Experts draw attention to the ‘hidden sorrows’ of COVID-19 and Parkin – Medical News Today

Experts draw attention to the ‘hidden sorrows’ of COVID-19 and Parkin – Medical News Today

San Diego lab discovers COVID-19 / coronavirus vaccine in …

San Diego lab discovers COVID-19 / coronavirus vaccine in …

April 8, 2020

SAN DIEGO In a race against the clock, a San Diego lab is scrambling to get a COVID-19 vaccine out and on the market. As the days go by, Inovio Pharmaceuticals is getting closer to releasing the desperately needed vaccine against the deadly virus.

Inovio Pharmaceuticals, which is located in Sorrento Valley, has also created a vaccine for the Zika virus, the Middle East Respiratory Syndrome (MERS), and the vaccine for Ebola.

RELATED: CDC cites label error in mixup involving San Diego COVID-19 patient

Dr. Trevor Smith, who is the director of research and development at Inovio, said, "It's something we are trained to do, and the infrastructure is here and the expertise is in house."

When Chinese scientists released the genetic sequence on Jan. 9, Inovio researchers got to work immediately and within 3 hours they had a vaccine for coronavirus, or COVID-19 as it is now being referred to.

"We have an algorithm which we designed, and we put the DNA sequence into our algorithm and came up with the vaccine in that short amount of time," said Dr. Smith.

Tens of thousands in China have been quarantined and continue to suffer from the virus. Thats why scientists at Inovio Pharmaceuticals say they feel the sense of urgency to get the vaccine out.

The vaccine has been tested on mice and guinea pigs. It will next be tried on a group of human patients.

Scientists hope the vaccine will work like a piece of biological software. In other words, the vaccine will give the human body instructions to create the proper attack in the form of T-cells and antibodies against COVID-19.

If all goes as planned, clinical trials in humans could begin by early this summer, but they will still need FDA approval.

Currently, an Inovio Pharmaceuticals lead researcher is in Sweden meeting with the World Health Organization to come up with the best plan of attack against COVID-19.

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Moderna’s New COVID-19 Vaccine Ready for Human Trials …

Moderna’s New COVID-19 Vaccine Ready for Human Trials …

April 8, 2020

Moderna (NASDAQ:MRNA) announced on Monday afternoon that the company's experimental mRNA COVID-19 vaccine, known as mRNA-1273, is ready for human testing. The initial batch of the vaccine has already been shipped to U.S. government researchers from the National Institute of Allergy and Infectious Diseases (NIAID).

The biotech company expects that the first clinical trials will begin near late April, with around 25 healthy volunteers participating in these tests. Initial clinical results could be available sometime in July or August.

Image source: Getty Images.

It's a remarkably fast development cycle for Moderna to be able to develop an initial vaccine just weeks after identifying the COVID-19 genetic sequence.

"Going into a phase one trial within three months of getting the sequence is unquestionably the world indoor record,"said NIAID Director Anthony Fauci in an interview. "Nothing has ever gone that fast,"

Moderna's mRNA technology is quite promising, with mRNA vaccines hypothetically being faster and more effective than their DNA-based counterparts. This is because DNA-based vaccines need to interact with the nucleus of the cell, whereas mRNA (or messenger RNA) is found all across the cell and is much more accessible. However, given that mRNA vaccines have never been tested before on humans, it's still uncertain how well Moderna's new coronavirus vaccine will perform.

While Moderna's vaccine is a newly developed treatment, other companies have found success in using drugs designed for other, similar conditions. Gilead Sciences'remdesivir, an Ebola drug, has been effective in helping reduce COVID-19 symptoms, with the World Health Organization (WHO) touting its potentialin a statement early today.


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Moderna's New COVID-19 Vaccine Ready for Human Trials ...
FluGen, UW-Madison researchers developing COVID-19 vaccine …

FluGen, UW-Madison researchers developing COVID-19 vaccine …

April 8, 2020

We are going to modify M2SR by adding part of the coding region for the coronavirus spike protein that the virus uses to latch onto cells and begin infection, said Neumann, a senior virologist in Kawaokas lab and co-founder of FluGen. CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza.

