Category: Covid-19 Vaccine

YELLOWSTONE NATIONAL PARK Before Covid-19 ever existed and long before we started using the phrases, Stay at Home and Shelter in Place in daily conversation, Yellowstone National Park had already contributed to the battle over the deadly virus.

It all started in Yellowstones famous, colorful and numerous hot springs.

Yellowstone has the largest concentration of hydrothermal features in the world, said Annie Carlson, Yellowstone National Park Research Coordinator.

Its in those hot spots where unique heat loving bacteria called thermophiles and extremophiles, have evolved. Anyone can see many of those springs just by touring the parks thermal features on designated boardwalks.

Back in the mid 1960s researcher Thomas Brock was taking a hot spring walk just like many people do every year. But he was intrigued by the organisms living in the extremely hot and acidic springs. Shortly afterward he identified a unique bacteria.

The bacterial species that they identified is called Thermus Aquaticus. Said Carlson.

And thats where the connection to the pandemic comes in. In 1985, scientists took an enzyme from that bacteria to invent a new laboratory process.

The enzymes solved a problem in DNA labs. Up until then, the enzymes used to map DNA were all destroyed by the heat the process generated. The Yellowstone enzyme was different because it thrives in such hot environments.

This gave researchers a way to quickly replicate small DNA strands in a process called PCR or a polymerase chain reaction.

So, one key molecule from a Yellowstone hot spring led to the DNA mapping we now take for granted in crime study, genealogy, and medicine, including vaccines, like the one being developed for Covid-19.

Carlson said, Medically its a very important technique.

That breakthrough, though decades old, still has a lot of potential. Carlson said, You can imagine that with any infectious disease in the future that could be used.

Yellowstones unique heat loving bacteria are so promising that a quarter of all the annual research permits in the park are issued to scientists looking for new and valuable bacteria.

Carlson said those scientists, Are really pushing the envelope with extremophile and thermophile research.

That research goes way beyond medicine. Some scientists are searching for the origins of life on earth and others are even looking for clues to life that may exist on other planets. The next time you visit Yellowstone, you may see some of those scientists, who have received special permits to carefully tiptoe between thermal areas sampling the unique life that lives there.

DIGITAL EXTRA: Extended interview with YNP Research Coordinator Annie Carlson

EXTENDED INTERVIEW with Annie Carlson, YNP Research Coordinator

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Local News Yellowstone enzyme may be key tool in creation of Covid-19 vaccine John Sherer - KBZK Bozeman News

As companies race against time to bring to market a vaccine for the new coronavirus SARS-CoV-2 that causes COVID-19, three contenders have emerged asfrontrunners, having advanced their candidates into the clinics.

Moderna Inc (NASDAQ: MRNA), Inovio Pharmaceuticals Inc (NASDAQ: INO) and CanSino Biological Inc./Beijing Institute of Biotechnology are those that have moved out of the crowd, even as the rest are either testing vaccines in labs,in vitro, or in animals in the preclinical stage.

Here's brief on the vaccine programs:

Moderna

Name of the vaccine candidate: mRNA-1273

Type: messenger RNA vaccine

Status: enrollment ongoing inPhase 1 study

Moderna is working on mRNA-1273 in collaboration with the NIH's National Institute of Allergy and Infectious Diseases. The vaccine encodes a prefusion-stabilized form of the SARS-CoV-2 spike protein.

The company said it took just 25 days to gofrom sequence selection to manufacturing of the vaccine, and 63 days from sequence selection to start of the Phase 1 trial.

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Source: Moderna

Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm about 28 days apart, with dosages of 25 mcg, or 100 mcg or 250 mcg.

The company's timeline suggests a commercial launch timeline of 12-18 months. Under emergency use, the vaccine could be available to some people and health care workers in the fall of 2020.

See also: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use

Inovio

Name of the vaccine candidate: INO-4800

Type: DNA vaccine

Status: enrollment and dosing ongoing in Phase 1 study

Inovio said it designed the vaccine within three hours of the release of the virus genomeusing its P2 MERS candidate. The program is in part funded by Coalition For Epidemic Preparedness Innovations and the Bill and Melinda Gates foundation.

Inovio said April 6 the FDA accepted its IND for INO-4800, signaling the regulatory agency's nod for undertaking clinical trials.

The company plans to enroll 40 healthy volunteers in Philadelphia and Kansas City. To assessinitial immune responses and safety, each participant is to receive two doses of the vaccine candidate four weeks apart.

Inovio also said it has manufactured thousands of doses to support the ongoing Phase 1 study as well as aplanned Phase 2 study. The company said is also working to scale up manufacturing so that it has about 1 million doses of INO-4800 available by year's end for additional trials and emergency use.

CanSino Biological Inc./Beijing Institute of Biotechnology

Name of the vaccine candidate: Ad5-nCoV

Type: Adenovirus Type 5 Vector (non-replicating vector type)

Status: Phase 1/2 studies

The vaccine candidate is based on the viral vector vaccine technology platform previously used to develop an Ebola vaccine.

Pfizer Inc. (NYSE: PFE) and Arcturus Therapeutics Ltd (NASDAQ: ARCT) shared atimeline for their jointly developed mRNA vaccine last week. The companies are targeting an end-of-April schedule for starting human trials.

Related Link: GlaxoSmithKline, Sanofi Collaborate On COVID-19 Vaccine Development: What You Should Know

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2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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3 Frontrunners In COVID-19 Vaccine Development: What You Need To Know - Yahoo Finance

So far, Australia has been doing pretty well in the fight against COVID-19. Using a combination of social distancing, tight travel restrictions and contact tracing, the country has kept its death toll under 100 people and seems to be leveling off its new cases. Its even managed to avoid closing schools. But despite the relatively minor impact the novel coronavirus has had on life in Australia, medical workers are still running low on masks, gloves and gowns.

