Category: Covid-19 Vaccine

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Achieving herd immunity to COVID-19 in the UK could result in the deaths of more than 1 million people with a further 8 million severe infections requiring critical care, says an observer.

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CANTERBURY: The UK government recently enacted its second phase of response to the COVID-19 pandemic: Delay.

According to ITV journalist Robert Peston, the governments strategy to minimise the impact of COVID-19 is to allow the virus to pass through the entire population so that people acquire herd immunity, but at a much delayed speed. This is so that those who suffer the most acute symptoms are able to receive the necessary medical support without overwhelming the National Health Service (NHS) with cases.

At face value, this seems like a sound strategy, but what exactly is herd immunity and can it be used to combat COVID-19?

HOW HERD IMMUNITY WORKS

Our bodies fight infectious diseases through the actions of our immune systems. When we recover, we often retain an immunological memory of the disease that enables us to fight off that same disease in the future.

This is how vaccines work, creating this immune memory without requiring getting sick with the disease.

If you have a new disease, such as COVID-19, that we dont have a vaccine for and no one in the country has ever been infected with, the disease will spread through the population.

But if enough people develop an immune memory, then the disease will stop spreading, even if some of the population is not immune. This is herd immunity, and it is a very effective way to protect the whole of a population against an infectious disease.

But herd immunity is typically only viewed as a preventive strategy in vaccination programmes. If we dont have a vaccine as we dont for COVID-19 achieving herd immunity would require a significant proportion of the population to be infected and recover from COVID-19.

So what would this mean for the spread of the disease in the UK?

The percentage of the population that needs to be immune to enable herd immunity depends on how transmissible a disease is. This is measured by the term R0, which is how many new infections each case will generate.

For COVID-19, the R0 is estimated to be 3.28, though studies are still ongoing and this number will probably change. This means that for herd immunity, about 70 per cent of the UK population would need to be immune to COVID-19.

Achieving herd immunity would require well over 47 million people to be infected in the UK. Current estimates are that COVID-19 has a 2.3 per cent case-fatality rate and a 19 per cent rate of severe disease.

This means that achieving herd immunity to COVID-19 in the UK could result in the deaths of more a million people with a further 8 million severe infections requiring critical care.

DELAY AS A PUBLIC HEALTH STRATEGY

However, it is not clear how much of this discussion of herd immunity reportedly proposed by David Halpern, chief executive of the Behavioural Insights Team, and later blogged about by Robert Peston shapesgovernment policy.

Also, the concept as discussed is not simply to let the disease run its course through the population, but to slow its spread and protect those most vulnerable from severe disease.

Slowing the spread of COVID-19 is a promising strategy, especially when combined with enhanced measures to protect the elderly and those with underlying health conditions

By slowing the spread of the disease, the NHS might have more time to prepare, we might be able to develop treatments or vaccines and we will be closer to the summer when we have lower incidences of other diseases that burden the NHS, such as the flu.

A delay strategy when combined with surveillance and containment, as recommended by the WHO, could be effective in combating the spread of COVID-19.

Yet if the UKslows the spread of the virus but relieson herd immunity to protect the most vulnerable people, itwould still need 47 million people to be infected.

Even if the UKmanages to protect the most vulnerable people (though no discussion is provided on how this will be done or for how long) the fatality rate for the otherwise healthy portion of the population may still be 0.5 per cent or higher. This means that even in this unlikely best case scenario we would still be looking at more than 236,000 deaths.

We can and we must do better than that. China is rapidly controlling the spread of COVID-19 without requiring herd immunity (only 0.0056 per cent of its population has been infected).

Waiting for herd immunity to COVID-19 to develop in the UK by letting the virus pass through the community is not a good public health strategy.

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Jeremy Rossman is Honorary Senior Lecturer in Virology at the University of Kent, and President of Research-Aid Networks. This commentary first appeared on The Conversation.

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Commentary: Is the UK's herd immunity strategy to combat COVID-19 worth pursuing? - CNA

There is no FDA-approved Covid-19 vaccines or drugs on the market currently. Nicol Campo/LightRocket via Getty Images

The unstoppable coronavirus Covid-19 is now officially a global pandemic. And we still havent found a cure or vaccine for it. The good news, though, is that a number of biotechnology and pharmaceutical companies, some with the support of government funding, are working around the clock to develop vaccines and treatment.