M2SR is a unique form of the flu virus. It lacks a gene called M2, which restricts the virus to undergoing only a single round of replication in cells.

Radspinner

The single replication means the virus can enter the cell, but it cant leave, says FluGen co-founder, president and CEO Paul Radspinner. So, in essence it tricks the body into thinking its infected with flu, which triggers a full immune response. But since it cant replicate further, you dont get sick.

CoroFlu, like M2SR, will be delivered intranasally. That mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system.

The Kawaoka group will insert genetic sequences from SARS-CoV-2 into M2SR and then assess CoroFlus safety and efficacy in animal models at UW-Madisons Influenza Research Institute. The institute has a high-level biosafety facility designated Biosafety Level 3 Agriculture with the ability to safely handle and study pathogens like highly pathogenic influenza viruses and the novel coronavirus.


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Why It’ll Still Take More Than a Year to Develop a COVID-19 Vaccine – Healthline

Why It’ll Still Take More Than a Year to Develop a COVID-19 Vaccine – Healthline

April 8, 2020

Were on the verge of great things; a new era of vaccinations. Weve just scratched the surface of what can be accomplished.

Thats how Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Childrens Hospital, closed a TED Talk he gave last November.

Today, Levy told Healthline, that statement takes on elevated meaning as scientists like him around the world push to find a vaccination for COVID-19, the pandemic virus that has all but put the world at a full stop.

We believe we are revolutionizing the way vaccinations are developed, Levy said.

Its important to note, though, as more labs announce concepts, plans, and vaccination formulas, that soon is a relative term when it comes to vaccines.

Despite positive reports from initial clinical trials, experts tell Healthline the best-case scenario for a vaccination delivered to market is probably 18 months to 2 years.

That may sound like too long, given the seriousness of the COVID-19 pandemic, but its quicker than the 5 to 10 years for many vaccines.

Levy said researchers around the globe are focusing on new methods, such as in vitro testing, and development that his lab does to speed up the research process.

This crisis induces a lot of creativity, Levy said.

He added theres no competition between labs. They all want the same result.

We hope we get scooped, Levy said. This is not a game.

Vaccines basically work by injecting a dead virus or another safe version of an illness into a person so their body attacks that fake virus and then has the antibodies available if a live virus invades.

The first vaccine was created in England around 1800 as a treatment for smallpox.

Since then, scientists have tweaked and studied the process, looking for streamlining that doesnt risk safety.

Thanks to discoveries made while working on the SARS (severe acute respiratory syndrome), MERS (Middle East respiratory syndrome), and swine flu vaccinations, researchers hope to streamline the discovery, development, and distribution of a COVID-19 vaccination, Levy said.

The process, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University in Tennessee, can be sped up but only by so much.

In the case of COVID-19, Schaffner believes new methods, as well as some prior work, could cut up to 5 years off the process.

But he warns, it will still take time.

We cannot take shortcuts, but we can run faster, he told Healthline.

In a classic case, Schaffner said, researchers work first to develop a vaccination in the lab.

You create the product that you think will actually stimulate the human immune system to stimulate the antibodies that cut off the disease, he said.

In the past, this was arduous, involving animal models and sometimes years of work.

Right now, he said, labs are benefiting from at least two things.

The first is a wealth of past research on coronaviruses and vaccinations.

The second is the publication of the COVID-19 genome by Chinese scientists to the world scientific community.

Within hours (of that release) the [National Institutes of Health] was at work, Schaffner said.

Maria Elena Bottazzi, PhD, the co-director of the Texas Childrens Hospital Center for Vaccine Development at Baylor College of Medicine, and her team are working full speed on developing a COVID-19 vaccination.

Theyre basing much of their research on what they learned working on a SARS vaccination in the early to mid-2000s.

She told Healthline that its important to remember that a virus job isnt to kill us.

Rather, its job is to find a way to use our bodies to survive.

In the case of COVID-19, the virus uses tiny spikes to attach to our cells as a key to open the cell door and let themselves in, where they can get what they need to reproduce.

Our bodies fight that invasion. Fever and other symptoms are a result of that battle.

Finding the right army for our bodies to stop those keys from opening those doors, Bottazzi said, is a complicated process that can take years.

