Category: Corona Virus Vaccine

As government response and public concern over Covid-19 ratchet up, the medical community is looking at two aspects. First, how much testing is optimal should we expand it beyond at-risk populations to fl atten the disease curve as South Korea has done, or does mass testing burden the healthcare system? Second, where do India and other countries stand in developing a vaccine?

ICMRS TESTING STRATEGY

INDIVIDUALS TESTED

WHERE ARE TESTS HAPPENING; AT WHAT COST?

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Coronavirus outbreak: How much testing should we do, and where are we on developing a vaccine? - Economic Times

Everything you need to know about COVID-19 vaccines.

COVID-19, the potentially fatal respiratory illness first detected in December 2019, has spread across the globe,forcing the cancellation of major events, postponing sports seasons and sending many into self-imposed quarantine. As health authorities and governments attempt to slow the spread, researchers are focusing their attention on the coronavirus that causes the disease: SARS-CoV-2.

Since it was first discovered as the causative agent of the new disease, scientists have been racing to get a better understanding of the virus' genetic makeup, how it infects cells and how to effectively treat it. Currently there's no cure, and medical specialists can only treat the symptoms of the disease. However, the long-term strategy to combat COVID-19, which has spread to every continent on Earth besides Antarctica, will be to develop a vaccine.

Developing new vaccines takes time, and they must be rigorously tested and confirmed safe via clinical trials before they can be routinely used in humans. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the US, has frequently stated that a vaccine is at least a year to 18 months away. Experts agree there's a ways to go yet.

Vaccines are incredibly important in the fight against disease. We've been able to keep a handful of viral diseases at bay for decades because of vaccine development. Even so, there exists confusion and unease about their usefulness. This guide explains what vaccines are, why they are so important and how scientists will use them in the fight against the coronavirus. As more candidates appear and are tested, we'll add them to this list, so bookmark this page and check back for the latest updates.

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A vaccine is a type of treatment aimed at stimulating the body's immune system to fight against infectious pathogens, like bacteria and viruses. They are,according to the World Health Organization, "one of the most effective ways to prevent diseases."

The human body is particularly resilient to disease, having evolved a natural defense system against nasty disease-causing microorganisms like bacteria and viruses. The defense system -- our immune system -- is composed of different types of white blood cells that can detect and destroy foreign invaders. Some gobble up bacteria, some produce antibodies which can tell the body what to destroy and take out the germs, and other cells memorize what the invaders look like, so the body can respond quickly if they invade again.

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Vaccines are a really clever fake-out. They make the body think it's infected so it stimulates this immune response. For instance, the measles vaccine tricks the body into thinking it has measles. When you are vaccinated for measles, your body generates a record of the measles virus. If you come into contact with it in the future, the body's immune system is primed and ready to beat it back before you can get sick.

The very first vaccine was developed by a scientist named Edward Jenner in the late 18th century. In a famous experiment, Jenner scraped pus from a milkmaid with cowpox -- a type of virus that causes disease mostly in cows and is very similar to the smallpox virus -- and introduced the pus into a young boy. The young boy became a little ill and had a mild case of cowpox. Later, Jenner inoculated the boy with smallpox, but he didn't get sick. Jenner's first injection of cowpox pus trained the boy's body to recognize the cowpox virus and, because it's so similar to smallpox, the young man was able to fight it off and not get sick.

Vaccines have come an incredibly long way since 1796. Scientists certainly don't inject pus from patients into other patients, and vaccines must abide by strict safety regulations, multiple rounds of clinical testing and strong governmental guidelines before they can be adopted for widespread use.

Vaccines contain a handful of different ingredients depending on their type and how they aim to generate an immune response. However, there's some commonality between them all.

The most important ingredient is the antigen. This is the part of the vaccine the body can recognize as foreign. Depending on the type of vaccine, an antigen could be molecules from viruses like a strand of DNA or a protein. It could instead be weakened versions of live viruses. For instance, the measles vaccine contains a weakened version of the measles virus. When a patient receives the measles vaccine, their immune system recognizes a protein present on the measles virus and learns to fight it off.

A second important ingredient is the adjuvant. An adjuvant works to amplify the immune response to an antigen. Whether a vaccine contains an adjuvant depends on the type of vaccine it is.

Some vaccines used to be stored in vials that could be used multiple times and, as such, contained preservatives that ensured they would be able to sit on a shelf without growing other nasty bacteria inside them. One such preservative is thimerosal, which has garnered a lot of attention because it contains trace amounts of easily cleared ethylmercury. Its inclusion in vaccines hasn't been shown to cause harm, according to the CDC. In places like Australia, single-use vials are now common, and thus preservatives such as thimerosal are no longer necessary in most vaccines.

In developing a vaccine for SARS-CoV-2, scientists need to find a viable antigen that will stimulate the body's immune system into defending against infection.

The pathogen at the center of the outbreak, SARS-CoV-2, belongs to the family of viruses known ascoronaviruses. This family is so named because, under a microscope, they appear with crownlike projections on their surface.

