BySarah LaFave
This week, the National Institutes of Health announced that Kaiser Permanente has begun the first clinical trial of a COVID-19 vaccine, called mRNA-1273. Scientists estimate that it will take at least one year to make a COVID-19 vaccine available to the general public.
To understand the steps required to develop, test, and produce a COVID-19 vaccine, Sarah LaFave, a PhD candidate at the Johns Hopkins School of Nursing, spoke with Ruth Karron, a professor in the Department of International Health at the Bloomberg School of Public Health. Karron is the founding director of the Johns Hopkins Vaccine Initiative and director of the Center for Immunization Research. Their conversation has been edited for length and clarity.
Karron: There are a number of groups working on vaccinesin academia, in biotech, in pharma. The developers are using new technologies which allow for rapid development, but we also aren't sure yet how those new technologies will work. That's why it's important that we have multiple groups working on developing multiple vaccines.
Coverage of how the COVID-19 pandemic is affecting operations at JHU and how Hopkins experts and scientists are responding to the outbreak
The first COVID vaccine was developed just four weeks after the first genetic sequence was available from China. The reason that was possible was in part because of investment by the Coalition for Epidemic Preparedness and Innovation. CEPI is a global partnership set up three years ago, specifically with a mission "to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks." One of the things they have focused on is preparing for "Disease X," meaning some disease that would exist in the future which we didn't yet know about and for which we didn't yet have a vaccine. CEPI was founded to support the development of technology platforms thatno matter what the pathogencould be used for rapid vaccine development. These technologies allow you to go from genetic sequence to vaccine without having to isolate the germ. COVID-19 is Disease X.
That's really difficult to project. We will likely know if we have a vaccine within six to nine months but then the challenge will be to scale up production. Developing and testing a vaccine is different from developing, say, an antiviral which you would use to treat someone who has an infection. If you are giving an antiviral in a treatment trial for someone with COVID, you reach the endpoint very quicklyyou look at the outcome for that patient immediately. But with a vaccine, you don't reach the endpoint immediately because you have to observe immune response over time, and for an efficacy study, have enough people naturally exposed to the virus to determine whether the vaccine prevents disease. That's why you will likely hear about results from COVID treatment studies before you will hear about results from COVID vaccine studies. There are also data coming out that suggest that different strains of COVID might exist. We don't yet know the biologic relevance of that, but it will be important to find out whether the vaccines and the antivirals are equally effective against all strains.
First there's the creation of the vaccine itself. Often, the vaccine is next evaluated in animals, depending on the vaccine and the particular disease. Then, under oversight from regulators (the Food and Drug Administration in the U.S., and other regulatory bodies in other countries), institutional review boards (IRBs), and Data Safety and Monitoring Boards (DSMBs), the vaccine moves through phases of clinical testing, typically first in small numbers of healthy younger adults, and then in larger groups and broader age ranges, often including people with underlying conditions. The CDC has a useful brief guide to the phases of vaccine testing online.
Ruth Karron
Founding director, Johns Hopkins Vaccine Initiative
Once a vaccine is shown to be safe and effective, bringing a vaccine to market is a complex effort that requires investment in manufacturing and distribution. In the coming months, we and others around the world will need to be thinking and acting to ensure that adequate investments are made, and will need to continue to collect and review data to determine who should be vaccinated, and when. You'll probably remember that with the 2009 flu pandemic, we didn't have enough vaccine available for everyone at once, so we prioritized vaccination based on risk. And of course this is a global diseaseso we need to be thinking about issues of global equity and justice as we consider vaccine supply.
We have fast-tracked vaccine developmentgetting from pathogen sequence to vaccine products available for clinical trials in a matter of weeks is a truly remarkable accomplishment. However, there are aspects of the trials that just can't be rushed. It takes time to develop an immune response to the vaccine, and it also takes time to evaluate the safety of these vaccines.
With that said, in an emergency situation, some stages of vaccine testing can be streamlined. How quickly you progress through the stages of vaccine evaluation will be influenced by the urgency of the problem. In the context of a pandemic, I know that we will move forward as safely and quickly as possible.
Vaccines are critical to halt the coronavirus pandemicbut they are not an overnight solution.
I also think it's important for people to understand that without investment in vaccine epidemic preparedness and technology, the rapid development of vaccines using novel platforms that is now underway wouldn't have been possible.
