The Research Brief is a short take about interesting academic work.
We are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for COVID-19.
This process is used for the treatment of blood products such as plasma, platelets and whole blood to prevent disease transmission when people receive transfused blood. It utilizes a common food ingredient, vitamin B2, or riboflavin, which is a light-sensitive chemical. When used in combination with ultraviolet light of specific wavelengths, B2 can alter genetic material, whether RNA or DNA, of infectious pathogens in the blood, making them unable to transmit disease.
Those genetic changes prevent pathogens, such as viral, bacterial and parasitic contaminants, in blood from replicating. By stopping the replication process, the method protects people from disease they could acquire through a blood transfusion.
Heres how we believe this technology can be applied to COVID-19 virus: When creating a vaccine candidate, the goal is to destroy the replication potential of the virus while preserving its proteins and antigens, the substances in the virus that prompt the body to produce antibodies. The presence of those proteins and antigens allows the body to recognize the virus as foreign and mount an immune response against it.
When this method is applied to a pure virus grown in cell culture, the B2 damages the viruss genetic material and thus blocks it from replicating. But the B2 treatment leaves the rest of the virus notably the viral proteins undamaged. That is important because the vaccine needs to contain proteins that appear on an infecting virus in order for a person to produce effective antibodies and protect against the disease.
Vaccines require an inactive form of a virus that cannot cause disease to stimulate the immune system. In 2009, during the H1N1 influenza outbreak, the U.S. experienced shortages in the manufacturing of needed vaccines, as the need to grow the virus was in high demand and the manufacturing plants that required the use of eggs to grow the virus were insufficient.
This resulted in the expansion of new ways to manufacture vaccines, some of which are now in use. Yet, there is still a lag time in the production of needed vaccines for the current coronavirus outbreak.
Most methods that are used today to prepare inactivated viruses employ chemicals that are both toxic and in some cases even pose explosion risk, meaning that facilities have to be constructed and operated in ways that protect workers and the public from their use and exposure.
Riboflavin is a compound that is generally recognized as safe because of its low toxicity in humans and animals and its presence in common products people routinely ingest. Using this approach can make this step in virus production much easier and applicable for use in appropriate biological containment facilities.
Over the last decade, there have been advances in manufacturing and in strategies to rapidly produce a vaccine.
Our work has been made possible by the investments made in the U.S. research infrastructure through the National Institute of Allergy and Infectious Diseases in order to expand research and manufacturing capacity and to address concerns over the potential threat of bioterrorism. It led to the construction of a manufacturing plant and research labs which are currently used by industry, government and academic partners pursuing manufacturing and process development for vaccines, therapeutics and diagnostic reagents.
Although the threat from bioterrorism never materialized to the extent that was initially envisioned, there is a need for rapid vaccine development to address emerging pathogens that threaten human health on a global basis, such as Zika.
Our vaccine construct, which we call SolaVAX, is undergoing animal testing and further laboratory characterization, such as studying the nature of the damage to the viral RNA that this process induces and its immunological effect when given to animals. We began our initial vaccine challenge studies earlier this month. These tests will determine if we can protect animals that are vaccinated with SolaVAX from developing the disease when they are later exposed to the live virus. This work is a first step on the path to human clinical evaluation. We also possess the nonprofit BioMARC manufacturing operation at Colorado State University, where testing and development of this inactivation method for vaccine production can be piloted.
If initial results in animal testing and pilot production of the vaccine are positive, the next steps into human clinical testing and evaluation and ultimate regulatory approvals represent the next major hurdle.
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Oxford Universityscientistsare to begin human trialsof a potentialcoronavirusvaccine next week.
Researchers said the jab could be ready to be rolled out for emergency use by the autumn followingsignificant progress in the early stages of development.
The Oxford team has tested the vaccine successfully on several animal species.
Sharing the full story, not just the headlines
TheWorld HealthOrganisation(WHO) has reported that more than 70 vaccines are being developed globally for Covid-19, which has infected morethantwo million people and killed128,886 across the world.
However, experts have cautioned it could take at least18 months to fully develop a jab that can be made available to millions people.
The Oxford teamjoin three other groups of researchers two in the United States and one in China in beginningtrialson humans.
Their projecthasrecruited 510 people, ranging from18 to 55 years old, to take part in the trials, said lead researcherProfessor Adrian Hill.