In developing a vaccine that targets SARS-CoV-2, scientists are looking at these projections intensely. The projections enable the virus to enter human cells where it can replicate and make copies of itself. They're known as "spike proteins" or "S" proteins. Researchers have been able to map the projections in 3D, and research suggests they could be a viable antigen in any coronavirus vaccine.

That's because the S protein is prevalent in coronaviruses we've battled in the past -- including the one that caused the SARS outbreak in China in 2002-03. This has given researchers a head start on building vaccines against part of the S protein and, using animal models, they've demonstrated they can generate an immune response.

There are many companies across the world working on a SARS-CoV-2 vaccine, developing different ways to stimulate the immune system. Some of the most talked about approaches are those using a relatively novel type of vaccine known as a "nucleic acid vaccine." These vaccines are essentially programmable, containing a small piece of genetic code to act as the antigen.

Biotech companies like Moderna have been able to generate new vaccine designs against SARS-CoV-2 rapidly by taking a piece of the genetic code for the S protein and fusing it with fatty nanoparticles that can be injected into the body. Imperial College London is designing a similar vaccine using coronavirus RNA -- its genetic code. Pennsylvania biotech company Inovio is generating strands of DNA it hopes will stimulate an immune response. Although these kinds of vaccines can be created quickly, none havs been brought to market yet.

Johnson & Johnson and French pharmaceutical giant Sanofi are both working with the US Biomedical Advanced Research and Development Authority to develop vaccines of their own. Sanofi's plan is to mix coronavirus DNA with genetic material from a harmless virus, whereas Johnson & Johnson will attempt to deactivate SARS-CoV-2, essentially switching off its ability to cause illness while ensuring it still stimulates the immune system.

Some research organizations, such as Boston Children's Hospital, are examining different kinds of adjuvants that will help amplify the immune response. This approach, according to the Harvard Gazette, will be targeted more toward the elderly, who don't respond as effectively when vaccinated. It's hoped that by studying adjuvants to boost a vaccine, the elderly can be vaccinated with a mix of ingredients that would supercharge their immunity.

Fauci, of the infectious diseases institute, posits that a vaccine is roughly a year and a half away, even though we're likely to see human trials start within the next month or two. This, according to a 60 Minutes interview with Fauci in March, is a fast turnaround.

"The good news is we did it more quickly than we've ever done it," Fauci told 60 Minutes. (Note: 60 Minutes and CNET share a common parent company, ViacomCBS.) "The sobering news is that it's not ready for prime time, for what we're going through now."

Why does vaccine production take so long? There are many steps involved and a lot of regulatory hurdles to jump through.

"For any medicine to be sold it needs to go through the standard process of clinical trials including phase 1 [to] 3 trials," said Bruce Thompson, dean of health at Swinburne University in Australia. "We need to ensure that the medicine is safe, will not do harm, and know how effective it is."

Scientists can't assume their vaccine design will just work -- they have to test, test and test again. They have to recruit thousands of people to ensure the safety of a vaccine and how useful it will be. The process can be broken down into six phases:

Traditionally, then, it could take a decade or more for a new vaccine to go from design to approval. In addition, once the regulatory processes have concluded a vaccine is safe, the drug companies have to send production into overdrive, so they can manufacture enough of the vaccine to increase immunity in the wider population.

With SARS-CoV-2, the process is being expedited in some instances. As STATnews reports, the vaccine in development by Moderna has moved from design straight into Phase I clinical trials of its mRNA vaccine, skipping tests in animal models. Those tests will take place at Seattle's Kaiser Permanente Washington Health Institute, and patients are now being enrolled.

Until that time, though, health workers, doctors and medical specialists must rely on current treatment options.

The best way to prevent illness is avoiding exposure. Those tips are below.

First: Antibiotics, medicine designed to fight bacteria, won't work on SARS-CoV-2, a virus. If you're infected, you will be asked to self-isolate, to prevent further spread of the disease, for 14 days. If symptoms escalate and you experience a shortness of breath, high fever and lethargy, you should seek medical care.

Treating cases of COVID-19 in the hospital is based on managing patient symptoms in the most appropriate way. For patients with severe disease adversely affecting the lungs, doctors place a tube into the airway so that they can be connected to ventilators -- machines which help control breathing.

There are no specific treatments for COVID-19 as yet, though a number are in the works, including experimental antivirals, which can attack the virus, and existing drugs targeted at other viruses like HIV which have shown some promise in treating COVID-19.

RemdesivirRemdesivir, an experimental antiviral made by biotech firm Gilead Sciences, has garnered a large part of the limelight. The drug has been used in the US, China and Italy, but only on a "compassionate basis" -- essentially, this drug hasn't received approval but can be used outside of a clinical trial on critically ill patients. Remdesivir isn't specifically designed to destroy SARS-CoV-2. Instead, it works by knocking out a specific piece of machinery in the virus, known as "RNA polymerase," which many viruses use to replicate. It has been shown in the past to be effective in human cells and mouse models.

