Category: Corona Virus Vaccine

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Pfizer, NYU working on innovative coronavirus vaccine that could be ready by end of summer – NBC News

May 9, 2020

Researchers at Pfizer Inc. and New York University are working on a never-before-tried coronavirus vaccine that the pharmaceutical company says could be available by September.

The vaccine, which carries genetic code known as messenger RNA, attempts to reprogram the deadly pathogen rather than manipulate the live virus.

"It is probably the fastest way of having a vaccine available to stem this pandemic, based on the data that I have seen," said Kathrin Jansen, who leads vaccine research for Pfizer.

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The vaccine instructs a person's cells to make proteins associated with the coronavirus without making the person sick. Researchers hope the body's immune system will then kick in, creating the antibodies needed to fight off COVID-19.

"Messenger RNA is something the body produces on its own normally," said Mark Mulligan, chief of infectious diseases at NYU Langone Health. "It's kind of a new thing, but it's really not anything that's too different from what the body does for itself."

But Dr. Peter Hotez, co-director of the Texas Children's Center for Vaccine Development at Baylor University, said no RNA vaccine has been licensed because they have worked well only in laboratory animals.

"Those immune responses have not translated into ... good human immune responses," he said.

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Mulligan said he is optimistic about a trial underway at NYU, but he added that "the data will speak for itself."

"This is the science," he said. "You don't have to have faith or belief. The answer will come from the investigations that we do."

The vaccine is one of dozens under review in the global fight against the pandemic.

Tom Costello is an NBC News correspondent based in Washington, D.C.

Tim Stelloh is a reporter for NBC News, based in California.

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Pfizer, NYU working on innovative coronavirus vaccine that could be ready by end of summer - NBC News

There are a lot of coronavirus vaccines in the works but these are the two that Indians should watch out for – Business Insider India

May 9, 2020

I think the Oxford vaccine and Chinese vaccine are certainly in the more advanced clinical phase as is the German vaccine. The two US vaccines are, of course, much talked about but we really dont know whether these RNA vaccines will really work like theyre considered to, Biocon founder Kiran Mazumdar Shaw told Business Insider as a part of its special series Hangout with BI.

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According to him, the risk of vector-based vaccines in India is that theres a strong possibility that people are already immune to certain adenoviruses because theyve already been exposed to them. This results in the possibility that the vaccine wont take. Every idea out there, every platform has pluses and minuses, he said.

Ordinarily it takes at least five years to develop a viable vaccine. But in these unprecedented times, its possible that a solution could present itself in a matter of months.

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The ones in the US may not be the best for Indian patientsThe US coronavirus vaccine candidates need to be stored at -80 degrees Celsius and have to be delivered intravenously. Were much more comfortable with a jab and a low-cost vaccine, which is what the Oxford and Chinese vaccines are all about. These are more typical and conventional vaccines, she explained.

China has the lead closely followed by the Indian project underway at OxfordChina is currently leading the charge to develop a coronavirus vaccine. Cansino Biological and the Beijing Institute of Biotechnology are using an Ebola-based candidate to develop a adenovirus type 5 vector coronavirus vaccine, currently in Phase-1 and Phase-2 of clinical trials.

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Coming in second is the University of Oxford, which is using a non-replicating viral vector approach based on MERS, influenza, TB, chikungunya, Zika and others to develop its coronavirus vaccine.

The Serum Institute of India (SII) the worlds largest vaccine maker is already manufacturing Oxfords vaccine even though it doesnt have approval yet. It's taking the risk of producing up to 400 million doses by the end of the year, if all goes well.

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See also:Dont hold your breath Biocon founder Kiran Mazumdar Shaw says India's Covid-19 vaccine will enter clinical trials in 9 months

Moderna skyrockets 16% to record high after FDA clears coronavirus vaccine for phase 2 study

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There are a lot of coronavirus vaccines in the works but these are the two that Indians should watch out for - Business Insider India

Coronavirus vaccine: How soon will we have one? Indias role in COVID-19 war, how to avoid a second wave – Times Now

May 7, 2020

Coronavirus vaccine likely by Sept-Oct: Indias role in COVID-19 fight and how to prevent a second wave  |  Photo Credit: iStock Images

New Delhi: The COVID-19 caused by the novel coronavirus has been rapidly spreading across the world, claiming thousands of lives. Yet, no specific antiviral drug or vaccine is currently available due to the novelty of the virus now called the SARS-CoV-2. Raising hopes of a cure for the dreaded respiratory disease, a team of Italian scientists on Wednesday claimed that it has successfully developed the worlds first COVID-19 vaccine that can neutralise the coronavirus.

Perhaps, its not just Italy, but other countries such as Israel, the US and the UK are claiming to have discovered vaccines and crucial drugs that can help treat COVID-19. More than 100 vaccines are currently being tested across the world as scientists speed up the race for coronavirus disease cure. In an Exclusive Interview with Times Now Digital, Dr Inder Maurya, Consultant -Emergency Medicine - CEO and Founder, Foreign OPD, discussed Indias role in coronavirus vaccine and how countries can help prevent or tackle a second wave of an outbreak among many others.

