Category: Covid-19 Vaccine

Hours after Gilead announced that an NIH trial testing their antiviral drug remdesivir in Covid-19 patients had succeeded, NIAID director Anthony Fauci sat on a couch in the Oval Office and gave the world the top-line readout.

The drug induced a 31% improvement on the primary endpoint of time to recovery: 11 days in the drug arm compared to 15 days in the placebo arm, he said, adding that patients taking the drug appeared less likely to die, with an 8% mortality rate in the drug arm compared to 11% in patients given the placebo.

The mortality data were not yet statistically significant, he cautioned but were trending in the right direction. Fauci, surrounded by President Trump, Vice President Mike Pence and several other advisors, said the news was a very optimistic sign in the hunt for treatments to fight the virus.

Although a 31% improvement doesnt seem like a knockout 100%, it is a very important proof of concept, he said. Because what it has proven, is that a drug has blocked this virus.

Fauci said more details would come and that the study would be submitted to a peer-reviewed journal. Trump, who deferred to Fauci in giving the readout, echoed Faucis commentary.

Its a beginning, that means you build on it, Trump said. But its a very positive event.

Shortly after the briefing, the New York Times reported that the FDA was preparing to issue an emergency use authorization for the drugs use in Covid-19. In an email to Endpoints News, the FDA did not confirm or deny the Times report, but a spokesperson said the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.

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AstraZeneca vaults to the front of the Covid-19 vaccine race, teaming up to globalize Oxford candidate - Endpoints News

The federal governments response to the coronaviruspandemic could turn out to be a policy mistake of epic proportions. The successof the current response depends on the development of an effective vaccine inrecord time which allows the country to quickly return to its pre-viruseconomic boom. Should reality fall short, Congress will have created a massiveamount of new federal debt with no plan B.

Policies that provide temporary support to shuttered businesseskeeping their non-working employees on the payroll are tremendously expensive.They will only work if the public-private initiatives underway can engineer aquick reduction in the virus spread that allows the nation to return tobusiness as usual, which is why the success of the governments response hingeson the rapid development of an effective vaccine.

History suggests that expectations of a quick vaccine are heavily optimistic. After almost 40 years of research, there is no vaccine for the HIV. Similarly, there are no vaccines for SARS, MERS, or the common cold. It took 10 years to develop a vaccine for the Avian H5N1 virus. Moreover, vaccines do not offer complete protection. According to the CDC, the current seasonal flu vaccine is estimated to be only 45 percent effective.

The probability of death after contracting COVID-19 is unknown but not insubstantial. In Connecticut, 7.6 percent of all confirmed COVID-19 patients have died. Death rates are similarly high in Massachusetts (5.3 percent), Louisiana (6.2 percent), and Minnesota (7.5 percent). Once asymptomatic cases are accounted for, experts expect the average mortality rate to be much lower, perhaps under 1 percent. Still, without an effective vaccine, the overall risks of the coronavirus are material because a person with the coronavirus likely infects on average between two and 2.5 other people. Without an effective vaccine, informed consumers are likely to demand social distancing mitigation once businesses reopen with or without a government social-distance mandate.

If social distancing remains the only practicalmitigant for the foreseeable future, then many businesses will be forced toadapt to remain viable. It is hard to imagine that airlines, cruise ships, masstransit, eat-in restaurants, sporting events, and all other types of activitiesthat rely on large concentrated gatherings of people will be able to resumepre-crisis operations profitably in this new environment. Taxpayers cannotafford to continue to support these businesses payrolls indefinitely. If the probabilityof survival of these types of businesses is remote in a COVID-19 world, it isshortsighted for Congress to be mortgaging Americas future on programs that freezethese potentially obsolete businesses in time, betting on the unlikely possibilitythat they can quickly and profitably be revived. Congresss failure to devote atleast some of these resources to developing a plan B a plan that does notrely on the timely development of a successful vaccine could end up being anexpensive policy mistake.

It is not surprising that funding for programs that maintain the businesses and lifestyles of voters harmed by the virus through no fault of their own garner unanimous political support. Politicians of all stripes favor programs that grease their own reelection chances, especially when the inevitable spending constraints imposed by shortsighted bailout programs are realized in the future.

However, while there is no doubt the economic transitions catalyzed by the COVID-19 pandemic will be painful for many, they are also unlikely to be avoidable. Congress and the executive branch need to rise above narrow self-interest and focus more attention on formulating a plan B with programs designed to transition the economy so it can continue grow and prosper should the world fail to develop an effective coronavirus vaccine.

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If we can't develop a COVID-19 vaccine, is there a 'plan B' for the economy? - American Enterprise Institute

Researchers at the University of Montana and two Missoula-based biotech companies with ties to venture capitalist Mike Goguen are engaged in separate efforts to develop a COVID-19 vaccine and gain authorization for a mass-scalable viral test.

Inimmune, a private company involved in UMs vaccine work and founded by nationally reputed vaccine scientists, is also gearing up to test an intranasal spray that researchers say has proven in animal testing to protect against other diseases and could offer protection against coronavirus. That testing will be conducted at the Rocky Mountain Laboratories in Hamilton.

Additionally, the biotech firm FYR Diagnostics is seeking emergency-use authorization from the U.S. Food and Drug Administration for a viral-detection test that it developed and which it believes could offer a viable solution to mass testing in Montana and elsewhere. Two Bear Capital, the Montana-based venture capital firm that Goguen launched in 2019, has provided FYR with seed funding and additional investments.

Goguen said this week that Two Bear Capital is also in venture capital funding discussions with Inimmune.