Suddenly it feels like a house of cards, said Simon Quilty, senior staff specialist at Alice Springs Hospital in Australias Northern Territory. We havent quite [run out of personal protective equipment], but weve come very close to it. We dont even have the pandemic. If we do get a pandemic, were fucked.

All around the world, whether hard-hit by the virus or not, countries are running low on crucial supplies. And while shortages are largely confined to disposable medical items for now personal protective equipment (PPE), swabs, chemicals used for COVID-19 testing experts say other shortages are likely. The spread of SARS-CoV-2 (the virus that causes COVID-19) is affecting the way we manufacture all sorts of products, and the way we get those products to where theyre needed. People who study these supply chains have seen problems coming for years. Now theyre scrambling to get ahead of the pandemic, before it ends up affecting even our ability to produce the vaccines we hope will stop the disease in its tracks.

Up until a few weeks ago, I knew very little about the supply chain, said Megan Ranney, a professor of emergency medicine at Brown University. It always just worked. But Ive learned a bunch, and its more fragile than we ever thought possible. COVID-19 has forced her and lots of other hospitalists around the country to become supply chain experts on the fly.

A supply chain is a fancy term to describe how products get made and moved all around the globe. Its a simple concept, but not a simple process. Supply chains arent a conveyor belt theyre a ballet. And there are many, many ways this spectacular show can fall flat on its face. The production of a single item often involves multiple factories in several different countries and depends on speedy, reliable international shipping to get each piece to the right place at the right time and then to the buyers exactly when they need it.

In fact, experts in both manufacturing and medicine have spent years warning of the risks a pandemic or another major disaster could cause to supply chains. In 2011, for instance, Quilty documented that the hospital where he worked at the time had less than a 30 days supply of penicillin and many other crucial pharmaceutical drugs. A 2017 paper by scientists with the Centers for Disease Control and Prevention pointed out that PPE supplies had run into problems during the 2009 H1N1 influenza pandemic and the 2014 Ebola virus epidemic, and warned that the system wasnt prepared to handle a sudden increase in demand. Multiple reports have been published on how avian flu pandemics could disrupt everything from computer manufacturing to the global food supply.

PPE is the canary in the coal mine, Ranney said. She, and other experts, told me that right now, thats the main place were seeing supply chains break down. But those same issues apply to damn near everything else we make and sell. The longer the pandemic goes on, the more products will be affected.

There are three big problems with the global supply chains, experts told me. First, the push toward lowest-cost production means a lot of cheap goods and cheap components of more valuable goods are made in places with low-cost labor. When those countries experience a pandemic outbreak or when a pandemic interrupts transport from those countries it creates a bottleneck.

Around half the worlds face masks came from China before the novel coronavirus pandemic began. The virus interrupted manufacturing there early on, Ranney said. Now, China can make masks again, but demand has jumped all over the world, and there are shipping delays. Several companies have told her to expect deliveries to take three or four weeks. In the meantime, shes been left to sort through sketchy, back-alley PPE dealers, some of whom produce low-quality masks that either fall apart or dont filter properly on testing. Other would-be suppliers have turned out to be basically the high-stakes equivalent of one of those youve inherited $3,000,000! email scams.

American manufacturing companies are starting to switch over production lines to make masks and other protective equipment here but thats not a quick process and presents its own complications. For example, the nonwoven textiles that N95 respirator masks use to filter out viruses have to be made on special machines. There are only a few of those machines in the whole world, said Julie Swann, professor of industrial and systems engineering at North Carolina State University. And you cant just go buy a new one off the shelf. Her university is producing some of this material now. But not at the volume youd make at a large manufacturer, she said.

The second problem is that a global pandemic causes sudden spikes in demand for certain products. Production is designed for steady demand with predictable increases and decreases. A big, unforeseen event, like a pandemic, throws everything out of whack, said Adegoke Oke, professor of supply chain management at Arizona State Universitys school of business. Take our toilet paper woes. That supply chain didnt account for sudden, nationwide increases in having to pee at home. It also didnt anticipate every office in the nation suddenly holding it, indefinitely. You might think that the demand in one sector could be met by the excess from the other, but it doesnt work that way. The type of toilet paper you use in the office the big rolls are totally different from what you use at home, Oke said. They require different supply chains and different manufacturing lines.

And when manufacturing capacity cant keep up with a sudden surge in demand, there are no emergency backup supply closets to raid. Thats because of a popular and widespread business practice called just in time supply. Essentially, it means that businesses from hospitals to grocery stores keep only a small amount of supplies on hand at any given time enough to get through a couple of weeks or a month. Just-in-time saves money on warehouse storage, energy and staffing, but it works only if the supplies can be produced and delivered when you need them. Its been very successful, Oke said. But at a time like this, the last thing you want is just-in-time.

Finally, supply chains are also getting disrupted in some truly surprising ways ripple effects that spread from one industry to another. Take the transportation of goods. Turns out, its pretty dependent on European tourism 80 percent of the air cargo capacity across the Atlantic comes aboard passenger flights. When those all but stopped, it created a transportation bottleneck for manufacturing, said James Robinson, an independent consultant who spent 30 years working in vaccine manufacturing for companies like Merck. Airlines are turning their empty passenger jets into cargo flights, but that takes retrofitting and time and money and its going to increase the cost of shipping, Robinson said.

