Category: Covid-19 Vaccine

Donald Trump may be very confident we will have a vaccine for COVID-19 by the end of the year, but the rest of us should be more cautious. Billions of dollars are being spent trying to develop vaccines and treatments as a more permanent solution to the crisis than the lockdowns currently being enforced around the world.

As of May 2020 there are 182 treatments and 99 different vaccines being developed globally. But, based on recent history, only one or two are likely to be transformative, a couple may be partially helpful, some will be shown as downright dangerous, and the majority will have conflicting evidence as to their effectiveness.

This is because medical research is a slow and painstaking process. It is also very complicated and easy to come to the wrong conclusions.

One good thing to have come out of the coronavirus pandemic seems to be a renewed trust in experts. The routine presence of scientists at government briefings seems to recognize that rather than deserving our suspicion, we need these people to beat the virus.

But more trust in experts means more scrutiny of science as it happens the latest studies showing promising results are now headline news. This can be worrying because, while there is no doubt that treatments for COVID-19 will eventually be found, it is easy for enthusiasm to turn into cynicism if expectations are not met as quickly as the public and politicians may hope.

Read: [Will a coronavirus vaccine change the minds of anti-vaxxers?]

There seems to be little recognition that, while thousands of drugs have shown promise in early animal or clinical tests for example, the vaccine trials at the University of Oxford the vast majority that show early promise will never make it into routine clinical use. On average it takes 12 years and over US$1 billion (805 million) to get a drug to market.

I chair research ethics committees. Over the last few years I have reviewed thousands of research protocols representing the very best, and occasionally some quite poor, examples of medical research.

Good research is defined as rigorous and reliable, producing results that are not only interesting but are practical, useful, and in some cases transformative. They are also reported clearly, transparently, and in the context of previous studies. This is precisely the type of research we need to address the COVID-19 crisis.

But such good research comes at a cost. Much of society think of thecost in terms of dollars and pounds, and indeed mindful of our own survival, scientists and researchers are of course always going to lobby for more investment. While it is very helpful to have the funds to order any chemical that is needed, access highly specialized equipment, or pay others to conduct experiments and analyze results quickly, we must take care never to underestimate the importance of taking time to think carefully about what results actually mean.

It is only once researchers have taken the time to understand the context of results that they can start turning them into effective applications or treatments. The real cost of good research is therefore time.

The frustrating truth about medical research is that the majority of experiments appear not to work because the subject being studied is so horrendously complex. In fact, rather than not working, many experiments are simply inconclusive. To make progress you have to slow down, look at the evidence , and take time to think very carefully about what the results might mean.

Positive results in animals often dont translate to scientific breakthroughs for humans. Credits: Shuttershock

The thinking needed for this takes years. I was involved with one project that was delayed for almost ten years while the team tried to work out why a single animal showed cardiovascular complications. Another project I worked on showed promise reducing an Alzheimer-like pathology in mice, yet 18 years later similar effects have yet to be conclusively shown in humans. Commendably, the team is still working on it.

The reality is that the long road to a vaccine or drug for any disease is littered with trials that did not lead to expected results. Even when a study is successful, it takes a long time to go from the lab to the general public.

One worrying aspect of the current situation is the pressure on researchers to work quickly and come up with solutions for COVID-19 almost immediately. For perhaps the first time, financial resources are not a limiting factor, and so politicians and the public are expecting researchers to take the cash and provide the answers. This has been coupled with significant pressure on regulators to streamline or even suspend some of the normal processes so that treatments can get to the clinic as quickly as possible.

Lured by promises of unlimited funding, and perhaps fame should their chosen idea work, some researchers may be tempted to engage in questionable research practices. History shows that whenever a large amount of money is involved, the temptation to commit, fraud, misconduct, or other questionable practices increase. The UK spent more than 400 million during the 2009 swine flu outbreak stockpiling a drug whose effectiveness had been inflated by the manufacturers due to publication bias where negative or inconclusive results from a trial are not published in scientific journals, but positive results are.

Without appropriate scrutiny, there is a real risk that ineffective, or even harmful, treatments begin to get used. This may be considered an acceptable risk in the current crisis, but if so, it is important that any new treatments are monitored very closely and withdrawn without hesitation if the harms mount up.

Given time maybe two, three or perhaps even ten years researchers will be able to take stock of the evidence from experiments and trials, perform a meta-analysis and systematic review, hold international conferences, and then, following careful thought, tell the world what the best treatment for COVID-19 is.