We are going into human trials next week. We have tested the vaccine in several different animal species, he added.
We have taken a fairly cautious approach, but a rapid one to assess the vaccine that we are developing.
Professor Sarah Gilbert, a vaccinologistat Oxford, has said she is80 per cent confident it will be a success.
There is now hope that thejab, developed by the clinical teams at the Jenner Institute and Oxford Vaccine Group, couldbe ready from as early asSeptember.
No hype, just the advice and analysis you need
However, Professor Hill saidthe team must continue to increase fundraising in order toaccelerate development.
Were a university, we have a very small in house manufacturing facility that can do dozens of doses. Thats not good enough to supply the world, obviously, he told the BBC World Service.
We are working with manufacturing organisations and paying them to start the process now.
So by the time July, August, September comes whenever this is looking good we should have the vaccine to start deploying under emergency use recommendations.
Thats a different approval process to commercial supply, which often takes many more years.
There is no point in making a vaccine that you cant scale up and may only get 100,000 doses for after a huge amount of investment.
You need a technology that allows you to make not millions but ideally billions of doses over a year.
The UKs chief scientific adviser Sir PatrickVallancehas saidit would be very lucky if acoronavirus vaccine was widely available within a year.
Sir Patrick told ITV:A vaccine that can be used generally wed be very lucky to get one within a year.
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(CBS)- With no vaccine yet for COVID-19, a worldwide effort is underway to find medications that target the virus and treat the symptoms. But proper drug testing takes time and patience.
Sometime in the summer, well start to see which are working, which are not, said Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.
Drugs under consideration include the experimental drug Remdesivir, originally designed for Ebola.. and Hydroxychloroquine, approved to treat malaria.
Northwell Health is testing the rheumatoid arthritis drug Kevzara, made by Regeneron, to see if it can dampen severe inflammation caused by the virus inflammation that ends up damaging the lungs.
My breathing was so difficult to that point, I felt like I was drowning, said Dr. Anar Yukhayev. Dr. Yukhayev is an OBGYN and the trials first patient.
The only question that I had really, for the doctors were, If you were in my place, would you do this? And without hesitation, both of them said Yes.
As part of the trials design, patients are randomly assigned either the drug or a placebo. That allows researchers to compare outcomes.
Genentech has launched a trial for Actemra, another anti-inflammatory.
The nature of this crisis has really caused us to work with, in many cases, breakneck speed to get this clinical trial conceived and approved, said Dr. Levi Garraway, Chief Medical Officer at Genentech.
Im just thankful to God that Im actually sitting here right now. Said Dr. Yukhayev.
Right now, critically ill patients are getting a cocktail of experimental drugs in a desperate attempt to save them. These clinical studies are crucial to figuring out what actually works.
The Road to a Vaccine, Ep. 1: How a COVID-19 Vaccine Might Work. Plus, How Quickly We Could Get There
This new eight-episode educational video series will examine the latest efforts to respond to the COVID-19 pandemic and break down the complex process of developing a vaccine.
In Episode 1 of The Road to A Vaccine series, Lisa Ling interviews scientists and healthcare workers about how vaccines work, the impact of the novel coronavirus and whats being done globally to create a COVID-19 vaccine.The Road to Vaccine is a live weekly video series hosted by journalist Lisa Ling that delves into the work underway to develop a vaccine to help bring an end to the COVID-19 global pandemic. Tune in on Tuesdays at 12:00pm EDT to catch the latest episode.
Tune in live at 12 pm EDT on TuesdaysonJNJ.com,Facebook,LinkedInorTwitter. Come backat any time to watch a replay.
SINGAPORE: Over 70 teams worldwide are now in a collaborative race to test different vaccine candidates against Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2) that causes COVID-19.
Although the pace of research efforts has been extraordinary, scientists still estimate that producing a vaccine, from innovation to access, will take at least 12 to 18 months. This timeline has the caveat if all goes well.
To the public, this seems like a long wait. But most vaccinologists who study and develop vaccines view this as very optimistic. It normally takes more than 10 years for a vaccine candidate to become an approved vaccine in a public immunisation programme.
Vaccine development is complex and financially risky. A vaccine candidate can fail at any point in development. Having a few candidates do well in clinical trials is considered a best-case scenario.
It is important to understand that all we have currently are experimental vaccine candidates not ready to be used soon. A vaccine candidate is not a confirmed human vaccine.
