Category: Covid-19 Vaccine

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A leading COVID-19 vaccine scientist answers our questions – World Economic Forum

May 2, 2020

Work to fast-track the development of a coronavirus vaccine received a boost last week as the UK government announced 42.5 million in funding for the countrys two leading efforts at Oxford University and Imperial College London. Last Thursday, Oxford Universitys programme, led by Professor Sarah Gilbert, became Europes first to enter human trials while the Imperial College team aim to begin clinical trials in June. This takes the total number of coronavirus vaccine clinical trials started in 2020 to 11.

Heading up the Imperial team is Professor Robin Shattock. In 2019, he spoke at the World Economic Forums Annual Meeting in Davos about the new techniques he was developing to facilitate the rapid development, testing and crucially local production of vaccines. Together, these techniques help to ensure that outbreak responses can be made quickly, with no region or country left behind. We spoke to him to learn how his teams efforts were progressing and to get his thoughts on the global response so far.

In 2019, you warned audiences in Davos of the threat posed by a pandemic, calling for action to ensure the world could respond quickly if one should occur. How did it feel to watch COVID-19 spread and how do you think the global effort to find a vaccine is doing so far?

It's been an interesting time to live through. When we presented in Davos, we were saying that these things will happen, but we were not thinking it was going to happen so soon, or that it would be a coronavirus. Everybody was predicting it would probably be an avian influenza outbreak.

In terms of the global response, its good news that there are many different vaccines being developed, with I think over 90 at the last count. There is a degree of coordination but all these groups are working independently on their own approaches or technology. Thats not necessarily a bad thing given theres so much risk in developing a vaccine, that means the risk is spread out, and I think its pretty clear that some groups will come through with an effective vaccine.

Your team has been working on developing a vaccine for COVID-19 since early February. Could you describe for our readers how a typical vaccine is made and how your approach using RNA differs?

The traditional vaccine approaches usually rely on physically growing the virus. This can be done either by growing the virus in huge volumes, 10s or 100s of thousands of litres, and then inactivating it, or by culturing viruses over time to gradually weaken them until they are safe. Both methods take a long time before they are ready for clinical use and require a lot of virus for an effective dose.

Our approach is to focus on just the genetic code of the spike protein on the surface of the virus and use that as our vaccine. When the vaccine is injected into the body, muscle cells naturally "amplify" it by producing copies of the spike protein which the immune system detects as a threat. This trains the bodys immune system to defend against SARS-CoV-2 through being able to recognise the spike protein if it encounters it again.

What are the advantages to working with RNA?

Using RNA allows us to be fast because the genetic sequence can be made synthetically in the lab, and because it can self-amplify, we need only a very low dose of the vaccine for it to be effective we can make the equivalent of a million doses in one litre of reaction material. This allows us to scale up very quickly and it is feasible to be making 10s of millions of doses per week from our lab. Adding more vaccine platforms working in parallel will only increase production capacity further.

Is distributed production ready to help and what other measures can be taken to ensure vaccines reach all those in need?

Right now, the distributed production mechanism is not there. Manufacturing facilities around the world are not set up with the same technology, so identical methods cannot be used. There is also a need for harmonization of regulatory approval to ensure that when a vaccine is cleared for use in one location, other manufacturing sites around the world can move swiftly to scale production.

I do not expect that such a network will get up and running in time to contribute significantly to the COVID-19 response. When effective vaccines are identified they will probably still be produced through a more traditional approach of working with very large manufacturers. However, developing such distributed production capabilities should be a key part of strengthening global resilience after this crisis has passed.

An example of what more can be done is that of the Serum Institute in India and some others that are offering to make vaccines royalty-free to ensure they are available to as many as possible without the obstacle of high cost.

A distributed approach to vaccine production would help distribute it faster and more widely.

Image: R. Shattock, Imperial College London

Some researchers are reporting lower than expected levels of viral antibodies in people who have recovered from COVID-19, possibly implying that any immunity gained will be temporary. Will a vaccine be able to stimulate a stronger response, giving longer lasting immunity?