However, since theyve already amassed data on such spikes from SARS research, she feels they may be able to reduce the research window.

Her lab is working on a protein-based product.

Viruses start as DNA, move to RNA, and then to protein in the body, Bottazzi explained. Some labs are working at taking on the virus at those earlier steps.

Her team believes introducing the vaccination as protein is a more efficient choice. Why?

Because first, many successful vaccines, such as hepatitis B and the human papillomavirus (HPV) infection are protein-based, so theres strong evidence showing that this approach works.

Also, Bottazzi said, manufacturers are adept at producing protein-based vaccinations quickly, cheaply, and in the billions.

A potential vaccine must go through a series of scientific trials.

The first step is a phase I study, which is what is happening now in Seattle.

Phase I studies are small and involve only healthy people with low to no risk. This level of study only checks the safety of a vaccine, not its effectiveness.

Once a phase I trial is deemed successful, it can shift to phase II. That involves a larger pool of participants and focuses on both safety and immunology. Even at this phase, effectiveness isnt studied.

Phase III is when effectiveness comes into play. An even larger pool of volunteers is used. Half are vaccinated and half are given a placebo.

With this double-blind trial, participants and doctors only find out afterward who was treated with the vaccine and who wasnt.

As that goes on, a Food and Drug Administration (FDA) Data and Safety Monitoring Board, which Schaffner has served on in the past, has the sole responsibility of watching closely to ensure the safety of the volunteers.

They alone can see the data without blinders and pull the plug at any point. They can also look for effectiveness and, should it be obvious thats not happening, they can end the research at that point, too, Schaffner said.

In a case where a drug is showing effectiveness in trials, manufacturers begin to gain interest and work at planning production.

All in all, this can take a decade from start to finish, but that might not be the case with a COVID-19 vaccine.

Heres whats different now.

First, new techniques such as the in vitro practice at Levys lab among others have helped push things along.

Last week, University of Pittsburgh School of Medicine scientists announced a potential vaccine against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic.

When tested in mice, the vaccine, delivered through a fingertip-sized patch, produced antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus.

The researchers were able to act quickly because they had already laid the groundwork during earlier coronavirus epidemics.

That background data, Schaffner said, helped speed up the road to phase I. Volunteers are now stepping up to be part of the study.

But, Schaffner warns, the public needs to be careful in reading such news. While headlines might feel hopeful, there are still many time-consuming steps ahead.

There are certain parts that slow down, he said. Seeing what something does in the bloodstream is going to take at least 3 months and there is no slowing that down Sometimes we can run rapidly around the track and other times we must slow down.

Schaffner feels its OK for manufacturers to contract to begin production perhaps before the trials are complete, so the public health community can be ready to deliver the moment its possible.

This whole thing can be done at breakneck speed, but we cannot cut back on safety, he said.

He foresees a year and a half before a vaccine is widely available.

We are working on a number (of solutions) simultaneously, so we are not putting all our eggs in one basket, he said.

Levy agrees, saying the process could take up to 2 years and even that, he said, would be unprecedented speed.

Experts say we need to be careful in how we describe a possible discovery.

Schaffner, who was a volunteer in the trials for the swine flu vaccination in 2009, remembers what happened when they overshot their estimates on a delivery date.

Many things were done right and some were done wrong, he said. But weve learned.

One big lesson?

Underpromise and overdeliver, he said. Back then, we developed a successful vaccine, but the media story was, The delayed vaccine is finally here. We need to not overpromise.

While all the researchers are confident there will, in time, be a vaccine, they agree on staying focused on the work and issuing overly optimistic estimates.

We have to have a level of humility here, said Levy. We are all very excited, but some things might not pan out. Weve got a complicated challenge here. But the biomedical field we have today is far advanced.

Bottazzi hopes that focus will be given to all 30 to 40 possible projects out there now, not only to find a COVID-19 vaccine but also to help build a catalog of information for the future.

This is not the last outbreak we will see, she said.