The world clearly needs scientific and medical answers to the current pandemic as soon as possible, but we need to recognize that initially, we may only find partial or tentative answers. Instead of a quick vaccine that completely prevents COVID-19, a variety of partial successes will be combined until eventually a full solution is found.

There may even be some blind alleys with promising, but ultimately futile, treatment ideas. This is not a failure of research, or misuse of resources. Above all, researchers need to be supported to work with integrity, and not be made scapegoats for the challenges that undoubtedly lie ahead.

This article is republished from The ConversationbySimon Kolstoe, Senior Lecturer in Evidence Based Healthcare and University Ethics Advisor, University of Portsmouthunder a Creative Commons license. Read the original article.

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Here's why we probably won't see a COVID-19 vaccine in 2020 - The Next Web

This is an excerpt fromSecond Opinion, aweeklyroundup of eclectic and under-the-radar health and medical science news emailed to subscribers every Saturday morning.If you haven't subscribed yet, you can do that byclicking here.

As researchers around the world race under immense pressure to develop a COVID-19 vaccine, a controversial approach could potentially help get them there faster but it's incredibly risky.

The process is known as a human challenge study, and it involves intentionally infecting willing volunteers with the coronavirus that causes COVID-19 in order to test the effectiveness of potential vaccines and treatments against it.

"These are very powerful studies that could make a difference, especially since we don't know a lot about the novel coronavirus," said Seema Shah, a medical ethicist at Northwestern University and Lurie Children's Hospital of Chicago.

"They could clarify what's happening in infections with people who are not symptomatic and people who have more severe disease even if they don't have underlying conditions that put them at higher risk."

Shah said COVID-19 human challenge studies could also help identify people who have developed immunity to the coronavirus, while also helping to narrow down the growing list of potential vaccines and treatments for patients.

"If there were a couple of vaccine candidates that had gotten through safety testing and there was a question about which one of those vaccines was more likely to work, a human challenge study could be a quick way to pick the best vaccine of the candidates," she said.

"It could also be useful to study whether the vaccine itself causes different kinds of harm."

The WHOsays any potential vaccine is still at least a year away, but human challenge trials could accelerate theprocess because of the time they save in the clinical trial phase.

Typically, researchers inject thousands of study participants with a vaccine or placebo and wait for symptoms to develop an approach that can take months or years after vaccine development.

Human challenge studies instead vaccinatea small group of people and then intentionally infectthem with the virus, saving critical research time, especially during a global pandemic.

But despite the potential benefits of a controlled human challenge study on COVID-19 patients, experts say the controversial approach is an ethical minefield that could have disastrous consequences if not handled carefully.

Human challenge studies typically recruit young, healthy volunteers in an effort to keep the risk of severe medical complications low.

Thousands of potential volunteers have already pledged to participate in human challenge trials on a website called 1DaySooner, but no such studies are yet underway.

Yet given what we know and don't know about the different ways in which COVID-19 attacks the human body even in young, healthy people, how do we effectively inform participants who may be unknowingly putting themselves at severe risk?

"We know that younger people tend to tolerate COVID-19 as an illness better, but what would worry me about that is there's a lot that is still unknown," said Kerry Bowman, a bioethicist and professor of global health at the University of Toronto.

He said the potential for COVID-19 patients of all ages to face long-term health implications and even death from a virus we still know so little aboutcalls into question how truly informed participants could be on the risks of a human challenge study.

"Do you truly have an informed decision?" he said. "You have consent, but is itreally well-informed? Do people fully understand? Because if we don't understand the virus itself, I wonder about the quality of informed consent that you can ask of people."

In a new paper published in the journal Science Thursday, Shah and a team of international researchers outline an ethical framework for how human challenge studies could be effectively used to combat COVID-19.

The researchers supportdeveloping a "challenge strain" of the coronavirus a stabilizedversion of the one thatis circulating worldwide to potentially infect participants, but stopped short of advocating for the work to proceed.

"The pandemic has affected just about everyone in the world in various ways, so the potential amount of social value is unprecedented here," Shah said.

"That's why our group concluded it's really important to give challenge studies a hard look and potentially invest in laying the groundwork for doing them.

"But then make that judgment call about whether and how to do them at a later date when they're ready to go."

The World Health Organization released specific criteria this week outlining its recommended approach to conducting human challenge studies, without advocating for or against them.

Among those recommendations is a need for "strong scientific justification" for the studies, ensuring that the potential benefits outweigh risksand that the selection of participants should be done with "rigorous" informed consent.