Yes, a vaccine must do better than natural immunity and there is strong evidence that it will. COVID-19 is a respiratory infection and those with a mild infection will not be exposed to much virus because it will only be on their respiratory surfaces. The natural immune response to such an infection will be much lower than that generated from a potent vaccine injection. If the vaccine does not generate a strong response, then it should not be rolled out to the general population.

For a vaccine to be highly effective, it should prevent infection in over 80% of vaccinated people and give them immunity for a minimum of a year (which would allow for annual boosting) but ideally longer.

In normal times, vaccine development takes many years but today we are seeing accelerated timelines coupled with pressure from governments, the media and the public. As a researcher, how are you dealing with this?

Its difficult to get the right balance. Its important for people to understand that were moving faster than anybodys moved before because were aiming to have a fully tested vaccine within 12-18 months when normally it would be five to eight years, or longer. That said, when the need is as urgent as it is today, even 1218 months seems slow.

There is a need to temper expectations slightly though, as while we will have vaccines tested soon, we wont have vaccines globally available for a much longer time period.

Vaccine hesitancy has reduced the efficacy of public vaccination programs in some areas, leading to outbreaks of measles and other preventable diseases. Are you at all concerned that such behaviour could limit the potential of a coronavirus vaccine?

Right now, I think people want a vaccine. I dont think there will be much hesitancy about having a vaccine while COVID-19 is at the forefront of our minds. The issue with vaccines is theyre so successful in preventing the disease that it goes away and the reason theyre necessary becomes less apparent.

A new strain of Coronavirus, COVID 19, is spreading around the world, causing deaths and major disruption to the global economy.

Responding to this crisis requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forums mission as the International Organization for Public-Private Cooperation.

The Forum has created the COVID Action Platform, a global platform to convene the business community for collective action, protect peoples livelihoods and facilitate business continuity, and mobilize support for the COVID-19 response. The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.

As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.

If in two, three or more years time, weve had a successful vaccine and were not seeing new COVID-19 infections, people may increasingly choose not to be vaccinated. That could be due to hesitancy or simply it not being top of their priority list since the virus no longer appears to be a threat. This could lead to outbreaks popping up and effective public engagement strategies will be needed to minimize the risk of this occurring.

What message would you like to leave our readers with?

We are already seeing the massive impact of this pandemic on the economies of the world. We must learn from this and make the necessary investments to limit the impact of future pandemics now. The investment needed is tiny compared with the economic and human toll of another pandemic. It just makes total financial sense and anything else doesnt. The world needs an insurance policy against pandemics.

This interview has been edited for brevity and clarity.

License and Republishing

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

Written by

Sam Leakey, Programme Specialist, Science and Society, World Economic Forum

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

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A leading COVID-19 vaccine scientist answers our questions - World Economic Forum

Emory University helps test the nation’s first potential COVID-19 vaccine and possible treatments – Atlanta Magazine

May 2, 2020

Dr. Evan Anderson, Emorys principal investigator for this study

Photograph by Johnathon Kelso

Evan Anderson, an infectious-disease doctor, heads to his post on the front lines of the COVID-19 battle just as the 7:30 a.m. bell tolls on the clock tower at Emory University, honoring the healthcare workers risking their lives in the hospital. Theres an urgency in the staccato repetition of those chimes, a reminder of the imperative facing Anderson and his colleagues.

In mid-March, Emorys Vaccine and Treatment Evaluation Unit, under Andersons leadership, joined the nations first clinical trial for a COVID-19 vaccine. Emory is also testing drugs that could slow or halt the devastating assault of the virus in the lungs.

Normally, developing a new vaccine takes about a decade. But with the economy crippled and deaths mounting, the race is on to find an effective vaccine in little more than a year. Anderson immersed himself in that research while helping care for the sickest patients in the hospital. It is a unique and unusual circumstance, says Anderson. But it helps to see firsthand the importance of this vaccine.

On a normal spring day, Anderson would have been in his office or lab testing vaccines against other threats, such as respiratory syncytial virus, which often causes mild cold symptoms but can be deadly to very young infants and older adults. Or evaluating whether a compound added to the influenza vaccine could boost the bodys immune response. He set aside those studies as this new project emerged with an ultrafast timeline. We had to drop a number of other things to get the study enrolling within two weeks, he says.