Inimmunes co-founder and CEO is Dr. Jay Evans, director of UMs Center for Translational Medicineand a research professor in biological sciences who is also the principal investigator on the universitys research team that was recently awarded $2.5 million from the National Institutes of Health (NIH) to identify and advance a COVID-19 vaccine candidate.

Evans and two other scientists founded Inimmune in 2016 after their employer, the pharmaceutical giant GlaxoSmithKline, closed its research and development center in Hamilton, leaving a stable of respected vaccine researchers out of a job. The founders established a partnership with UM and launched Inimmune in conjunction with the formation of the colleges Center for Translational Medicine to maintain and expand scientific research in Montana.

Evans said the relationship between the company and university is a mutually beneficial public-private partnership that bolsters research, funding and commercialization opportunities. The center alone has brought the university nearly $70 million in vaccine research funding since 2016.

The research center boasts unique expertise in adjuvants, which are the components added to vaccines to improve the immune response, and novel delivery systems to ensure vaccines are safely and efficiently delivered to the right cells.

These technologies now are being used for the COVID-19 project to rapidly advance a safe and effective vaccine toward human clinical trials, UM stated.

Evans said the 40 people at UM and additional personnel at Inimmune who are involved in vaccine discovery and development form a powerhouse research team. And hes hoping to recruit 10 more researchers as the university center grows.

Theres a reason that NIH comes to our team when theres a national crisis and they need a vaccine developed quickly with good delivery systems and adjuvants, Evans said in an interview earlier this week.

I dont know of another group in the world that has the capacity we do, he added. When we say that were a world-class vaccine discovery and development team, I dont think thats an overstatement.

The university notes that its research team works on a range of new or improved vaccines for influenza virus, tuberculosis, pertussis, Pseudomonas aeruginosa, Lyme disease, E. coli and opioid addiction. After the NIH contacted the university in February, the researchers shifted their attention to developing a vaccine for SARS-CoV-2, the virus strain that causes COVID-19.

We quickly adjusted lower-priority vaccine projects to focus our efforts on this urgent need, Evans said, adding that researchers have navigated school closures, stay-at-home orders and social distancing to rapidly advance this vaccine and continue working on other essential research projects of critical importance to our community and the nation.

Its not every day you can be involved in an essential vaccine project with global health implications, added Dr. Stephanie Lathrop, a UM immunologist and COVID-19 project leader who has been instrumental in designing studies and coordinating staff schedules during the pandemic. It has been amazing to see the UM community rally behind us in support of our efforts.

Evans said the UM team is currently conducting animal testing on COVID-19 vaccine candidates. Although the university was the sole recipient of the recent NIH award, the vaccine development work involves technology produced by both UM and Inimmune.

The $2.5 million allows us to take the technology that currently exists at the university and Inimmune and apply that technology to identify a coronavirus vaccine candidate, Evans said.

After UMs testing is complete, likely in a couple months, the universitys partner in the research, the Icahn School of Medicine at Mount Sinai in New York City, will conduct further testing, moving it closer to human clinical trials, which will require another infusion of funding.

In theory, in six months, we could be in a position to apply for a larger batch of funding that could take us through Phase 1 clinical trials, Evans said, noting that such additional funding could come from agencies or private sources such as venture capital.

Thats where someone like Mike Goguen could really come into the story, he added, noting that Goguen has been assisting Inimmune in an unofficial capacity by helping navigate the different aspects of how to make a company successful in this environment.

More broadly, Evans said Two Bear Capital has emerged as a critical driver of the biotech sphere in Montana.

What Mike is doing for biotech in Montana is pretty incredible, Evans said. Between Next Frontier Capital and Two Bear, if youre a biotech company in Montana, theyre propping up the whole system.

Inimmune has worked for years, independent of UM, to develop an intranasal spray that can protect against certain diseases such as influenza and RSV. If found to work on COVID-19, Evans said the spray could be administered every couple weeks for prolonged protection.

Theres a strong reason to believe these treatments would be effective with the current coronavirus outbreak, Evans said.

Since launching last year, Goguens venture capital firm has focused much of its attention on biotech companies. One such firm is FYR Diagnostics, a Missoula-based molecular diagnostics company that has been developing a mass-scalable and cost-effective COVID-19 viral infection test.

The FDA has approved two different types of COVID-19 tests: antibody tests that detect an individuals immune response to the virus and viral tests that detect the presence of the SARS-CoV-2 virus itself. FYR Diagnostics product is a rapid virus-detection test called Adaptive Low Resource Testing (ALRT), which the company says is effective at identifying a potentially active and contagious infection, even in asymptomatic individuals, but not effective at identifying those who have recovered from the virus.

We are proud to be doing our part to address the COVID-19 crisis, said FYR Diagnostics CEO Chris Booth, Ph.D.

FYR President Sarjubhai Patel is a research professor at UM. Another company cofounder, Braxton Norwood, Ph.D., grew up in Kalispell and graduated from Flathead High School in 1999.

Officials at FYR Diagnostics say several viral-detection diagnostic tests have been approved by the FDA and are in use across the country, but supply chain and equipment shortages have inhibited their capability on a mass scale.

FYR Diagnostics ALRT test opens this bottleneck through alternative reaction components and technologies that do not require scarce equipment or costly specialized devices, the company states. The ALRT test is designed to be low cost, simple to administer without specialized training, and suitable for use at low-resource testing sites beyond hospitals and clinics. It can produce a yes/no test result in 30-40 minutes.