SEE ALSO: Severe Covid-19 Patients in US Are Testing Out a Last-Resort Coronavirus Drug

Here are five promising preventive and antiviral therapies in the works that may survive clinical trials and reach the market.

British pharmaceutical giant GSK is working with two outside organizations for preclinical studies on Covid-19 vaccines using its pandemic vaccine adjuvant platform, a technology used to develop HPV and flu vaccines in the past.

GSK has provided the technology to University of Queensland program funded by the Coalition for Epidemic Preparedness Innovations (CEPI), an international organization based in Oslo, Clover Biopharmaceuticals, a Chinese biotech company thats making a vaccine called Covid-19 S-Trimer.

In collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a division under the Department of Health and Human Services (HHS), Johnson & Johnson is exploring candidates for both vaccines and antiviral drugs.

Similar to GSK, the American pharma giant is using its vaccine platform technology, which was used for the developing an experimental Ebola vaccine in 2009.

We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world, Paul Stoffels, Johnson & Johnsons chief scientific officer, said in a statement last month.

The company aims to start a Phase 1 clinical trial by the end of 2020, Stoffel said last week.

Inovio recently completed the preclinical testing of a DNA-based vaccine called INO-4800. And clinical trials are expected to begin in April with patients in the U.S., as well as China and South Korea.

The company expects to have first trial results in the fall and have one million vaccines doses ready by the end of the year.

Biotech startup Moderna is developing an RNA-based vaccine candidate called mRNA-1273 through a program funded by CEPI. Last month, the company shipped a batch of the vaccine to the National Institute of Allergy and Infectious Diseases (NIAID), a division under the National Institutes of Health. Clinical trials are expected to start next week and conclude on June 1 next year.

A frontrunner among existing Covid-19 therapy projects, Gileads antiviral drug, Remdesivir, is currently used in a phase 3 trial on over 1,000 patients around the world.

The experimental drug was first tested on Covid-19 patients in Wuhan, China, the epicenter of the coronavirus outbreak. Last month, the NIAID allowed the company to expand phase 3 trials to other countries hit by the virus.

Trial results from China can be expected as soon as April.

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5 Promising Covid-19 Vaccines and Drugs That Could End Coronavirus Pandemic - Observer

Borders across Europe closing to limit the spread of COVID-19 as the first human trial of a vaccine gets underway in the US.

This undated handout picture courtesy of the British Health Protection Agency shows the coronavirus seen under an electron microscope. Picture: AFP.

JOHANNESBURG - More countries are being placed on lockdown on Tuesday morning with borders across Europe closing to limit the spread of COVID-19 while the first human trial of a vaccine gets under way in the US.

More than 7,000 people have died globally from the coronavirus out of over 182,000 cases.

However, almost 80,000 people have made full recoveries.

In South Africa, President Cyril Ramaphosa said the ANC was confident government's COVID-19 preventative measures would work.

Ramaphosa said the party was focused on coming up with a plan to minimise the effects of the spread of the virus.

South Africa has 62 confirmed cases with more expected to be announced in the coming days.

The president declared a state of disaster on Sunday night announcing travel restrictions, school closures and cancelling mass events.

WATCH: South Africas coronavirus interventions

PANIC BUYING

Many grocery shops were overrun on Monday by consumers panic buying and stock-piling items.

Videos on social media show long snaking queues with scores of people standing in close quarters.

South Africans have been urged to be rational when shopping for supplies as so-called panic-buying spikes.

The dean of the Gordon Institute of Business Science Nicola Kleyn said this could also be referred to as rational disaster buying.

Its entirely rationale if people think they wont have access to those things for a period. People want to go home and have a feeling of Ive done what I need to do so I dont need to go out anymore.

To track the latest developments around the coronavirus both in South Africa and abroad, click on this live status report from Strategix.

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First human trial of COVID-19 vaccine gets under way in the US - EWN

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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.

Original post:

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.

Continue reading here:

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.

Originally posted here:

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