"The overarching, really important one is to minimize risk to participants as much as possible," said bioethicist Dr. Ross Upshur, of the University of Toronto's Dalla Lana School of Public Health, who helped work on the WHO guidelines.

"You need to make sure that people understand what's being proposed:what they're going to be doing;how they're going to be managed in this situation;how their safety and their well-being is going to be protected.

"But it's also incumbent on the researchers to outline all of the uncertainties,because we may not be able to actually quantify some of those risks."

Timothy Caulfield, a Canada Research Chair in health law and policy at the University of Alberta who has researched human challenge studies, said those ethical dilemmas have historically plagued this approach.

"I understand the desire to use human challenge trials, especially in this context, because people are desperate to get a vaccine quickly, not just for clinical reasons, but also for economic and social reasons," he said.

"So the pressure is intense, but the exact reason that we have research ethics guidelines is to protect research participants."

Caulfield said the damage that could be done if a human challenge trial were to go awry would be devastating.

He points to the ethics scandal involvingJesse Gelsinger, a teenager who died in a clinical trial for gene therapy in 1999, as an example of a failed human study that set the research ethics field back immensely.

Gelsingerhad a genetic disease called ornithine transcarbamylase (OTC) that he controlled through diet and medication, but after enrolling in the trialhe was injected with an experimental therapy and died a few days later.

"Just imagine the impact that it could have on vaccine research, especially in this environment where there's so much uncertainty," Caulfieldsaid.

"If it doesn't go well and if we cut corners on research ethics standards, it could end up backfiring and being really problematic."

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Could intentionally infecting volunteers with COVID-19 help find a cure sooner? - CBC.ca

Vaccines are chemicals that help the body develop antibodies while antibodies are developedby the bodys immune system to fight pathogens

Italy and Israel both claim to have had breakthroughs indeveloping methods to neutralise the novel coronavirus (SARS-CoV-2), that is responsible for the disease (COVID-19) pandemic, suggest several media reports.

Media reports suggestthe vaccine had antibodies that worked on human cells, blocking the virus from infecting humans.

Some media reports used the terms vaccines and antibodies interchangeably. There is, however, a difference between them.

Vaccines are chemicals that when injected into the body, help it develop antibodies. Antibodies, on the other hand, are developed by the bodys immune system to fight pathogens.

Italian researchers at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, Italy claim they found a vaccine to treat the SARS-CoV-2 infection. Takis the firm working on developing the vaccine used it to produce antibodies in mice that was then used to neutralise the virus in human cells.

This suggested that the vaccine may lead to a similar production of antibodies in human beings and would help shield the person from the infection.

A component from the pathogen is introduced into the body through a vaccine. While this component does not lead to the disease, it trains the bodys immune system to prepare a response for when the actual pathogen attacks.

The pathogen component that triggers the reaction in the body can be inactivated, weakened or even a toxin produced by the pathogen.

Another way of using antibodies produced in experimental animals or designed in silico (produced through computer simulations or modelling) can be to use them as a medicine or therapy.

This option is being explored as well to combat SARS-CoV-2. The Israel Institute for Biological Research (IIBR)claimed it developed an antibody that can neutralise the virus. Naftali Bennet, Israels defence minister claimed the monoclonal neutralising antibody developed by IIBR, attacks the virus and neutralises it inside the virus carriers body.

Monoclonal antibodies as the name suggests are cloned from a single recovered cell. This cell was obtained through plasma samples collected from patients who recovered from COVID-19.

These antibodies form the basis for plasma therapy too.

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COVID-19: Here's the difference between vaccines, antibodies - Down To Earth Magazine

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Title: Gene therapy expert leads project to develop AAV-based COVID-19 vaccine

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Gene therapy expert leads project to develop AAV-based COVID-19 vaccine - Chemical & Engineering News

RESEARCHERS IN Italy have claimed to have developed a successful vaccine against Covid-19.

Scientists from Rome's Lazzaro Spallanzani Hospital, which specialises in studying infectious diseases, say they have successfully developed a vaccine which neutralises the coronavirus in human cells.

Luigi Aurisicchio, Chief executive of Takis, the company working on the treatment, told Italian news agency Ansathat tests carried out on mice created antibodies after just one vaccine, which they expect to also work in human trials.

This is the most advanced stage of testing of a candidate vaccine created in Italy, Mr Aurisicchio said, adding that "as far as we know we are the first in the world so far to have demonstrated a neutralisation of the coronavirus by a vaccine".