Read the original: Why It'll Still Take More Than a Year to Develop a COVID-19 Vaccine - Healthline
We Need a Covid-19 VaccineLets Get It Right the First Time – WIRED

We Need a Covid-19 VaccineLets Get It Right the First Time – WIRED

April 8, 2020

On a rainy night in January 1976, a batch of new Army recruits training at Fort Dix, New Jersey, were sent on a 5-mile march. The next day, one of the recruits, Private David Lewis, collapsed with severe pneumonia. Lewis died, and a whole swath of his platoon fell ill with chest congestion and fever: almost 200 men, 13 of whom had to be hospitalized. January is within flu season, and military physicians assumed that the flu had somehow made its way onto the basea problem for the group and a tragedy for the dead soldier, but not unexpected.

Tests upended that thinking. The soldiers did have the flu, but among some of them, at least, the virus that was causing their illness was not the common strain that was circling the globe that year. It was instead an unfamiliar virus to which almost no one had immunity. It was among the strains of flu designated H1N1, and it was genetically related to a flu epidemic that some people in medicine at the time were old enough to still remember: the world-spanning, millions-killing pandemic of 1918.

Plus: What it means to flatten the curve, and everything else you need to know about the coronavirus.

The discovery of what came to be known as the 1976 swine flu electrified the country. Before the end of that March, President Gerald Ford declared the US would vaccinate every man, woman, and child in the United States against it. Congress appropriated emergency funds. Manufacturers rushed to make a new vaccine formula. By Thanksgiving, almost 45 million Americans, a quarter of the population at the time, received the new shot. Ford led the way: He was photographed receiving it in the Oval Office on October 14.

But unlike 1918, this time there was no pandemic. The cases among the soldiers were a spark that did not catch. And by the time that became clear, more than 500 people out of that 45 million had come down with an extremely rare condition, a paralysis called Guillain-Barr syndrome. Thirty-two of them died.

The events of 1976 had a profound effect on the US public health system. Congress held hearings for months. The director of the CDC (then called the Center for Disease Control) was fired. The rush to counter the apparent threat came to be seen as a mistake, and the possibility of a pandemic came to seem so unlikely that it took another 27 years before the federal government drafted a plan to respond to one.

That campaign cost the government a great deal of credibility, says Howard Markel, a physician and historian of epidemics who is director of the University of Michigan's Center for the History of Medicine. It created for many years a Chicken Little response by government officials: They were afraid to act too quickly. Yet the thing about epidemics is, when they begin, you have to act quickly, without a lot of data.

The pandemic that didnt happen in 1976 did arrive 33 years later, when a different flu strainanother H1N1, but not the virus of 1976 or 1918swept the world. It arose after the flu season should have ended, starting in April 2009 with a cluster of cases in Mexico, California, and Texas. By June, the World Health Organization declared the new strain was causing a pandemic. Eventually, more than 60 million people were infected just in the United States, and an estimated 203,000 people died worldwide.

Yet that response was troubled, too. A new vaccine was ginned up to respond, and though there were no obvious adverse reactions, there were significant stumbles in organizing manufacturing, and in getting the new formula out where it was needed most.

The flaws in these past campaigns matter, because they are among the largest, fastest emergency vaccination efforts to occur in the United States in the lifetimes of people making policy and practicing science today. Covid-19 isnt influenza, but it is a pandemic, and it too is triggering a rapid search for a vaccine that could end in giving millions of shots to those who are vulnerable. So the lessons learned in 1976 and 2009 are importantespecially since some of their mistakes are being made again.

Health experts see one in particular being repeated right now: Letting politicians, instead of scientists, be the spokespeople for what the country needs to do. Politicians always want to overpromise, and then youre at risk of underdelivering when the time comes, says William Schaffner, a physician and professor of infectious diseases at Vanderbilt University School of Medicine, who in 1976 had just joined the Vanderbilt faculty after serving as a CDC disease detective. You should always aim to do it the other wayunderpromise and overdeliverbecause then youre a hero.


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We Need a Covid-19 VaccineLets Get It Right the First Time - WIRED
AI and cloud computing used to develop COVID-19 vaccine – Drug Target Review

AI and cloud computing used to develop COVID-19 vaccine – Drug Target Review

April 8, 2020

A potential COVID-19 vaccine has been developed by researchers using AI and cloud computing to prevent the Spike protein from binding to the ACE2 receptor on human cells.

