Category: Covid-19 Vaccine

The current consensus by scientists and public health experts is that the only way to end the coronavirus' devastating effects on America's citizens and its economy is to develop, produce at scale and widely distribute an effective vaccine against COVID-19 as quickly as possible.

There are, of course, myriad scientific challenges inherent to that imperative, among them the virus' potential mutability, our lack of knowledge about whether antibodies provide protection against reinfection (and, if so, for how long), and the time it takes to discover an effective vaccine, test it, receive regulatory approval and begin commercial production.

But there is one more problem we've rarely had to consider: By pharmaceutical companies own estimates, no company has anywhere near the production capacity needed to meet the demand, once those effective vaccines (or treatments) have been found.

The number of vaccine producers has been dwindling for years, because vaccines do not offer the kinds of profits that pharmaceutical companies think they deserve. And, despite their very public proclamations of support for vaccine research at moments like these, companies often pull out of such efforts before a fully viable product can be produced because of a lack of market incentives.

For instance, a number of companies reported losing money on Ebola or SARS vaccine development programs. In recent years, GSK made, then later abandoned, its commitments to Ebola vaccine development; Sanofi did much the same with Zika; and Novartis got rid of its whole vaccine development unit in 2014.

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There is, then, but one viable solution: We should nationalize what remains of the American vaccine industry now, thereby assuring that any coronavirus vaccines produced can be made as widely available and as inexpensive soon as possible.

If that sounds like a drastic (or even un-American) solution, nothing could be further from the truth. We should recall that nationalizations in times of emergency in the United States are common. The tradition includes the telephone system during World War I; the thousands of coal mines, railroads, and manufacturers during World War II; gold and silver during the New Deal era; and even the savings and loan industry in the 1980s.

Also during World War I, we nationalized the U.S. subsidiaries of the pharmaceutical giants Merck and Bayer.

Furthermore, the U.S. has specific experience with critical public sector mobilizations through public-private partnerships that specified that the private actors could not profit off the work of vaccine development, production and distribution, including our highly successful vaccine program during World War II, one of several wartime programs that developed and improved 10 vaccines in a short period of time.

In another example, at the turn of the 20th century, the New York City Public Health Department played a pivotal role in developing the testing and immunization for diphtheria, which had reached epidemic levels and caused thousands of deaths in the city. It offered free immunization to the poor to stem the tide of the crisis.

Additionally, a legal analysis shows that nationalizing the vaccine industry could be accomplished for next to nothing, given the industrys substantial reliance on government funding and licensing.

Furthermore, there are three major roadblocks to the development and widespread distribution of a COVID-19 vaccine that could be resolved if the sector were nationalized.

First, instead of allowing firms to compete with one another for monopoly rights to manufacture a future COVID-19 vaccine, thereby squandering limited financial and scientific resources to ensure future potential profits, the whole sector could immediately be put to work, collaboratively, in the public interest, both developing and producing the vaccines we need.

As recent history has already definitively shown, vaccine development is a textbook case of a public good that the free market simply cannot efficiently provide and, when it comes to a coronavirus vaccine in the United States, that failure is already beginning to play out again. As a recent New York Times article noted in regards to a promising vaccine collaboration coming out of the United Kingdom: The team has not yet reached an agreement with a North American manufacturer, in part because the major pharmaceutical companies there typically demand exclusive worldwide rights before investing in a potential medicine.

Second, any vaccine developed in the public sector could be licensed through a global pool or developed and marketed without patents altogether, eliminating the monopoly rights pharmaceutical manufacturers enjoy in the United States. Providing one manufacturer exclusive rights to a COVID-19 vaccine could be devastating for millions worldwide, as it would take any one supplier many years to meet demand. In the meantime, entire swaths of the globe would be unable to afford sufficient vaccine supplies from for-profit manufacturers even if they sold those supplies at cost.

But eliminating monopoly rights would ensure that every vaccine developed with public funds would be available to all at a reasonable cost, ensuring the timely and equitable access necessary for coherent public health interventions especially with COVID-19, when time is so clearly of the essence.

Finally, rather than waiting to build production facilities from scratch after a proven vaccine is developed, nationalizing vaccine development would allow us to scale up the existing infrastructure of the American vaccine industry by pooling the existing resources of organizations that would not normally cooperate at all. Only nationalization would allow for the sort of high-level coordination required to meet the challenge of a pandemic like COVID-19, leveraging the full capacity of the sector to meet the most pressing public health needs, rather than shareholders desires for quick returns.

Taking the few remaining vaccine producers into public ownership could also hasten the transition to a full public option in pharmaceuticals which we badly need in the long term to ensure public health-oriented innovation and long-term access to medicines in the U.S. and beyond.

But in the short term, it is clear that only a robust, nationalized program of vaccine development and production can meet the challenge of rapidly inoculating our population against a threat like COVID-19.

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To recover from COVID-19, America needs a vaccine. To get it, we can't rely on corporations - NBCNews.com

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

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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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

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.

Read the original here:

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.

Continue reading here:

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

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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The rest is here:

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