Then theres all the food being trashed in response to a pandemic thats cleared grocery shelves nationwide. The same parallel but separate home and business supply chains that affect the toilet paper supply also affect food. What people eat in a restaurant or at school and how much of it they eat isnt the same as what they eat at home. And the farmers who have typically supplied commercial kitchens dont have the sales, marketing, packaging and transport networks in place to get their food where its needed. Fresh vegetables and milk have simply been thrown out. And thats not to mention facilities closing when food industry workers are taken out by illness or migrant farm workers not being able to cross borders at future harvest times things that researchers have long predicted could cause food shortages in the U.S. during a time of pandemic. The food supply could be vulnerable, Swann said. As much as I dont want to scare people.

These supply chain issues can also create a weird sort of feedback loop: The virus increases demand for certain products, which jumbles supply chains for those products, which in turn hampers efforts to use those products to keep the virus in check. And that gives the virus time to beat up the economy even more.

Which is all to say that problems with the PPE supply could be only the beginning. As people like Robinson try to coordinate what will become an international effort to manufacture a COVID-19 vaccine in the months ahead, for example, theyre looking at whats going on with products like PPE knowing that the same things could happen to vaccines.

A vaccine manufacturer like Sanofi might source several thousand ingredients to make a vaccine, Robinson told me. But each material is coming from factories with hundreds of sources, and those sources have sources. Like the connection between holiday travel and international shipping, supply chains for vaccines can end in unexpected places like a Chilean tree farm.

Robinson is vice chair of the scientific advisory committee for the Coalition for Epidemic Preparedness Innovations, an international organization that helps coordinate funding and research for vaccines against emerging infectious diseases. CEPI is involved in the development of 10 different coronavirus vaccines, and Robinson expects at least three of those will eventually make it to widespread use. One of these vaccines, though, uses an adjuvant a substance to help strengthen the bodys immune response to a vaccine that contains an oil extracted from the Quillaja saponaria Molina tree, common to Peru, Chile and Bolivia. The bark is harvested only between November and January each year, so this years harvest didnt take the new coronavirus into account. Theres only so much of that adjuvant available until next year, Robinson said.

Other expected supply chain issues with vaccines are shaped by years of international trade patterns. For example, doses of vaccines are delivered in glass vials, and theres been a global shortage of glass stretching back to at least 2015. The medical glass industry was just beginning to catch up with increased demand, Robinson said, and now, novel coronavirus vaccines will create additional pressure. Even if the vaccine is loaded into 10-dose vials, thats still hundreds of millions of vials that will be needed, he told me. Janssen, a division of Johnson & Johnson, is developing a novel coronavirus vaccine that Robinson regards as one of the most promising. [Janssen has] already preordered 250 million vials, and that might be all thats out there, he told me. Were trying to procure another 200 million.

What it boils down to is that even the vaccine industry isnt prepared for a sudden increase in demand on this scale which would likely far outpace even the spikes associated with a bad flu season. In 2009, H1N1 rapidly increased manufacturing and got up to 400 million doses in a year. But for a pandemic, we might need billions, Robinson said.

The biggest thing experts are taking away from all this is the weakness of that just-in-time supply chain. In lean terminology, inventory is waste because its supply you arent using, Robinson said. But now, when demand is sharply rising, that inventory would be helpful and so many industries are tied together that when one runs out of supply it affects the ability of other industries to keep functioning.

Production can be ramped up, and it is. But it takes time and investment and its important to remember that those investments are a risk. We might need American-made masks now, but will we keep buying them after the threat of COVID-19 has passed? Or will we revert to just-in-time supply from cheaper factories overseas? History suggests the latter. During previous epidemics of influenza, Texas-based company Prestige Ameritech saw demand soar, Swann told me. But it proved to be a boom and bust. The company invested in new machines to meet demand during the 2009 H1N1 pandemic, Swann said. And then they almost went out of business later because [the Texas companys product] was a little more expensive than the ones from China, she said. We need to be willing to pay a little more during times of peace without crisis so we have supply available during crisis.

Continued here:

How COVID-19 Is Wreaking Havoc On Our Ability To Make Things Including Vaccines - FiveThirtyEight

More than three months had passed since the pathogen appeared on the map in Central China, tearing through Wuhan, an industrial city of 11 million, with alarming speed. Nearly two months had passed since the disease crossed the Pacific Ocean and landed in Washington State, where it quickly began spreading among residents. And a little over a week had passed since the potentially deadly, SARS-like respiratory virus that causes COVID-19 officially touched down outside the nations fourth-largest city, promising to unleash upon Texas the same chaos that was still rippling across Asia and much of Europe.

If there was ever a time to consider every possible solution to the rapidly encroaching pandemic, it was now. But as they sat in a cozy office on the fifth floor of a glassy, twenty-story office building inside Houstons Texas Medical Center on a Friday in mid-March, Peter Hotez and Maria Elena Bottazzitwo of the worlds most prominent infectious-disease expertsinstead found themselves desperately, and mostly unsuccessfully, trying to get the worlds attention.

They claimed to have a possible vaccine for COVID-19at least 20,000 doses of which sat untouched in a lab freezer in a strip mall three miles down the road from their office. It was a stockpile of a four-year-old SARS (severe acute respiratory syndrome) vaccine they had manufactured that, because of the similarities between that disease and this new one (both are coronaviruses), had the potential for cross protection. Nobody could say for certain whether the vaccine was capable of saving lives, but at the very least, the researchers maintained, they should be given an opportunity to find out.

We have the experts in Texas, we have the facilities in Texas, we have the virus here, and we have the clinical people who can do the studies, said Bottazzi, her voice rising in frustration. She is the co-director of Texas Childrens Hospitals Center for Vaccine Development and associate dean of the National School of Tropical Medicine at the Baylor College of Medicine. We have the largest medical center in the world, and with all this combined, we should already have had this vaccine in the human population.