Patel said emergency-use authorization from the FDA would allow for the tests deployment on a broad scale. Goguen, who is FYR Diagnostics executive chairman, noted that insufficient testing capacity here in Montana and throughout the U.S. is amplifying and prolonging the COVID-19 crisis while putting more lives at risk.

FYRs highest priority is to quickly enable mass COVID-19 testing in our home state, and then expand elsewhere, Goguen said.

Goguen founded Two Bear Capital after previously spending 20 years at one of the worlds leading venture capital firms in Silicon Valley, Sequoia Capital. He said the research and development occurring in the state, from universities to private companies, is a badge of honor for Montanans.

In my opinion, we have a lot to be proud of in Montana to have such important work being done right here in our state because of the expertise of folks at UM and at these companies, Goguen said.

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Development of COVID-19 Vaccine, Tests Advancing in Montana - Flathead Beacon

As the number of coronavirus infections worldwide surpasses 3 million, the hunt for a vaccine against COVID-19 grows ever more urgent. At least 13 potential vaccines are in development, with three already being tested in humans, but scientists say the public may have to wait months, if not a year or more.

Here & Now's Tonya Mosley speaks withHelen Branswell(@HelenBranswell), infectious diseases and global health reporter for STAT.

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Tracking The Growing List Of COVID-19 Vaccine Developments - WBUR

Youve heard about hydroxychloroquine, but do you know about Remdesivir, Roivant, and Athersys? If youre keeping an eye on a possible vaccine, do you know there are more than a dozen vaccine candidates that are either doing trials now or hoping to start soon? This tracker from healthcare news outlet STAT has you covered.

The tracker doesnt include every possible drug and vaccine effort, but it does list some of the most talked about and sorts them to put the ones whose development is the furthest along at the top of the chart.

For drugs, the top entry is Remdesivir, which has begun phase 3 trials. It was previously tested on SARS, MERS, and Ebola, in the hopes that it could act as an all-purpose antiviral. Now its being tested on COVID-19 patients, although the phase 3 trials in China were both suspended due to a lack of eligible patients.

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Among vaccines, the top entry is Modernas mRNA vaccine, which began its phase 1 trials in March. None of the vaccine candidates have yet begun phase 2 trials, meaning it will be a while before we even know if any of them work, much less get a worldwide supply manufactured and distributed. We may be years away from the first vaccine (the fastest vaccine ever developed took four years), but with this chart we can keep an eye on how that process is going.

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Track All the COVID-19 Drug and Vaccine Candidates With This Chart - Lifehacker

Australia is in the fortunate position of having good news on the coronavirus front. Over the last few weeks, the curve has noticeably bent. The daily rate of increase in confirmed Covid-19 cases has fallen dramatically, from a peak of 460 on 28 March to around 15-20 in recent days.

Several prominent commentators have responded to this by arguing for a rapid end to social distancing. According to this view, Australia has over-reacted to the crisis and is paying insufficient attention to the costs of the downturn, both narrowly economic and in terms of broader wellbeing.

Since the economic costs fall disproportionately on young people, especially those in short-term casual employment, while the health risk falls disproportionately on elderly people, some have argued that it would be better to quarantine the most high-risk members of society and otherwise let economic activity return quickly to normal now that the pandemic is seemingly under control.

This is a dangerous idea. Low fatalities and slowing rates of transmission cannot be taken for granted. They are consequences of the policies we pursue. It is no coincidence that the bending of the curve happened here in Australia and in other countries following the imposition of tough social distancing restrictions.

Absent a vaccine, a quick return to normal risks tragic consequences and should not be taken lightly.

The idea that high-risk individuals can be quarantined as the virus diffuses through the low-risk population is foolish and wishful thinking. First, it is not feasible to achieve this separation. It is not possible to identify everyone who is high-risk individuals may think they are low-risk but have an undiagnosed comorbidity, making them actually high-risk. Even for those who are clearly high-risk, such as the elderly and those with acute conditions, they need carers, they need medical support. There is no way to reduce their contact to zero. So long as the virus is present in the rest of the population, any contact, however minimal, will eventually lead to the virus mixing into the high-risk population.

On the off chance you are not persuaded by appeals to morality, perhaps you will be persuaded by economic argument

Second, even if such a separation were feasible (which it is not), it would still mean exposing the low-risk population to unnecessary harm, making many people seriously ill, with potentially long-lived health complications, and numerous fatalities. Low risk is not no risk.

In our view, the idea of putting hundreds of thousands of vulnerable people at risk simply because it involves a high economic cost is immoral.

But on the off chance you are not persuaded by appeals to morality, perhaps you will be persuaded by a more dispassionate economic argument.

The overwhelming view among economists is that the best prospects for economic recovery involve comprehensively beating the pandemic, eradication or something close to it. Think of it as an investment that pays off in the future.

Absent near-eradication, lifting social-distancing restrictions will not let the economy bounce back to near-normal because people, fearing for their health, will still refrain from many kinds of economic activity. They still wont go back to bars and restaurants at normal rates. Low-margin businesses will still struggle to be viable. In other words, this approach risks the worst of all worlds, compromising our public health goals and at the same time not getting a proper economic recovery.

In this sense, achieving our public health goals and achieving our economic goals are not fundamentally in opposition.

The precautionary principle suggests that we should be very careful when the consequences of getting the calculation wrong on one side are worse than getting the calculation wrong on the other side. The potential medical and economic losses associated with easing social restrictions prematurely are much larger than the economic losses associated with not easing them soon enough.