Its effectiveness is still being debated, and much more rigorous study will be needed before this becomes a general treatment for SARS-CoV-2, if it does at all.

Other treatment optionsAn HIV medicine, Kaletra/Aluvia, has been used in China to treat COVID-19. According to a release by AbbVie, an Illinois-based pharmaceutical company, the treatment was provided as an experimental option for Chinese patients during "the early days" of fighting the virus. The company suggests it is collaborating with global health authorities including the Centers for Disease Control and Prevention and the World Health Organization.

A drug that has been used to treat malaria for around 70 years, chloroquine, has been floated as a potential candidate. It appears to be able to block viruses from binding to human cells and getting inside them to replicate. It also stimulates the immune system. A letter to the editor in journal Nature on Feb. 4 showed chloroquine was effective in combating SARS-CoV-2. A Chinese study emanating from Guangdong reports chloroquine improved patient outcomesand "might improve the success rate of treatment" and "shorten hospital stay."

It's not a good idea to rely on a vaccine to stop the spread of coronavirus because that's many months away. The best way to stop the spread, right now, is to continue practicing good personal hygiene and to limit interactions with others. "The best thing to do is the simple things like hand washing and hand sanitizing," Thompson said.

This outbreak is unprecedented, and changing behaviors is absolutely critical to stopping the spread.

There are a huge number of resources available from the WHO on protecting yourself against infection. It's clear the virus can spread from person to person, and transmission in communities has occurred across the world. Protection boils down to a few key things:

For much more information, you can head to CNET's guide

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Coronavirus vaccines and treatment: Everything you need to know - CNET

As COVID-19 continues to spread both around the world and in the U.S., two separate efforts to find a medical solution to the virus are moving forward. At the University of Nebraska, the first patients have volunteered to test an experimental drug to treat COVID-19. And at Kaiser Permanente Washington Health Research Institute, researchers have begun recruiting people to test a possible vaccine.

A number of U.S. passengers aboard the Diamond Princess cruise ship were brought to Nebraska for quarantine; two of these passengers have agreed to participate in a trial for remdesivir, an antiviral drug originally developed for Ebola, but which showed encouraging results in animals in fighting SARS and MERS, two other illnesses caused by coronaviruses.

The drug is designed to treat infections that are moderate to severe, and is targeted to those with the most intensive symptoms. In order to qualify for the remdesivir study, run by the National Institute of Allergy and Infectious Diseases (NIAID), patients must test positive for COVID-19 and have pneumonia. Of the more than two dozen people diagnosed with COVID-19 from the cruise ship who were brought to Nebraska for quarantine, four required hospitalization and two developed pneumonia. Those two patients were asked if they wanted to volunteer for the study, and both agreed, says Dr. Andre Kalil, professor of medicine in the division of infectious disease at University of Nebraska Medical Center.

The study will eventually include 400 patients; initial results wont be analyzed until the first 100 have completed treatment. Given the relatively low rate of moderately to severely affected patients in the US at this point, Kalil says that NIAID plans to collaborate with health officials from other countries with higher case volumes, including Korea, Japan and Italy. For now, the trial will stay open for three years in order to recruit the needed number of patients.

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This study, says Kalil, is also designed to be more flexible than most drug trials. This is not just a remdesivir trial, he says. It will test as many [COVID-19] therapies as possible, and remdesivir is just the first. Lets say a couple of months from now, we realize that remdesivir is a good drug, that it works better than placebo. Then patients receiving the placebo would be offered the drug and we would move on to test another drug. If remdesivir turns out not to be effective, then we would remove it from the study and bring another drug to test against placebo. Its a dynamic, fast way to run a randomized trial. The design is a way to accelerate testing of antiviral drugs against COVID-19, since infections are on-going and there is no treatment yet.

Meanwhile, other labs are working on developing vaccines that would provide some protection against the virus in the first place. The vaccine study that is furthest along (and which is also overseen by NIAID) is currently recruiting its first participants at Kaiser Permanente Washington Health Research Institute. Unlike the remdesivir trial, this study will enroll healthy volunteers. Dr. Lisa Jackson, lead investigator on the study, says 45 healthy people will be recruited to test three different doses of the vaccine.

Kaiser is currently getting thousands of daily online requests from people interested in participating. Researchers are contacting the volunteers by phone to assess their eligibility for the study. Once the participants are chosen, they will be given one of the three vaccine doses being tested. The scientists will track patients immune responses after that injection, and then give each patient a second injection (of the same dosage). The goal is to figure out which dosage is most effective, and whether one or two shots of that dosage is needed.

Theyll be looking for levels of antibodies that the bodys immune system produces against the so-called spike protein, one of the proteins that stud the surface of the SARS-CoV-2 virus responsible for causing COVID-19. Scientists will analyze antibody levels in the participants a year after their second vaccination, so results wont be available for at least 12 to 18 months, says NIAID director Dr. Anthony Fauci. Given that coronaviruses like the one behind COVID-19 seem to be appearing more frequently, however, having a vaccine against this particular virus could be useful in creating future coronavirus vaccines as well.