In 2015, Stanley Plotkin, Adel Mahmoud and Jeremy Farrar published a landmark article in the New England Journal of Medicine in which they called for the establishment of an organization like CEPI to support rapid vaccine development. Many of the vaccines that are in development for COVID-19 were made possible because researchers had seed funding for technologies that make rapid vaccine development possible. That funding came from CEPI before we ever knew COVID-19 would exist.
SPRINGFIELD, Mass. (WWLP) A Massachusetts-based company is working on a vaccine for COVID -19. Researchers are making record time, trying to get a vaccine for COVID -19 as soon as possible.
Researchers from the Massachusetts based biotechnology company, Moderna, Inc. in Norwood gave the first test round of a possible COVID -19 vaccine to the first human test subject on Monday.
For the first phase, Moderna shipped hundreds of vials of the test vaccine to the National Institutes of Health (NIH), which is overseeing the study in multiple centers in the US. Its the beginning of a series of studies and tests needed to prove whether the vaccine is safe to treat people for COVID-19 during the pandemic.
The chief research officer at Baystate Health is hoping a vaccine will be out soon.
Im hoping within a year that there will be a vaccine that we will be able to use, said Peter Friedmann. The group that really needs it is the healthcare workers. Im optimistic there will be something but Im not sure how long lasting and successful it will be.
Moderna said they are preparing to accelerate its manufacturing. Currently, there are no FDA-approved therapies or vaccines for COVID-19. The National Institute of Allergy and Infectious Diseases within the National Institutes of Health is leading the funding of federal research and response to COVID-19.
It could be another 12 to 18 months before a vaccine is available to the public.
Take a step back from the breakneck COVID-19 news cycle and it doesn't take much to wonder: How long is this pandemic going to last and ultimately, what can be done to stop it?
To better-understand the long-term outlook for the novel coronavirus and the trade-offs inherent in our current social-distancing strategy, WBUR spoke with Michael Mina, an assistant professor of epidemiology at Harvard specializing in immunology and infectious diseases.
Minas research focuses on the life-history of infectious pathogens, and he begins with the concept of herd immunity."
On how "herd immunity" works
Herd immunity is actually quite a simple idea, in that once there are enough people in the population who have been exposed to the virus or perhaps in other cases, a vaccine so that they are immune, then each one of those people that is immune becomes almost like a firebreak for preventing spread.
So if you walk into a room, for example, and everyone is susceptible to a virus and you bring that virus in, then there's no herd immunity. And on average, you'll infect two or three people. But if 90% of the room is immune already, then it's unlikely that when you walk into that room, you'll infect more than one person because most of the people you bump into will already be immune.
On whether the coronavirus that causes COVID-19 is susceptible to herd immunity
Absolutely. That's one of the great things about herd immunity, is that as long as people can individually become immune to the virus, then herd immunity is possible. And for this particular virus, it's about 65% of the population that might need to be immune before we actually can really inhibit further spread of the virus.
On the importance of establishing herd immunity vs. social distancing
That's a very good and somewhat controversial question. Essentially, a different way to put it is, 'Could we just get lots of younger people infected with this virus so that they can no longer necessarily transmit it?' And because we know that younger people maybe don't experience as severe a disease as older people, that would be a benefit.
The problem there is we know that actually, younger people can still get very sick and can die. But I think that there are some takeaways that we could get from this idea: One small slice of that question might be: 'Well, if we know that there are a number of young people who have already been infected and are immune, then maybe they can be the ones who are the nurses for people in a nursing home,' for example.
But I think it is a controversial idea to just say that all young people should go out and get infected in order to confer greater herd immunity because we know that it still is a dangerous virus even for the young people in this population.
On the balancing act we need to achieve to prevent spread
That's one of the real dilemmas we find ourselves in today. I've been astounded to see just how much social distancing is happening, at least in some of our states and cities; and this is really terrific. This is what is needed at this moment in time to prevent ... a collapse of the health care system, if you will, in terms of the hospitals getting overridden with people.
But the problem with doing such a good job right now is that we might come out of this wave of the epidemic with less than 2% of the population infected. And as a population, we'll be just as susceptible, say, come the fall, as we were a few months ago.
On the necessity of social distancing at this particular point in time
Because this virus came into our population pretty quickly and then we kind of squandered a couple of months in figuring out how to deal with it ... now we're trying to catch up, if you will, to really control some of our essential services, like ensuring that we have enough ICU beds and ventilators for all the people who might need them. We just are trying to buy some time so that we can deal with it more appropriately in a more prepared way, maybe in a few months from now.