The first phase of a drug trial involves just a few dozen people, but they need to be healthy and reliable. With two clinical vaccine research sitesthe Emory Childrens Center Vaccine Research Clinic at the main campus, and the Hope Clinic of the Emory Vaccine Center just north of Decaturthe university has a track record of enrolling participants who stick with the protocol. (Infectious-disease doctor Nadine Rouphael, lead investigator for this trial at the Hope Clinic, is a coprincipal investigator for Emorys overall vaccine program, along with Anderson and Carlos del Rio, a global health expert at Emory.)

Sean Doyle, an MD/PhD student at Emory, opened an email from the vaccine center on Saturday afternoon, March 21. It was short and to the point. Would he be willing to be part of a COVID-19 vaccine trial? I was 100 percent on board, says Doyle, 31, who had received an experimental Ebola vaccine a few years before. I didnt even have to think about it.

Two days later, he came for his screening, and received his first dose of the mRNA-1273 vaccine on Friday, March 27less than a week after the initial email. Doyle was one of the first 17 Atlantans in this Phase One study, which checks for safety and signs of immune response. Another 28 people received the same vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle, the lead institution for the trial. The first vaccine dose was administered there on March 16, just over two months after Chinese scientists shared the genetic sequence of the coronavirus.

Anderson met with Doyle to discuss how the vaccine works, its potential risks, and the requirements of the trial. He checked on him after a nurse injected the vaccine in his right upper arm. It was a little bit tender for maybe a day. After that, it was like nothing had been injected there, says Doyle. All participants receive a second dose a month after the first.

By mid-April, the vaccine trial had been safe enough to enable its expansion to a vulnerable group: older adults. Researchers added 30 people between the ages of 56 and 70 and 30 people 71 and older, split among sites at Emory, in Seattle, and at a National Institutes of Health center in Bethesda, Maryland.

The coronavirus has a crown of protein spikes, which the virus uses to gain entry to human cells. It then hijacks the human DNA to make copies of itself. The mRNA-1273 vaccine, developed by the National Institute of Allergy and Infectious Diseases and Moderna Therapeutics, a Massachusetts-based biotech company, contains a synthetic version of the viruss messenger RNAa strand of genetic code that instructs the bodys cells to make a section of the spike protein. The hope is that this will prime the bodys immune system to make antibodies and maybe other infection-fighting cells, which can prevent infection of the real COVID-19, Anderson says.

As much as Anderson wants mRNA-1273 to work, he knows most vaccine candidates dont ultimately succeed. Two months after the first doses were given, the researchers will decide whether to advance to a Phase Two trial, which enrolls as many as a few hundred people and looks for an immune response and evidence that the vaccine spurs a protective effect. Were cautiously optimistic, but were trying to be prepared to move forward with other vaccines, he says. There are more than 70 other candidates, including one the University of Oxford developed for other uses that might stop COVID-19 and could be available this fall.

Some patients Anderson sees are eligible for experimental treatments. About 100 Emory patients have been part of a study of remdesivir, an antiviral developed to treat Ebola. On April 29, the National Institute of Allergy and Infectious Diseases announced preliminary results of this randomized, controlled U.S. trial involving 1,063 patients that showed the drug led to quicker recovery. In response, the FDA was expected to authorize its emergency use for COVID-19. Clinical trials are also beginning on EIDD-2801, a different type of therapy developed by an innovative drug-development group at Emory.

Meanwhile, Emory doctors and nurses rely on basic medical techniques they have used in treating other infectious diseases. Their work is shaped by the intense experience of treating Americans with Ebola in 2014; all four patients recovered, and no Emory healthcare workers became ill. Infectious-disease doctor Aneesh Mehta was on call for the biocontainment unit when the first Ebola patient arrived. Inspired by the teamwork underlying the effective care, he later helped found a national consortium to assist hospitals in preparing for future outbreaks.

Those plans unfolded this spring. The first week of March, he was doing rounds at the hospital when he received a call from the emergency department about a young patient with cough, fever, and body aches who had recently traveled to an area with a COVID-19 outbreak. The patient wasnt terribly ill and recovered at home, but the wave was coming.