The kernel of truth in the contrarian rush to end social restrictions is that, absent a vaccine, in the event that confirmed cases are near zero, we will have to carefully think through the tradeoffs involved in slowly allowing some forms of economic activity to restart. The economic pain, and the mental health side effects of a prolonged shutdown, are real. But we need to start from the premise of carefully easing the toughest social restrictions where the potential societal gain is largest, not from the premise of a soon-as-possible snap-back to life as normal.

In our view, the role of economists in this debate is to help create space for public health experts to craft the policy (as they have been doing with great success) and in light of the health policy help craft economic policies to mitigate all the suffering caused by this crisis, not just the narrowly economic but also the broader loss of wellbeing.

We should not be using spurious economic arguments to undermine the views of public health experts.

With thousands of people dying daily in major cities around the world, with temporary morgues set up on ice rinks and temporary graves in public parks, it beggars belief that anyone could take lightly the apparent relative successes Australia has had to date. We are in a very fortunate position through a combination of good policy and good luck. Lets not blow it.

Chris Edmond is professor of economics at the University of Melbourne and Richard Holden is professor of economics at UNSW Business School

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A quick return to normal in Australia with no Covid-19 vaccine would risk lives and the economy - The Guardian

In the race to develop a vaccine to end the COVID-19 pandemic, governments, charities and Big Pharma firms are sinking billions of dollars into bets with extraordinarily low odds of success.

Theyre fast-tracking the testing and regulatory review of vaccines with no guarantee they will prove effective. Theyre building and re-tooling plants for vaccines with slim chances of being approved. Theyre placing orders for vaccines that, in the end, are unlikely to be produced.

Its the new pandemic paradigm, focused on speed and fraught with risks.

The crisis in the world is so big that each of us will have to take maximum risk now to put this disease to a stop," said Paul Stoffels, chief scientific officer at Johnson & Johnson , which has partnered with the U.S. government on a $1 billion investment to speed development and production of its still-unproven vaccine. If it fails, Stoffels told Reuters, it will be bad.

Coronavirus tracker: Live statistics of cases and deaths in Israel and around the world>>Latest coronavirus stories

Historically, just 6% of vaccine candidates end up making it to market, often after a years-long process that doesnt draw big investments until testing shows a product is likely to work. But the traditional rules of drug and vaccine development are being tossed aside in the face of a virus that has infected 2.7 million people, killed more than 192,000 and devastated the global economy. With COVID-19, the goal is to have a vaccine identified, tested and available on a scale of hundreds of millions of doses in just 12 to 18 months.

Drug companies and the governments and investors that finance them are boosting their at-risk spending in unprecedented ways. The overriding consensus among more than 30 drug company executives, government health officials and pandemic-response experts interviewed by Reuters is that the risks are necessary to ensure not only that a vaccine for the new coronavirus is developed quickly, but that it is ready to distribute as soon as its approved.

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Investments from governments, global health groups and philanthropies have been aimed primarily at the most promising of the more than 100 vaccine candidates in development worldwide. But only a handful of those have advanced to human trials, the real indicator of safety and efficacy - and the stage where most vaccines wash out.

Even among the more encouraging prospects, very few are likely to succeed. Its possible more than one will work; its possible none will.

For companies in the race, there are some likely benefits: It's a proving ground for vaccine technologies and a chance to burnish reputations and boost shares. While some large companies, including Johnson & Johnson and GlaxoSmithKline Plc , have said they plan to make the vaccine available at cost - at least at first - they may reap profits down the road if seasonal vaccination is needed and countries invest in stockpiles.

But finding a vaccine that works does little good without the ability to produce and distribute it. That means building manufacturing plants now.

"We want to make investments up front, at risk, even before we know the vaccines work, to be able to (immediately) manufacture them at a scale of tens or hundreds of millions of doses, said Richard Hatchett, a physician who managed U.S. pandemic flu policy under former President George W. Bush and returned to advise the Obama White House during the 2009 swine flu pandemic.

Hatchett now heads the Coalition for Epidemic Preparedness Innovations (CEPI), a vaccine-development consortium supported by private donors as well as the United Kingdom, Canada, Belgium, Norway, Switzerland, Germany and the Netherlands. The organization has raised more than $915 million of the $2 billion it anticipates spending to accelerate testing and build specialized production plants for at least three coronavirus vaccine candidates.

In the United States, the Biomedical Advanced Research and Development Authority (BARDA), a federal agency that funds disease-fighting technology, has announced investments of nearly $1 billion to support coronavirus vaccine development and the scale-up of manufacturing for promising candidates.

One underlying fear, shared by everyone Reuters interviewed, is that even if a vaccine does prove effective, there wont be enough to go around.

Having reserves ready worldwide to immediately inoculate critical populations - health care workers, the elderly, people made vulnerable by medical conditions - would stamp out the pandemic faster and reignite economies, Hatchett said. The alternative, he said, is a replay of past pandemics, including the H1N1 influenza outbreak of 2009, with wealthy countries hoarding the vaccines.

If that happens, pandemic experts warn, infection hot spots will continue to pop up, each with the potential to create a new wave of illness.

FULL SPEED AHEAD

The scale of the coronavirus vaccine race has no historical parallels. CEPI has identified at least 115 ongoing vaccine initiatives worldwide. And the race is shattering norms of speed and safety in drug and vaccine development.

Some developers are running safety and efficacy trials in tandem, instead of sequentially, as is typical, and short-cutting traditional testing protocols. Others are working with regulators in multiple countries simultaneously, looking for the quickest path to market.

The resulting uncertainty makes it especially risky to invest in manufacturing facilities for a given candidate, since different types of vaccines can require very distinct production lines.