Hotez, her co-director and dean of the NSTM, agreed. A normally affable scientist, hed begun to appear angrier than might be expected for a man who favors polka-dot bow ties. Thats because, despite all of his and Bottazzis credentials and the urgency of the moment; despite their appeals to health officials, Congress, and the public; despite their needing only $3 million to pull the vaccine out of the freezer and start testing on people, they were stuck. Rather than leading the fight against COVID-19 from their lab, they were waging a daily battle, in emails and phone calls, against bureaucracy.

In 2016, the researchers said, half a decade after their research began, their team was ready to begin testing their SARS vaccine. Unfortunately, as the researchers soon discovered, the interest in SARS vaccines had dried upand with it any available funding from investors and grants to advance testing to a clinical phase. With the virus no longer circulating (the SARS outbreak occurred in 2003), the interest in that disease had been displaced by more-pressing epidemics like Middle East Respiratory Syndrome (MERS), Ebola, and the Zika virus. But in December of last year, when news of a new SARS-like virus began circulating among health officials in China, neither Hotez nor Bottazzi were totally surprised. Weve always thought if there was a SARS and then there was a MERS, maybe theres going to be something else, Bottazzi said.

I havent been getting much sleep, said Hotez, his eyes bleary. Though his own efforts to revive his labs vaccine had so far been frustrating, he maintained optimism about the wider efforts underway to tackle COVID-19 in Texas and beyond. Indeed, his fatigue was typical of that felt by scientists across the state in several other labs at the forefront of the worldwide struggle to contain the disease. Hastened by the viruss genome being published online by Chinese scientists in January, their work has moved at a never-before-seen pace. By the time the first COVID-19 cases were identified in Texas, in February, the combined efforts of the states scientists were already having an unmistakable impact on the race for a breakthrough.

Hotez and Bottazzi in their vaccine-development lab in 2019.

Agapito Sanchez/Baylor College of Medicine

There may be no other institution in the world throwing as much brainpower at COVID-19 as the University of Texas Medical Branch at Galveston (UTMB). Over several decades, the Galveston National Laboratory at UTMB, a high-security biocontainment facility, was instrumental in developing the first Ebola vaccine, which was approved by the FDA late last year, as well as testing a Zika vaccine, after the 2015 U.S. outbreak of that virus. The lab also partnered with Hotez and Bottazzi in developing their SARS vaccine.

In February, UTMBs researchers were among the first in the world to receive live coronavirus samples from the Centers for Disease Control and Prevention. Scott C. Weaver, director of the Institute for Human Infections and Immunity and scientific director of the Galveston National Lab, estimated that ten UTMB scientists were actively working with the virus in their labs while several others were studying the virus using data.

Among their most intriguing campaigns is a project using genetically modified mice to trace how coronaviruses replicate and spread through cells. These mice may be key to a lot of research that seeks to understand the disease process and for efforts to create new antiviral drugs, said Weaver.

UTMB has also notched an agreement with Moleculin, a Houston biotech firm that has developed a cancer-fighting drug that may be able to interfere with coronaviruses by slowing down or stopping the replication of virus-infected cells, giving the bodys immune system more time to fight back. UTMB also has an expert exploring which bat viruses require mutation in order to jump to human hosts, offering possible clues about the origins of the latest outbreak.

The research circulated by UTMB, which has allowed its researchers to assist and influence labs all over the world, partly explains why there are already 44 possible COVID-19 vaccine candidates in development, according to the World Health Organization. Back during the Zika crisis, UTMBS research spread across the global medical community rapidly, helping establish new digital trade routes for research. Such collaboration and early dissemination of findings has only increased with the latest outbreak. Coronavirus has created an unprecedented sharing of data, Weaver said. Scientific communication has had some underlying improvements because of these global emergencies.

Two hundred miles northwest of Galveston, the Sauer Laboratory for Structural Biology at UT-Austin, which opened in 2017 and has become a global leader in the use of an imaging technology known as cryo-electronic microscopy, has underscored the importance of investments in advanced research facilities. There, associate professor Jason McLellan made news in February by leading a team that created the first 3D map of the coronavirus spike proteins, the portion of the virus that gains access to human cells, passing along the infection. In recent weeks, McLellans team, which has been researching coronaviruses like SARS and MERS for years, has shared the map with researchers across the world.

With the atomic scale model in place, a scientist at the National Institutes of Health, working with Massachusetts-based biotech firm Moderna Inc., has created an early vaccine that is in the first stage of a clinical trial, which will determine the vaccines safety on several dozen healthy volunteers.

As soon as we knew this was a coronavirus, we felt we had to jump at it, McLellan told UT News, because we could be one of the first ones to get this structure. We knew exactly what mutations to put into this, because weve already shown these mutations work for a bunch of other coronaviruses.

His comments parallel those of Hotez and Bottazzi. As COVID-19 was racing through China in January, a research contact in that country confirmed to the team in Houston that the virus was more closely related to SARS than to MERS. As soon as scientists were able to identify the new coronaviruss genetic code, Bottazzi and Hotez began to explore the similarities between it and the SARS virus in closer detail. What theyve discovered, they said, is promising.

Not only do the two viruses exhibit similar genetic codes and bind to the same receptors on human cells, new lab experiments appear to show that the blood of patients infected by SARS in 2003 can neutralize the virus that causes COVID-19, meaning some people may have an inherent immunity.

Thats when the little light bulb turned on, Bottazzi said. We realized that theyre so similar that maybe our vaccine is something that can be repurposed for this new outbreak. Even though it may not be the perfect vaccine, its certainly sufficiently similar that it will provide some added value in reducing the severity of the disease.