Below are excerpts from the Interview.

Will we have a vaccine for COVID-19 by September/October this year?

Dr Inder Maurya: Yes. Italy and Israel are already at the forefront of it. The vaccine is already in phase 3 trials and is being tested in humans. Having said that, the world has got together to defeat coronavirus. We are at the peak of science and technology. We have a high-end AI and its system which can help accelerate the process and were not available a decade before. Hence, I have a firm belief that we would see a fully functional vaccine by then.

Why are so many vaccines being tested/developed for COVID-19?

Dr Inder Maurya: Well, desperate time, desperate measures. Multicentric multinational clinical trials are going on as the world unites to fight covid war together. Oxford has already started the largest clinical trial in Europe with more than 800 volunteers participating in the trials. Australia too has finished with successful animal trials and has begun human trials.

How do scientists measure how well a vaccine will work?

Dr Inder Maurya: Vaccine works on the principle of immunology. When we suffer some infection, say SARS-CoV-2, the immune system release antibodies (IGM) against this virus. They (antibodies) fight off the infection. And once the infections get defeated, the body memory cells get stimulated and protective antibodies (IGG) are stored. So next time, when the virus (SARS- CoV-2) infects, these protective antibodies will immediately rise and destroy the infection. This is the whole principle behind the vaccine as well. We inject sufficient antigen (attenuated) to elicit an immune response but not cause infection, thereby helping the body forms protective antibodies.

Will the COVID crisis end if a vaccine is found?

Dr Inder Maurya: It depends, if the virus undergoes genetic mutations then we would have to develop a new vaccine for that strain. But not to worry, since in case of influenza A (swine flu) we are every year injecting new vaccine depending upon the new viral strain.

What are Indian drugmakers doing in the fight against coronavirus disease? Please elaborate Indias role in COVID-19 vaccine research and treatment.

Dr Inder Maurya: India has been at the forefront in fighting the COVID war. But you do realise that you need more government funding towards healthcare research - we contributed less than 1% of GDP to the healthcare segment. After the Narendra Modis government came to power, we started concentrating more on healthcare research. Newer guidelines were framed, the number of PhD students increased, more funds are allocated to research, etc. International collaborations are being done at top Israeli and American institutes.

A top Indian pharmaceutical company has recently sought ICMRs nod for the clinical trial of pegylated interferons alfa 2b against coronavirus disease. The antiviral drug is used in Hepatitis B and C Rx.

Research has warned that the COVID-19 is likely to last 2 years and return with a vengeance. Do you think will there be a second wave of coronavirus? How do we stop or tackle a second outbreak?

Dr Inder Maurya: Yes, there will be a second wave, perhaps, thats how a pandemic works. However, the severity will be much lesser. Since by then we shall be very well equipped to handle the second wave with drugs like remedisivir showing promising results. Also, we might have a vaccine by then.

However, people must adhere to the guidelines such as - social distancing, wearing masks, regularly washing hands, or using hand sanitiser, effective communication strategies, etc.

Mass awareness about the prevention of the COVID-19 will go a long way in preventing the spread of the killer SARS-CoV- 2 virus.

The views expressed by the author are personal and do not in any way represent those of Times Network.

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Coronavirus vaccine: How soon will we have one? Indias role in COVID-19 war, how to avoid a second wave - Times Now

Here’s what four Colorado research teams have learned from working on a coronavirus vaccine – The Colorado Sun

May 7, 2020

As Colorado slogs into its third month of the coronavirus pandemic, there is new hope around the globe that somebody, somewhere is getting close to developing a vaccine that would make this interminable misery actually terminable.

Multiple vaccine candidates have launched into human trials in the last couple of weeks the most recent being a trial by the drugmaker Pfizer, which on Monday started poking needles into healthy volunteers in New York and Maryland. The White House has picked 14 vaccine candidates for a project it has dubbed Operation Warp Speed, a name that encapsulates the gonzo-scientific, just-crazy-enough-to-work pace at which vaccine development is taking place.

The latest from the coronavirus outbreak in Colorado:

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But, as this research charges furiously ahead, there is also growing skepticism that its going to end well or, at least, soon. Humankind has never successfully produced a vaccine against any type of coronavirus, much less a brand new coronavirus variant. Previous efforts have been shown to cause harm in their test subjects or lost their funding when the virus they were targeting abated.

The reality is that the majority of vaccines will fail, said Dr. Gregg Dean, a veterinarian and professor at Colorado State University who studies viruses. So its really important that we have as many groups as we do with all their different ideas and hopefully one or a couple of different groups will get it right.

Scientists in Deans lab are among at least four teams in Colorado currently working on developing a vaccine against COVID-19, the disease caused by the coronavirus. (The virus, itself, is known scientifically as SARS-CoV-2.) In the handful of weeks that they have all been hard at work on the challenge, heres what theyve learned:

There are at least 115 COVID-19 vaccine candidates in development across the world right now.

They all attempt to do the same thing induce the bodys immune system to produce antibodies that can fight off an infection by the coronavirus. But they have different methods for what goes into a dose of vaccine. Some deaden the real-deal virus; some synthesize just a bit of that virus; and some hijack other viruses.

