Category: Covid-19 Vaccine

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SEATTLE (AP) U.S. researchers gave the first shots in a first test of an experimental coronavirus vaccine Monday, leading off a worldwide hunt for protection even as the pandemic surges.

With careful jabs in the arms of four healthy volunteers, scientists at the Kaiser Permanente Washington Research Institute in Seattle began an anxiously awaited first-stage study of a potential COVID-19 vaccine developed in record time after the new virus exploded out of China and fanned out across the globe.

Were team coronavirus now, Kaiser Permanente study leader Dr. Lisa Jackson said on the eve of the experiment. Everyone wants to do what they can in this emergency.

The Associated Press observed as the studys first participant, an operations manager at a small tech company, received the injection in an exam room.

We all feel so helpless. This is an amazing opportunity for me to do something, Jennifer Haller, 43, of Seattle said before getting vaccinated. Her two teenagers think it's cool that she's taking part in the study.

After the injection, she left the exam room with a big smile: I'm feeling great."

Three others were next in line for a test that will ultimately give 45 volunteers two doses, a month apart.

Neal Browning, 46, of Bothell, Washington, is a Microsoft network engineer who says his young daughters are proud he volunteered.

Every parent wants their children to look up to them, he said. But hes told them not to brag to their friends. Its other people, too. Its not just Dad out there.

Mondays milestone marked just the beginning of a series of studies in people needed to prove whether the shots are safe and could work. Even if the research goes well, a vaccine would not be available for widespread use for 12 to 18 months, said Dr. Anthony Fauci of the U.S. National Institutes of Health.

Still, finding a vaccine is an urgent public health priority, Fauci said in a statement Monday. The new study is an important first step toward achieving that goal.

This vaccine candidate, code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company Moderna Inc. Theres no chance participants could get infected because the shots do not contain the coronavirus itself.

Its not the only potential vaccine in the pipeline. Dozens of research groups around the world are racing to create a vaccine against COVID-19. Another candidate, made by Inovio Pharmaceuticals, is expected to begin its own safety study next month in the U.S., China and South Korea.

The Seattle experiment got underway days after the World Health Organization declared the new virus outbreak a pandemic because of its rapid global spread, which has infected more than 169,000 people and killed more than 6,500.

COVID-19 has upended the worlds social and economic fabric since China first identified the virus in January, with broad regions shuttering schools and businesses, restricting travel, canceling entertainment and sporting events, and encouraging people to stay away from each other.

Starting what scientists call a first-in-humans study is a momentous occasion for scientists, but Jackson described her teams mood as subdued. Theyve been working around-the-clock readying the research in a part of the U.S. struck early and hard by the virus.

Still, going from not even knowing that this virus was out there ... to have any vaccine in testing in about two months is unprecedented, Jackson told the AP.

Some of the studys carefully chosen healthy volunteers, ages 18 to 55, will get higher dosages than others to test how strong the inoculations should be. Scientists will check for any side effects and draw blood samples to test if the vaccine is revving up the immune system, looking for encouraging clues like the NIH earlier found in vaccinated mice.

We dont know whether this vaccine will induce an immune response or whether it will be safe. Thats why were doing a trial, Jackson stressed. Its not at the stage where it would be possible or prudent to give it to the general population.

Most of the vaccine research under way globally targets a protein aptly named spike that studs the surface of the new coronavirus and lets it invade human cells. Block that protein and people cannot get infected.

Researchers at the NIH copied the section of the virus genetic code that contains the instructions for cells to create the spike protein. Moderna encased that messenger RNA into a vaccine.

The idea: The body will become a mini-factory, producing some harmless spike protein. When the immune system spots the foreign protein, it will make antibodies to attack and be primed to react quickly if the person later encounters the real virus.

Thats a much faster way of producing a vaccine than the traditional approach of growing virus in the lab and preparing shots from either killed or weakened versions of it.

But because vaccines are given to millions of healthy people, it takes time to test them in large enough numbers to spot an uncommon side effect, cautioned Dr. Nelson Michael of the Walter Reed Army Institute of Research, which is developing a different vaccine candidate.

The science can go very quickly but, first, do no harm, right? he told reporters last week.

The Seattle research institute is part of a government network that tests all kinds of vaccines and was chosen for the coronavirus vaccine study before COVID-19 began spreading widely in Washington state.

Kaiser Permanente screened dozens of people, looking for those who have no chronic health problems and are not currently sick. Researchers are not checking whether would-be volunteers already had a mild case of COVID-19 before deciding if they are eligible.

If some did, scientists will be able to tell by the number of antibodies in their pre-vaccination blood test and account for that, Jackson said. Participants will be paid $100 for each clinic visit in the study.

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WASHINGTON (AP) A clinical trial evaluating a vaccine designed to protect against the new coronavirus will begin Monday, according to a government official.

The first participant in the trial will receive the experimental vaccine on Monday, the official said, speaking on the condition of anonymity because the trial has not been publicly announced yet. The National Institutes of Health is funding the trial, which is taking place at the Kaiser Permanente Washington Health Research Institute in Seattle, the official said.

Public health officials say it will take a year to 18 months to fully validate any potential vaccine.

Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna Inc. Theres no chance participants could get infected from the shots, because they dont contain the virus itself. The goal is purely to check that the vaccines show no worrisome side effects, setting the stage for larger tests.

Dozens of research groups around the world are racing to create a vaccine as COVID-19 cases continue to grow. Importantly, theyre pursuing different types of vaccines shots developed from new technologies that not only are faster to produce than traditional inoculations but might prove more potent. Some researchers even aim for temporary vaccines, such as shots that might guard peoples health a month or two at a time while longer-lasting protection is developed.

For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. The worldwide outbreak has sickened more than 156,000 people and left more than 5,800 dead. The death toll in the United States is more than 50, while infections neared 3,000 across 49 states and the District of Columbia.

The vast majority of people recover. According to the World Health Organization, people with mild illness recover in about two weeks, while those with more severe illness may take three weeks to six weeks to recover.

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Others at Kansas home tied to COVID-19 death tested negative - hays Post

Even at their most effective and draconian containment strategies have only slowed the spread of the respiratory disease Covid-19. With the World Health Organization finally declaring a pandemic, all eyes have turned to the prospect of a vaccine, because only a vaccine can prevent people from getting sick.

About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals. The first of these produced by Boston-based biotech firm Moderna will enter human trials in April.

This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of Sars-CoV-2, the virus that causes Covid-19. China shared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.

But there is another reason for the head start. Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus flu is generally considered to pose the greatest pandemic risk vaccinologists had hedged their bets by working on prototype pathogens. The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses, says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations (Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.

Coronaviruses have caused two other recent epidemics severe acute respiratory syndrome (Sars) in China in 2002-04, and Middle East respiratory syndrome (Mers), which started in Saudi Arabia in 2012. In both cases, work began on vaccines that were later shelved when the outbreaks were contained. One company, Maryland-based Novavax, has now repurposed those vaccines for Sars-CoV-2, and says it has several candidates ready to enter human trials this spring. Moderna, meanwhile, built on earlier work on the Mers virus conducted at the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.

Sars-CoV-2 shares between 80% and 90% of its genetic material with the virus that caused Sars hence its name. Both consist of a strip of ribonucleic acid (RNA) inside a spherical protein capsule that is covered in spikes. The spikes lock on to receptors on the surface of cells lining the human lung the same type of receptor in both cases allowing the virus to break into the cell. Once inside, it hijacks the cells reproductive machinery to produce more copies of itself, before breaking out of the cell again and killing it in the process.

All vaccines work according to the same basic principle. They present part or all of the pathogen to the human immune system, usually in the form of an injection and at a low dose, to prompt the system to produce antibodies to the pathogen. Antibodies are a kind of immune memory which, having been elicited once, can be quickly mobilised again if the person is exposed to the virus in its natural form.

Traditionally, immunisation has been achieved using live, weakened forms of the virus, or part or whole of the virus once it has been inactivated by heat or chemicals. These methods have drawbacks. The live form can continue to evolve in the host, for example, potentially recapturing some of its virulence and making the recipient sick, while higher or repeat doses of the inactivated virus are required to achieve the necessary degree of protection. Some of the Covid-19 vaccine projects are using these tried-and-tested approaches, but others are using newer technology. One more recent strategy the one that Novavax is using, for example constructs a recombinant vaccine. This involves extracting the genetic code for the protein spike on the surface of Sars-CoV-2, which is the part of the virus most likely to provoke an immune reaction in humans, and pasting it into the genome of a bacterium or yeast forcing these microorganisms to churn out large quantities of the protein. Other approaches, even newer, bypass the protein and build vaccines from the genetic instruction itself. This is the case for Moderna and another Boston company, CureVac, both of which are building Covid-19 vaccines out of messenger RNA.

Cepis original portfolio of four funded Covid-19 vaccine projects was heavily skewed towards these more innovative technologies, and last week it announced $4.4m (3.4m) of partnership funding with Novavax and with a University of Oxford vectored vaccine project. Our experience with vaccine development is that you cant anticipate where youre going to stumble, says Hatchett, meaning that diversity is key. And the stage where any approach is most likely to stumble is clinical or human trials, which, for some of the candidates, are about to get under way.

Clinical trials, an essential precursor to regulatory approval, usually take place in three phases. The first, involving a few dozen healthy volunteers, tests the vaccine for safety, monitoring for adverse effects. The second, involving several hundred people, usually in a part of the world affected by the disease, looks at how effective the vaccine is, and the third does the same in several thousand people. But theres a high level of attrition as experimental vaccines pass through these phases. Not all horses that leave the starting gate will finish the race, says Bruce Gellin, who runs the global immunisation programme for the Washington DC-based nonprofit, the Sabin Vaccine Institute, and is collaborating with Cepi over a Covid-19 vaccine.

There are good reasons for that. Either the candidates are unsafe, or theyre ineffective, or both. Screening out duds is essential, which is why clinical trials cant be skipped or hurried. Approval can be accelerated if regulators have approved similar products before. The annual flu vaccine, for example, is the product of a well-honed assembly line in which only one or a few modules have to be updated each year. In contrast, Sars-CoV-2 is a novel pathogen in humans, and many of the technologies being used to build vaccines are relatively untested too. No vaccine made from genetic material RNA or DNA has been approved to date, for example. So the Covid-19 vaccine candidates have to be treated as brand new vaccines, and as Gellin says: While there is a push to do things as fast as possible, its really important not to take shortcuts.