As recently as late January, Hotez himselfa renowned expertunderestimated the severity of COVID-19, telling CBS Austin that I guarantee you, [ the flu ] will kill more Americans by orders of magnitude than what will happen with this n-coronavirus.

For all the good work being done, researchers like Bottazzi and Weaver caution that there is no quick fix for the new coronavirus. Even the most sanguine forecaststhose that assume unpredictable human trials will proceed without a hitchdo not predict a widely used vaccine for the public until well into 2021, at the earliest.

Thats simply how long it takes to develop and test a vaccine, to ensure that its not only effective but safe, in the general population and for groups of patients with specific characteristics. But its also a reminder of the importance of funding research with uncertain tangible results in times when theres no imminent crisis. The neglect of Hotez and Bottazzis SARS vaccine is an example of what can happen when research funding freezes up. When funding continues, so can progress. Three years ago, using a technology developed by microbiologist John Schoggins, of UTSouthwestern Medical Center, in Dallas, researchers began a study that identified a protein produced by the human immune system that can inhibit coronaviruses, including SARS and MERS. With the benefit of multiple grants, Schoggins and his international partners continued their work and determined this February that the same protein inhibits the COVID-19 virus. Any potential for developing this knowledge into a treatment remains years offbut its years closer than it would have been without continued funding.

Hotez and Bottazzi are hopeful that their vaccine will be tested in clinical trials soon. Once they get funding in place, they said, they could begin testing their vaccine in clinical trials on Texans infected with COVID-19 in as little as six weeks, possibly sooner. The idea that just $3 milliona sum of money amounting to a modest NBA contractis all that stands in the way is simply too absurd for them to consider it insurmountable. Im upbeat because, you know, if I focused on my frustration, I could just sit down and cry, said Bottazzi, forcing a smile twelve hours into a day that began, like so many recently, with buzzing text messages from researchers around the world at 3 a.m. I mean, the frustration is invigorating us to do a hundred thousand things at the same time.

As we spoke, Hotezs iPhone began buzzing. On the line: a reporter from 60 Minutes. Normally a great opportunity, as far as interviews spotlighting academic work are concerned, but not the audience the researchers were truly seeking. Who they really wanted to talk to, they said, was somebody in the federal government with the power to fast-track the testing of their vaccine.

Even now, when everything is going crazy and we should have all the resources at our command to move this forward, were still getting these emails that say, Heres a request for applications, Hotez said, referring to government agencies that have asked his team to apply for grant money, a process that would take months at best.

Navigating Americas sprawling, regulation-clogged public health infrastructure is a familiar challenge to researchers, of course. Hotez has recently become more strident in his public remarks. When he testified before the House Committee on Science, Space, and Technology on March 5, he said that by failing to fund vaccine development when the private sector wouldnt, the government had missed a major opportunity to avoid a health crisis. Its tragic that we wont have a vaccine ready for this epidemic, Hotez said then. Practically speaking, well be fighting these outbreaks with one hand tied behind our backs.

In the meantime, he and Bottazzi have pivoted to soliciting the investment they need from regional philanthropists. Bottazzi, who was born in Italy but has spent thirty years in Texas, has shaped her appeal around a theme that Texans are uniquely receptive to: bragging rights. It would be fantastic to say that Houston has one of the first vaccines [for COVID-19] being evaluated, she said. How could that not resonate?

Additional reporting by Jason Heid.

This article originally appeared in the May 2020 issue ofTexas Monthlywith the headline Is a Vaccine Sitting Untested in Texas? Subscribe today.

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Inside the Franticand FrustratingRace to Develop a COVID-19 Vaccine in Texas - Texas Monthly

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Auburn native participates in first COVID-19 vaccine trial; what's next for him? - Auburn Journal

Oxford Universityscientistsare to begin human trialsof a potentialcoronavirusvaccine next week.

Researchers said the jab could be ready to be rolled out for emergency use by the autumn followingsignificant progress in the early stages of development.

The Oxford team has tested the vaccine successfully on several animal species.

Sharing the full story, not just the headlines

TheWorld HealthOrganisation(WHO) has reported that more than 70 vaccines are being developed globally for Covid-19, which has infected morethantwo million people and killed128,886 across the world.

However, experts have cautioned it could take at least18 months to fully develop a jab that can be made available to millions people.

The Oxford teamjoin three other groups of researchers two in the United States and one in China in beginningtrialson humans.

Their projecthasrecruited 510 people, ranging from18 to 55 years old, to take part in the trials, said lead researcherProfessor Adrian Hill.

We are going into human trials next week. We have tested the vaccine in several different animal species, he added.

We have taken a fairly cautious approach, but a rapid one to assess the vaccine that we are developing.

Professor Sarah Gilbert, a vaccinologistat Oxford, has said she is80 per cent confident it will be a success.

There is now hope that thejab, developed by the clinical teams at the Jenner Institute and Oxford Vaccine Group, couldbe ready from as early asSeptember.

No hype, just the advice and analysis you need

However, Professor Hill saidthe team must continue to increase fundraising in order toaccelerate development.

Were a university, we have a very small in house manufacturing facility that can do dozens of doses. Thats not good enough to supply the world, obviously, he told the BBC World Service.

We are working with manufacturing organisations and paying them to start the process now.

So by the time July, August, September comes whenever this is looking good we should have the vaccine to start deploying under emergency use recommendations.

Thats a different approval process to commercial supply, which often takes many more years.

There is no point in making a vaccine that you cant scale up and may only get 100,000 doses for after a huge amount of investment.

You need a technology that allows you to make not millions but ideally billions of doses over a year.