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Typically, the researchers arent starting from scratch. They have been working in vaccine development for years and have quickly pivoted their existing methods to create a vaccine for the coronavirus.

In Colorado, each of the four teams is trying a different approach:

MacNeill said its important to have many different options in vaccine development. Some might work better for some people than others. There are manufacturing, transportation, storage and price concerns to think about.

I think of it all as being complementary to each other, she said. I hope that one of the ones thats really advanced will be the one that helps everybody and makes it go away. But chances are it will be helpful to have multiple vaccine platforms available.

All of the research teams working in Colorado right now agree on something: They probably wont be the first to develop a vaccine ready for widespread use. And, they also agree, thats not a bad thing.

This isnt an arms race, Price said.

Quite often in vaccine development, the frontrunners arent the most ideal. For instance, they may require one or more booster doses. They may need to be refined to create a stronger immune response. And, in the meantime, its important for researchers to understand the vaccines effects.

Let Dean introduce you here to the concept of antibody-dependent enhancement. Sometimes, Dean said, a vaccine can induce the body to produce antibodies that actually help the virus gain entry into human cells.

If you think of a lock-and-key metaphor, viruses contain keys that allow them to unlock human cells. Antibodies grab hold of those keys and block them. But what if another part of that antibody is itself a key that can unlock a cell? Its been a persistent problem in work to develop a vaccine for feline coronavirus, he said.

Its a normal part of the immune system, he said. But in this case, the virus can take advantage of that and use it to sneak into those cells using a different receptor.

So, taking this measured approach, all of the Colorado research teams are still relatively early in the development timeline.

Goodrichs team, which includes veteran infectious disease researcher Dr. Richard Bowen, is about halfway through a 10-week test of its candidate in hamsters. Dean and MacNeill are working to construct their vaccine candidates before moving into tests in animals.

Greffex is the furthest along, with Price saying that his team is about eight to 10 weeks away from entering clinical trials with a target date of completing its work by the end of the year. But Price reiterated the first across the finish line isnt the prize here.

It doesnt matter, he said. Get them all successful and make sure you know how to manufacture them.

Even if the Colorado vaccines arent first heck, even if they turn out not to work each of the research teams say there is still value in the work.

Theres still a lot we dont know about the coronavirus and how the immune system responds to it. That makes every study and every vaccine project currently underway valuable, Goodrich said.

If the problem gets solved before we get to the finish line and I hope it does all of the knowledge that were gaining, all of the experience were gaining is going to be useful when another pandemic arrives, he said. Maybe that knowledge will help us not only respond to the next pandemic but will help us prevent the next pandemic from occurring.

MacNeill said the research being done by one team will help inform the work of other teams. Vaccines could eventually be combined in a single dose to enhance efficacy. And its not just humans who could benefit from a vaccine with evidence growing that some animals can also be infected by SARS-CoV-2.

Maybe my vaccine will never go into people but it will be the one that gets all cats vaccinated, she said.

So, to the big question: Can we actually develop a successful vaccine for COVID-19? Every one of the Colorado researchers says yes.

I honestly believe were still on target, Price said of his companys candidate.

Dean talked about the massive coming together of the scientific community to focus on this one virus. Literally all of the worlds best minds in medicine and biology are currently working on vaccines or treatments to stop the pandemic.

What I see is that scientists are doing everything they can to work together and quickly share information, he said.

Goodrich pointed to promising results from a team at Oxford University that inoculated a half dozen rhesus macaques with their vaccine candidate and then bombarded the monkeys with live coronavirus to no avail.

And MacNeill noted promising research recently published on vaccines for MERS, a respiratory disease caused by a different coronavirus. Somebodys going to figure this out, she said. This is within human capability.

I think that we can get it done and I think we can get it done much more quickly because of what we know from similar coronaviruses, she said. I think, with what we know about the biology of the virus and how it gets into cells, we should be able to stop that.

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Here's what four Colorado research teams have learned from working on a coronavirus vaccine - The Colorado Sun

Will a coronavirus vaccine be accessible to everyone or only the privileged few? – Euronews

May 7, 2020

In 2016, Dr Peter Hotez and his team were working on a coronavirus vaccine in Texas. The next step would have been to begin trials on people. Instead, he had to pull the plug due to a lack of interest and funds.

In March this year Hotez, the co-director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine in Houston, testified before the US House Committee on Science.

His team's vaccine had been created in response to the SARS outbreak over a decade earlier.

"We had the vaccine ready to go," Hotez told the committee. "But by then nobody was interested in a coronavirus vaccine."

Twenty years have passed since the outbreak of SARS, yet the pharmaceutical industries haven't considered infectious diseases a matter of priority because they are not as profitable as chronic diseases, Massimo Florio, professor of public economics at the University of Milan, told Euronews.

Analysis by Bloomberg intelligence has shown that the world's 20 largest pharmaceutical companies operated around 400 new research projects over the past year. Roughly half were devoted to tackling cancer, while only 65 dealt with infectious diseases. Of those 20 big firms, only four had special vaccine units.