Even amid these difficult days, Mehta finds reasons for hope. We have definitely had a lot of successes, says Mehta, who is Emorys lead researcher for remdesivir. It heartens the team to get those patients back to their families. We hope to continue to do that until this outbreak is finished.

This article appears in our June 2020 issue.

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Emory University helps test the nation's first potential COVID-19 vaccine and possible treatments - Atlanta Magazine

Bill Gates on whether this bullish timeline for a COVID-19 vaccine is realistic: Theres simply no alternative – MarketWatch

May 2, 2020

Bill Gates has been a steady voice in delivering a mix of good news we should be able to get out of this with the death numbers well short of that and bad news it is impossible to overstate the pain ever since the first signs of a looming pandemic emerged.

The Microsoft MSFT, -2.58% co-founders latest take is mostly an example of the former, as he laid out a timeline for a return to normalcy, which, he said, is dependent on a vaccine.

Humankind has never had a more urgent task than creating broad immunity for coronavirus, he wrote in a blog post on Thursday. Realistically, if were going to return to normal, we need to develop a safe, effective vaccine. We need to make billions of doses, we need to get them out to every part of the world, and we need all of this happen as quickly as possible.

How quick is quickly? Five years, Gates wrote, is currently the record for a vaccine timeline. But he thinks we could see one for COVID-19 within 18 months.

This is what that shortened timeline might look like:

Its going to require a global cooperative effort like the world has never seen, Gates explained. But I know itll get done. Theres simply no alternative.

He said that, in the five-year scenario, the process works just fine. But this time its different.

The normal development timeline isnt good enough right now, he continued. Every day we can cut from this process will make a huge difference to the world in terms of saving lives and reducing trillions of dollars in economic damage.

Gates said that as it stands now, there are 115 different COVID-19 vaccine candidates in the development pipeline, up to 10 of which he sees as particularly promising.

Ultimately, he believes that the answer could look like the smallpox vaccine, the only vaccine that has successfully eradicated an entire disease. But it was also pretty brutal to receive, he said, adding that he is aiming for a more perfect solution.

Another major hurdle is the need to distribute at least 7 billion doses of the COVID-19 vaccine, which presents a unique set of problems for the manufacturer.

In order to stop the pandemic, we need to make the vaccine available to almost every person on the planet, Gates said. Weve never delivered something to every corner of the world before. And, as I mentioned earlier, vaccines are particularly difficult to make and store.

That, he said, could take years to complete. Nevertheless, Gates remains hopeful.

Eventually, though, were going to scale this thing up so that the vaccine is available to everyone, he said. And then, well be able to get back to normal and to hopefully make decisions that prevent us from being in this situation ever again.

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Bill Gates on whether this bullish timeline for a COVID-19 vaccine is realistic: Theres simply no alternative - MarketWatch

Yale researchers pursuing COVID-19 vaccine based on powerful Yale platform – Yale News

May 2, 2020

The urgent search for a vaccine to protect against COVID-19 is well underway, with a number of experimental gene-based vaccines in various stages of development by biotech companies and academic scientists worldwide. Yale pathologist John Jack Rose believes a proven vaccine platform he pioneered decades ago using a livestock virus called vesicular stomatitis virus (VSV) could produce better immunity than other candidates, and be scaled up quickly to meet global demand.

The VSV platform was used to develop the Ebola vaccine that received FDA approval in December 2019 and has since been effectively administered to more than 235,000 people, including over 60,000 health care and frontline workers.

Rose, professor emeritus of pathology and senior research scientist at Yale, and a small team of researchers that includes pathology chair Dr. Chen Liu and Craig Wilen, assistant professor of laboratory medicine and of immunobiology, are now working around the clock to develop a VSV-based COVID-19 vaccine and begin animal testing.

It is so critical that we provide at least an alternative approach for a vaccine, said Liu, who enlisted Rose in the challenge and set up his own lab alongside Roses to share in the work. There are DNA or protein-based vaccines for COVID-19 in trials, but, in my opinion, the viral vector [a vaccine using a live virus] would be more robust in generating immunity.