An illustration of that is a vaccine that was produced in the 1960s against respiratory syncytial virus, a common virus that causes cold-like symptoms in children. In clinical trials, this vaccine was found to aggravate those symptoms in infants who went on to catch the virus. A similar effect was observed in animals given an early experimental Sars vaccine. It was later modified to eliminate that problem but, now that it has been repurposed for Sars-CoV-2, it will need to be put through especially stringent safety testing to rule out the risk of enhanced disease.

Its for these reasons that taking a vaccine candidate all the way to regulatory approval typically takes a decade or more, and why President Trump sowed confusion when, at a meeting at the White House on 2 March, he pressed for a vaccine to be ready by the US elections in November an impossible deadline. Like most vaccinologists, I dont think this vaccine will be ready before 18 months, says Annelies Wilder-Smith, professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. Thats already extremely fast, and it assumes there will be no hitches.

In the meantime, there is another potential problem. As soon as a vaccine is approved, its going to be needed in vast quantities and many of the organisations in the Covid-19 vaccine race simply dont have the necessary production capacity. Vaccine development is already a risky affair, in business terms, because so few candidates get anywhere near the clinic. Production facilities tend to be tailored to specific vaccines, and scaling these up when you dont yet know if your product will succeed is not commercially feasible. Cepi and similar organisations exist to shoulder some of the risk, keeping companies incentivised to develop much-needed vaccines. Cepi plans to invest in developing a Covid-19 vaccine and boosting manufacturing capacity in parallel, and earlier this month it put out a call for $2bn to allow it to do so.

Once a Covid-19 vaccine has been approved, a further set of challenges will present itself. Getting a vaccine thats proven to be safe and effective in humans takes one at best about a third of the way to whats needed for a global immunisation programme, says global health expert Jonathan Quick of Duke University in North Carolina, author of The End of Epidemics (2018). Virus biology and vaccines technology could be the limiting factors, but politics and economics are far more likely to be the barrier to immunisation.

The problem is making sure the vaccine gets to all those who need it. This is a challenge even within countries, and some have worked out guidelines. In the scenario of a flu pandemic, for example, the UK would prioritise vaccinating healthcare and social care workers, along with those considered at highest medical risk including children and pregnant women with the overall goal of keeping sickness and death ra tes as low as possible. But in a pandemic, countries also have to compete with each other for medicines.

Because pandemics tend to hit hardest those countries that have the most fragile and underfunded healthcare systems, there is an inherent imbalance between need and purchasing power when it comes to vaccines. During the 2009 H1N1 flu pandemic, for example, vaccine supplies were snapped up by nations that could afford them, leaving poorer ones short. But you could also imagine a scenario where, say, India a major supplier of vaccines to the developing world not unreasonably decides to use its vaccine production to protect its own 1.3 billion-strong population first, before exporting any.

Outside of pandemics, the WHO brings governments, charitable foundations and vaccine-makers together to agree an equitable global distribution strategy, and organisations like Gavi, the vaccine alliance, have come up with innovative funding mechanisms to raise money on the markets for ensuring supply to poorer countries. But each pandemic is different, and no country is bound by any arrangement the WHO proposes leaving many unknowns. As Seth Berkley, CEO of Gavi, points out: The question is, what will happen in a situation where youve got national emergencies going on?

This is being debated, but it will be a while before we see how it plays out. The pandemic, says Wilder-Smith, will probably have peaked and declined before a vaccine is available. A vaccine could still save many lives, especially if the virus becomes endemic or perennially circulating like flu and there are further, possibly seasonal, outbreaks. But until then, our best hope is to contain the disease as far as possible. To repeat the sage advice: wash your hands.

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When will a coronavirus vaccine be ready? - The Guardian

Nothing can stop a global outbreak in its tracks better than a vaccine. Unfortunately, creating a vaccine capable of preventing the coronavirus that causes COVID-19 will probably take at least a year to 18 months, health officials say.

That is the time frame, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the House Oversight and Reform Committee this week. Anyone who says they can do it faster will be cutting corners that would be detrimental.

While there are about 10 vaccine candidates in the works and at least one of them could begin clinical trials in April it would still take about three more months to conduct the first stage of human testing and another eight months or so to complete the next stage of the trial process, he added.

New vaccines require copious research and time-consuming testing that can cost hundreds of millions of dollars. Theres no guarantee of success, but even if everything goes well, the final product might not hit the market until after an outbreak has subsided.

Heres a look at how vaccines are made and why the process takes so long.

Your body has a multi-pronged defense system for recognizing and combating dangerous invaders: your white blood cells. There are several types, each with a different purpose:

Macrophages engulf and then eat pathogens or cells that are dead or damaged. They leave behind identifying fragments of the invading microbes. These fragments are called antigens.

B-lymphocytes produce antibodies that recognize and bind to those antigens. If a pathogen with those antigens shows up in the blood stream again, those antibodies can mount an attack.

If those pathogens are already hiding out inside your cells beyond the antibodies reach, T-lymphocytes can attack those infected cells.

Your immune system has to go through this process each time it encounters a threat from a new virus or bacterium.