The UKs chief scientific adviser Sir PatrickVallancehas saidit would be very lucky if acoronavirus vaccine was widely available within a year.

Sir Patrick told ITV:A vaccine that can be used generally wed be very lucky to get one within a year.

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Coronavirus: Oxford University set to begin human trials of Covid-19 vaccine - The Independent

The Research Brief is a short take about interesting academic work.

We are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for COVID-19.

This process is used for the treatment of blood products such as plasma, platelets and whole blood to prevent disease transmission when people receive transfused blood. It utilizes a common food ingredient, vitamin B2, or riboflavin, which is a light-sensitive chemical. When used in combination with ultraviolet light of specific wavelengths, B2 can alter genetic material, whether RNA or DNA, of infectious pathogens in the blood, making them unable to transmit disease.

Those genetic changes prevent pathogens, such as viral, bacterial and parasitic contaminants, in blood from replicating. By stopping the replication process, the method protects people from disease they could acquire through a blood transfusion.

Heres how we believe this technology can be applied to COVID-19 virus: When creating a vaccine candidate, the goal is to destroy the replication potential of the virus while preserving its proteins and antigens, the substances in the virus that prompt the body to produce antibodies. The presence of those proteins and antigens allows the body to recognize the virus as foreign and mount an immune response against it.

When this method is applied to a pure virus grown in cell culture, the B2 damages the viruss genetic material and thus blocks it from replicating. But the B2 treatment leaves the rest of the virus notably the viral proteins undamaged. That is important because the vaccine needs to contain proteins that appear on an infecting virus in order for a person to produce effective antibodies and protect against the disease.

Vaccines require an inactive form of a virus that cannot cause disease to stimulate the immune system. In 2009, during the H1N1 influenza outbreak, the U.S. experienced shortages in the manufacturing of needed vaccines, as the need to grow the virus was in high demand and the manufacturing plants that required the use of eggs to grow the virus were insufficient.

This resulted in the expansion of new ways to manufacture vaccines, some of which are now in use. Yet, there is still a lag time in the production of needed vaccines for the current coronavirus outbreak.

Most methods that are used today to prepare inactivated viruses employ chemicals that are both toxic and in some cases even pose explosion risk, meaning that facilities have to be constructed and operated in ways that protect workers and the public from their use and exposure.

Riboflavin is a compound that is generally recognized as safe because of its low toxicity in humans and animals and its presence in common products people routinely ingest. Using this approach can make this step in virus production much easier and applicable for use in appropriate biological containment facilities.

Over the last decade, there have been advances in manufacturing and in strategies to rapidly produce a vaccine.

Our work has been made possible by the investments made in the U.S. research infrastructure through the National Institute of Allergy and Infectious Diseases in order to expand research and manufacturing capacity and to address concerns over the potential threat of bioterrorism. It led to the construction of a manufacturing plant and research labs which are currently used by industry, government and academic partners pursuing manufacturing and process development for vaccines, therapeutics and diagnostic reagents.

Although the threat from bioterrorism never materialized to the extent that was initially envisioned, there is a need for rapid vaccine development to address emerging pathogens that threaten human health on a global basis, such as Zika.

Our vaccine construct, which we call SolaVAX, is undergoing animal testing and further laboratory characterization, such as studying the nature of the damage to the viral RNA that this process induces and its immunological effect when given to animals. We began our initial vaccine challenge studies earlier this month. These tests will determine if we can protect animals that are vaccinated with SolaVAX from developing the disease when they are later exposed to the live virus. This work is a first step on the path to human clinical evaluation. We also possess the nonprofit BioMARC manufacturing operation at Colorado State University, where testing and development of this inactivation method for vaccine production can be piloted.

If initial results in animal testing and pilot production of the vaccine are positive, the next steps into human clinical testing and evaluation and ultimate regulatory approvals represent the next major hurdle.

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Researchers seek to repurpose an existing manufacturing platform to produce a COVID-19 vaccine - The Conversation US

DIAMOND (HOST): Yes we do need to look at the community. But what we don't need to happen is what happened with Africa when Bill Gates and them took that vaccine to Africa trying to vaccinate. They felt like stuff can start right there in certain parts of Africa --

SILK (HOST): Africa.

DIAMOND: That's what we don't need to -- you're not going to make Black people the guinea pigs for this here right here.

SILK: We're not going to be your experiment or your project. Not Black folks.

...

DIAMOND: Kudos if you make your vaccines for people and you want to help people. But I have a problem receiving any vaccine from any entity, especially anybody like Bill Gates who pushed for population control. The same thing that Margaret Sanger pushed for.

SILK: Abortions. Genocide.

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Fox News' Diamond & Silk declare they will refuse any COVID-19 vaccine Bill Gates was involved with, falsely claiming he pushed for population...

A participant in a COVID-19 vaccine trial receives an injection in Kansas City, Mo., on April 8, 2020.

The Canadian Press

Question: Ive read that it could be one to two years before we have a vaccine that will guard against COVID-19. Why is it going to take so long?

Answer: The development of any vaccine can be compared to a long and challenging marathon with an uncertain outcome and that is especially true when dealing with a new pathogen.

The purpose of a vaccine is to expose the bodys immune system to some portion of the virus so it can prepare in advance for a real attack. For instance, a vaccine might include an antigen, or protein, from the surface of the virus. But finding the antigen that will trigger an effective immune response is easier said than done.

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Science cannot be rushed, says Rob Kozak, a clinical microbiologist at Sunnybrook Health Sciences Centre in Toronto. Researchers must follow well-established regulatory protocols that are designed to ensure a therapy is both effective and safe.