To make a vaccine using the VSV platform, scientists insert a protein from the virus they are trying to protect against such as Ebola or SARS CoV-2, the virus strain that causes COVID-19 into the livestock virus. The livestock virus is well suited for safely passing genetic material into cells and stimulating an immune response, Rose said. It is genetically stable, does not cause illness in humans, and generates a very strong antibody and T-cell response.

And a livestock virus can be reproduced much more easily than messenger RNA and DNA vaccines.

It would be easy to scale up production of a VSV vaccine for SARS CoV-2. We could get to millions of vaccine doses easily.

John Jack Rose

It would be easy to scale up production of a VSV vaccine for SARS CoV-2, said Rose. We could get to millions of vaccine doses easily.

Wilens lab is growing the live SARS CoV-2 virus strain, necessary for testing the new vaccines effectiveness.

Hes also making synthetic versions of the virus spike protein that will be inserted into the livestock virus. In high-resolution electron micrographs of the SARS CoV-2 virus, the spike proteins appear as protrusions emerging from the central mass like so many sucker feet. Its these proteins that allow the virus to bind to human cells and cause infection.

Because SARS CoV-2 is so contagious and potentially lethal, the Yale scientists wear complete protective gear including respirators and work in an isolated, negative-pressure room.

The coronavirus is similar in terms of virology to the norovirus, Wilens focus before the pandemic hit, he said. We were the first lab at Yale to culture the virus. Were working to pop out the normal VSV protein called G and swap it with the coronavirus protein.

Wilen said he and two postdoctoral students have taken over additional lab space in order to practice social distancing while they work.

The scientists have reason to hope that their VSV-based COVID-19 vaccine will work. Beyond its successful use in protecting against Ebola, the VSV platform has been used to develop other vaccine candidates that have shown promise in animal models for protecting against avian flu, HIV, and SARS CoV-1. The latter virus spread across 26 countries in 2013 and led to over 8,000 cases and 774 deaths.

SARS CoV-2 is a stealth version of SARS, Rose said. The original SARS made people very sick much faster and it was easier to trace contacts.

In his work creating the original SARS vaccine, Rose was able to successfully insert the spike protein into the VSV virus and engineer protection against SARS in mice. Because that virus was easier to contain than the slow-to-emerge SARS CoV-2, the work ended before the vaccine reached human trials.

But he learned important lessons about how the novel coronavirus operates. For one, its hard to generate immunity against it.

Even with the live virus, SARS CoV-1 didnt get a strong immune response [in mice], Rose said. It was protective, but low. It suggests we need a robust vector system.

Preliminary data shows that inserting SARS CoV-2 into the VSV platform will work to generate that protective immune response, Rose said.

Said Liu: This has a really good chance.

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Yale researchers pursuing COVID-19 vaccine based on powerful Yale platform - Yale News

Twenty Things that Caught My Eye Today: Sudan, Ethical COVID-19 Vaccine & More (April 30, 2020) – National Review

May 2, 2020

Jamie Metzl, a member of the World Health Organizations International Advisory Committee on Human Genome Editing, has speculated that the coronavirus originated in a lab in Wuhan, China."When they have outbreaks in China, the zoonotic jump [of the virus from animal to humans] tends to happen in the south ...Read More

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Twenty Things that Caught My Eye Today: Sudan, Ethical COVID-19 Vaccine & More (April 30, 2020) - National Review

Covid-19 treatment on the horizon but vaccine remains elusive – Pharmaceutical Technology

May 2, 2020

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The Covid-19 pandemic that has swept the globe has led to a massive search for a drug with which to combat this deadly virus, yet despite many pharmaceutical companies continuing to pour their resources into a cure for this virus, the development of prophylactic vaccines for Covid-19 appears to be lagging.

According to GlobalDatas Pharma Intelligence Center Pipeline Database and the Coronavirus Disease 2019 (Covid-19) dashboard, there are, as of 23 April, 80 therapeutic drugs in Phases I, II, and III that may be able to treat Covid-19, but only nine prophylactic vaccine drugs in Phases I and II, indicating that while a possible cure for Covid-19 may be imminent, a prophylactic vaccine to combat the pandemic may need more time to come to fruition.