A vaccine provides a shortcut. Essentially, it helps your immune system learn to recognize a specific threat by tricking it into thinking its under attack. Then it can produce the antibodies it needs without having to face a real infection.

Nope. The Centers for Disease Control and Prevention describes several types of vaccines:

Attenuated vaccines, like those for chickenpox and measles, use a live virus or bacteria that has been intentionally weakened so that it cant cause serious disease in a healthy immune system.

Inactivated vaccines, such as the one for polio, use germs that have been killed. They typically dont provide as much immunity as attenuated vaccines, so they may require boosters over time.

Toxoid vaccines, including the DTaP vaccine for diphtheria and tetanus, use weakened versions of the toxins created by invading bacteria to teach the body how to fight the pathogens.

Subunit vaccines, such as DTaPs whooping cough component, only use fragments of the virus or bacterium they protect against.

Conjugate vaccines teach the immune system to fight bacteria that try to disguise their antigens in the long chains of sugar molecules that form the walls of bacterial cells.

The immune system learns how to fight a virus by studying its face the outside of the particle, including those telltale antigens. So a vaccine needs to give your body a snapshot of that face.

One classic technique involves injecting a person with a killed virus. Another uses live viruses that have been grown and deliberately weakened, typically by removing specific genes in their RNA or DNA.

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Both of these strategies take some time, and scientists worry that if they use them on novel viruses, they may not behave the way researchers predict, said Dr. Kathryn Stephenson, who runs the clinical trial unit at Beth Israel Deaconess Medical Centers Center for Virology and Vaccine Research.

Another option for scientists is to reconstruct that snapshot using information from a virus genetic code, which may be made of either RNA or DNA.

Nowadays, researchers can get started fast. Scientists in China made the coronavirus RNA sequences available on Jan. 10, and many labs began working toward a vaccine the next day, Stephenson said.

Hardly. Designing the vaccine is just the first step. Then it has to be produced.

There are many different vaccine-making platforms, each with its own set of advantages and disadvantages.

What would make a great vaccine for coronavirus is one that you can make quickly and one that would provide long-lasting and effective immunity, Stephenson said. Those are not always the same thing.

For example, a vaccine based on the virus genome can be made quickly, in perhaps a month or two, but it may be harder to manufacture in giant quantities.

Another option is to take the virus genetic snapshot and put it into a different virus for transport. When introduced into the body, the so-called viral vector vaccine enters cells, prompting them to produce huge numbers of this snapshot for the immune system to see. These vaccines take longer to make say, six to eight months but they can be scaled up more readily.

A lot of us are working on both of those, Stephenson said.

Before a vaccine candidate is approved for use, it must be proven safe and effective in a series of trials that are monitored by the Food and Drug Administration.

The first step is to show that its safe in preclinical studies. These can be conducted in vitro (using cells in a laboratory dish) or in vivo (using an animal as a stand-in for humans). Finding the right animal for testing can be a challenge, said Robert Grenfell, director of health and biosecurity at CSIRO, Australias national science agency, but scientists working on a vaccine for the new coronavirus wont have to start from scratch. The new virus shares much of its genome with the coronavirus that caused the 2003 outbreak of severe acute respiratory syndrome, and some Australian researchers already have been studying the SARS virus in ferrets.

Then clinical trials in humans can begin. Phase 1 trials are small, usually with a few dozen closely monitored participants. The main goal here is to make sure the vaccine is safe. Phase 2 trials typically enroll hundreds of patients to expand the safety assessment and allow scientists to dig into the bodys immune response. Phase 3 trials can enroll thousands of people, typically with some of them randomly assigned to get the vaccine and some getting a placebo.

This process can take years under normal circumstances. In an emergency, it could be sped up dramatically.

The big sticking point is often the Phase 3 trial. In an epidemic, many study volunteers may not want to risk getting a placebo instead of the vaccine, Stephenson said.

Researchers faced this dilemma during the Western African Ebola outbreak that took off in 2014. The virus had a mortality rate of about 40%, making people desperate for the still-unproven vaccine. So researchers employed a novel experimental design that involved vaccinating people with varying degrees of separation from an Ebola patient and using computer models to help determine if the vaccine had had an effect.

I think people learned from that that there are ways to be creative, Stephenson said. A creative solution may be needed when a coronavirus vaccine is ready for Phase 3 testing, she added.

The FDA wants it to be both safe and effective in other words, it has to protect enough people with as few unwanted side effects as possible. But exactly what qualifies as safe and effective may depend on the disease in question.

For some perspective: Stephenson, who also studies HIV, said that researchers would be very happy if they could come up with an HIV vaccine that protected 50% or so of those who got it. On the other hand, for a highly contagious virus like measles, a vaccine would need to work in almost everyone to establish herd immunity, she said.

David Weiner, a molecular immunologist who directs the Wistar Institutes Vaccine and Immunotherapy Center, said a successful coronavirus vaccine wouldnt have to be 100% effective.

I would like us to see it work in the majority of people, he said, but if it worked in 50%, 50% is a big improvement over 0%.

Definitely not. The labs that create a successful vaccine probably wont be the ones that are able to scale up theyll need a dedicated manufacturer for that part. And many companies may be wary of investing the resources it takes to manufacture a new vaccine when the epidemic could end before theres a chance to bring it to market, Weiner said.