It must undergo ethical reviews, be evaluated in animal studies, for safety and efficacy in clinical trials involving human volunteers, before receiving regulatory approval and licensing for marketing and widespread use.
Vaccine manufacturing plants must be pre-inspected and approved for sterile manufacturing conditions, quality controls, and production ramped up to support potentially billions of vaccine doses.
Public health policies and financing decisions for national public programmes need to be in place. Follow-up studies must be set up to closely monitor the vaccines long-term safety and effectiveness with large-scale immunisation.
This is even more important for an accelerated vaccine using new technology against a new virus.
ACCELERATING IN PARALLEL
For the COVID-19 pandemic, scientists, regulators, government and industry leaders have been working closely to accelerate coordination of the different requirements to run at parallel speed with some vaccine candidates which have already entered clinical trials.
In addition to the World Health Organizations guiding role, the Coalition forEpidemic Preparedness Innovations was established in 2017 by the Wellcome Trust, the Bill & Melinda Gates Foundation and several governments, and has invested in several projects to help speed up the development of COVID-19 vaccines.
Timelines for animal and human trial studies are being compressed, but always carefully weighing potential risks.
For vaccine candidates developed using more well-known and evaluated technologies, some clinical studies in human volunteers have started earlier and overlapped with animal studies usually carried out before human studies.However, some areas cannot be shortened or accelerated, such as collecting ongoing safety data on side effects.
Regulatory reviews are being sped up. Instead of requiring submission of all information from completed clinical trials, regulatory agencies are now open to receiving data on an ongoing rolling basis.
To save on time needed for analysis and discussion, chapters of clinical trial data can be submitted for review in real-time, rather than wait until the end to submit the usual complete book of data when all trials are finished.
Each vaccine has its own benefits and risks profile. Regulators must be updated and agile to manage risk tolerance and potential benefits of these urgently needed new technologies.
Manufacturing plans are also being accelerated in some countries.Plans in the US are already underway to scale up manufacturing to produce massive amounts of certain vaccine candidates.
Bill Gates has publicly supported developing manufacturing capacity for some vaccine candidates just starting clinical trials, fully aware not all candidates will cross the finish line.
Such early production, with quality checks done in advance, can shave off weeks to months for manufacturing billions of vaccine doses needed to reduce the ongoing human and economic toll.
Several questions are emerging surrounding financing and equitable distribution of any vaccines that get developed. What will it cost? Will the vaccine be considered a common good for all people? Will the technology be shared? Which countries and which populations groups are prioritised to gain access first?
This last question is a concern if countries with ongoing spread are unable to afford a vaccination programme. Strong leadership, global governance and a collective commitment to social justice will be needed.
HOW VACCINES WORK
All vaccines work using the same principles.A healthy person (the vaccinee) is given a piece of the germ or the germ itself in order to give a heads up to his or her immune system, so that it can later recognise and tackle the virus appropriately.
If the person gets exposed to the real virus later, his or her immune memory will activate earlier to kill the virus and block its spread. The vaccinee stays healthy, often unaware of being exposed to the threat.
Choosing the best picture (antigens) of the SARS-CoV-2 virus to show to our immune systems, in order to stimulate the right immune memory and appropriate antibodies, is where the challenge really lies for scientists.
A good, safe and effective SARS-CoV-2 vaccine must accurately capture the important features of this virus in order to generate the best immune memory. Ideally, a vaccine would show the immune system the entire process of SARS-CoV-2 infection so that it can develop ways to attack the virus at different fronts.
But it is challenging to genetically weaken SARS-CoV-2 such that it would cause infection but not the disease itself.
Most vaccine researchers have thus turned to technologies that can present different pictures, or pieces, of SARS-CoV-2 to our immune systems.
Much research has been focused on the spike proteins forming the crown or corona of SARS-CoV-2. This appears crucial in how the virus attaches to and infects human cells.
We are beginning to learn that the spike protein is liberally decorated with sugars. Displaying the right sugars on vaccines appears important to show the immune system the correct picture.
Some vaccine candidates in the running present the genetic code (RNA or DNA) of the spike protein. Our cells then translate the genetic code to make the spike protein in the body.
Another method is to insert SARS CoV-2 genes into a safe, licensed viral vaccine to deliver the piece of SARS CoV-2 using a well-known, harmless virus.