"The current research system is the victim of an incurable contradiction between the priority of science for health and that of science for profit," Professor Florio says.

As countries around the world race to find a COVID-19 vaccine, governments and the European Union are being called upon to guarantee that once one becomes available, it will be accessible and economically affordable for all countries even the poorest.

On April 17 the European Parliament passed a resolution insisting that any publicly funded research for a coronavirus vaccine must stay in the public domain.

This is a powerful statement, Belgian Green Party MEP Petra De Sutter told Euronews. The idea that the market solves everything is fake. In a time of crisis, governments have to face the issue.

Before the resolution was voted, she was one of the signatories to a letter from a cross-party group to the European Commission, demanding urgent action to ensure the economic affordability of any COVID-19 vaccine funded by the European Union. The letter expressed alarm that no such provision had been included in publicly-funded research projects.

The pharmaceutical one is not like a common industry. Its not about buying a new television set. Consumers have no choice when they are ill and in need of a specific drug, De Sutter explained.

Right now, its the market that sets the agenda on the development of new drugs. Yet, the market would never invest in something that doesnt appear to be profitable. Moreover, some highly expensive drugs are developed also thanks to public funding. For this reason, we need to rethink a European-led research on health and drugs in accordance with peoples needs, De Sutter said.

According to the World Health Organization, 62 research programmes are currently underway in laboratories around the world to find a vaccine for COVID-19.

Recently, Costa Rica asked the WHO to create a voluntary pool to collect patent rights, data and other information so as to widen access to medical products for combating the coronavirus.

In response, the world health body launched a global project named Access to COVID-19 Tools Accelerator to ensure worldwide access to resources, although the extent to which the project will include a pool to collect patent rights remains unclear.

In Europe, although there is a European Patent Office whose monopoly patents generally last 20 years each country independently negotiates the cost of a drug with the pharmaceutical industry.

In Germany, the Protection against Infection Act has been recently amended to give the Federal Health Ministry additional powers including the competence to order limitations on patents when the Bundestag finds there is an epidemic situation of national significance.

Outside the EU, Canada has amended its laws amid the COVID-19 emergency to gain easier access to compulsory licenses, a mechanism which enables governments to pay a set fee for an intellectual property without seeking the rights holders consent.

In the past, some developing countries used similar strategies to treat their citizens. In 1997 South Africa passed a Medicines Act to obtain patented HIV life-saving medicines from countries where they were sold more cheaply. At the time some of the worlds largest pharmaceutical companies took the South African government to the Pretoria High Court before backing down in the face of overwhelming public pressure.

On April 15 more than 20 organisations wrote to the UK government asking that any COVID-19 vaccine or treatment obtained with public funds be made available for all.

Without such safeguards, there may be stark global inequality in access to new COVID-19 technologies, as was experienced during the H1N1 flu outbreak in 2009 where the wealthiest countries bought up most of the vaccines first, the letter says.

The patient campaign Just Treatment, which has been demanding fair access to medicines for years, is among those who signed the document. A year ago the group supported the campaign to made Orkambi, a drug to treat cystic fibrosis, available to all patients.

While today the deadlock has been resolved, at the time the NHS said it couldnt afford the high prices of the new drug to make it available. As a result, some parents of children with the disease clubbed set up a buyers club to buy a generic version of the medicine from Argentina at a more affordable price.

We are facing a new wave of patent-protected drugs, mostly cancer drugs, at a very high price in the European market. We are likely to see monopolies leading to restrictions on access, based largely on price, Diarmaid McDonald, Just Treatment's lead organiser, told Euronews.

Right now, we have a global pandemic and the response also should be global. This is the moment to clear conditions about public funding.

Just Treatment supported also hepatitis C patients to obtain the drug they needed. When Sofosbuvir came to the market, in 2015, the high price of the medicine had been a barrier to access it. The NHS rationed it so that the drug was immediately available only to the sickest patients: others were forced to wait for months and years to access the treatment, McDonald explained.

This must not happen again, Simon Brasch, a Just Treatment leader and a former hepatitis C patient told Euronews. I clearly remember I went through a medical examination to learn whether or not I could access the treatment. The doctor told me my liver hadnt deteriorated enough, so I had to wait. I couldnt believe it. I said to myself: maybe I should drink a couple of vodkas every night till my liver gets worse, so that finally I could be treated.

Finally, I accessed the medicine, but what about the next expensive drug that wont be available in the future? Its the entire system of the pharmaceutical market that has to change, Brasch said.

Doctors Without Borders has also signed the letter to the UK government. Since 1999, when the NGO won the Nobel Peace Prize, it has been fighting for the affordability of medicines, through its Access campaign. We know too well from our work around the world what it means to not be able to treat people in our care because a needed drug is just too expensive or simply not available, the NGO said in a public statement.

A year ago, for the first time in Europe, Doctors Without Borders and other NGOs used a new humanitarian mechanism to vaccinate refugee children in Greece against pneumonia at an affordable price. Thanks to this mechanism the vaccine has a special reduced price of about US$9 (8.23). Without that safeguard, the price of the vaccine in Greece would have been US$168 (153.80) per child.