Big Pharma is afraid to go in because the outbreaks end and they lose all the money they put in, he said. Thats why the Oslo-based Coalition for Epidemic Preparedness Innovations, or CEPI, has stepped in with funding to help shepherd some of those efforts, he added.

One of the big technical challenges in large-scale manufacturing is quality control, Stephenson said.

Every vaccine has its own particular issue, she said, but the manufacturing challenges mainly have the most to do with safety precautions and making sure that when youre done, the vial of vaccine has in it what you say it has.

This can be a difficult question when theres a limited amount of vaccine and a whole lot of demand.

Since older adults appear to be most at risk from COVID-19, its likely that health officials would focus on them first, Stephenson said.

Medical professionals who are both at high risk of exposure and are needed to care for those who are sick would likely be a priority as well.

Front-line healthcare workers are usually one of the first groups you vaccinate because you need your workforce in place, she said.

Vaccines are often less effective in older people than they are in younger ones, and this could affect the way that a vaccine is administered. A vaccine might be given in multiple doses, or an adjuvant might be added to it to boost the immune systems reaction to it.

The CDC suggests some common-sense ways for people to protect themselves:

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Coronavirus vaccine: why will it take so long to create? - Los Angeles Times

]]> Janssen works on Covid-19 vaccine and treatments. Credit: Janssen Cilag.

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

Follow the latest updates of the outbreakon ourtimeline.

Johnson & Johnson (J&J) subsidiary Janssen Pharmaceutical has partnered with the Beth Israel Deaconess Medical Center (BIDMC) to advance Covid-19 vaccine development.

The partners started preclinical testing of different vaccine prospects. The aim is to select a vaccine candidate for clinical trials by the end of this month.

Janssen expects to launch a Phase I clinical trial by the end of the year. The company is also working to upscale production and manufacturing capacities to meet public vaccination needs globally.

J&J chief scientific officer Paul Stoffels said: It is critical to work with the best scientific minds as we look to rapidly identify and develop solutions to the Covid-19 outbreak. We are grateful for talented and experienced collaboration partners like Dan Barouch and his team at BIDMC.

By mobilising our collective resources, we believe we can leverage the top science and cutting-edge capabilities to respond to this pandemic.

For the Covid-19 vaccine project, Janssen is leveraging its AdVac and PER.C6 technologies that enable rapidly upscale production.

The company is using its vaccine technology also utilised to create its investigational Ebola, Zika, RSV and HIV vaccines.

BIDMC Center for Virology and Vaccine Research director Dan Barouch said: We are currently evaluating a series of potential vaccine candidates for Covid-19.

This collaboration with Janssen is aimed at the development of a Covid-19 vaccine that would allow for rapid development, large-scale manufacturing, and global delivery.

In February, Janssen collaborated with the US Department of Health & Human Services (HHS) to develop an investigational vaccine candidate against coronavirus.

Later, the alliance was expanded to discover effective Covid-19 therapies.

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Covid-19 vaccine in development by J&J and BIDMC. - Pharmaceutical Technology

1. First COVID-19 vaccine trial starts Monday in Seattle, government official says  KOMO News
2. First dose to be delivered Monday in clinical trial for potential COVID-19 vaccine  FOX 10 News Phoenix
3. First in Human: COVID-19 Vaccines & Tales of Phase 1 Clinical Trials Past | Absolutely Maybe  PLoS Blogs
4. Clinical trial for COVID-19 vaccine to begin in US  ABC 57 News
5. Covid19 Vaccination and its latest update for Human Trials  Economic Times
6. View Full Coverage on Google News

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First COVID-19 vaccine trial starts Monday in Seattle, government official says - KOMO News

As companies and institutions around the world race to develop a vaccine against the strain of coronavirus sweeping around the world, Cepi has come forward with an estimate of how much money it might take to cross the finish line: $2bn.

The not-for-profit foundation, whose full name is the Coalition for Epidemic Preparedness Innovations, wants funds for an extensive research programme aiming to have at least three candidates submitted for approval in 2021. Commercial developers are typically reluctant to discuss development costs of individual products, so this call for funding is interesting as it puts a figure of sorts of what level of investment might be required.

Back in 2008, when avian H5N1flu was the pandemic of the moment, Glaxosmithkline said it had spent $2bn developing a vaccine. Establishing manufacturing is likely to be a very big part of this cost estimate, something that the Cepi figures seem to support.

Developing vaccines against both avian and swine H1N1 flu was also a costly global preoccupation EvaluatePharma Vision*estimates that $745m was spent on trials of the various candidates that entered the clinic. This estimate only includes studies that were listed on clinicaltrials.gov, so the real number could be higher still.

The table below singles out some of the more costly products that actually made it to market;several other programmes were abandoned before reaching regulators. And not all are still available: Arepanrix has been withdrawn owing to lack of demandafter governments cancelled large orders as the threat of swine flu receded.

Total estimated trial cost ($m)*

Since 2007 Glaxosmithkline has split out what it spends on vaccine R&D, and it is notable that this investment ticked higher in the late-2000s,both in real terms and as a proportion of total R&D spend,when much of its work into the avian and swine flu products would have been going on.