Many of the candidates attracting the most investment rely on proven vaccine approaches being adapted by Big Pharma companies with regulatory and production acumen. Some funders are gambling on smaller biotech companies and academic labs, which may have promising technologies but little to no experience getting a drug or vaccine approved and produced at scale.

BARDA, the U.S. R&D agency, is one of the biggest vaccine funders, with some $5 billion to spend. The agency plans to invest in five vaccine candidates, focusing mostly on projects from experienced drug makers.

"Each is coming with a lot of prior experience, said Rick Bright, who until this month was BARDAs director. They all know how to scale up."

In one of its biggest bets, BARDA is pouring nearly $500 million into a J&J effort.

J&Js coronavirus vaccine candidate uses a cold virus, rendered harmless, to deliver genes derived from the spiky, crown-shaped proteins on the surface of the new coronavirus, prompting an immune response.

J&J is using the same technology to develop vaccines for other viruses, including Ebola. While none has completed testing and won full U.S. approval, trials so far in tens of thousands of people have produced data showing the basic approach is safe, which could speed regulatory approval for the new coronavirus vaccine. But its far from a sure bet: Animal test data, due this summer, will give the first hint of the vaccine's effectiveness and human trials will begin in September.

By end of the year, well know whether it protects humans, said Stoffels, J&Js chief science officer.

In China, CanSino Biologics Inc has vaccine technology similar to the one being used by J&J. CanSino is further along with its testing, having announced this month that its candidate had cleared initial safety trials in humans and was set to advance to the next stage.

Sanofi SA, the worlds largest vaccine maker, has attracted BARDA money for another proven approach, based on its approved Flublok flu shot. Sanofi uses insect cells instead of the traditional chicken eggs to grow the genetically altered virus proteins used to spur an immune response.

Not all the vaccine projects getting attention have a Big Pharma pedigree.

Moderna Inc, a biotech firm based in Cambridge, Massachusetts, was the first in the United States to begin human trials when it began testing its vaccine last month. Working with the U.S. National Institutes of Health, the company received seed money from CEPI, and this month, BARDA kicked in $483 million to support the vaccines development and help scale up manufacturing. That includes hiring 150 skilled workers to eventually produce vaccine around the clock.

Modernas vaccine uses genetic material called messenger RNA (mRNA) to instruct cells in the body to make specific coronavirus proteins that then produce an immune response.

No mRNA vaccine has ever been approved for public use, but the technology is drawing interest, in part because it makes a vaccine easier to design and produce in vast quantities.

The end game is millions of doses," Tal Zaks, Moderna's chief medical officer, told Reuters. The company hopes to have an approved vaccine available as early as March 2021, and possibly before then for healthcare workers.

German vaccine makers CureVac and BioNTech SE , which is partnering with Pfizer Inc, are preparing to begin trials with similar mRNA-based vaccine candidates. So is Lexington, Massachusetts-based Translate Bio Inc, which is working with Sanofi.

EXTRAORDINARY SHORTCUTS

Even for vaccine hopefuls already in human tests, it will be months before theres conclusive evidence on safety and effectiveness - something funders are keenly aware of.

The rush has prompted scientists to consider previously unthinkable shortcuts.

Normally, vaccines would need to undergo clinical trials involving thousands of people before widespread inoculation is allowed. But after testing a prospective vaccine in a smaller group to ensure it is not toxic, Swiss researchers seek to immunize a lot of the Swiss population in the next six months and then produce for a world market, Dr Martin Bachmann, head of immunology at Inselspital, the University Hospital of Bern, said this week.

A spokesman for Swissmedic, the countrys drug regulator, said it was in contact with Bachmann's group and would not allow trials until the agency is assured that safety risks are addressed.

The Swiss vaccine employs virus-like particles to provoke an immune response, an approach that theoretically is considered safer because it does not directly expose people to the actual coronavirus. So far, it has only been tested in mice.

Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, is among those worried about the risks of injecting a large group of people with a vaccine that has only been through minimal testing in humans.

"I dont see how this is possible, he told Reuters, referring to Inselspitals plan.

LESSONS UNLEARNED?

The war on COVID-19 is haunted by lessons from the fight against another virus a decade ago.

In the spring of 2009, the H1N1 swine flu virus emerged in the United States and Mexico and spread worldwide. Within weeks, the World Health Organization(WHO) declared it the first pandemic since 1968.

Wealthier governments that had provisional contracts with vaccine makers immediately exercised them, effectively monopolizing the global vaccine supply," according to Hatchett and numerous official reports. The U.S. alone ordered 250 million doses, and Australia,Brazil, France, Italy, New Zealand, Norway, Switzerland and Britain all had vaccine.

Under pressure from the WHO, those countries ultimately committed to share 10% of their stockpiles with poorer nations. But due to production and distribution snarls, only about 77 million doses were shipped far less than needed and only after the disease had peaked in many regions.

If an effective vaccine emerges for the new coronavirus, a replay is possible, experts in pandemic preparedness say. None of the global health authorities consulted by Reuters believes there will be sufficient supplies to satisfy the immediate demand. Governments will be under tremendous pressure to immunize their own citizenry and get life back to normal, so hoarding remains a serious risk.

Ronald St. John, a physician who has held government posts on infectious disease control in the United States and Canada, expects a similar scenario with vaccines.

There is going to be a lot of self-interest in terms of the production, he said.

BARDA explicitly gives preference to vaccine projects promising U.S. production capacity.

We're asking the American taxpayer to give a lot to the vaccine effort, so its important to ensure U.S. access to any successful vaccine, said Bright, BARDAs recent chief.

But he added that BARDA also is encouraging the companies it backs to build manufacturing capacity outside the United States, so we can have a global supply all at once.