While the Humanitarian Mechanism has been useful in protecting children in crisis, countries at all income levels continue to struggle to access the pneumonia vaccine at an affordable price, the NGO said on a statement.

Approximately one-third of countries globally have not been able to include the pneumonia vaccine in their standard vaccination package due to the exorbitant price charged by Pfizer and GSK, Doctors Without Borders announced, referring to the two pharmaceutical producers of the vaccine. Pneumonia remains the single largest killer of children under five worldwide, the organisation went on to say.

According to a WHO report, in 2017 more than 800,000 children under five died due to pneumonia, accounting for 15% of all deaths of children in that age group.

The emergency we are experiencing must be an opportunity to rethink the rules that have defined the pharmaceutical market in recent decades, says Professor Massimo Florio of the University of Milan.

Various surveys have shown that in recent years pharmaceutical companies tend to invest only in the final stages of research when the profit appears assured, while the initial steps are carried out thanks to the resources of universities or associations.

This pandemic highlights the failure of the current pharmaceutical market. For this we need a European public structure that produces the drugs that the private sector does not care about or that exist on the market only at exorbitant prices, Professor Florio says.

Today we cant believe that developed countries like ours woke up without a vaccine and drugs to fight COVID-19, and even without masks. This must not happen again.

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Will a coronavirus vaccine be accessible to everyone or only the privileged few? - Euronews

The coronavirus appears to have mutated. What does that mean for contagiousness? – NBC News

May 7, 2020

A new study has sparked fears that the coronavirus has mutated to become more contagious, but experts say there is no evidence these changes make it any more dangerous or transmissible than it already is.

"Viruses mutate all the time, [and] most mutations have no significance even if they spread," said Adriana Heguy, director of the Genome Technology Center at New York University, who was not involved with the research.

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The study was posted on the preprint server bioRxiv on April 30. Preprints are studies that have not undergone the rigorous peer-review process required for publication in medical or scientific journals. In the rush to share new research on COVID-19, many scientists have been sharing their work online before undergoing the full review process.

The authors, who included researchers from the Los Alamos National Laboratory in New Mexico, analyzed the genetic sequences of samples of the virus gathered worldwide, zeroing in on a mutation called D614G.

"We were concerned that if the D614G mutation can increase transmissibility," the study authors wrote, "it might also impact severity of disease."

The corresponding author at the Los Alamos National Laboratory did not respond to an interview request from NBC News.

The hypothesis is concerning for a virus that has already infected millions and is responsible for more than 260,000 deaths worldwide.

But outside experts were quick to point out that changes in viruses especially coronaviruses are common, and may mean nothing at all.

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Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, explained viral mutations using the analogy of an automobile.

"If the mutation takes out your carburetor, the car can no longer operate," Poland said. "On the other hand, if the mutation changes one spark plug, the car can still operate."

What's unclear is whether the D614G mutation slows or speeds the viral "car" or, in fact, does nothing.

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Heguy said the D614G mutation had already been identified in viral sequences from around the globe, particularly in Europe.

The researchers "used that for their model to see if there was an indication that this particular mutation ... would make it more transmissible. According to their model, it is possible," Heguy said. "Having said that, it is only a model."

That is, models only reflect what could possibly happen in the future. Scientists have not found the virus has evolved to become any more dangerous or deadly in people.

Mutations are common in viruses, but the coronavirus "so far has been pretty darn stable with little mutations around the edges," Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, said.

"That's what these investigators are looking at," Schaffner said. "They're trying to determine whether these little mutations have implications for how well it's transmitted." But, there is "no evidence that this is happening that I can see clinically," he added.

Dr. Robert Gallo, the co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine, said "the paper, I believe, is a strong paper by a quality group."

But, he said, "no conclusions can be made about biology or functionality" of the virus based on this study.

While the research may not be reflective of any impact on patients, scientists say it's still incredibly useful as a way to track how the virus acts over time.

Poland noted that experts tracking the virus through its genetic sequencing have found that while it is changing, it's not doing so very quickly.

"Unlike influenza, this virus accumulates mutations more slowly, which is a good thing," he said. "It gives us time to track it and to understand what's happening."

Rapidly mutating viruses make it more difficult for researchers to develop vaccines. Flu vaccines, for example, are notoriously difficult to get right because the various strains of influenza have a tendency to change and mutate quickly.

If this virus were to follow suit, it might mean trouble for ongoing COVID-19 vaccine research.

"It's possible that you'll get vaccines early enough and quick enough to prevent [a person's] first infection with the coronavirus," Gallo said. "We may look like heroes that stop this early on."

But, if the virus mutates too much, and the vaccine proves to be a poor match to future strains of the coronavirus, "we may be chasing our tail like with influenza. And that's not a bright prospect with a virus that is already so infectious."

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Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

Tonya Bauer and Judy Silverman contributed.

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The coronavirus appears to have mutated. What does that mean for contagiousness? - NBC News

When will the coronavirus vaccine be ready? Everything we know right now – CNET

May 5, 2020

Experts are hopeful that a vaccine against the SARS-CoV-2 virus will become available sooner rather than later.