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Coronavirus Drug and Vaccine Studies Are Recruiting Their First Volunteers - TIME

The UK faces having to wait longer and pay more to acquire a coronavirus vaccine because it has left the EU, health experts and international legal experts warn today.

In an article published today on the Guardian website, the academics and lawyers say Boris Johnsons determination to go it alone, free of EU regulation, after Brexit means the UK will probably have to join other non-EU countries in a queue to acquire the vaccine after EU member states have had it, and on less-favourable terms.

The authors include Martin McKee of the London School of Hygiene and Tropical Medicine, and legal academics Anniek de Ruijter of Amsterdam Law School and Mark Flear of Queens University, Belfast.

The UK will leave the European Medicines Agency (EMA), the body responsible for the scientific evaluation, supervision and safety monitoring of medicines, at the end of the transition period on 30 December. This means it will no longer be part of the EUs regulatory regime, which allows for accelerated assessment of products developed by drugs companies during a pandemic.

The UK has already withdrawn from the EUs emergency bulk-buying mechanism for vaccines and medicines, under which member states strike collective agreements with pharmaceutical companies, which speeds up their access to the latest products during a crisis.

The academics write: For all these reasons ... the UK is likely to have to join the queue for access with other countries outside the EU, and to pay more than it would otherwise as an EU member state.

Looking further ahead, this problem will not be limited to emergencies and the UK can expect slower and more limited access to medicines, especially those for rare conditions or those used to treat children, where the market is small.

They argue that the UK could still avoid the worst by agreeing to align fully with the EMAs regulations from outside the EU. But they say Johnson has so far indicated that his team have no intention of doing so and do not want to operate as rule takers.

While it appears the UK government wants to press ahead with its own regulatory system and rapid market authorisation system for emergencies, the experts say this will be all but impossible to put in place in time for a new Covid-19 vaccine, which is expected in about a year.

Even then the view in medical circles is that pharmaceutical companies are likely to look first to the EU for regulatory approval and an agreement on sale, given the scale of the market they would be selling into.

Olivier Wouters of the London School of Economics and Political Science, said: After the Brexit transition period, the UK will no longer be part of the EMA and will therefore have to make its own regulatory decisions, unless ongoing EU-UK trade negotiations result in the UK aligning itself with European rules.

The UK could, in theory, choose to recognise any approval decision made by the EMA to prevent delays, but this seems at odds with the UK governments pledge to take back control. If the UK authorities instead choose to set up a separate review and approval process for medicines and vaccines, then it might delay access to a new coronavirus therapy.

The country could experience disruptions as the Medicines and Healthcare products Regulatory Agency (MHRA), the countrys counterpart to the EMA, works to fill the gap left by the departure of the EMA.

Vaccine makers and drug companies may decide to first seek approval from the EMA, which represents some 500 million patients, before seeking approval from the UK MHRA, which covers a smaller patient pool.

Asked about the prospect of the UK having to pay higher prices for a vaccine, he said: If a coronavirus vaccine is developed, EU countries may choose to band together to jointly procure the vaccine. This would give EU countries more bargaining power against a vaccine maker to try to secure a lower price. If the UK were excluded from such a joint procurement scheme, its possible that the UK would end up paying a higher price than the EU for the same vaccine.

EMA was based in London until January last year, when Brexit saw it relocate to Amsterdam.

A Department of Health and Social Care spokesperson said: The UK and our friends and partners across Europe are part of a concerted international effort to combat the threat of COVID-19. We are confident that our current close working relationships will continue as we ready ourselves for all eventualities. Were fully supporting the UKs world-leading, disease research sector to play a key role in the global effort, with 40 million of new funding for rapid research into the virus.

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Brexit means coronavirus vaccine will be slower to reach the UK - The Guardian

First patient injected in trial of coronavirus vaccine

Updated: 2:11 PM EDT Mar 16, 2020

We all feel so helpless. This is an amazing opportunity for me to do something, said Jennifer Haller, 43, of Seattle.

We all feel so helpless. This is an amazing opportunity for me to do something, said Jennifer Haller, 43, of Seattle.

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First patient injected in trial of coronavirus vaccine - WCVB Boston

The coronavirus of 2019 has infected more than 155,000 people and claimed more than 5,000 lives. Some countries have closed their borders and discriminatory practices of xenophobia have swarmed their way into classrooms, the workplace, media and other institutions.

Hysteria, fear and anxiety have become the hallmarks of this growing epidemic since the first cases were reported in Wuhan, China. Exact incubation periods, profile of symptomatology and whether or not this is truly the first time coronavirus has been around are still in question. The anxiety surrounding this disease is even hampering the vitality of domestic and global economies. Last week, stocks tumbled for 7 consecutive days, with one of the sharpest declines occurring after President Trump gave a news conference earlier last week.