The response from pharma and biotech companies globally to finding a Covid-19 vaccine has contributed to 438 unique drugs to treat Covid-19: 298 therapeutic drugs and 140 prophylactic vaccines, spread across all stages of development (Discovery, Preclinical, Phase I, Phase II, and Phase III), which is especially remarkable considering that the virus was only identified at the beginning of this year. In these unprecedented times, this massive pipeline in such a short time is demonstrative of the pharmaceutical industry compiling resources and talent, to finding a drug to combat this pandemic of the Covid-19 virus.

Therapeutic drugs account for two thirds of the entire pipeline, with prophylactic vaccines accounting for the remaining third of the current Covid-19 pipeline. Therapeutic drugs have 73% of their pipeline in early-stage development (Preclinical and Discovery) and 27% in late-stage development (Phases I, II, and III); despite the majority of drugs being in early stages, there is a viable pipeline of late-stage drugs that may in the coming months offer a solution to the ongoing crisis. The key drugs to watch are two small moleculebased drugs, remdesivir by Gilead Sciences Inc. and favipiravir by Fujifilm Toyama Chemical Co Ltd, and sarilumab, a monoclonal antibody by Regeneron Pharmaceutical, all three of which are currently in Phase III. At the same time as they are being developed for the Covid-19 virus, these drugs are also being developed for multiple other indications.

In direct contrast, the prophylactic vaccine pipeline largely comprises drugs in early-stage development, with 94% of the pipeline. There are currently only three drugs in Phase II, the current highest stage of development for prophylactic vaccine pipeline. These three Covid-19 vaccines are being developed by Sinovac Biotech Ltd, the University of Oxford, and the third vaccine, named CIGB-2020, is being developed by the Center for Genetic Engineering and Biotechnology. This huge disparity in late-stage and early-stage development is indicative of a lack of focus within the industry for vaccines in comparison to the therapeutic drugs pipeline. The massive global response towards the coronavirus and the massive increase in the therapeutic pipeline, however, does mean that this state of affairs is liable to change in the coming weeks. As this pandemic continues and governments and pharmaceutical companies continue to look for ways to combat Covid-19, the therapeutic landscape is sure to change, but as of now any hopes for a fast vaccine may not materialize.

You can view more information on the Covid-19 therapeutic landscape on GlobalDatas Pharma Intelligence Center Pipeline Database and the Coronavirus Disease 2019 (Covid-19) dashboard where the most up-to-date and latest information on drugs, trials, and news on Covid-19 can be found.

GlobalData is this websites parent business intelligence company.

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Covid-19 treatment on the horizon but vaccine remains elusive - Pharmaceutical Technology

Treatments and vaccines for COVID-19: Where are we now? – WTSP.com

May 2, 2020

TAMPA, Fla. Researchers, scientists, and health professionals all over the world are working around the clock to find treatments for the coronavirus. There are several trials going on right now, but it could take months to find which ones work best.

They are also working to find a vaccine. But according to the New England Journal of Medicine that could take years.

Developing a vaccine takes time and is an expensive process. It is going to take multiple candidates and years to produce a licensed vaccine.

The New England Journal of Medicine

In the meantime, let's focus on some of the treatments currently on trial or being tested.

Remdesivir-- is currently at the top of the list of treatments the world is excited about.

On May 1, 2020, the Food and Drug Administration (FDA) allowed the emergency use of Remdesivir as a treatment for COVID-19. The experimental drug appears to help some coronavirus patients recover faster.

The research-based biopharmaceutical company, Gilead Sciences, Inc. has been studying Remdesivir for more than 10 years.

Gilead scientists tested the drug as a treatment for hemorrhagic fever viruses such as Ebola, Marburg, and Nipah viruses, as well as other coronaviruses such as SARS and MERS.

When COVID-19 started to turn into a global pandemic, Gilead Sciences put Remdesivir into clinical trials to test how it would work as a treatment. The National Institute of Allergy and Infectious Diseases sponsored the Adaptive COVID-19 Treatment Trial, ACTT.

In February 2020, the first study site opened at the University of Nebraska Medical Center. The trial stopped taking new volunteers on April 19.

One of the ACTT trial sites is right here in the Tampa Bay area at Sarasota Memorial Hospital (SMH.)