Doctors and scientists are scrambling to develop avaccine to stop the coronavirus, which is now responsible forover 250,000 deaths worldwide. It's estimated that the COVID-19 pandemic is expected to ravage society until between 60% and 70% of the world'spopulation is immune.

There are currently more than95 coronavirus vaccines being tested, withseven reportedly already in clinical trials, which means there aremore scientists working harder and faster on finding a vaccine than ever before in the history of pandemics. But even if one of the vaccines now under development turns out to be effective,the FDA approval process typically takes a year or longer.

Keep track of the coronavirus pandemic.

It's still too early to make predictions, but here's what we know so far about the race to develop a coronavirus vaccine that may help usher in an end to the current pandemic.

One more note before we get underway. This article is intended to be a resource to help you understand current coronavirus vaccine research. It isn't intended to serve as medical advice. If you're seeking more information about coronavirus testing,here's how to find a testing sitenear you (and here'sanother way for Apple Mapsusers). Here'show to know if you qualify for a testandwhy there aren't any coronavirus at-home test kitsyet. This story is updated frequently as new information comes to light.

Read more:What it will take for life to return to normal after lockdown ends

A vaccine is a medical treatment that protects you against a disease like the coronavirus. For a deeper dive into how vaccines work, check outthis in-depth coronavirus treatment explainer by CNET's Science Editor Jackson Ryan. But the short and sweet of it is that a vaccine tricks your body into thinking it's already had the disease, so your body's natural defense -- the immune system --builds antibodies against it. Then, if you were to become infected, your body would call upon the antibodies to fight the virus before you feel sick.

Vaccines typically take about10 to 15 years to develop. That's in part because any new medical treatment needs to be thoroughly tested for safety before it can be distributed to millions or billions of people. Themumps vaccine took four years, which is widely considered the fastest vaccine approval in the history of infectious disease.

Read more:Need a pulse oximeter? These models are in stock starting at $24

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Last week, the White House announced "Operation Warp Speed," a sort of coronavirus vaccine task force that has identified14 vaccine projects it says it will focus on fast-tracking. The project's stated goal is to have300 million doses of vaccineavailable by January 2021. That's a bit faster than the12- to 18-month estimated timeline proposed by the US' top infectious disease expert, Dr. Anthony Fauci.

As of this writing there are97 vaccine projects underway in countries around the world, including the US, UK, Germany, Japan and China. Twelve are either already in clinical trials or starting in the next few months. Out of those 12, Oxford University seems to be leading the pack with a vaccine that researchers saycould be ready by the fall of 2020.

Scientists from around the world are working toward developing a vaccine. So far 12 projects have either started or will soon start clinical trials.

Not great. Only about6% of vaccine candidates ever make it through to market, and not just because they don't work. There's a whole litany of problems that could cancel even a promising candidate. Take, for example, what happened when scientists tried to develop a vaccine for SARS --it backfired and actually made people more susceptible to the disease. Same thing happened with avaccine for Dengue fever. To make matters worse, coronaviruses are a large class of viruses andso far there are no vaccines for any of them.

However, this particular coronavirus, SARS-CoV-2, has some unique traits that may help researchers working on a vaccine. For example, some viruses, like the flu, mutate quickly and often, which is why there's a new flu vaccine every year.This coronavirus doesn't seem to do that. Although it's still too early to be completely certain what will happen by the time a vaccine is ready, it's thought that the virus has not yet mutated significantly enough to disrupt vaccine development, nor is it expected to.

Rules and regulations vary by country, but, generally speaking, most industrialized nations have similar protocols for approving a vaccine. The following path is how vaccines are approved in the US under the Food and Drug Administration:

Until there's a vaccine, expect safety precautions like face masks and social distancing to be a part of everyday life.

The longer we go without a vaccine, the more likely focus will shift toward treatments, such as theexperimental antiviral drug remdesivir, which has been showing promising results. Many viruses that used to be fatal are no longer death sentences. Patients with HIV, for example, now can expect to enjoythe same life expectancyas non-HIV-positive individuals, thanks to tremendous advances in treatment.

Without a coronavirus vaccine, the road back to normal may be harder and longer, but not necessarily impossible.Coronavirus testing, includingantibody testing, andcontact tracingefforts would probably need to intensify. Lockdown measures wouldprobably lift slowly, althoughdepending on how people handle itcities and states may bring them back, including requiringface masksandsocial distancing. Eventually, the global population may reach the 60% to 70% rate required forherd immunityto protect those who aren't immune.

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When will the coronavirus vaccine be ready? Everything we know right now - CNET

A coronavirus vaccine cannot be reasonably expected until the end of 2021, professor says – CNBC

May 5, 2020

A vaccine for Covid-19will not be ready until the end of next year,according to Dale Fisher, chair of the World Health Organization (WHO) Global Outbreak Alert and Response Network.

That timeline would be a "very reasonable" expectation because of the necessary Phase 2 and 3 trials of any vaccine to guarantee both safety and efficacy, Fisher explained. There would also need to be aramp up in production and distribution, as well as actually administering the vaccine, he said.