Human trials are expected to take place after the summer, he told the outlet.

While the researchers are developing the vaccine with "Italian research, with an all-Italian and innovative technology, tested in Italy" he said that the vaccine, if successful, will be made available to everyone.

In order to reach this goal, we need the support of national and international institutions and partners who may help us speed up the process.

The researcher worked on developing a vaccine which centred around the coronavirus's 'spike' DNA protein which it uses to latch on to and enter human cells, and so far the trials are proving a success.

The next part of the vaccine trial will be to test how long the immunity lasts.

Meanwhile in the UK, human trials have begun on a vaccine developed at Oxford University's Jenner Institute, with researchers there saying a vaccine could be available as early as September.

Originally posted here:

Scientists in Italy claim to have successfully developed Covid-19 vaccine - Irish Post

The University of Washington Medical Center is quiet on April 1, 2020.

UW medical experts explained the current state of COVID-19 vaccine and treatment development and what it could mean for the course of the pandemic in a May 4 webinar hosted by the department of global health.

Deborah Fuller, a professor of microbiology, discussed how the fastest development of a vaccine to date is five years, meaning the timeline for rapid development of a COVID-19 vaccine looks very different.

The race for a COVID-19 vaccine follows an accelerated timeline with the three major phase trials condensed into an 18-month timeframe. Fuller said nucleic acid vaccines, like the DNA and RNA vaccines she is developing, are believed to be perhaps the most reliable candidate for a rapid response vaccine.

When a vaccine does become available, Fuller said distributing it to billions across the world will serve as a major hurdle, suggesting ring vaccination as a solution for stopping the pandemic without everyone needing to be vaccinated, though Fuller said the broader goal is still to vaccinate the majority of individuals.

Instead of having to vaccinate the entire 90% of the population, you would actually vaccinate all of the close contacts, forming a ring around that person so the virus really has nowhere to go, she said. The chain of transmission gets broken and thats going to be able to shut down the pandemic much quicker.

Christine Johnston, the associate director of UW Medicines Virology Research Clinic, explained how the nature of emergency response to the pandemic is also affecting treatment options, including the process of collecting evidence and utilizing pre-existing treatments for the virus.

Due to the long time frame for producing new medications, Johnston said the main focus has been to repurpose drugs to treat COVID-19. The drug hydroxychloroquine, for example, has been touted as a potential treatment with a reliable safety profile, though preliminary studies have been conflicted on its effectiveness and associated risks.

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The hydroxychloroquine is not what people would call a huge game changer in the hospitalized patient setting, but I still think it begs more clinical trials and more well conducted studies, Johnston said. I dont think Im ready to say that this medication is ineffective yet.

Johnston also said another potential treatment option known as remdesivir, which was previously developed as a treatment for Ebola, had promising in vitro data, animal model data, and preliminary clinical trial results. The U.S. Food and Drug Administration granted remdesivir Emergency Use Authorization and Johnston noted that remdesivirs manufacturer will be donating 1.5 million doses of the drug.

Responding to a student question on ensuring an equitable distribution of COVID-19 vaccines and treatment, Fuller said it was important to make the vaccines free to the public. She also explained there is likely to be numerous vaccines with different levels of effectiveness across demographic groups which will establish a cross fertilization of vaccines to accommodate the wider population.

Addressing the same question, Johnston voiced her concerns that the distribution of treatments will not be equitable in the United States and that this inequity will be magnified worldwide.

I think its very difficult for people to take equity into account even in the best cases of situations and so in a pandemic I think the equity issues are even more skewed, Johnston said. This is an opportunity for us to think about how to make equity front and center when were developing new treatments.

Reach reporter Jax Morgan at news@dailyuw.com. Twitter: @jaxbmorgan

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UW medical experts share the latest COVID-19 vaccine and treatment developments - Dailyuw

