufacturing coronavirus vaccines before they’re proven to work – The Week

April 8, 2020

With the federal stockpile for personal protective equipment dwindling during the COVID-19 pandemic, the Trump administration reportedly sent shipments to states in a third and "final push" before the private sector takes on the bulk of the effort.

But new details from the Department of Health and Human Services and the Federal Emergency Management Agency released by the House Oversight Committee show that the government did not appear to meet states' specific requests upon delivery. The first two rounds of shipments were based on census data from 2010, while the third round apparently wasn't adjusted for population at all.

Vermont and Texas, for example, which aren't remotely comparable in size, both received 120,900 N95 respirator masks. That's good news for Vermont, but not so much for Texas. To put in perspective, Vermont received 193 respirators for every 1,000 residents while Texas got five per 1,000. While equal distribution sounds nice in theory, it doesn't seem to make much sense in this case. Tim O'Donnell

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Pandemic expert calls for manufacturing coronavirus vaccines before they're proven to work - The Week

A vaccine for coronavirus is the goal, but what does it take to get there? – ABC News

April 8, 2020

New South Wales Premier Gladys Berejiklian has warned that social distancing restrictions will be in place in her state "until a vaccine is found".

But what exactly goes into developing a vaccine for a new disease? And how long will that take?

SARS-CoV-2, the virus that causes coronavirus, was only identified a few months ago, and while researchers have been rapidly finding out about the virus and the disease it causes, there's still so much about it we don't understand.

But that doesn't mean the quest for a vaccine is coming from a standing start.

Rapid vaccine development technologies mean that the time it takes to develop a vaccine, which used to be in the order of two to five years, could be condensed down to the 12 18 month timeframe that many experts have been referring to.

And the science that has gone into developing past vaccines also gives researchers a jump on COVID-19.

Even so, creating a new vaccine isn't as simple as taking an existing vaccine and swapping the viruses, said Larisa Labzin, an immunologist from the University of Queensland.

"For each virus or different bacterium that causes a disease, we need a different vaccine because the immune response that's mounted is different," Dr Labzin said.

"Just because we've got a really good vaccine against polio doesn't mean the same thing will work with coronavirus because it's so different."

University of Queensland researchers are one of the groups worldwide working on a potential vaccine for COVID-19.

(Supplied: The University of Queensland)

University of Queensland researchers are one of the groups worldwide working on a potential vaccine for COVID-19.

Supplied: The University of Queensland

Before we had vaccines, the main way to become immune to an illness was to catch it and then recover.

In the process of recovering from an infection, your body develops antibodies and specialised immune cells that learn to fight that particular illness-causing invader, or pathogen.

If you are exposed to the same pathogen in the future, your immune system "remembers" it and dispatches those purpose-built antibodies and specialised immune cells to fight it so you don't get sick again.

"The point of a vaccine is to trick your immune system into thinking it's seen it before without having to go through the whole process of actually getting sick with the virus," Dr Labzin said.

There are a few techniques researchers are exploring for COVID-19 that can be used to stimulate this response in the body, and they each have their pros and cons.

These involve introducing a "live" virus into the body, but one that has been "attenuated" or weakened.

Live attenuated vaccines, such as those used for measles, mumps and rubella, cause a strong immune response, but they take a long time to make and "there's always the possibility that they could mutate within the body or the population to become more dangerous again" Dr Labzin said.

Inactivated vaccines, such as those used for Hepatitis A and the seasonal influenza injection, contain the whole virus, but it's been "killed" by being exposed to ultraviolet light or a chemical.

"The virus is there but it's in a straitjacket. It's still got all its components for the immune system to recognise and mount a response against but it can't cause disease," Dr Labzin said.

The downside of these is that because the virus isn't a threat to the body, the body might not mount much of an immune response to it, and the dose of virus in the vaccine might need to be higher to cause enough of an effect.

Subunit and similar types of vaccines introduce a fragment of the virus into the body, for example, the "spike" protein that sticks out on the shell of a coronavirus.

The spike protein is what actually binds to the receptors in your body and allows the virus to enter your cells.

The idea behind a subunit vaccine is that when the body recognises the protein it creates specialised immune cells that block the receptors, effectively shutting down the door to the virus.

Dr Labzin said there are quite a few subunit vaccines in development for COVID-19 because they have the benefit of being relatively quick to make in comparison to live attenuated and inactivated virus vaccines.

But they carry the same downside of inactivated virus vaccines, in that the challenge is getting the body to recognise the virus fragment as enough of a threat to create an effective immune response.

Unlike the other types, which include the actual virus or portions of it, genetic vaccines simply contain DNA or RNA the code that tells cells what to produce.

These vaccines take advantage of the body's own cells, giving it instructions to create the protein of the virus the vaccine is aiming to protect against.

The body then detects both the genetic material and new protein as foreign and mount an immune response against it.

These types of vaccines are relatively easy and inexpensive to make, but they're newer technology.

Dr Labzin said RNA vaccines were so new there aren't actually any existing vaccines of this type yet.

These vaccines introduce a different type of virus that has been engineered to include proteins of the virus the vaccine is aiming to protect against.

Even though this type of vaccine involves a virus, it can't cause disease but does stimulate an immune response.