Australian researchers have developed and are testing a COVID-19 vaccine candidate to fight against the SARS-CoV-2 coronavirus.

Working with Oracle cloud technology and vaccine technology developed by Vaxine, the researchers from Flinders University analysed the COVID-19 virus and used this information to design the vaccine candidate.

The vaccine has progressed into animal testing in the US and once we confirm it is safe and effective will then be advanced into human trials, said Professor Nikolai Petrovsky at Flinders University and Research Directorat Vaxine.

As soon as the genomic sequence of COVID-19 became available in January, we immediately used this, combined with our previous experience in developing a SARS coronavirus vaccine, to characterise the key viral attachment molecule called the Spike (S) protein, Petrovsky said.

The researchers used computer models of the S protein and its human receptor, angiotensin converting enzyme 2 (ACE2), to identify how the virus was infecting human cells. They were then able to design a vaccine to block this process.

Computer simulated model of COVID-19 spike protein binding to the human ACE2 receptor through which it gains entry into cells lining the human lung. Vaxines COVID-19 vaccine is designed to mimic the portion of the S protein attaching to ACE2, with the aim of inducing human antibodies that will bind to the COVID-19 S protein thereby blocking it from binding to ACE2 and getting inside human cells, preventing infection [credit: Flinders University].

The team has exploited the very latest technologies, including artificial intelligence (AI), advanced manufacturing and cloud computing to accelerate vaccine design, shaving years off normal development timeframes, said Flinders University Associate Professor Dimitar Sajkov.

We achieved great results with Vaxines swine flu vaccine developed during the 2009 swine flu pandemic, where we commenced clinical trials of a vaccine within three months of discovery of the virus. We hope to achieve similar results with their COVID-19 vaccine candidate when it is ready for human testing, said Sajkov.


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AI and cloud computing used to develop COVID-19 vaccine - Drug Target Review
Follow this Seattle scientist as he’s injected in COVID-19 vaccine project – KUOW News and Information

Follow this Seattle scientist as he’s injected in COVID-19 vaccine project – KUOW News and Information

April 8, 2020

Ian Haydon of Seattle is part of a project to develop an experimental COVID-19 vaccine. He got his first injection on Wednesday morning.

The vaccine is being developed by a Boston-based company called Moderna. It involves the use of something called messenger RNA to try to prompt the body's immune system to fight the virus.

Haydon himself is a trained scientist and science writer. He works as a communication manager at the Institute for Protein Design at the University of Washington, which itself also develops vaccines. He spoke to KUOW's David Hyde about how the vaccine would work, and about his own experience (KUOW will follow his progress in the program).

Ian Haydon: It's a little bit like getting ready to go on a big trip where, you know, you've you've been thinking about this thing and counting down the days and then all the sudden it's upon you.

David Hyde: What's your understanding of what this vaccine is attempting to do and how it does it and how that compares to other vaccines that we're more familiar with, like the regular flu vaccine?

Haydon: Normally, a vaccine would work by taking either an entire virus that has been killed or just a piece of that virus and injecting it into a healthy person in hopes that their immune system is going to recognize it and respond by making antibodies. And then the hope is those antibodies protect that person from an actual infection. What's going on here is a little bit different than that.

What I'll actually be receiving is a little snippet of the virus's genetic code. In this case, a single MRNA, molecule messenger RNA, and that genetic code is going to hopefully enter my cells and temporarily instruct them to make one of the proteins from the virus -- in this case, the spike protein, and it's that spike protein if it gets made that hopefully my immune system is going to react to, it's going to make antibodies against it. And hopefully those antibodies would be protective against the real virus.

Hyde: What vaccines are currently out there that have used messenger RNA?

Haydon: I don't believe there are any licensed vaccines that have used this MRNA technology. The same platform is in clinical testing now for other diseases, but none has produced a license vaccine yet. And it may not. It's not yet known whether this way of stimulating the immune system is actually going to work in humans.

Hyde: So you're almost like a vaccine astronaut in a way.