However, this writing wont be a political debate. It wont determine the fitness of Vice President Mike Pence to lead this national health emergencybut rather, will give needed attention to a public health and ethical concern.

Americans and other people around the world have been following the growing list of CDC guidelines. Weve been washing our hands for 20 seconds (approximate length of the Happy Birthday song sung twice), obeying travel restrictions, self-quarantining at the start of flu-like symptoms. Although these measures have potentially slowed the spread of the virus, an instrument to cease its transmission is needed. A vaccine would be the answer. Problem solved? Not quite.

On one hand, its estimated that a coronavirus vaccine may not be market-ready for approximately 1-2 years. On the other hand, according to U.S. Health and Human Services Secretary Alex Azar, the Trump administration cant promise that a vaccine will be affordable to all. Panicked and vulnerable Americans may not be able to get a preventative treatment to ensure their protection. A promising formula hasnt even made its way into a syringe yet, but somehow, has already been assigned an expensive price tag. Why so prematurely?

Market exclusivity appears to be a main culprit behind high drug prices in the U.S. As the coronavirus vaccine is in development, the first drug company to reach success in developing a vaccine will be granted a patent by the Food and Drug Administration (FDA), essentially ensuring several years of protected monopoly status and profit given it meets FDA qualifications. The presence of generic vaccines wont be a reality for several years, which is one of the most useful tactics in driving prices down.

Newsflash.America has seen this before. We have seen our best minds, resources and capital funneled towards public health crises. However, when the prized breakthrough is achieved, the less fortunate are the last in line to reap its benefits. For example, in 2013, the more effective drugs Solvaldi and Olysio were added to the market for treatment and cure of Hepatitis C, a viral infection that can cause liver damage and cancer.

A study in the Journal of Health & Biomedical Law highlighted the challenges patients face in getting these promising drugs within our complex healthcare system. Specifically, just one pill of Sovaldi costs approximately $1,000, which brings the total cost of the 12-week treatment to $84,000, according to the study. While patients with private insurance showed higher rates of denied authorization, even patients with Medicare and Medicaid faced strict restrictions when trying to access these drugs. Some need access to a primary care doctor, a hepatologist or to show proof that they do not use alcohol. This is a difficult laundry list for people to accomplish, particularly those who are a part of the lower economic class, with limited access to routine care or specialists who accept Medicaid.

What should be established as a low hanging and accessible fruit has been selfishly turned into a high-hanging potential source of disparity. I would argue that a medical practice or development fueled by a profitable end falls short of providing equitable access to healthcare. The practice of medicine exists for the expedient and efficient treatment of all, not the few with hefty pockets.

Although the warnings of HHS Secretary Azar and health care leaders may appear to simply be rhetoric at the moment, health disparities are not. Marginalized members of society will predictably carry the heaviest burden of this disease. Notably, Duke Health has been reported as the largest employer in Durham county, employing over 19,000 within its healthcare system. It can therefore be deduced that it is one of the largest contributors to not only the economy of Durham county, but the health of its residents. In light of its mission to deliver a healthier tomorrow, DukeHealth should not only investigate the epidemiology of this disease, but the access (or lack thereof) that residents may have to upcoming technologies and medical advances.

Whether private investors are called upon to make this vaccine a reality, which significantly drives up the cost, or not, the federal government should have the health and pockets of all in mind. To our public leaders and advisors, such as those with the federal Centers for Disease Control who are working on the front lines of this emerging pandemic: We, the people, are doing our part with adherence to guidelines that have been established to prevent transmission of COVID-19. We are hopeful that a vaccine would be economically accessible to everyone at risk. In the meantime, the subsidizing of coronavirus diagnostic tests and related treatment for non or underinsured people remains a reasonable public health response. Should the latter become a reality, our government can begin to match what has been its potential for centuries. Enabling the latter will begin to lessen the burdens of human finitude and show us what equitable human flourishing truly looks like.

Kirsten Simmons is a third-year medical student at Duke University School of Medicine. She is also completing a Masters of Health Science in Clinical Research and a Masters of Theological Studies at Duke University Divinity School as a Theology Medicine and Culture Fellow.

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A coronavirus vaccine is in the making But you may have to check your pockets first - Duke Chronicle

America is still more than a year away from a COVID-19 vaccine, but a treatment for the disease caused by the new coronavirus could be available in several months.

Since the first case was identified in the U.S. on January 21, more than 560 people have tested positive for the virus, including instances of community spread in multiple states. As cases increase, so does public concern about the virus, raising questions about the progress that's being made on a vaccine and a cure.

Thanks to the rapid sequencing of the virus' genetic sequences, experts have been able to develop a potential vaccine at an unprecedented pace. Clinical trials are expected to start less than six months after the virus was identified in humans for the first time. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said it would be more than a year until the vaccine is widely administered.

"The good news is that we did it fast. The bad news is the reality of vaccinology means this is not going to be something we're going to have tomorrow," Fauci told a House Appropriations subcommittee on March 4.