Many governments are pouring money into vaccine initiatives with expectations that they will be first in line if a viable vaccine emerges.

Arcturus Therapeutics Holdings Inc, a San Diego biotech, is receiving up to $10 million from the Singapore government to develop its mRNA-based coronavirus vaccine candidate in partnership with the Duke-National University of Singapore Medical School. If the vaccine is approved, Singapore gets first access, said Arcturus CEO Joseph Payne. Everything after that, he said, goes to whoever pays for it.

Arcturus is not responsible for the ethics of distribution - governments are - but in order for governments to get the vaccine, they need to pay for it, Payne said. The country that will win is the country that stockpiles multiple vaccines at risk.

The company raised $80.5 million this week from a common stock public offering.

In China, a major global producer of vaccines, the government is backing several coronavirus vaccine projects, raising the prospect it will inoculate its 1.4 billion people first.

One government-backed effort, by Sinovac Biotech Ltd. , is already testing vaccine candidates in humans and awaiting initial data..

Sinovac got 60 million yuan ($8.4 million) in low-rate credit lines through a discount loan program supported by Chinas central bank. Government officials quickly made land available for the company to build production plants, including a factory meant to produce up to 100 million doses a year of its coronavirus vaccine.

Sinovac would not discuss how much public money is being invested. The relevant government agencies declined requests for comment.

On Friday, the World Health Organization announced a landmark collaboration across the international community to raise $8 billion to accelerate the coronavirus vaccine development and ensure equitable access worldwide to any successful vaccine. Countries across Europe, Asia, Africa, the Middle East and the Americas announced their participation, but the United States and China, two of the worlds biggest pharma forces, did not.

There will be no U.S. official participation, a spokesman for the U.S. mission in Geneva told Reuters, adding that the U.S. supports global cooperation to develop a vaccine.

Broader questions about U.S. policy on international vaccine distribution are still under consideration within the Trump administration, according to a member of the White House coronavirus task force who spoke to Reuters on condition of anonymity. The official noted that the U.S. Department of State and the U.S. Agency for International Development are spending nearly $500 million to assist with the COVID-19 response internationally.

A WHO spokeswoman said Fridays announcement was the beginning of a global collaboration and we would welcome more countries coming on board. China did not respond to a request for comment.

People involved in the global vaccine race told Reuters that the greatest incentive for countries to promise to share coronavirus vaccines may be the uncertainty around which ones will work.

Since no country can be sure the candidates it backs will prove successful, committing to sharing with other nations can help assure theyll have an initial supply to inoculate health care workers and other critical populations.

"That's enlightened self-interest, as well as a global public good," said Jeremy Farrar, an infectious disease expert and director of the Wellcome Trust global health charity

The rest is here:

COVID-19 vaccine: How companies and countries are risking billions in race unsure to pay off - Haaretz

Sinovac Biotech has created a new COVID-19 vaccine by growing the novel coronavirus in the VERO monkey cell lineand inactivating it with chemicals.

By Jon CohenApr. 23, 2020 , 1:05 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

For the first time, one of the many COVID-19 vaccines in development has protected an animal, rhesus macaques, from infection by the new coronavirus, scientists report. The vaccine, an old-fashioned formulation consisting of a chemically inactivated version of the virus, produced no obvious side effects in the monkeys, and human trials began on 16 April.

Researchers from Sinovac Biotech, a privately held Beijing-based company, gave two different doses of their COVID-19 vaccine to a total of eight rhesus macaque monkeys. Three weeks later, the group introduced SARS-CoV-2, the virus that causes COVID-19, into the monkeys lungs through tubes down their tracheas, and none developed a full-blown infection.

The monkeys given the highest dose of vaccine had the best response: Seven days after the animals received the virus, researchers could not detect it in the pharynx or lungs of any of them. Some of the lower dosed animals had a viral blip but also appeared to have controlled the infection, the Sinovac team reports in a paper published on 19 April on the preprint server bioRxiv. In contrast, four control animals developed high levels of viral RNA in several body parts and severe pneumonia. The results give us a lot of confidence that the vaccine will work in humans, says Meng Weining, Sinovacs senior director for overseas regulatory affairs.

I like it, says Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai who has co-authored a status report about the many different COVID-19 vaccines in development. This is old school but it might work. What I like most is that many vaccine producers, also in lowermiddle-income countries, could make such a vaccine.

But Douglas Reed of the University of Pittsburgh, who is developing and testing COVID-19 vaccines in monkey studies, says the number of animals was too small to yield statistically significant results. His team also has a manuscript in preparation that raises concerns about the way the Sinovac team grew the stock of novel coronavirus used to challenge the animals: It may have caused changes that make it less reflective of the ones that infect humans.

Another concern is that monkeys do not develop the most severe symptoms that SARS-CoV-2 causes in humans. The Sinovac researchers acknowledge in the paper that Its still too early to define the best animal model for studying SARS-CoV-2, but noted that unvaccinated rhesus macaques given the virus mimic COVID-19-like symptoms.

The study also addressed worries that partial protection could be dangerous. Earlier animal experiments with vaccines against the related coronaviruses that cause severe acute respiratory syndrome and Middle East respiratory syndrome had found that low antibody levels could lead to aberrant immune responses when an animal was given the pathogens, enhancing the infection and causing pathology in their lungs. But the Sinovac team did not find any evidence of lung damage in vaccinated animals who produced relatively low levels of antibodies, which lessens the concern about vaccine enhancement, Reed says. More work needs to be done though.