We might not be able to develop a vaccine that provides the perfect picture of the virus to vaccinees. But even a partially effective, safe vaccine could be very valuable. The vaccine may not stop all cases or symptoms but could prevent severe respiratory distress and deaths.
When many people become immune either through vaccination or surviving the infection - the virus cannot infect enough susceptible people to propagate. This population herd immunity is needed to end an epidemic or prevent one from gaining traction.
THE NEED FOR DIVERSITY AND SOME LUCK
While there are many ways to make vaccine candidates, we do not yet know how to pick winners. Furthermore, scientists still have much to learn about how this new virus behaves.
There remains an element of luck when looking for a good vaccine against a new virus we are only getting to know.But our chances have improved with the unprecedented number of vaccine candidates being developed and with the scientific world so focussed on COVID-19.
The huge human, social and economic fallout from this pandemic means we should leave no stone unturned and invest heavily in a wide range of vaccine candidates to find good, safe and effective vaccines.
Many SARS-CoV-2 vaccine candidates are exploring using new technologies.To help shorten clinical trial duration and reduce the number of human volunteers, some research groups are studying the use of molecular technologies to complement clinical trials.
There is also hope that the similar explosion of studies for safe, effective medicines to treat COVID-19, including anti-viral medicines and potential antibody treatments, will yield positive results. These are likely to arrive much sooner than a vaccine.
The unfortunate surge of clinical experience in managing severe respiratory distress with COVID-19 could also lead to other best practices to improve patient outcomes where capacity is available.
MEANWHILE, CARRY ON
A COVID-19 vaccine will unfortunately not be available this year. If all goes well, a vaccine or even a few vaccines will be rolled out in 2021.
For now, other public health measures are essential to save lives, including early case detection, contact tracing, isolation and quarantine.
We must practise frequent hand washing, physical distancing, staying at home, avoiding crowded places, and wearing face masks if we really need to go out.
COVID-19 is testing our collective scientific ingenuity, our individual responsibilities and social compact at a national and global level.
We must stay committed to our individual contributions and believe in our collaborative power in science to help develop and deliver long-term solutions.
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Dr Tippi Mak is Academic Visiting Expert at the Centre of Regulatory Excellence, Duke-NUS Medical School, Consultant at the SingHealth Duke-NUS Global Health Institute, and Board Director of the Vaccine and Infectious Disease Organization - International Vaccine Centre at the University of Saskatchewan, Canada.
Professor Ooi Eng Eong is Deputy Director at the Emerging Infectious Diseases Programme, Duke-NUS Medical School and Co-Director at the Viral Research and Experimental Medicine Centre@SingHealth Duke-NUS.
Professor John CW Lim is Executive Director at the Centre of Regulatory Excellence, Duke-NUS Medical School, Policy Core Lead at the SingHealth Duke-NUS Global Health Institute, and Chairman of the Singapore Clinical Research Institute & National Health Innovation Centre.
A participant in a COVID-19 vaccine trial receives an injection in Kansas City, Mo., on April 8, 2020.
The Canadian Press
Question: Ive read that it could be one to two years before we have a vaccine that will guard against COVID-19. Why is it going to take so long?
Answer: The development of any vaccine can be compared to a long and challenging marathon with an uncertain outcome and that is especially true when dealing with a new pathogen.
The purpose of a vaccine is to expose the bodys immune system to some portion of the virus so it can prepare in advance for a real attack. For instance, a vaccine might include an antigen, or protein, from the surface of the virus. But finding the antigen that will trigger an effective immune response is easier said than done.
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Science cannot be rushed, says Rob Kozak, a clinical microbiologist at Sunnybrook Health Sciences Centre in Toronto. Researchers must follow well-established regulatory protocols that are designed to ensure a therapy is both effective and safe.
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Viruses are constantly mutating and evolving. The strain of a virus circulating in Canada might be slightly different from the one in China or Europe. This means the antigen must produce immunity against all strains, or variants, of the virus.
Once an antigen is selected, it has to be tested in animals before human trials can begin. Finding the appropriate animal model also presents challenges. The animal needs to respond to the virus and the vaccine in the same way as people.
Fortunately, researchers can look to previous vaccine studies for clues on how to respond to the current pandemic, including selecting appropriate animal models and viral targets.