It's likely health professionals will have a treatment before a vaccine, according to Fauci. Several options have already been administered to animals, and trials are underway in Washington state and the University of Nebraska for a drug called remdesivir.

If it's at least "somewhat effective" in reducing the viral load, the intervention could be available in the next "several months," Fauci said.

To determine the drug's efficacy, participants were divided into a placebo group and a treatment group. On the first day, the treatment group received 200 milligrams of remdesivir and 100 milligrams on each subsequent day, for up to 10 days. The placebo group received a solution that resembles remdesivir at equal volumes.

On March 2, President Donald Trump and members of the Coronavirus Task Force discussed how the federal government could accelerate vaccine and treatment development with pharmaceutical and biotechnology companies. Trump claimed they were "working very hard" to expedite the process of bringing a vaccine to the public but acknowledged that a treatment would "likely" be available first.

"It always goes faster than vaccine, because you're dealing with someone who is already sick," Fauci said. "So the safety issues are going to be much, much different. And you will know your result almost immediately, whereas with vaccines it takes a long time."

Biotechnology company Moderna shipped its first batch of a potential vaccine to the NIAID on February 24, and a trial is expected to begin in about four weeks. After the Phase I trial, which is expected to take three to four months, a larger trial involving hundreds of people will be conducted over six to eight months, according to Fauci.

Daniel O'Day, chairman and CEO of Gilead Sciences, which makes remdesivir, told Trump his company should know whether the treatment is effective at some point in April.

According to Fauci, if a company knows by June that the treatment is effective, a company can scale it up, manufacture it and "you're good to go."

Newsweek reached out to the NIAID for comment but did not receive a response before publication.

Antivirals are much less strain-specific than vaccines because they target parts of the virus that don't change as easily, Dr. William Haseltine, chair and president of ACCESS Health International, told Newsweek. So researchers can develop a potential antiviral for a coronavirus strain before an outbreak even occurs.

However, Nicole Errett, a disaster researcher at the University of Washington, said that this requires government investment because pharmaceutical companies have less of a vested interest in developing a product for a market that doesn't yet exist.

After three coronavirus outbreaks in 20 yearssevere acute respiratory syndrome, Middle East respiratory syndrome and now SARS-CoV-2it's an investment that needs to be made, Haseltine said,

"These diseases are as much a natural disaster as earthquakes and hurricanes," he noted. "We can't prevent natural disasters, but we can certainly prepare for them, and we should treat these the same way we treat other natural disasters."

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Coronavirus Vaccine At Least a Year Away, But Treatment Could Be Here in Months - Newsweek

With the U.S. now in a state of emergency, international travel restricted and the economy in danger of slipping into recession, one of the central questions for resolving the crisis is how long it will take to develop a vaccine for the coronavirus.

There will be a vaccine. The question is as we sit here in March of 2020, when will it be available? Jonathan D. Moreno, a professor of medical ethics and health policy at the University of Pennsylvania, told Yahoo News in an interview. The best we can say is that hopefully, by some time in early 2021, there will be a vaccine available, maybe a little earlier given the advances in our technology.

Even once a vaccine is available, making it available to the U.S. population will take time. Here's an irony on our current situation, we don't have that production capacity in this country. Where is it? It's mostly in China, said Moreno. So we are going to be getting millions and millions, we hope, of doses of vaccine from China in the next eight or 10 or 12 months, as soon as we have the formula of the vaccine.

Yet with reports of billionaires jetting off to survival bunkers and paying for concierge doctors, another public concern is likely to be over who will get access to any new therapies or vaccines. We have to be very careful about reassuring the public that the dissemination of the vaccines, when these vaccine doses are available ... is done fairly and that nobody is unfairly advantaged because they have the money or because they have the power to get access to them, said Moreno, who is the co-author of the recent book, Everybody Wants to Go to Heaven but Nobody Wants to Die.

Even now, Moreno mentioned that members of Congress were able to get tested at a time when testing kits are in short supply. That is probably not a good thing because they were not, as far as we can tell, they were not symptomatic, he said, and frankly, it's entirely possible that the tests that those people got are taking tests, at least theoretically, away from people who are symptomatic and are more vulnerable than they were.

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Once the vaccine is available the priority should be first responders and healthcare professionals, they absolutely have to be protected, Moreno said. Not only because we need them to take care of us, but also because we need them to come to work. We need them to feel safe. We need them to feel that they're not taking it home to their families.

Next in line for vaccination might be members of the military, especially if the Defense Department assists with domestic medical care. I wouldn't be surprised if the Defense Department starts standing up hospitals and clinics, the way that was done in Liberia in 2014 in the outbreak of Ebola.

Yet with the vaccine still perhaps a year away, the challenge, said Moreno, is getting people to limit the spread of the virus, just as previous generations had to do with illnesses such as polio before a vaccine became available. That was in 1955. We just don't have a memory of this anymore in this country, he said.