Haydon: I guess so. Yeah. I don't think I'm particularly unique in wanting to step up into this trial. I actually consider myself quite fortunate for getting in, being healthy enough to get in.

Hyde: You're taking on a certain amount of personal risk to try to benefit the rest of us, hopefully through the development of a safe vaccine. What is your sense of the risks that you face by participating in this clinical trial?

Haydon: I understand the risks to be quite small, but there are a few of them. One thing that may happen is sort of the day of the injection. Some patients who receive this type of experimental vaccine report some pain in their arm. They've reported headaches, redness at the site of the injection. And those effects, which usually last just about a day, can be severe. So that's on my mind, other risks. You know, this is a new virus and we don't know how it interacts with the immune system.

And this is a new vaccine and we don't really know what it is doing to the immune system just yet. So in very rare cases, an experimental vaccine can actually make infection worse where your body does produce antibodies, but those make it easier for the virus to infect you rather than blocking infection. So that's one of the things that clinical trials for any coronavirus vaccine are going to have to evaluate. And it's one of the reasons why you can't just rush a promising vaccine out of the laboratory and start giving it to a lot of people. You really need to know whether or not it's safe and well tolerated and also whether it's effective in blocking the infection.

Hyde: So part of what you're doing is making sure that in the future, hopefully, there's going to be a vaccine that's safe for all of us.

Haydon: That's right. And I'm in a Phase 1 study, which is just the very first step in that long process. Then comes Phase 2 and 3 in those later stages. It's not just safety that's being evaluated, but it's efficacy of the vaccine as well.


Read the original post: Follow this Seattle scientist as he's injected in COVID-19 vaccine project - KUOW News and Information
Virologist says it’s "optimistic" to think a COVID-19 vaccine will be ready in a year – WTSP.com

Virologist says it’s "optimistic" to think a COVID-19 vaccine will be ready in a year – WTSP.com

April 8, 2020

ST. PETERSBURG, Fla Information about COVID-19 has been rapidly changing, from added symptoms, to whether or not you should cover your face. So, 10News reporter Liz Burch caught up with an expert to ask him some of your questions.

Doctor Michael Teng is an associate professor at USFs Morsani College of Medicine. He's spent decades studying vaccines, so we asked what he thought the biggest piece of coronavirus news was this week.

"The first thing is that I think our models have gotten better, the new modeling is showing a decrease in mortality and morbidity, which is great," Dr. Teng said.

He stressed that the models are "just well-educated guesses."

He also mentioned that work has started on a vaccine and shared when he believes the public can realistically expect one.

"When I hear a year, a year and a half for a vaccine, thats an aggressive estimate, optimistic opinion, about when it could be done. This is if everything goes right," he said.

So it could be a little longer, but Teng says the good news is, a lot of resources are going into developing that vaccine right now.

On Twitter, a user named Donald asked: If youre asymptomatic carrying the virus, how long does it last in you?"

"Thats a really good question that we dont have a great answer for. If youre asymptomatic you dont know a start and stop to when you got infected, what we know from people who have symptoms, if that they are infectious before and after they have symptoms," Teng responded.

And on Instagram, a user named Jay asks: "Once a vaccine is developed, will it be needed yearly?"

"If we do have a vaccine, it will be a vaccine that will protect you for a while, but, what we dont know is how long that vaccine will last," Teng said.

Dr. Teng says he believes we have started to flatten the curve because of what he calls significant social distancing.

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Virologist says it's "optimistic" to think a COVID-19 vaccine will be ready in a year - WTSP.com
GSK allies with Innovax for COVID-19 vaccine R&D project – FierceBiotech

GSK allies with Innovax for COVID-19 vaccine R&D project – FierceBiotech

April 8, 2020

GlaxoSmithKline has teamed up with Xiamen Innovax Biotech to evaluate a vaccine against the novel coronavirus behind the COVID-19 pandemic. The agreement gives Innovax access to a GSK adjuvant to enhance the immune response triggered by its recombinant protein-based vaccine.

GSK teamed up with Innovax last year to develop a human papillomavirus vaccine, tapping into the work of the Chinese biotech to drive its search for a successor to Cervarix. The latest deal moves the partnership into COVID-19 and, in doing so, continues GSKs effort to support the response to the pandemic SARS-CoV-2 virus through the provision of its AS03 adjuvant.