There are eight people enrolled in the ACTT trial at SMH. "We are using the experimental drug in very sick people on ventilators, so it is difficult to assess the benefit of the drug on our patients at this time, said Kirk Voelker, a critical care pulmonologist caring for COVID-19 patients in Sarasota Memorial Hospitals ICU and medical director and sub-investigator of the health systems COVID-19 research trials.

Although SMH is in the early phase of the ACTT trial, Voelker said things look promising. "We are seeing positive indications in the trial and are hopeful that this treatment, along with other therapies we are researching, will be effective.

The initial group of people in the ACTT trial are Americans who quarantined aboard the Diamond Princess cruise ship, which was docked in Yokohama, Japan.

There are 68 study sites around the world, including 47 in the United States. The other test sites are located throughout Europe and Asia.

This week, Dr. Anthony Fauci, director of the NIAID, said findings from the Remdesivir trial are promising. He said the drug reduced the time it takes people to recover by 31 percent 11 days on average versus 15 days for those just given usual care.

What it has proven is that a drug can block this virus. This will be the standard of care," Dr. Fauci said.

The National Institutes of Health (NIH) also followed up with its own study and found patients who took Remdesivir recovered faster than patients who did not.

However, the NIH study also found eight percent of patients who took the drug died versus 11.6 percent of patients who did not take Remdesivir.

Chloroquine This drug is primarily used to prevent or treat malaria, which is caused by mosquito bites.

Its currently in clinical trials. And as with any drug, researchers realized chloroquine is not ideal for every patient.

Research of how effective chloroquine is for COVID-19 is still in the beginning stages. And collecting enough data might take longer than anticipated because currently theres a shortage of the medication.

The FDA put out warning labels for users of Chloroquine Phosphate.

They list cardiac effects, hypoglycemia, retinopathy, central nervous system effects, muscular weakness, and potential carcinogenic risk as possible side effects.

A report from the Institute of Virology of the Chinese Academy of Sciences showed the dosing of Chloroquine is very sensitive and taking too much could have major side effects or even death.

The FDA has yet to approve chloroquine as a treatment for COVID-19

Hydroxychloroquine is less toxic than chloroquine.

It is prescribed to those with rheumatoid arthritis, lupus, and porphyria cutanea tarda, a blood disorder that affects 1 out of 25,000 people.

Hydroxychloroquine is being tested as a preventative for healthcare workers. If it works for health professionals, will the general population gain access to it as a preventative drug?

Plasma Infusions Doctors are using plasma infusions on COVID-19 patients on ventilators.

Blood banks and the American Red Cross are asking for plasma donations from people who have tested positive for COVID19 and then negative. Donors should be symptom-free for 28 days.

According to the American Society of Hematology, convalescent plasma could provide short-term immunity against the SARS-CoV-2 coronavirus.

Most patients who recover from COVID-19 develop antibodies to various SARS-CoV-2 proteins two to three weeks after being infected. Transfer of plasma from these patients is supposed to neutralize the virus and stop tissue damage.

Plasma infusions should work best on those with less severe infection, according to the American Society of Hematology.

Azithromycin Is an antibiotic that has never been used for viral infections. According to the U.S. National Library of Medicine, Azithromycin is used to treat bacterial infections, such as bronchitis, pneumonia, sexually transmitted diseases and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

So far, there hasnt been any solid research, but some medical observers found that azithromycin could help reduce an overactive immune response to the COVID-19 infection. Harvard Medical School

Studies that have been done suggest azithromycin can be deadly if its used in combination with hydroxychloroquine. The human heart just couldnt hold up.

Vitamin C--Some people who are critically ill with COVID-19 have been treated with high doses of vitamin C through their IV. Doctors hope high doses of vitamin C will speed up the recovery process.

Theres no scientific evidence that a vitamin C IV drip works for COVID-19 infections.

Researchers in China are currently conducting a study to see if the high doses of vitamin C will help those with severe COVID-19. Results are expected in the fall of 2020. Harvard Medical School

Lopinavirritonavir is an antiviral drug used to treat patients with human immunodeficiency virus, HIV. The drug is currently on the Chinese clinical trial register and is administered to adults with severe COVID-19 symptoms.