Some scientists who believe theyre on the verge of a breakthrough begin testing at Children's Hospital on a COVID-19 vaccine being described as "revolutionary." Pfizer is working on a genetic vaccine that could be ready as early as September.Childrens Hospital, which has extensive experience in vaccine testing, is among a select few organizations conducting part of the study.The tests at Childrens begin on the Pfizer vaccine May 11.Its very interesting technology, very elegant technology, said Dr. Robert Frenck, who is heading up the research at Childrens. Its just going to simulate the infection then our body, when it sees the real infection, it already has some protection mounted to be able to fight the disease.The vaccine is different than others because it does not inject a patient with the virus. Instead, it uses a piece of the messenger RNA, which is part of the genetic code of the virus.The messenger RNA in the vaccine instructs the cells to make the proteins associated with the coronavirus, but without making someone sick.Through processes inside the body, the vaccine basically tricks the immune system into making COVID-19 antibodies to fight the virus.Thats really the main part of this study is to look and make sure theres not any significant side effects, Frenck said.Phase one of the tests at Childrens is expected to be complete by June, then phase two begins. If there are no issues, phase three is expected to begin in September and would include more widespread use of the vaccine.Although the tests are at Children's Hospital, the participants in phase one are between 18 and 55 years old.A total of 90 people will be tested in phase one. Childrens is still taking applications for those who want to participate in the testing. People can fill out a questionnaire at is.gdcovid19researchstudy.

Some scientists who believe theyre on the verge of a breakthrough begin testing at Children's Hospital on a COVID-19 vaccine being described as "revolutionary."

Pfizer is working on a genetic vaccine that could be ready as early as September.

Childrens Hospital, which has extensive experience in vaccine testing, is among a select few organizations conducting part of the study.

The tests at Childrens begin on the Pfizer vaccine May 11.

Its very interesting technology, very elegant technology, said Dr. Robert Frenck, who is heading up the research at Childrens. Its just going to simulate the infection then our body, when it sees the real infection, it already has some protection mounted to be able to fight the disease.

The vaccine is different than others because it does not inject a patient with the virus. Instead, it uses a piece of the messenger RNA, which is part of the genetic code of the virus.

The messenger RNA in the vaccine instructs the cells to make the proteins associated with the coronavirus, but without making someone sick.

Through processes inside the body, the vaccine basically tricks the immune system into making COVID-19 antibodies to fight the virus.

Thats really the main part of this study is to look and make sure theres not any significant side effects, Frenck said.

Phase one of the tests at Childrens is expected to be complete by June, then phase two begins. If there are no issues, phase three is expected to begin in September and would include more widespread use of the vaccine.

Although the tests are at Children's Hospital, the participants in phase one are between 18 and 55 years old.

A total of 90 people will be tested in phase one.

Childrens is still taking applications for those who want to participate in the testing. People can fill out a questionnaire at is.gdcovid19researchstudy.

Read more from the original source:

'Revolutionary' COVID-19 vaccine to be tested at Children's Hospital - WLWT Cincinnati

Donald Trump may be very confident we will have a vaccine for COVID-19 by the end of the year, but the rest of us should be more cautious. Billions of dollars are being spent trying to develop vaccines and treatments as a more permanent solution to the crisis than the lockdowns currently being enforced around the world.

As of May 2020 there are 182 treatments and 99 different vaccines being developed globally. But, based on recent history, only one or two are likely to be transformative, a couple may be partially helpful, some will be shown as downright dangerous, and the majority will have conflicting evidence as to their effectiveness.

This is because medical research is a slow and painstaking process. It is also very complicated and easy to come to the wrong conclusions.

One good thing to have come out of the coronavirus pandemic seems to be a renewed trust in experts. The routine presence of scientists at government briefings seems to recognise that rather than deserving our suspicion, we need these people to beat the virus.

But more trust in experts means more scrutiny of science as it happens the latest studies showing promising results are now headline news. This can be worrying because, while there is no doubt that treatments for COVID-19 will eventually be found, it is easy for enthusiasm to turn into cynicism if expectations are not met as quickly as the public and politicians may hope.

There seems to be little recognition that, while thousands of drugs have shown promise in early animal or clinical tests for example, the vaccine trials at the University of Oxford the vast majority that show early promise will never make it into routine clinical use. On average it takes 12 years and over US$1 billion (805 million) to get a drug to market.

I chair research ethics committees. Over the last few years I have reviewed thousands of research protocols representing the very best, and occasionally some quite poor, examples of medical research.

Good research is defined as rigorous and reliable, producing results that are not only interesting, but are practical, useful and in some cases transformative. They are also reported clearly, transparently and in the context of previous studies. This is precisely the type of research we need to address the COVID-19 crisis.

But such good research comes at a cost. Much of society thinks of cost in terms of dollars and pounds, and indeed mindful of our own survival, scientists and researchers are of course always going to lobby for more investment. While it is very helpful to have the funds to order any chemical that is needed, access highly specialised equipment, or pay others to conduct experiments and analyse results quickly, we must take care never to underestimate the importance of taking time to think carefully about what results actually mean.