For the current pandemic the UK pharma giant has pledged to contribute its adjuvant platform technology to Cepiand other developers working on coronavirus;a deal is in place with Chinas Clovis Biopharmaceuticals, for example.

The length of time that traditional vaccines take to develop means that many are hoping that alternative technologies will respond more quickly. Not that Glaxo hung around with its pandemic work: the company put its first H5N1 candidate into the clinic in early 2016, and this became available a little over 12 months later.

The furore over Curevac, which was reportedly offered $1bn by the US president, Donald Trump, for exclusive access to any successful vaccine, shows that progress at these companies is being monitoredclosely, at all levels.

Big hopes rest with Moderna and its RNA-based approach, which according to reports will be moving into the clinic today. With luck,early immunogenicity data could emerge in the summer.

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On the hunt for a Covid-19 vaccine - Vantage

Inovio Pharmaceuticals said Thursday that it has received a $5 million grant from the Bill & Melinda Gates Foundation to scale up testing and production of a portable device to deliver a DNA-based COVID-19 vaccine that the company is developing.

Inovios San Diego Device Manufacturing facility will build the initial number of the proprietary vaccine delivery devices as well as demonstrate how to manufacture them in larger numbers.

After that, production could be transferred to additional contract manufacturers if increased capacity is necessary, the company said.

Inovio is fast tracking the development of a COVID-19 vaccine, with Phase 1 human trials involving up to 50 healthy people set to begin in April in the U.S.

Work on the vaccine, which was created in Inovios San Diego lab, is being funded through a $9 million grant from the Coalition for Epidemic Preparedness Innovations, or CEPI.

A public/private partnership, CEPI has invested more than $27 million to date in several efforts to develop a COVID-19 vaccine from a range of organizations.

Inovio is based near Philadelphia but operates a core research lab in San Diego. It is one of roughly 10 companies working on a COVID-19 vaccine, all of which are in fairly early stages of testing.

To deliver its DNA-based vaccine, Inovio aims to use a hand-held device that runs on AA batteries. The system was developed initially with a $8.1 million grant from the medical arm of the U.S. Defense Threat Reduction Agency. It has been used to deliver 6,000 doses of other treatments that Inovio is working on.

The company has no approved drugs to date, though some are in clinical trials. It is preparing for a Phase 2 trial for a vaccine for Middle East Respiratory Syndrome, or MERS, which also is a strain of corona-virus.

Inovios shares have been whipsawed this week after a Twitter post from Citron Research on Sunday that the U.S. Securities and Exchange Commission should investigate the companys claims that it designed its initial COVID-19 vaccine in three hours after the genetic sequence of the virus became publicly available.

This has been a serial stock promotion for years, according to the Citron Tweet. This will trade back to $2. Investors have been warned.

Inovios shares dropped 32 percent on Monday. A handful of shareholder class action law firms announced that they were conducting investigations of the company.

Inovio responded on Twitter Monday, posting a note to shareholders that said Citron demonstrated a lack of understanding of the science behind DNA medicines.

Based on extensive prior work creating DNA vaccines using our proprietary DNA medicines platform, we are confident we have a viable approach to address the COVID-19 outbreak, the company said.

Inovios shares ended trading Thursday up 13 percent at $9.50 on the Nasdaq exchange but remained below the March 6 high of $14.09.

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Inovio Pharm gets $5M from Gates Foundation to further COVID-19 vaccine project - The San Diego Union-Tribune

Italy's surge of COVID-19 cases continued today in the wake of a national lockdown announced yesterday, as some of the countrys neighbors closed borders and other countries in Europe, such as France, reported similar steep rises.

Meanwhile, more countriesincluding the Ebola-hit Democratic Republic of Congo (DRC)reported their first cases, while cases continued to decline in South Korea, and two groups made announcements about funding to develop treatments and a vaccine.

The World Health Organization (WHO) said in its daily update today that the global total is 113,702 cases, 32,778 have now been reported from outside of China, including 4,105 new illnesses reported yesterday. So far, 109 countries have reported cases. Newly affected countries include Mongolia, which reported a case in its capital in a worker from France and the DRC, a 50-year-old man who arrived in Kinshasa from France.

Italy's health ministry today reported 977 new cases, plus 168 more deaths, boosting its totals to 10,149 cases, of which 631 were fatal. The country's government yesterday announced a nationwide lockdown, the broadest so far of the COVID-19 epidemic, due to an outbreak centered in Lombardy and neighboring regions in the north.

Along with the lockdown, Italy's government said it would suspend mortgage payments to ease the burden of the new COVID-19 restrictions.

Today, three neighboring countriesSlovenia, Malta, and Austriareported border closures. Slovenia said its closure doesn't apply to freight, and Malta closed its border with Italy and turned away a cruise ship from Italy. Austria has also banned Italians from entering the country and imposed a 14-day quarantine on Austrians returning from Italy, according to the BBC.

Meanwhile, the pace of new cases continued to accelerate in other European countries. France reported 372 more cases, along with 3 new deaths, raising its respective totals to 1,784 and 33. France's President Emmanuel Macron today warned the country is at the beginning of its epidemic, and the government announced that the country's culture minister tested positive for the virus and is self-isolating, Reuters reported.