The COVID-19 illness is caused by a coronavirus, officially known as SARS-CoV-2. In recent years, humanity has been challenged by two other deadly coronaviruses Severe Acute Respiratory Syndrome (SARS) in 2003 and Middle East Respiratory Syndrome (MERS) in 2012. During both of these outbreaks, researchers started to develop vaccines. In the case of SARS, the work was never completed partly because the virus ceased to pose an immediate threat; it seems to have morphed and disappeared. MERS vaccine trials are continuing.
Previous SARS research reinforces the importance of doing thorough testing in animal models before any potential vaccine is given to human volunteers.
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In one study, an experimental SARS vaccine made lab animals worse, says Arinjay Banerjee, an emerging-viruses researcher at McMaster University in Hamilton.
This study showed that when mice were vaccinated and then challenged with the pathogen, there was an enhancement of the infection, he says. The vaccinated mice developed disease more rapidly and died more rapidly than the unvaccinated mice.
Another study revealed that some investigational SARS vaccines produced negative side effects in some types of animals (such as ferrets) but not in others (such as mice). For that reason, many researchers are convinced that a vaccine should be tested in two different types of animals, Kozak says.
All this preclinical work is time consuming. Laboratory animals require specific time periods to develop a response to the vaccine and then to react to the virus. The clock cannot be made to run faster, Kozak says. And if an experimental vaccine fails, a research team could find itself again at the starting gate.
After a vaccine has successfully passed animal testing, it is then tried in a small group of healthy volunteers. This is known as a phase-one clinical trial. Its basically a safety check to make sure the vaccine does not cause serious side effects.
If the vaccine clears this critical hurdle, trials are expanded gradually to include more people who are observed for longer periods of time in order to gain a better understanding of its risks and benefits.
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Scientists around the world are already exploring various ways to deliver a COVID-19 vaccine. Each of them have their advantages and disadvantages, Kozak says.
To be honest, I dont think we are going to have just one vaccine, he adds. In fact, I hope we dont. I hope we have three or four amazing candidates that all work basically as well as each other, and that could be critically important because you dont want to be dependent on only one company to provide for the world.
Like other experts, Dr. Kozak estimates it will take between one to two years to develop a vaccine. And once a vaccine does exist, special production facilities will have to gear up operations to meet the global demand. That, too, will take time.
All of which means that a quick fix vaccine is not on the immediate horizon.
China has approved early-stage human tests for two experimental vaccines to combat the coronavirus as it battles to contain imported cases. Chinese citizens planning to return from neighbouring Russia are being told to remain where they are. Reuters
Paul Taylor is a Patient Navigation Adviser at Sunnybrook Health Sciences Centre. He is a former Health Editor of The Globe and Mail. Find him on Twitter @epaultaylor and online at Sunnybrooks Your Health Matters.
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DIAMOND (HOST): Yes we do need to look at the community. But what we don't need to happen is what happened with Africa when Bill Gates and them took that vaccine to Africa trying to vaccinate. They felt like stuff can start right there in certain parts of Africa --
SILK (HOST): Africa.
DIAMOND: That's what we don't need to -- you're not going to make Black people the guinea pigs for this here right here.
SILK: We're not going to be your experiment or your project. Not Black folks.
...
DIAMOND: Kudos if you make your vaccines for people and you want to help people. But I have a problem receiving any vaccine from any entity, especially anybody like Bill Gates who pushed for population control. The same thing that Margaret Sanger pushed for.
SILK: Abortions. Genocide.
WASHINGTON, N.C. (WITN) - When the weather is nice, a popular gathering spot is the waterfront in downtown Washington.
Even with the pandemic going on, that continues to be somewhat of the case. Mayor Mac Hodges says other parts of Main Street in the downtown area are really quiet. Fast food restaurants are doing fine, but small businesses, like so many throughout the country, are struggling. He knows of some that have been forced to close, which has been hard on employees. Hodges says they have had to go find other jobs in the area in the meantime.
"A lot of people started walking and activity going up and down the waterfront out here," Hodges said.0" Other than that, it is pretty quiet. You can walk down Main Street and not see two people. At all."
Moving forward, Hodges said he is concerned about how a return to normalcy could impact those who are scared of the virus.
"People that are really scared of this virus are just going to stay home anyway," Hodges said. "They're not coming out until they feel confident that there's a vaccine or a treatment."
Hodges said on Monday night, the city council approved a 30 percent deduction in electric bills for this upcoming month.