It is only once researchers have taken the time to understand the context of results that they can start turning them into effective applications or treatments. The real cost of good research is therefore time.

The frustrating truth about medical research is that the majority of experiments appear not to work because the subject being studied is so horrendously complex. In fact, rather than not working, many experiments are simply inconclusive. To make progress you have to slow down, look at the evidence and take time to think very carefully about what the results might mean.

The thinking needed for this takes years. I was involved with one project that was delayed for almost ten years while the team tried to work out why a single animal showed cardiovascular complications. Another project I worked on showed promise reducing an Alzheimer-like pathology in mice, yet 18 years later similar effects have yet to be conclusively shown in humans. Commendably, the team is still working on it.

The reality is that the long road to a vaccine or drug for any disease is littered with trials that did not lead to expected results. Even when a study is successful, it takes a long time to go from the lab to the general public.

One worrying aspect of the current situation is the pressure on researchers to work quickly and come up with solutions for COVID-19 almost immediately. For perhaps the first time, financial resources are not a limiting factor, and so politicians and the public are expecting researchers to take the cash and provide the answers. This has been coupled with significant pressure on regulators to streamline or even suspend some of the normal processes so that treatments can get to the clinic as quickly as possible.

Lured by promises of unlimited funding, and perhaps fame should their chosen idea work, some researchers may be tempted to engage in questionable research practices. History shows that whenever a large amount of money is involved, the temptation to commit, fraud, misconduct or other questionable practices increase. The UK spent more than 400 million during the 2009 swine flu outbreak stockpiling a drug whose effectiveness had been inflated by the manufacturers due to publication bias where negative or inconclusive results from a trial are not published in scientific journals, but positive results are.

Without appropriate scrutiny there is a real risk that ineffective, or even harmful, treatments begin to get used. This may be considered an acceptable risk in the current crisis, but if so, it is important that any new treatments are monitored very closely and withdrawn without hesitation if the harms mount up.

Given time maybe two, three or perhaps even ten years researchers will be able to take stock of the evidence from experiments and trials, perform a meta-analysis and systematic review, hold international conferences, and then, following careful thought, tell the world what the best treatment for COVID-19 is.

The world clearly needs scientific and medical answers to the current pandemic as soon as possible, but we need to recognise that initially we may only find partial or tentative answers. Instead of a quick vaccine that completely prevents COVID-19, a variety of partial successes will be combined until eventually a full solution is found.

There may even be some blind alleys with promising, but ultimately futile, treatment ideas. This is not a failure of research, or misuse of resources. Above all, researchers need to be supported to work with integrity, and not be made scapegoats for the challenges that undoubtedly lie ahead.

See the article here:

Don't hold your breath for a COVID-19 vaccine in 2020 - The Conversation UK

In the race for a vaccine to end the global COVID-19 pandemic, eight contenders are at the front of the pack.

These eight vaccine candidates are undergoing human testing in clinics in China, the United States, Britain and Germany. Behind them are at least 94 others in various stages of development.

The Trump administration is pushing to have hundreds of millions of doses of a vaccine available by the end of the year. However, experts say the unprecedented speed risks taking shortcuts on safety, and there's no guarantee that any of the vaccine candidates will work.

"It worries me, actually, that we aren't going to know key issues about safety and effectiveness if we're planning on rolling it out that quickly," said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

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Three ways

The eight vaccine candidates fall into three categories.

One category might be called the classical technique: triggering the patient's immune system to respond to the virus by injecting a killed version of it. Three separate groups of Chinese researchers are testing inactivated-virus vaccines.

A second method uses one virus to fight another.

Whether it causes COVID-19, Ebola disease or the common cold, a virus is basically just an envelope containing instructions to make more of the virus.

In this novel vaccine strategy, scientists strip out instructions from one virus and replace them with instructions to make just a piece of the coronavirus.

A shot of the modified virus does not cause illness. The virus infects some of the patient's cells, but instead of copies of infectious virus, those cells produce the piece of coronavirus. The patient's immune system responds to the coronavirus protein so it can fight off the invader later.

Two separate groups from China and Britain are pursuing this approach.

A third novel strategy cuts out the middleman. Rather than delivering instructions in a virus, researchers inject genetic code for a piece of the coronavirus directly into the patient in the form of DNA or RNA.

Two groups are working on RNA vaccines, and one on a DNA shot.

The newer methods are fast and flexible, according to Kimberly Taylor, head of the biodefense vaccine development section at the National Institute of Allergy and Infectious Diseases.