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Viruses are constantly mutating and evolving. The strain of a virus circulating in Canada might be slightly different from the one in China or Europe. This means the antigen must produce immunity against all strains, or variants, of the virus.

Once an antigen is selected, it has to be tested in animals before human trials can begin. Finding the appropriate animal model also presents challenges. The animal needs to respond to the virus and the vaccine in the same way as people.

Fortunately, researchers can look to previous vaccine studies for clues on how to respond to the current pandemic, including selecting appropriate animal models and viral targets.

The COVID-19 illness is caused by a coronavirus, officially known as SARS-CoV-2. In recent years, humanity has been challenged by two other deadly coronaviruses Severe Acute Respiratory Syndrome (SARS) in 2003 and Middle East Respiratory Syndrome (MERS) in 2012. During both of these outbreaks, researchers started to develop vaccines. In the case of SARS, the work was never completed partly because the virus ceased to pose an immediate threat; it seems to have morphed and disappeared. MERS vaccine trials are continuing.

Previous SARS research reinforces the importance of doing thorough testing in animal models before any potential vaccine is given to human volunteers.

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In one study, an experimental SARS vaccine made lab animals worse, says Arinjay Banerjee, an emerging-viruses researcher at McMaster University in Hamilton.

This study showed that when mice were vaccinated and then challenged with the pathogen, there was an enhancement of the infection, he says. The vaccinated mice developed disease more rapidly and died more rapidly than the unvaccinated mice.

Another study revealed that some investigational SARS vaccines produced negative side effects in some types of animals (such as ferrets) but not in others (such as mice). For that reason, many researchers are convinced that a vaccine should be tested in two different types of animals, Kozak says.

All this preclinical work is time consuming. Laboratory animals require specific time periods to develop a response to the vaccine and then to react to the virus. The clock cannot be made to run faster, Kozak says. And if an experimental vaccine fails, a research team could find itself again at the starting gate.

After a vaccine has successfully passed animal testing, it is then tried in a small group of healthy volunteers. This is known as a phase-one clinical trial. Its basically a safety check to make sure the vaccine does not cause serious side effects.

If the vaccine clears this critical hurdle, trials are expanded gradually to include more people who are observed for longer periods of time in order to gain a better understanding of its risks and benefits.

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Scientists around the world are already exploring various ways to deliver a COVID-19 vaccine. Each of them have their advantages and disadvantages, Kozak says.

To be honest, I dont think we are going to have just one vaccine, he adds. In fact, I hope we dont. I hope we have three or four amazing candidates that all work basically as well as each other, and that could be critically important because you dont want to be dependent on only one company to provide for the world.

Like other experts, Dr. Kozak estimates it will take between one to two years to develop a vaccine. And once a vaccine does exist, special production facilities will have to gear up operations to meet the global demand. That, too, will take time.

All of which means that a quick fix vaccine is not on the immediate horizon.

China has approved early-stage human tests for two experimental vaccines to combat the coronavirus as it battles to contain imported cases. Chinese citizens planning to return from neighbouring Russia are being told to remain where they are. Reuters

Paul Taylor is a Patient Navigation Adviser at Sunnybrook Health Sciences Centre. He is a former Health Editor of The Globe and Mail. Find him on Twitter @epaultaylor and online at Sunnybrooks Your Health Matters.

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Why will it take so long to develop a COVID-19 vaccine? - The Globe and Mail

SINGAPORE: Over 70 teams worldwide are now in a collaborative race to test different vaccine candidates against Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2) that causes COVID-19.

Although the pace of research efforts has been extraordinary, scientists still estimate that producing a vaccine, from innovation to access, will take at least 12 to 18 months. This timeline has the caveat if all goes well.

To the public, this seems like a long wait. But most vaccinologists who study and develop vaccines view this as very optimistic. It normally takes more than 10 years for a vaccine candidate to become an approved vaccine in a public immunisation programme.

Vaccine development is complex and financially risky. A vaccine candidate can fail at any point in development. Having a few candidates do well in clinical trials is considered a best-case scenario.

It is important to understand that all we have currently are experimental vaccine candidates not ready to be used soon. A vaccine candidate is not a confirmed human vaccine.

It must undergo ethical reviews, be evaluated in animal studies, for safety and efficacy in clinical trials involving human volunteers, before receiving regulatory approval and licensing for marketing and widespread use.

Vaccine manufacturing plants must be pre-inspected and approved for sterile manufacturing conditions, quality controls, and production ramped up to support potentially billions of vaccine doses.

Public health policies and financing decisions for national public programmes need to be in place. Follow-up studies must be set up to closely monitor the vaccines long-term safety and effectiveness with large-scale immunisation.

This is even more important for an accelerated vaccine using new technology against a new virus.

ACCELERATING IN PARALLEL

For the COVID-19 pandemic, scientists, regulators, government and industry leaders have been working closely to accelerate coordination of the different requirements to run at parallel speed with some vaccine candidates which have already entered clinical trials.

In addition to the World Health Organizations guiding role, the Coalition forEpidemic Preparedness Innovations was established in 2017 by the Wellcome Trust, the Bill & Melinda Gates Foundation and several governments, and has invested in several projects to help speed up the development of COVID-19 vaccines.

Timelines for animal and human trial studies are being compressed, but always carefully weighing potential risks.

For vaccine candidates developed using more well-known and evaluated technologies, some clinical studies in human volunteers have started earlier and overlapped with animal studies usually carried out before human studies.However, some areas cannot be shortened or accelerated, such as collecting ongoing safety data on side effects.

Regulatory reviews are being sped up. Instead of requiring submission of all information from completed clinical trials, regulatory agencies are now open to receiving data on an ongoing rolling basis.