"There are licensed vaccines of that type, it has a known track record of working," said Trevor Drew, head of CSIRO's Australian Centre for Disease Preparedness.

A colorised scanning electron micrograph image of a VERO E6 cell (blue) heavily infected with SARS-COV-2 virus particles (orange), isolated from a patient sample.

(Flickr: NIAID)

A colorised scanning electron micrograph image of a VERO E6 cell (blue) heavily infected with SARS-COV-2 virus particles (orange), isolated from a patient sample.

With so many potential avenues to explore, how do researchers and funding bodies know where to direct their efforts?

In an attempt to get an effective COVID-19 vaccine ready as quickly as possible, Dr Lazbin said the World Health Organisation (WHO) and Coalition for Epidemic Preparedness Innovations (CEPI) are "trying to put their eggs in lots of different baskets".

The WHO has released a list of more than 60 vaccines in development all around the world, including a number in Australia.

But even once a vaccine is developed that has promise, there are hurdles it must clear before it can be rolled out around the world.

You might have heard about different phases of clinical trials before. Here's what they mean for the purposes of a COVID-19 vaccine:

Amidst these, the potential vaccine also has to be approved for use by relevant regulatory bodies and, crucially, it has to be manufactured in sufficient amounts and distributed around the world.

As mentioned, there are multiple research groups investigating different approaches to developing a vaccine for COVID-19. Most of these are still at the preclinical phase, although a few in the WHO document are in Phase I trials.

Last week, the CSIRO announced it had begun testing potential vaccines on ferrets at its Australian Animal Health Laboratory in Geelong.

This pre-clinical stage, which is expected to take three months, involves testing potential vaccines for effectiveness as well as evaluating how best to deliver the vaccine, such as via an injection into the muscles or a nasal spray.

The CSIRO site is a pipeline for a number of potential COVID-19 vaccines.

Professor Drew, who is leading CSIRO's COVID-19 virus and vaccine work, said the facility had actually been preparing for these tests since before COVID-19 even broke out.

"We called it Disease X. we didn't know what would come but we knew something would come," he said.

"And then suddenly COVID emerged as the disease."

Ezekiel Uba Nwose, a medical scientist at Charles Sturt University, said you could only speed up processes by so much.

"Normally vaccines take up to five years or more to develop, but ... the relevant authorities can decide to speed up on the conventional protocols to fast-track bringing it to trials," Dr Nwose said.

"No matter what, it needs to undergo trials and validation.

"With the COVID-19 vaccine, I think the earliest several authorities have indicated the earliest we are going to get it is 2021."

Yes, it's possible, Dr Labzin said. Every virus is different and what has worked in the past may not work for the new coronavirus.

"We don't have vaccines against any coronavirus yet," she said.

SARS, MERS and some forms of the common cold are caused by other coronaviruses.

But she's optimistic.

"I think that by taking so many different approaches we should be able to."

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A vaccine for coronavirus is the goal, but what does it take to get there? - ABC News

Trump says there’s light at the end of the tunnel with coronavirus vaccine and treatment research – CNBC

April 8, 2020

President Donald Trump speaks during the daily briefing on the novel coronavirus, COVID-19, in the Brady Briefing Room at the White House on April 6, 2020, in Washington, DC.

Mandel Ngan | AFP | Getty Images

While the coming days in the nation's coronavirus fight look bleak, President Donald Trump gave Americans some reason to hope. "There's tremendous light at the end of the tunnel," he said at a White House press briefing Monday.

"Currently, ten different therapeutic agents are in active trials and some are looking incredibly successful," he said. "But they have to go through a process and it's going to be a quick process based on what the FDA told me." He said another 15 potential treatments are working toward clinical trials, "so they're advancing rapidly."

Trump echoed comments made earlier Monday by World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus, who said the research to develop vaccines and treatments to fight the coronavirus has "accelerated at incredible speed."

Tedros said more than 70 countries have joined WHO's trial to accelerate research on effective treatments and "about 20 institutions and companies are racing to develop a vaccine."

"The viral genome was mapped in early January and shared globally which enabled tests to be developed and vaccine research to start," Tedros said at a news conference at WHO headquarters in Geneva.

White House health advisor Dr. Anthony Fauci said last week that the first human trial testing a potential vaccine to prevent COVID-19 is "on track" with public distribution still projected in 12 to 18 months, which would be the "ultimate game changer" in the fight against the pandemic.

U.S. health officials have been fast-tracking work with biotech companyModernato develop a vaccine to prevent COVID-19. Theybegan their first human trialson a potential vaccine March 16.

New York state last month began the first large-scale clinical trial looking at hydroxychloroquine as a possible treatment for the coronavirus after the Food and Drug Administration fast-tracked the approval process.

Chloroquine has gained a lot of attention aftera small studyof 36 COVID-19 patients published March 17 in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding azithromycin,commonly known as a Z-Pak, to the mix "was significantly more efficient for virus elimination," the researchers said. A small study in China also found that combining chloroquine with azithromycin was "found to be more potent than chloroquine."

"Stay inside and let's win this and let's get our country as soon as we can. I think it's going to be sooner than people think. Things are going really well," Trump said.

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Trump says there's light at the end of the tunnel with coronavirus vaccine and treatment research - CNBC

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