"They are very good for pandemic platforms because they're typically plug-and-play very quick manufacturing, very quick to get into the clinic," she said.

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Pros and cons

Each technique has pros and cons.

"We're not going to put all our eggs in one basket," said Emory University Vaccine Center Associate Director Walter Orenstein. "Different groups are looking to see what will work and what might not work."

The killed-virus system is the most tried-and-true. But killing the virus can change its shape. The immune system might respond to the killed virus differently than the real thing.

Viral vectors are a new strategy, and it's not clear how well different carrier viruses will work. In some cases, people may have already been exposed to the carrier virus, which would reduce its effectiveness.

DNA vaccines require special equipment.

"It's not as simple as just using a needle and syringe. You have to have this whole other device," Taylor said.

And an RNA vaccine would need some additive to keep the active ingredient from breaking down.

Groups Sow Doubt About COVID Vaccine Before One Even Exists

In recent weeks, vaccine opponents have made several unsubstantiated claims, including allegations that vaccine trials will be dangerously rushed or that Dr. Anthony Fauci, the nation's top infectious diseases expert, is blocking cures to enrich vaccine makers

'You never know'

Experts are concerned that the extremely compressed timeline will not allow for definitive answers on whether a vaccine is safe and effective.

Developing a vaccine typically takes around 20 years. It's usually tested in tens of thousands of people before it's approved for wider distribution, because safety issues may not be immediately obvious.

For example, in a clinical trial of 35,000 patients, researchers discovered that a dengue vaccine did more harm than good for children under 9 years old who had not had a case of dengue before receiving the vaccine. They developed more serious cases of dengue than those who had not been vaccinated before their first dengue infection.

"You never know until you put things into large numbers of people," Offit said. "Then and only then do you find out what the story is."

People may lower their standards for a coronavirus vaccine, however.

"Because people are reasonably panicked by this virus, I think they're willing to accept a certain level of risk that they wouldn't normally accept," Offit added.

Leaders Aim to Drum up Billions for Virus Vaccine Research

An alliance of world leaders is holding a virtual summit Monday hoping to drum up billions of dollars to fund research into a vaccine for the new coronavirus as well as develop better treatments and more efficient testing

Since speed is of the utmost importance, manufacturers need to ramp up production before they know if their vaccine works.

"If you're a manufacturer, what is your willingness to manufacture loads and loads of doses if it turns out your vaccine fails?" Orenstein asked.

"And how would we cushion the risk? Should there be a fund to say, 'If you develop that vaccine, we'll buy as many doses even if we have to flush them down the toilet because the vaccine didn't work or was unsafe?'"

The U.S. government has signed deals with two vaccine companies totaling nearly $1 billion that include scaling up production.

Vaccine test results are still several months away for all the candidates.

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How Close Are We to a COVID-19 Vaccine? - Voice of America

Vaccines to prevent Covid-19 infection are hurtling through development at speeds never before seen. But mounting promises that some vaccine may be available for emergency use as early as the autumn are fueling expectations that are simply unrealistic, experts warn.

Even if the stages of vaccine development could be compressed and supplies could be rapidly manufactured and deployed, it could take many more months or longer before most Americans would be able to roll up their sleeves. And in many countries around the world, the wait could be far longer still perpetuating the worldwide risk the new coronavirus poses for several years to come.

That reality is being obscured by reports that some of the earliest vaccine candidates including one from the biotechnology company Moderna and another from University of Oxford may within months have enough evidence behind them to be administered on an emergency use basis.

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Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy, is worried people arent preparing for the possibility of a fall wave of infections which some experts fear will be bigger than what weve seen so far because they expect a vaccine will be at hand.

Ive actually heard higher education experts say, Well, you know, were kind of counting on the vaccine maybe by September because we keep hearing about that. And of course, in their mind, theyre equating [that to mean] colleges and universities will have the vaccine, he told STAT.

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Osterholm and other experts make clear that there will not be enough vaccine for college-age students in that time frame, even in the best-case scenario. Its likely any supplies that will be available if any of the vaccines prove themselves to be protective by the fall will be designated for health care workers and others on the front line of the response effort.

I dont think were communicating very well at all with the public, because I keep having to tell these people, you know, even if we had a vaccine that showed some evidence of protection by September, we are so far from having a vaccine in peoples arms, Osterholm said.

Assuming a vaccine can be developed quickly, the issue of manufacturing is not a small one. Production of some vaccine candidates could be more easily ramped up than others, noted Emilio Emini, who is leading work at the Bill and Melinda Gates Foundation on the issue.