To save on time needed for analysis and discussion, chapters of clinical trial data can be submitted for review in real-time, rather than wait until the end to submit the usual complete book of data when all trials are finished.

Each vaccine has its own benefits and risks profile. Regulators must be updated and agile to manage risk tolerance and potential benefits of these urgently needed new technologies.

Manufacturing plans are also being accelerated in some countries.Plans in the US are already underway to scale up manufacturing to produce massive amounts of certain vaccine candidates.

Bill Gates has publicly supported developing manufacturing capacity for some vaccine candidates just starting clinical trials, fully aware not all candidates will cross the finish line.

Such early production, with quality checks done in advance, can shave off weeks to months for manufacturing billions of vaccine doses needed to reduce the ongoing human and economic toll.

Several questions are emerging surrounding financing and equitable distribution of any vaccines that get developed. What will it cost? Will the vaccine be considered a common good for all people? Will the technology be shared? Which countries and which populations groups are prioritised to gain access first?

This last question is a concern if countries with ongoing spread are unable to afford a vaccination programme. Strong leadership, global governance and a collective commitment to social justice will be needed.

HOW VACCINES WORK

All vaccines work using the same principles.A healthy person (the vaccinee) is given a piece of the germ or the germ itself in order to give a heads up to his or her immune system, so that it can later recognise and tackle the virus appropriately.

If the person gets exposed to the real virus later, his or her immune memory will activate earlier to kill the virus and block its spread. The vaccinee stays healthy, often unaware of being exposed to the threat.

Choosing the best picture (antigens) of the SARS-CoV-2 virus to show to our immune systems, in order to stimulate the right immune memory and appropriate antibodies, is where the challenge really lies for scientists.

A good, safe and effective SARS-CoV-2 vaccine must accurately capture the important features of this virus in order to generate the best immune memory. Ideally, a vaccine would show the immune system the entire process of SARS-CoV-2 infection so that it can develop ways to attack the virus at different fronts.

But it is challenging to genetically weaken SARS-CoV-2 such that it would cause infection but not the disease itself.

Most vaccine researchers have thus turned to technologies that can present different pictures, or pieces, of SARS-CoV-2 to our immune systems.

Much research has been focused on the spike proteins forming the crown or corona of SARS-CoV-2. This appears crucial in how the virus attaches to and infects human cells.

We are beginning to learn that the spike protein is liberally decorated with sugars. Displaying the right sugars on vaccines appears important to show the immune system the correct picture.

Some vaccine candidates in the running present the genetic code (RNA or DNA) of the spike protein. Our cells then translate the genetic code to make the spike protein in the body.

Another method is to insert SARS CoV-2 genes into a safe, licensed viral vaccine to deliver the piece of SARS CoV-2 using a well-known, harmless virus.

We might not be able to develop a vaccine that provides the perfect picture of the virus to vaccinees. But even a partially effective, safe vaccine could be very valuable. The vaccine may not stop all cases or symptoms but could prevent severe respiratory distress and deaths.

When many people become immune either through vaccination or surviving the infection - the virus cannot infect enough susceptible people to propagate. This population herd immunity is needed to end an epidemic or prevent one from gaining traction.

THE NEED FOR DIVERSITY AND SOME LUCK

While there are many ways to make vaccine candidates, we do not yet know how to pick winners. Furthermore, scientists still have much to learn about how this new virus behaves.

There remains an element of luck when looking for a good vaccine against a new virus we are only getting to know.But our chances have improved with the unprecedented number of vaccine candidates being developed and with the scientific world so focussed on COVID-19.

The huge human, social and economic fallout from this pandemic means we should leave no stone unturned and invest heavily in a wide range of vaccine candidates to find good, safe and effective vaccines.

Many SARS-CoV-2 vaccine candidates are exploring using new technologies.To help shorten clinical trial duration and reduce the number of human volunteers, some research groups are studying the use of molecular technologies to complement clinical trials.

There is also hope that the similar explosion of studies for safe, effective medicines to treat COVID-19, including anti-viral medicines and potential antibody treatments, will yield positive results. These are likely to arrive much sooner than a vaccine.

The unfortunate surge of clinical experience in managing severe respiratory distress with COVID-19 could also lead to other best practices to improve patient outcomes where capacity is available.

MEANWHILE, CARRY ON

A COVID-19 vaccine will unfortunately not be available this year. If all goes well, a vaccine or even a few vaccines will be rolled out in 2021.

For now, other public health measures are essential to save lives, including early case detection, contact tracing, isolation and quarantine.

We must practise frequent hand washing, physical distancing, staying at home, avoiding crowded places, and wearing face masks if we really need to go out.

COVID-19 is testing our collective scientific ingenuity, our individual responsibilities and social compact at a national and global level.

We must stay committed to our individual contributions and believe in our collaborative power in science to help develop and deliver long-term solutions.

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Dr Tippi Mak is Academic Visiting Expert at the Centre of Regulatory Excellence, Duke-NUS Medical School, Consultant at the SingHealth Duke-NUS Global Health Institute, and Board Director of the Vaccine and Infectious Disease Organization - International Vaccine Centre at the University of Saskatchewan, Canada.

Professor Ooi Eng Eong is Deputy Director at the Emerging Infectious Diseases Programme, Duke-NUS Medical School and Co-Director at the Viral Research and Experimental Medicine Centre@SingHealth Duke-NUS.

Professor John CW Lim is Executive Director at the Centre of Regulatory Excellence, Duke-NUS Medical School, Policy Core Lead at the SingHealth Duke-NUS Global Health Institute, and Chairman of the Singapore Clinical Research Institute & National Health Innovation Centre.

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Commentary: COVID-19 vaccine why is it taking so long to develop one? - CNA