So far, doctors have not seen any benefits of the drug as a treatment.

What are we missing?

As mentioned at the beginning of this article, everyone is chipping in to find an ideal treatment for COVID-19.

What treatments or clinical trials have you learned about?

E-mail your findings to TCody@wtsp.com and I'll dig into the research and then ask the experts how well the treatments are working.

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Treatments and vaccines for COVID-19: Where are we now? - WTSP.com

‘Operation Warp Speed’ aims to deliver a COVID-19 vaccine by year-end: Bloomberg – FiercePharma

May 2, 2020

Biopharma players worldwide have committed big money and talent to the hunt for a COVID-19 vaccine, striking some unprecedented partnerships along the way.

Behind the scenes, another joint effort has been taking shape at the White House, Bloomberg reports.

The Trump administration is working up a Manhattan Project-style joint initiative, bringing biotech, pharma and federal agencies together to speed up the workand let the U.S. government take on the financial risks.

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Dubbed Operation Warp Speed," the project's goal is delivering 100 million doses of a viable COVID-19 vaccine by the end of the year, according to the report. It would be a radical acceleration of the typical vaccine development timeline, which is typically described in years, not months.

To help move things along, the administration wants to help biopharma companies coordinate their separate efforts with assistance from federal agencies and the U.S. military, according to the report. U.S. taxpayers would fund the losses from failed projects, Bloomberg reports.

For instance, officials are exploring a master trial protocol that would allow researchers to study numerous vaccines at the same time rather than separately through independent studies by each company.

To speed up distribution, the team is planning to scale up manufacturing capabilities as the vaccines enter large human trials. Bill Gates has pitched such an approach, and hes acknowledged the strategy will result in billions of lost capital spending as many projects fail.

RELATED: Gates is ableand willingto lose big money funding factories for COVID-19 vaccines

Over the past two months, drugmakers, academics and others have started dozens of COVID-19 vaccine projects. Johnson & Johnson has inked manufacturing deals in recent days to prep for its rollout, while GlaxoSmithKline, Sanofi, Pfizer and Merck also have R&D projects underway.

The "Warp Speed" program arises from the administrations desire to smash the 12- to 18-month timeline often quoted for developing a COVID-19 vaccine, which itself is optimistic. Analysts and others have predicted it could be several years before the world sees a vaccine, and, historically, some vaccines have taken decades to develop.

RELATED: Biopharma's no-holds-barred fight to find a COVID-19 vaccine: The full list

Still, some vaccine programs are moving ahead with unprecedented speed. Researchers with Oxford University's Jenner Institute plan to start a 6,000-participant trial next month, The New York Times reports. The team is also working with drug manufacturers in Europe and Asia to quickly produce up to 1 billion doses upon a potential approval.

Also this week, Pfizer said it might be ready for an emergency rollout by the end of 2020, The Wall Street Journal reports.

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'Operation Warp Speed' aims to deliver a COVID-19 vaccine by year-end: Bloomberg - FiercePharma

Covid-19 vaccine could be ready sooner than expected – WWLP.com

May 2, 2020

SPRINGFIELD, Mass. (WWLP) Most public health officials had been saying it would take at least a year to develop a vaccine for COVID-19 but now, scientists in England are claiming that one could be ready by this fall.

Researchers at Oxford University have made significant progress recently in the global race to develop a vaccine. Human testing is now underway for their vaccine, and theyre hoping to have it ready for public use by September.

The FDA has strict requirements for vaccines before they are released to the public. But due to the severity of this health crisis, local doctors say they may ease back those requirements.

They may say theres no long term data but we know it protects for a couple months at least, so lets roll it out and watch how it does once its already available, said Dr. Daniel Skiest, an Infectious Disease Specialist at Baystate Medical Center.

Dr. Skiest told 22News progress is also being made right now on an antiviral medication that could help reduce the severity of symptoms.

He added that social distancing protocols would most likely continue for much longer, if it ends up taking longer to develop both a successful vaccine or an antiviral medication.

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Covid-19 vaccine could be ready sooner than expected - WWLP.com

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

May 2, 2020

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

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