Fisher said "we are currently on target" for a vaccine in 2021 with five Phase 1 studies currently underway.

"We've always felt that by about April, May, we would be in Phase 1 studies, so this means a potential vaccine has been invented if you like; we're now trying it on individuals, basically to see if it's safe," Fishertold CNBC's "Street Signs Asia" on Monday.

The current trials would allow "early collection of data" to assess whether the potential vaccine "actually works," before larger trials on safety and efficacy could be carried out, said Fisher, who is also a senior consultant at the infectious disease division at the National University Hospital in Singapore.

Fisher also said President Donald Trump's comments on Sunday that he wasconfidenta coronavirus vaccinewouldbe developed by the end of 2020 were "a bit premature."

Meanwhile, Severin Schwan, CEO of pharmaceutical giant Roche, also expressed some skepticism over the president's proposed time frame, saying the end of this year was "certainly an ambitious goal."

"I have no doubt that as so many companies are working on a vaccine in parallel, and as we see such great collaboration with regulators including the FDA, we can actually speed up the approval of vaccines," he told CNBC's "Squawk Box Europe" on Monday.

"But still, typically it would take years to develop a new medicine. Most experts agree that it will take at least 12 to 18 months until we see a vaccine which is available in the necessary quantities for patients."

The preliminary results of clinical trials for Gilead Sciences' antiviral remdesivir have been promising, indicating it could shorten the recovery time for hospitalized coronavirus patients. The U.S. Food and Drug Administration has since granted emergency use authorization for the drug.

Despite very positive information on remdesivir, it is still far from being the proven wonder drug we would love to see, according to Fisher.

But ultimately, the best defense against Covid-19 would be a vaccine which would "get immunity in the public to stop this," Fisher said. Natural herd immunity was not the way to go, he said.Herd immunityrefers to a situation where enough people in a population have become immune to a disease such that it effectively stops the disease from spreading.

Until a vaccine is ready, each individual has to understand the role they have to play in public health, Fisher said. He emphasized that there needs to becontinual "messaging" on that.

Instead of just relying on contact tracing measures, simple efforts including social distancing, presenting oneself at hospitals and not heading out when sick were "so important" and necessary, Fisher said.

Continued here:

A coronavirus vaccine cannot be reasonably expected until the end of 2021, professor says - CNBC

Trump says he is ‘confident’ the US will have a coronavirus vaccine this year. Experts say it could take up to 18 months. – Business Insider

May 5, 2020

President Donald Trump said during a Fox News town hall on Sunday night that he was "confident" the US would have a COVID-19 vaccine by the end of the year, despite estimates from health experts that it could be 12 to 18 months before one is readily available to the public.

"We are very confident that we'll have a vaccine by the end of the year," Trump said at the virtual town hall.

"We think we are going to have a vaccine by the end of this year," he said. "We're pushing very hard."

He added that companies like Johnson & Johnson, one of more than 70 firms around the world working to develop a coronavirus vaccine, were getting close to having a vaccine ready for public use.

"Many companies are, I think, close," he said.

Though companies are moving forward on vaccines at record speed, health experts have estimated that the development and distribution of a vaccine could take 12 to 18 months. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in March that the process would take "a year, a year and a half, at least."

Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic

Trump acknowledged the ambitiousness of his projection, saying at the town hall: "The doctors would say, 'Well you shouldn't say that.' But I'll say what I think."

Some scientists have expressed concern that even as companies move quickly toward a vaccine and as the Food and Drug Administration's approval processes have been condensed, rushing a vaccine is risky.

According to the Coalition for Epidemic Preparedness Innovations, at least 115 COVID-19 vaccines are in development.

A volunteer participating in a clinical trial for a coronavirus vaccine on March 16 at the Kaiser Permanente Washington Health Research Institute in Seattle. Ted S. Warren/Associated Press

But vaccines for other coronavirus outbreaks, including the MERS and SARS viruses, took over 18 months to develop and have yet to be fully approved for use on the public. The vaccine for SARS took 20 months just to be trialed on humans, and the fastest vaccine ever developed, for mumps, took four years.

Chris Whitty, the UK's chief medical adviser, said last month that the chances of securing an effective vaccine or treatment for the coronavirus this year were "incredibly small." The Swiss pharmaceutical giant Roche said last month that a coronavirus vaccine probably wouldn't be ready before the end of 2021.

Dr. Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, told Reuters in March that there was a risk a coronavirus vaccine would actually make the disease worse in people infected with COVID-19, instead of protecting them from it.

Bill Gates, the billionaire Microsoft cofounder who recently said his foundation was giving "total attention" to the coronavirus pandemic, wrote in a blog post last week that he considered eight to 10 candidates for a coronavirus vaccine to be promising. He added that a vaccine could take 18 months to develop, though it "could be as little as 9 months or as long as two years," given the sheer number of approaches being tested simultaneously.

Read more: There are more than 70 potential coronavirus vaccines in the works. Here are the top efforts to watch, including the 16 vaccines set to be tested in people this year.