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When will there be a coronavirus vaccine and who will get it first? - Yahoo News

A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.

COVID-19, which was first detected in December in Wuhan, China, has sickened more than 100,000 people worldwide and killed at least 3,400. There are no Food and Drug Administration-approved vaccines or therapies for the disease.

In the U.S., the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.

Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:

Company: Gilead Sciences Inc. GILD, -2.61%

Type: Treatment

Stage: Phase 3 clinical trials

Name: remdesivir

Background: Gilead is a longtime drug maker that is best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by Chinas Food and Drug Administration in February.

Clinical trials:

1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide. The trial is expected to conclude April 1, 2023. Sites include the National Institutes of Health in Bethesda, Md., (not recruiting), the University of Nebraska Medical Center in Omaha (recruiting), the University of Texas Medical Branch in Galveston (not recruiting), and Providence Sacred Heart Medical Center in Spokane (recruiting).

2. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 600 patients with moderate COVID-19. The trial is expected to start enrolling patients in March, with results to come in May.

3. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 400 patients with severe COVID-19. The trial is expected to start enrolling patients in March, with results in May.

Year-to-date stock performance: Shares of Gilead are up 17.6%.

Company: GlaxoSmithKline GSK, -11.04%

Type: Pandemic adjuvant platform for vaccines

Name: AS03 Adjuvant System

Background: GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmakers vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.

Year-to-date stock performance: Shares of GSK have tumbled 12.8%.

Company: Inovio Pharmaceuticals Inc. INO, -14.86%

Type: DNA-based vaccine

Stage: Preclinical

Name: INO-4800

Background: Another CEPI grantee, Inovio has said it already began preclinical testing and small-scale manufacturing.

Timeline: Inovio develops immunotherapies and vaccines but hasnt yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company plans to begin clinical trials in the U.S. with 30 participants in April. It also plans to launch human trials in China and South Korea that same month, and that it has a total of 3,000 doses prepared for the trials in the three countries. Inovio said it expects to have the first results from the trial in the fall and to have 1 million does of the vaccine ready for additional clinical trials or emergency use by the end of the year.

Year-to-date stock performance: Shares of Inovio have soared 278.2%.

Company: Johnson & Johnson JNJ, -5.33%

Type: Vaccine

Name: TBD (We are still in the process of identifying a vaccine candidate, so no there is no name at this time, a spokesman said March 4.)

Background: On Feb. 11, J&J said it is working with BARDA to test its vaccine candidate, with both organizations providing funding for research and development and the public-health organization funding the Phase 1 trials. Similar to GSK, J&Js AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&Js experimental Ebola vaccine. We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world, Dr. Paul Stoffels, J&Js chief scientific officer, said in a statement. J&J also said Feb. 18 that it is partnering with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against COVID-19.

Timeline: The company aims to start a Phase 1 clinical trial by the end of 2020, compared to the typical five to seven years it takes for this milestone in vaccine development, Stoffels said on Dr. Paul Stoffels, J&Js chief scientific officer and leader of J&Js global COVID-19 response, said March 2.

Year-to-date stock performance: Shares of J&J are down 4.8%.

Company: Moderna Inc. MRNA, +24.36%

Type: RNA-based vaccine candidate

Stage: Preclinical

Name: mRNA-1273

Background: On Jan. 23, Moderna received funding from CEPI to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.

Clinical trials: On Feb. 21, the NIAID said it would begin enrolling 45 healthy adult patients in an open-label Phase I clinical trial at one location to test mRNA-1273 as a vaccine for COVID-19 on March 19. The trial is expected to conclude June 1, 2021. Participants will be followed for one year. The trial will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle.

Year-to-date stock performance: Modernas shares have gained 45.7%.

Company: Regeneron Pharmaceuticals Inc. REGN, -5.31%

Type: Treatment

Stage: Preclinical

Name: No name yet

Background: On Feb. 4, Regeneron announced it is working on developing monoclonal antibodies as treatments for COVID-19. The companys VelocImmune platform uses genetically-engineered mice with humanized immune systems in preclinical testing. We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by end of August, a spokesperson said. Christos Kyratsous, VP of infectious disease R&D and viral vector technology, is running the project.

Year-to-date stock performance: Regenerons shares are up 27.8%.

Company: Sanofi SNY, -5.03%

Type: Vaccine

Stage: Preclinical

Name: No name yet

Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform. It has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. The French drugmaker previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteurs EVP, is leading the project.

Timeline: A spokesperson said Sanofi aims to put a vaccine into a Phase 1 clinical trial between March 2021 and August 2021.

Year-to-date stock performance: Shares of Sanofi are down 4.3%.

Company: Takeda Pharmaceutical Company Ltd. TAK, -10.18%

Type: Treatment

Stage: Preclinical

Name: TAK-888

Background: Takeda is one of the most recent entrants to the race to develop a treatment for COVID-19. The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection. As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from COVID-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takedas vaccine business, is the co-lead of the companys COVID-19 response team. Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.