In Spain, health officials reported 415 new cases, plus 5 more deaths, increasing its totals to 1,646 and 35. About half of the cases are in the capital city of Madrid, with the Basque country and Rioja region as the country's other hot spots, the Financial Times reported today. Government officials announced new measures to curb the spread of the virus, including suspending Parliament meetings, banning flights to Italy, and banning large gatherings in Madrid and other locations.

In the United Kingdom, 373 cases have been reported so far, along with 6 deaths, according to an online tracker from Public Health England. Of the total, 324 of them are from England, 27 are from Scotland, 16 from Northern Ireland, and 6 from Wales. Health officials in Belfast voted last night to cancel the city's St Patrick's Day parade to slow the spread of the virus, BBC reported.

Iran's health ministry today reported 881 new cases, along with 54 more deaths, boosting its respective totals 8,042 and 291, Arab News reported today. A country health official speaking at a media briefing said deaths were up 18% from the day before and cases increased by 12%.

Several other countries in the Middle East have reported cases, and some besides Iran are reporting outbreaks, though not as large, with Bahrain, the United Arab Emirates, Iraq, and Egypt reporting dozens of cases, according to an update today from the World Health Organization Eastern Mediterranean regional office.

In other Middle East developments, Israel announced yesterday that it would place all international visitors entering the country in 14-day quarantine, according to a BBC report.

South Korea's daily totals continue to decline, with 131 new cases today and 3 more deaths, putting the country's overall respective totals at 7,513 cases and 54 deaths, according to the Korea Centers for Disease Control. Despite the drop in cases, health officials are warning of new clusters at an insurance company call center in Seoul and at a dance class in South Chungcheong province, Reuters reported.

The country has now completed testing about 200,000 members of a religious sect, which fueled a large outbreak in the city of Daegu, which has accounted for about 90% of the cases.

Elsewhere in Asia:

Efforts to speed treatments and develop a vaccine took two new steps forward today. To push the development of COVID-19 treatments, the Bill and Melinda Gates Foundation, Wellcome Trust, and Mastercard announced yesterday that they are committing $125 million on seed funding.

Called the COVID-19 Therapeutics Accelerator, the effort will coordinate research and remove barriers to drug development, Wellcome Trust said in a statement. The Gates Foundation and Wellcome Trust each contributed $50 million and Mastercard's Impact Fund committed $25 million. The Gates Foundation portion is part of the $100 million COVID-19 response that it announced in February.

Jeremy Farrar, MD, PhD, said in the statement, "Investing now, at scale, at risk and as a collective global effort is vital if we are to change the course of this epidemic. We welcome others to join us in this effort."

Also, the Coalition for Epidemic Preparedness Innovations (CEPI) today announced that it is expanding its COVID-19 vaccine portfolio by investing an extra $4.4 million in partnerships with Novavax and the University of Oxford to develop COVID-19 vaccine candidates. The extra funding boosts CEPI's overall COVID-19 investment to $23.7 million.

CEPI said the initial funding for Novavax will allow it to prepare for phase 1 trials and the money for the University of Oxford project will cover the production of vaccine materials for preclinical and phase 1 testing.

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Italy COVID-19 total tops 10000; funding grows for treatments, vaccines - CIDRAP

A congressional aide tapes up a sign with office policies to prevent the spread of the coronavirus in the Rayburn Building. (Tom Williams / CQ Roll Call via AP Images)

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Former Vice President Hubert Humphrey reminded us long ago that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life, the sick, the needy and the handicapped.Ad Policy

It is also the practical testespecially during a pandemic such as the one that the United States is now experiencing.

If we commit to provide the very best care and support for those who are most vulnerable, those who are most threatened physically and economically by the coronavirus outbreak, threads of human decency and common sense intersect to the benefit of the whole of society. That means that our responses to the coronavirus must be universal in every sense. If care is too costly, if workers feel pressured to show up for jobs when they feel ill, then this country is not responding realistically or responsibly to the crisis.

Thats why Representative Ayanna Pressley argues, Coronavirus testing must be made free to the public if we are going to understand the scope of this crisis. Anything less will undermine Americas effort to protect our communities and save lives. MORE FROM John Nichols

And thats why Representative Pramila Jayapal has written to Vice President Mike Pence to argue, Coronavirus impacts all of us. Stopping immigrants from seeing the doctor is harmful and downright dangerous during a public health emergency. Putting up barriers to care for some is a public health risk for all. The Trump Administration must immediately suspend its wealth test.

Thats a reference to the Trump administrations scheming to block immigrants who might at some point make use of federal safety-net benefits to get by. But the fact is that there are millions of people in the US who cannot afford needed health care and millions more who cannot take a day off work without risking their livelihoods.

The unfolding coronavirus outbreak threatens the stability of the US economy. It threatens to upend the 2020 election campaign, as rallies are canceled and debates are moved. Election turnout could be severely diminished in states that have not fully developed vote-by-mail systems. Yet, the most serious threat is to the health and safety of those millions of Americans who lack access to health care, who lack the resources that are required to pay for that care, and who lack the freedom to take time off when they or family members are ailing.Current Issue

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If society fails to meet everyones needs, no matter what their immigration status, and no matter what their ability to pay, then there will be a class divide in our response to the pandemic. And that divide will render the response dangerously inadequate.