While GSK developed its own vaccine against the 2009 H1N1 pandemic, the Big Pharma has opted to play a supporting role in the industrys response to COVID-19, primarily by providing its AS03 adjuvant to Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

Innovax will apply the adjuvant to a vaccine it is developing with Xiamen University. The vaccine, like others in development, is based on the coronavirus spike protein. Innovax is screening a series of truncated spike proteins to gather immunogenicity data to inform the selection of a lead candidate. Adding AS03 to the mix may reduce the level of protein needed to protect patients.

GSK has early evidence to suggest AS03 can deliver those benefits to COVID-19 vaccines, noting that one of its collaborators has reported encouraging preclinical data. The Big Pharma expects partners to publish more data over the next three months, setting them up to plot out clinical strategies. GSK is also evaluating further collaboration opportunities with several other companies and institutions.

The vaccine work is advancing in parallel to efforts to develop COVID-19 medicines. In a statement about its activities related to the pandemic, GSK said it is evaluating whether drugs in its portfolio of experimental and approved medicines can play a role in the response to COVID-19, either as a direct antiviral or in the management of secondary complications.

As previously disclosed, GSK is part of a group of companies that have made libraries of compounds available for screening by the COVID-19 Therapeutics Accelerator, an initiative involving the Bill & Melinda Gates Foundation. The accelerator is screening compounds shared by Big Pharma companies for efficacy against SARS-CoV-2.


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GSK allies with Innovax for COVID-19 vaccine R&D project - FierceBiotech
Beaufort Man and his Atlanta Based company inching closer to COVID-19 vaccine – WSAV-TV

Beaufort Man and his Atlanta Based company inching closer to COVID-19 vaccine – WSAV-TV

April 8, 2020

SAVANNAH, Ga. (WSAV)- Beaufort Native, David Dodd and his company GeoVax are inching closer to a vaccine for the coronavirus. Scientists have narrowed down three possible vaccines.

He says each vaccine is considered a candidate because all three will go through animal testing before they are narrowed down to one.

The company has dedicated their efforts to the COVID-19 outbreak since early January. They have also teamed up with another vaccine developer, BravoVax who are located in Wuhan, China.

Weve been identified as one of the 30 or so companies worldwide that are working on a COVID-19 vaccine and have requisite experience and doing such, said David Dodd, CEO of GeoVax.

All three vaccine candidates are in what is called the purification process.

In looking at the genetic structure and the virology and what we learned from SARS in the past weve actually constructed four vaccines of which weve put into testing, said Dodd. Three of which we are going to move forward into animal testing and all.

Once the vaccine moves through animal testing it will go into the human testing phase. Dodd said that could happen by the end of the year.

We need a vaccine to be able to halt this from infecting additional people, said Dodd. Especially if there should be additonal outbreaks in the future and all.

Using their signature MVA-VLP platform scientists are able to move faster.

The bases of their vaccine has already been tested on thousands of people in six clinical trials for HIV.

We have shown our platform is really safe and we can make single dose vaccines you know against the most terrible diseases like Ebola, Zika and so on, said Dr. Farshad Guirakoo, GeoVaxs Chief Scientific Officer. But, as a small company it is really difficult until they realize how good the platform is.

For a company like GeoVax, funding is paramount.

Dodd is in talks with the Biomedical Advanced Research and Development Authority (BARDA) about grant money.

BARDA is an agency within the U.S. Dept. of Health and Human Services that oversees the manufacturing, production, and purchasing of COVID-19 vaccines and treatments.

We made an application in February to BARDA based upon our plans, timelines, budgets, and what we were going to develop, said Dodd.

Dr. Guirakoo tells WSAV News 3 that funding is absolutely critical at this point in the vaccine development process.

The safety needs to be studied carefully in large number of people before you can deploy the vaccine, he said. Before the effects can be seen in millions and billions of people.

Dodd hopes all the planning leads to a vaccine that will one day save lives.


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Beaufort Man and his Atlanta Based company inching closer to COVID-19 vaccine - WSAV-TV