Year-to-date stock performance: Shares of Takeda are down 8.7%.

Company: Vir Biotechnology Inc. VIR, +4.81%

Type: Treatment

Stage: Preclinical

Background: Vir said Feb. 25 it is collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for COVID-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. The preclinical company is run by George Scangos, the former CEO of Biogen.

Year-to-date stock performance: Vir shares have jumped 279%.

Editors note: An earlier version of this report referred to Gilead as a vaccine maker. The company is a drug maker. The story has been updated.

Excerpt from:

These nine companies are working on coronavirus treatments or vaccines heres where things stand - MarketWatch

A collective of biohackers has begun circulating a document proposing a plan to create, test, and distribute a vaccine to battle SARS-CoV-2. To get started, they say they need "between $10-25k."

Reason's Zach Weissmueller sat down with the lead biologist on the project, who requested anonymity due to fear of retribution from the Food and Drug Administration (FDA). Reasonhas verified his identity, as well as that of his business partner and a Silicon Valley investor who has confirmed his interest in the project.

The anonymous biologisthas worked in the commercial biotech sector and has long been involved in the "biohacker" community, a grassroots movement of professional and amateur scientists who experiment with genetic engineering in their homes and community labs. People like Josiah Zayner, founder of The Odin, which distributes kits allowing anyone to experiment with the gene-editing tool CRISPR.

Member of this community have created glowing yeast by inserting jellyfish genes, injected themselves with homemade vaccines, attempted to reverse-engineer patented pharmaceuticals, and tried to genetically engineer dogsall without seeking FDA approval.

"If someone is trying to develop and distribute an unapproved medicine, [the FDA] will come down hard, and they have," says the anonymous biohacker. "It's a severe risk to our livelihoods outside of this project if we were to be deanonymized."

The standard methods for creating vaccines are to combine a sample of a virus with a less infectious variant, or to inactivate the virus with heat or chemicals and then allow it to propagate immunity throughout the body. This team is attempting to create a vaccine using synthetic DNA constructed in a lab, which could save both money and time, though it might require a special device to deliver an electrical pulse to help the vaccine penetrate cell membranes.

There are no vaccines on the market created this way, but the pharmaceutical company Inovio is pursuing the same approach, and the Bill and Melinda Gates Foundation has expressed interest in funding projects that use this method.

"The company that we are, shall we say, cribbing the most off ofthey have a phase two clinical trial using the exact same approach for MERS [Middle Eastern Respiratory Syndrome]," says the biohacker.

The method has successfully produced antibodies to MERS but remains untested on a large population because there has been no outbreak since it was developed. Still, this gives the biohacker and his team enough confidence to proceed.

The proposal says the team will first look for positive responses in blood samples, rely on safety testing results from the company whose techniques they are mirroring, and then begin distributing dried versions of the vaccine to willing volunteers who would self-report results daily in exchange for free access to the vaccine.

He hopes to rely on a network of biohacker "community labs" to help with this process. He acknowledges that most people won't be willing to inject a non-FDA-approved vaccine but believes that if the pandemic gets bad enough they could fill a gap between the time the government approved an official vaccine and the time that vaccine is shown in trials to be relatively safe and able to generate antibodies in the blood.He says that DNA plasmid-based vaccines are less likely to cause injury than virus-based ones.

"Maybe it seems a little crazy, but at a certain point not doing something that seems pretty safe in the face of a disease that could kill you or loved ones.It depends on where everyone's particular risk threshold is," he says. "And I don't blame anyone waiting for an FDA-approved vaccine."

The biohacker places the group's odds of success at "less than 50 percent," but he still believes it's better to try than to do nothing in the face of a pandemic. He also believes the failure of public health agencies such as the World Health Organization and the Centers for Disease Control to act swiftly and decisively early in the outbreak increases the likelihood that an unapproved vaccine could play a useful role in slowing the spread of the virus.

"The people who are on the ground at these [public health] organizations, they mean well, but governments have to, as they say, 'Make number go up' with the economy, even if that means putting people's lives at risk," he says.

The Coronope document says that after the team successfully constructs a synthesized plasmid, which they believe they could do in 2 to 4 months, they could begin "producing thousands of doses per day." From there, the biohacker says, it's simply "an economy of scale," since replication of a bacterial-based DNA vaccine is far more efficient than a viral one that must be cultivated in slower-replicating animal cells.

Watch the video above for the full interview. The team suggests anyone interested in learning more or contributing contact them at coronope@protonmail.com, or use their public bitcoin wallet address bc1qccn54y3l4a9un7dhqnuewd22jx5vnruhf0dqve.

Produced by Zach Weissmueller. Camera by Justin Monticello and John Osterhoudt. Music: "Cendres" and "Fryeri," by Kai Engel.Photo credits: Coronavirus in Rome, Matteo Trevisan/ZUMA Press/Newscom.

Originally posted here:

Biohackers Are on a Secret Hunt for the Coronavirus Vaccine - Reason