Vermont Senator Bernie Sanders has been making this point for weeks, delivering now is the time for solidarity speeches and statements that go far beyond merely pointing out that we would all be better off with a single-payer Medicare for All health care system.

We have to make sure that everybody, right now, feels free when youre sick to go to a doctor, regardless of your income. And you know what? The government will pay that bill, the Democratic presidential contender said on the Tonight Show Wednesday. Number two, we are the only major country on Earth not to guarantee paid medical leave. If you can believe it, there are people who are sick today, who may actually believe they have symptoms of the coronavirus, who are going to work because they have no income (if they do not). Theyre making $12, $13 an hour, theyve got to feed their family, they go to work. We have got to do what every other country on Earth does and guarantee paid family and medical leave and do it right now on an emergency basis.

Paid sick leave cant be treated as an option anymore. Its not just inhumane to force people to work while sick. Its also a massive threat to public health, says Wisconsin union activist Randy Bryce. Representative Val Demmings says, Paid sick leave is required to control coronavirus.

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Sanders points to a wide range of additional requirements, especially the need for free vaccines.

The senator argues that the Trump administrations refusal to take steps to eliminate the wealth test for the vaccine that will be developed to prevent the spread of coronavirus is a crock. That is ridiculous. We have got to make sure that when that vaccine comes out, it is available to everybody in this country, regardless of their income.

After Alex Azar, the former pharmaceutical corporation executive who serves as Trumps Secretary of Health and Human Services secretary refused to guarantee in congressional testimony that any coronavirus vaccine or treatment would be affordable for all, Sanders declared, Under the Trump doctrine, if you are wealthy you can buy a vaccine and not succumb to the sickness. If you are poor or working class, you may have to get sick or even die. That is an outrage. That is unacceptable. We need a vaccine that is available to all.

Were he in the White House, the senator says he would make the vaccines available for free. And is that a radical statement? the senator asks. That is the most obvious statement anybody could make.

Obvious, but not assured by any means.

President Trumps miserable response to the crisis keeps confirming Joe Bidens observation that Unfortunately, this virus laid bare the severe shortcomings of the current administration. Public fears are being compounded by pervasive lack of trust in this president. After Trump delivered a convoluted, error-filled speech on Wednesday regarding the coronavirus outbreakwhich emphasized travel bans, tax fixes, and negotiation with the insurance industryHouse Democrats offered a sounder response, in the form of their Families First Coronavirus Response Act, which strikes down a few wealth barriers.

The Families First Coronavirus Response Act is focused directly on providing support for Americas families, who must be our first priority in this emergency, says Pelosi. We cannot fight coronavirus effectively unless everyone in our country who needs to be tested knows they can get their test free of charge. We cannot slow the coronavirus outbreak when workers are stuck with the terrible choice between staying home to avoid spreading illness and the paycheck their family cant afford to lose.

The plan provides for:

These are fine first steps, and Americans should demand that the Republican-controlled Senate follow the lead of the Democratic House and take them. But demands for a comprehensive response that provides health care and economic security for all shouldnt stop there. Representative Alexandria Ocasio-Cortez says the need for dramatic action now to stave off the worst public health and economic effects of the coronavirus outbreak requires an exploration of broader initiatives such as debt relief and universal basic income initiatives. This is not a time for half steps, says AOC.

Shes right; its time to expose the wealth barriers that get in the way of a comprehensive response to the coronavirus outbreakand to strike them down.

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Free Tests, Free Vaccines: Remove the Wealth Barriers to Fighting COVID-19 - The Nation

The European Medicines Agency (EMA) announced it will provide free advice to those working on COVID-19 therapeutics and vaccines in the hopes of accelerating approval of a treatment.

The European Medicines Agency (EMA) has released a statement saying it is providing full fee waivers for scientific advice given to developers of potential COVID-19 therapeutics or vaccines. The overall aim is to accelerate the approval of a safe and effective therapeutics to treat those infected with the coronavirus.

The EMA intends this service to identify products which are advanced enough to benefit from fast-track scientific advice, designed to give guidance on the best methods and study designs to generate the data required for drug approval.

According to the agency, it has already organised teleconferences with several developers and is working closely with other international regulatory bodies, while also keeping its member states apprised of all activities.

The EMA is supporting the World Health Organizations (WHOs) work to prioritise and analyse all available evidence regarding the efficacy and safety of repurposed agents and investigational agents currently under investigation. The priority is to develop a therapeutic for COVID-19.

According to the agency, this is due to vaccine development being at an early stage, with no existing vaccines able to be repurposed. In their statement, the EMA revealed that, while vaccine development timelines are hard to predict, it is estimated that the first COVID-19 clinical trails will not begin until after April/May 2020. As a result, it will take several months for these vaccines to be ready for larger clinical trials. Once they have sufficient information, the agency will assess any applications for marketing authorisation within the shortest possible timelines.

This may include use of the PRIME scheme, accelerated assessment and/or conditional marketing authorisation procedures. Adequate demonstration of quality, safety and efficacy is expected in order to support the authorisation of COVID-19 medicinal products.

Developers are invited to contact the agency for advice find more information here.

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EMA offers free advice to COVID-19 vaccine and therapeutic developers - European Pharmaceutical Review