Should some of the more scalable vaccines prove to be protective, its conceivable that they could be made at existing plants, rather than require the construction of whole new facilities. Production of this type of candidate could reach hundreds of millions of doses within about a year, Emini said. But any vaccines that would require bricks-and-mortar construction is obviously going to take longer to reach those output levels.

The World Health Organization, which is closely monitoring the field of candidate Covid-19 vaccines, lists more than100 projects, though many are being designed in academic laboratories without commercial production capacity. Of the total, eight are already being tested in people, four of them in China.

Among the others is an RNA vaccine project being developed by Pfizer and partner BioNTech, which began testing four possible vaccines in a compressed Phase 1/2 trial in the U.S. on Tuesday. The companies estimate they will be able to produce millions of doses this year, in facilities in the United States and Europe; by 2021, production could reach hundreds of millions of doses though final figures will depend on how much vaccine it takes to protect each person, said Philip Dormitzer, Pfizers vice president and chief scientific officer.

Weve set a goal that were pursuing. And the data are going to tell us to what degree thats an easy goal or very difficult goal to meet but its not going to be very easy, Dormitzer said.

The WHO has called for equitable sharing of Covid-19 vaccines, insisting they should be seen as a global resource. But there have been concerns from the earliest days of this pandemic that countries that are home to vaccine production facilities will nationalize any output to ensure domestic needs are met before vaccine can be exported for use elsewhere.

Robin Robinson, who led the Biomedical Advanced Research and Development Authority from 2008 to 2016, said the agency has spent billions of dollars building up vaccine production capacity in the United States based on that assumption.

A recent recipient of BARDA funding is Moderna, which is expanding production capacity at its Norwood, Mass., facility. Were going to be making millions of doses per month in 2020, ramped to tens of millions of doses a month in 2021, CEO Stphane Bancel said recently.

We are highly aware that given almost everybody on the planet needs to be vaccinated, were going to need a lot of capacity. And we are discussing with a lot of parties how to get there, Bancel said. Are we going to get to a place where we can do seven billion doses next year? The answer is clearly no. But are we in a place where we could be even doing another five-times, ten-times increase from the tens of millions of doses per month? Were working very hard and when we have a clear plan well communicate about it.

The Cambridge, Mass.-based company announced last week that it had signed a deal with Swiss pharmaceutical company Lonzo to help produce 1 billion doses of the vaccine in the U.S. and in Switzerland.

While China has extensive vaccine production capacity and several developing countries including India, Indonesia, and Brazil are among the worlds largest vaccine producers and exporters, a sizable amount of the manufacturing capacity belonging to pharmaceutical companies that sell vaccine in North America and Europe is based in the United States.

Marie-Paule Kieny, who formerly led the WHO group responsible for spurring development of epidemic and pandemic vaccines and drugs, said when the global health agency worked on pandemic planning in the lead-up to the 2009 H1N1 influenza pandemic, it was proposed that health care workers around the world have first access to vaccine. That group, she said, is estimated to be about 2% of the global population roughly 156 million people.

I think its reasonable to say that this should be the first target, because as weve seen everywhere, including in the U.S., when you have a health system which cannot accommodate sick people, then everybody suffers, said Kieny, who is now research director at Inserm, the French equivalent of the National Institutes of Health.

Health care workers would likely followed by people at the highest risk those 65 and older and people with chronic health conditions, like diabetes, that have been seen to increase the risk of dying from Covid-19, Robinson said.

I dont think that the general population will have vaccine probably until the second half of 2021. And thats if everything works OK, he said.

The Advisory Committee on Immunization Practices, an expert panel that makes recommendations to the Centers for Disease Control and Prevention on vaccine use, is typically tasked with drawing up the priority groups during pandemics.

Regardless of who gets vaccines when, its believed that most if not all of the new vaccines will require at least two doses to be effective, so any estimates of numbers of doses available in the autumn will need to be divided by two to find out how many people could expect to be vaccinated.

Osterholm said the public both here and abroad need clearer communications about realistic time lines to Covid-19 vaccine access. When vaccines do start to become available, demand will be enormous and supply will be minimal.

Its going to be like filling Lake Superior with a garden hose at first, he warned. Lets just be honest, whichever country gets the vaccine first is going to both be in the drivers seat and a very difficult spot.

Eight billion people are going to want this vaccine overnight when it becomes available.

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Mounting promises on Covid-19 vaccines are fueling false expectations - STAT