Trump stressed at the town hall that the US was doing things that had "never happened before."

"This country needs a vaccine," he said, "and you're going to have it by the end of the year."

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Trump says he is 'confident' the US will have a coronavirus vaccine this year. Experts say it could take up to 18 months. - Business Insider

Is it possible to have a safe coronavirus vaccine by New Years Eve? – ABC News

May 5, 2020

With top White House officials indicating a coronavirus vaccine may be available by January 2021, scientists and vaccine experts outside the Trump administration are cautious but optimistic that a vaccine could be delivered on such an accelerated timeline.

Experts interviewed by ABC warned that developing a vaccine within a 12-month time frame could mean throwing normal scientific standards out the window, but added that a vaccine could be available by the new year if everything goes perfectly.

While President Donald Trump has been bullish in his promise to have a "vaccine by the end of the year," his top advisors have taken a more measured approach, saying a January deadline is a best-case scenario. Last week, Dr. Anthony Fauci, the nation's top infectious disease doctor, said, "we want to go quickly, but we want to make sure it's safe and it's effective."

Since the start of the U.S. epidemic, Fauci has been estimating a vaccine is 12 to 18 months away. But the prior record for vaccine development -- the mumps vaccine -- took four years, meaning Fauci's early estimates drew skepticism among many vaccine experts.

But with the growing sense of urgency as the death toll mounted dramatically in March and April, vaccine developers collapsed the normal development timelines by running concurrent studies that would normally be conducted in a stepwise approach. Meanwhile, drug companies are already scaling up production without even knowing which vaccine is likely to work.

"It is not impossible," said Paul Duprex, PhD, Director of the Center for Vaccine Research and professor of microbiology and molecular genetics at the University of Pittsburgh. "It's of course very aggressive -- but it is possible."

"You'd have to be lucky," said Dr. Paul Offit, co-inventor of the rotavirus vaccine, who sits on the Food and Drug Administration's vaccine advisory committee. "It would be remarkable, but not completely ridiculous."

The first box of the vaccine candidate to be used in Phase I / II trial, at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020.

Dr. Paul Goepfert, professor of medicine at the University of Alabama at Birmingham (UAB) and an expert in vaccine design, said a vaccine by January would only be possible "if everything works out perfectly."

To have a new vaccine by January, experts said a study would need to be conducted in parts of the world where the pandemic is still raging. This would help ensure a big enough group of patients were exposed, and then protected, from the virus.

Then, one of the vaccines currently being developed would have to show positive results, which isn't a guarantee. That vaccine would also have to prove safe, without any dangerous side effects. Finally, vaccine makers would have to be ready with hundreds of millions of doses as soon as data is in hand.

"It is possible but not likely," Goepfert said.

Right now there are more than 100 vaccines being studied, and at least eight of those have already progressed outside the laboratory and into human studies, according to the World Health Organization. The furthest along include candidates from the University of Oxford, Pfizer, Moderna Therapeutics, Inovio Pharmaceuticals and China's CanSino Biologics.

Many of these vaccines use different technology -- some brand-new to vaccine science -- and experts still don't know which is the most likely to work.

Meanwhile, the White House's Operation Warp Speed has resulted in a handful of vaccine candidates that might work against the novel coronavirus -- although those will also need further study.

Right now, many of the vaccines already tested in people have been accelerated far beyond the normal, methodical timelines. Instead of moving from animal studies in a laboratory to a carefully tiered Phase I, II and III system of in-human study, some of these studies are being conducted simultaneously -- with some even skipping normal animal studies.

Under normal circumstances, it would be too expensive for drug developers and too risky for human volunteers to run these types of studies concurrently. But vaccine developers are deviating from the normal rule book because of the sheer devastation of the global pandemic.

A researcher works on coronavirus vaccine development at the Walter Reed Army Institute of Research in Silver Spring, Md., April 28, 2020.

"We as scientists are rather linear individuals," said Duprex. "There are huge financial reasons for that." Now, he said, "there are people taking risks, doing something that might not lead to fruition."

The scientific challenges are unprecedented, considering how little is known about the novel coronavirus that has killed more than 250,000 people across the globe.

For example, said Offit, most vaccines work by triggering an immune response inside the body without making a person sick. But for this novel coronavirus, scientists still haven't had time to adequately study the body's immune response to infection -- meaning we don't know whether an immune system response necessarily protects against a future infection.

And rushing development could mean that important safety issues are missed.

"Most vaccines have been pretty safe, but there have been problems in the past," said Goepfert.

And the downside of immunizing millions of people with a rushed, unsafe vaccine could have long-ranging consequences.

"Vaccines are so, so important for public health," Duprex said. If something goes wrong the general public will extrapolate that vaccines are unsafe."

"Time is critical, of course, but safety is critical," said Duprex. "In the middle of this fast approach, we absolutely cannot compromise on safety."

Tune into ABC at 1 p.m. ET and ABC News Live at 4 p.m. ET every weekday for special coverage of the novel coronavirus with the full ABC News team, including the latest news, context and analysis.

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Is it possible to have a safe coronavirus vaccine by New Years Eve? - ABC News

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