SARS-CoV-2 seems to accumulate mutations slowly; even so, variants might pose a challenge for a vaccine. In test tube experiments, the Sinovac researchers mixed antibodies taken from monkeys, rats, and mice given their vaccine with strains of the virus isolated from COVID-19 patients in China, Italy, Switzerland, Spain, and the United Kingdom. The antibodies potently neutralized all the strains, which are widely scattered on the phylogenic tree, the researchers noted.

This provides strong evidence that the virus is not mutating in a way that would make it resistant to a #COVID19 vaccine, tweeted immunologist Mark Slifka of Oregon Health & Science University. Good to know.

Sinovac is an experienced vaccinemakerit has marketed inactivated viral vaccines for hand, foot, and mouth disease;hepatitis A and B;and H5N1 influenza or bird flu. But Meng says it could produce, at most, about 100 million doses of the vaccine and might need to partner with other makers if the companys COVID-19 vaccine proves safe and effective in human trials.

The company recently started phase I clinical trials in Jiangsu province, north of Shanghai, which aim to gauge safety and immune responses in 144 volunteers. An equal number of participants will receive the high and low doses or a placebo. Although placebos are not typicallyused in phase I studieswhich do not assess efficacyMeng says this can help better evaluate whether the vaccine causes any dangerous side effects. The company hopes to start phase II studies by mid-May that have the same design but enroll more than 1000 people, with results due by the end of June.

If all goes well, Meng says, Sinovac will seek to launch traditional phase III efficacy trials that compare the vaccine with a placebo in thousands of people. The company has alsodiscussed joining international vaccine trials being organized by the World Health Organization (WHO). Given the low level of transmission now occurring in China, the company is considering still more efficacy trials in other countries being hit harder by the virus. We cant put all our eggs in one basket, Meng says.

To quickly obtain more efficacy data after the phase I and II trials and potentially help people, Meng says Sinovac may ask regulatory agencies in China and other countries for emergency authorization to give the vaccine to those at high risk of becoming infected, such as customs agents and police officers who do not typically wear the protective gear used by health care workers. The Democratic Republic of the Congo in 2018 began to widely usean experimental Ebola vaccine under that status and the evidence suggests it powerfully helped curb that epidemic. (That Ebola vaccine first received regulatory approval in November 2019.)

According to WHO, six other vaccines had entered human trials as of 23 April, and 77 others were in development. The vast majority of these vaccines use the modern tools of genetic engineeringonly four rely on the old-fashioned inactivation technologybut Meng says what ultimately matters is whether a vaccine is safe and effective, not how its made. We are not comparing ourselves to anyone, Meng says. In this pandemic situation, the most important thing is to make a vaccine, no matter what kind of vaccine it is, thats safe and effective as soon as possible.

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COVID-19 vaccine protects monkeys from new coronavirus ...

BERLIN (Reuters) - German biotech company BioNTech, which has approval for human trials of potential coronavirus vaccines, has lately received several approaches about a possible takeover but has rejected them, a newspaper reported on Saturday.

BioNTech chief Ugur Sahin said the company had been approached by several players in the industry, Welt am Sonntag newspaper quoted him as saying, without identifying any of the potential interested parties.

"Takeovers are out of the question for the majority shareholders and for us anyway. Our vision is to build a biopharmaceutical company that addresses the medical needs of the 21st century," Sahin told the newspaper.

A BioNTech spokeswoman confirmed the content of the interview.

Earlier this week, shares in BioNTech soared after Germany gave the green light for human trials of potential coronavirus vaccines it is developing with Pfizer.

BioNTech said it was developing four vaccine candidatesunder a programme with Pfizer named BNT162 in what is the fourth trial worldwide of a vaccine targeting the virus.

(Reporting by Emma Thomasson; Editing by David Holmes)

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German biotech firm working on COVID-19 vaccines rejects takeover approaches - Yahoo Finance

In a tense scene from the 2011 movie Contagion, now making a comeback on streaming services as life imitates pandemic art, a heroic scientist pulls a sample out of a freezer at her lab late one night.

She injects herself and heads to a crowded hospital where her father, a doctor who continued treating his patients during the outbreak, is dying of a mysterious new flu-like virus.

Im testing my vaccine, she tells him with a smile as she rips off her goggles and mask despite his objections and kisses his clammy forehead. By day 133 of the fictional timeline, less than five months after Gwyneth Paltrows patient zero contracted the deadly disease, officials are pulling birthdays in a lottery to determine who gets the vaccine first.

Unfortunately, in real life it will take more than a trial of one to find a vaccine for COVID-19, which has been widely heralded as the key to getting back to our pre-pandemic lives. The time frame of at least 12-to-18 months, mentioned by Dr. Anthony Fauci, part of U.S. President Donald Trumps coronavirus task force, at a televised meeting in early March, has become a benchmark in the race to find it.

Thats just an estimate and not the start of a clock. But it would be the fastest development of a vaccine in human history. There are a few things that give some scientists hope it could happen, if we get lucky, from advances in science, to infusions of cash, to manufacturing vaccines before we even know if they work. There are also plenty of real challenges.

Twelve-to-18 months is an incredibly optimistic timeline, said Natasha Crowcroft, director of the Centre for Vaccine Preventable Diseases, and a professor at the Dalla Lana School of Public Health. Nobodys done this before.

Under normal circumstances, new vaccines take several years to develop. The fastest ever was for mumps, at four years.

The Ebola vaccine took five.

I dont think its wrong to be optimistic, and I dont think anybody really knows the answer, Crowcroft added. According to the World Health Organization, as of April 20 there were five vaccines in clinical trials around the world, including the first in human trials, a messenger RNA candidate from U.S. biotech company Moderna. There are also 71 candidates at the preclinical stage.

Back in January, before COVID-19 even had a name, Chinese scientists were able to quickly sequence the genetic code of the virus, thanks to leaps forward in science, said Crowcroft. That gave the world a big head start.

Researchers are also trying to make some of the usual steps of a clinical trial happen in parallel, she said.

Clinical trials usually progress in measured steps to examine safety and effectiveness, starting with animals and then moving to humans in bigger sample sizes and different age groups, before a vaccine or drug can get approval and then be manufactured and distributed.

Its usually so expensive to take a vaccine through all the steps. Pharmaceutical companies dont want to spend money on a step they might not need if it fails a previous step, said Crowcroft. Many vaccines get caught in the valley of death, a promising idea from researchers without the money to take it through a trial. But given the global emergency, big money is flowing from governments that are taking on that risk for the public good.

Scientists at Oxford University in the U.K., with the help of funding from the British government, jabbed their first volunteer in the arm this week in the first phase of a human clinical trial. Their vaccine contains the genetic sequence of the club-shaped spike protein on the outer coat of SARS-CoV-2 and uses a harmless chimpanzee virus to deliver it, according to news releases on their website. The hope is that this will trick the body into thinking it has COVID-19 and trigger the immune system so that it will be ready to attack if it comes into contact with the actual virus.

The team was actually already working on a vaccine for Disease X, the next big one, without knowing what that would be, so they were easily able to pivot, lead researcher Sarah Gilbert told The Lancet.

At the same time, production of the vaccine is being scaled up to be ready for larger trials, and future rollout, if it works.

Philanthropist Bill Gates has the same idea on a bigger scale. He told the Daily Shows Trevor Noah in early April that the Gates Foundation would fund factories for seven of the most promising COVID-19 vaccine candidates, even though it would mean throwing away billions on vaccines that dont work out.

The Gates Foundation did not provide more specifics on where the factories might be or what vaccine candidates theyd produce when contacted this week by the Star.

But even with these time-saving measures, there are still many unknowns.

A major one, said Claire Cupples, former dean of science and professor of molecular biology and biochemistry at Simon Fraser University, is that we still dont understand how strong the immune response is to the virus. People whove had it should develop antibodies and have some type of immunity. But we dont have enough science to prove that because the virus is so new.

The immune response might just not be very strong at all, so that really is quite a concern in my mind, she said.

Its going to be a challenge to get a strong response from a vaccine, and would that be enough to protect people?

Because theres still so much we dont know, its possible that strengthening the immune response might actually make it worse, Cupples said.

While coronaviruses are more accurate at replicating themselves than, for example, flu, which keeps mutating so much that we need a new vaccine each year, there is still no vaccine for the coronaviruses that cause severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS), or common colds.

Certainly the fact that other coronaviruses keep on coming back year after year, and presumably we dont have a good response to them, is another thing that suggests that getting a vaccine might be really difficult, Cupples said.

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Even in an emergency, we still need to do our due diligence and vaccines are held to a higher standard because they expose healthy people to risk, rather than offering sick people without options something that might help.

If we turn around a really crummy vaccine and make people sick, thats going to set back vaccine acceptance for decades, she said.

This has happened before. In 1976, a vaccine for swine flu was pushed through in the U.S., even though a feared epidemic never happened. The vaccine caused Guillain-Barr syndrome, a rare condition that causes nerve damage in about one in 100,000 people.

Trudo Lemmens, professor and Scholl Chair in Health Law and Policy at the University of Toronto, said its definitely acceptable to prioritize clinical trials of a vaccine in a pandemic and to speed up the review process by health authorities. But its important to make sure were not shortcutting the important steps of evidence gathering that have to take place.

Clinical trials should be assessed by independent monitoring committees that can examine data and research. There should be full transparency, including with preclinical data, which is usually kept secret.

If a vaccine is rolled out, researchers should continue collecting and sharing data so they can correct any issues that arise, he added.

Even if we do get to that point, said James Tiessen, an associate professor and director of Health Services Management at Ryersons Ted Rogers School of Management, theres plenty of work still involved.

Canada has very little, if any, vaccine production capacity and would have to rely on other suppliers, as it does for the flu vaccine. But officials would probably be able to manage, he said.

We could end up with not just one vaccine, but two or three, one for older people and one for others, for example. So the challenge is just going to be volume and determining who to give it to.

Tiessen said hes been impressed so far with the unprecedented amount of worldwide co-operation on the science, which is ironic given our borders are otherwise closed.

Thats also something that makes Cupples hopeful, the fact the government, industry, and academic institutions are working together, that theyre publishing their results quickly and not behind paywalls.

Even so, its entirely possible we may never find a vaccine.

We dont have one for HIV, for example, which first appeared in the early 1980s. Thats why its important to also continue looking for treatments such as antiretrovirals, Cupples said, and better understand who gets very sick and who gets mild or no symptoms (aside from factors like age and other medical conditions).

All of these things can be done at the same time as other teams of scientists continue to work on dozens of fledging vaccine candidates.

Its a good thing to have so many at this point, added Crowcroft.

We dont know which ones are going to be the best, but we also dont know what best means.

One vaccine could work 100 per cent of the time, but have side-effects, while another could be 70 per cent effective, but safer.

At this stage were going so fast, what we really need is a lot of choice, she said.

If any one of these approaches that people are trying, if any one of them makes it through to the end, why not?

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The race is on to develop a COVID-19 vaccine. Heres what you need to know - Toronto Star