On whether an effective vaccine is likely in 12 to 18 months
Twelve to 15 months has been a timeframe that's been passed around as a minimum that it could take to develop a vaccine and bring it to market. But there's a caveat out there. That 12-to-15-month timeframe assumes that the vaccine actually works and protects us. But that's actually really the hard part ... finding the right combination of things to put in the vaccine to make sure that it elicits a good amount of immunological protection. And so it could be that 12 months from now, we're starting back at ground zero with a new trial.
I think that 12 to 15 months is probably not the most realistic timeframe. I anticipate that it will be quite a bit longer, if ever. And it's important to remember that we don't have any useful vaccines currently for many of the seasonal viruses that we see every year.
GAITHERSBURG, Md. (WJZ) As the number of coronavirus cases continues to grow both in Maryland and around the world, the race is on to find a vaccine.
At Novavax lab in Montgomery County, researches said they are seeing some positive results after just a few weeks of trial.
CORONAVIRUS COVERAGE:
Maryland officials are reporting at least 423 cases of coronavirus across the state as of Wednesday morning.
The state is now up 74 cases from Tuesday the biggest one-day jump to date since cases began in the state. Of the total cases, 217 cases are for people ages 20-54. There are also five pediatric cases in the state.
Soon after the impact of the novel coronavirus that causes COVID-19 became apparent, academic researchers, public health institutions and private companies began the search for a vaccine to prevent infection and treatment to manage it. New trials are announced daily, and data sharing has been unprecedented. As part of efforts to encourage data sharing and progress toward vaccines and treatments, the Milken Institutes FasterCures has developed a tool for tracking that progress. SmartBrief spoke with Executive Director Esther Krofah about the tool, and the R&D and funding landscape.
Lets start with the COVID-19 vaccine and treatment tracker. Your team has created and is regularly updating this resource. Having looked at the landscape, how would you describe the movement toward a treatment and a vaccine?
There has been quite a significant level of activity toward development of a treatment and vaccine. I am quite heartened to see the all of the various research institutions, academic institutions and companies that are moving really rapidly to look at their libraries of compounds and identifying what could be useful for COVID-19.
And so we have a really broad landscape on the treatment side where we are looking at antibodies, antivirals and other mechanisms of action as well as on the vaccine front. Theres a significant amount being done.
On the treatment side, we have over 58 treatments that we are tracking and over 43 vaccine candidates that we are tracking. Of course, as we have seen in news reports, Moderna has the first clinical trial under way for a vaccine candidate, a first-in-human phase I trial, but we expect to see more coming down the pike.
Altogether, we have over 100 candidates that are being investigated for the coronavirus. Of course, attention is going to be on what can we get to patients as quickly as possible.
Can you talk about what looks most promising?
Its quite early to talk about what is most promising. It is helpful to see how quickly weve been able to sequence the virus and how quickly we have been able to initiate clinical trials. Everyone is moving at breakneck speed. A vaccine of course is going to take a little bit longer. It will likely be 12 to 18 months before we see a vaccine broadly available for a general population.
I have a lot of hope in the promise of treatments in the short term, whether antibodies or antiviral treatment. If we can start to extract from convalescent patients the antibodies that they have developed after infection and use that to treat ill patients, that might be a very quick treatment in the short term. And were seeing a lot of activity there.
Between the clinical trials under way with remdesivir and with Regenerons medicines, those might really be able to help in the short term. And clinical trials are under way with hydroxychloroquine and azithromycin as a combination. These trials are being used to make sure they are safe and effective for coronavirus, as many of these therapies have already been approved for other indications
How does the regulatory process fit into this picture?
The FDA and NIH are actually working quite quickly to ensure that there are no barriers getting in the way from a clinical trial perspective. That early coordination is quite helpful and provides some guidelines to the research community and companies that are looking at this. Of course, we have a quite defined process to ensure safety and efficacy. And those standards are not being diminished. What is happening is ensuring that guidance is being brought quickly around sites of care and patient enrollment, and information is being shared quickly and clearly with the appropriate parties.
So, the coordination is happening much more quickly, but the standards are being upheld to first ensure safety and then to get the appropriate dosage before expanding upon those clinical trials.
I will also say what the FDA has been doing quite well is ensuring compassionate use where there are trials under way and there may be potential for patient benefit. We are seeing compassionate use being approved very quickly for products like remdesivir and the extraction of serum, creating a pathway for patients to get access to potential treatments with approval from the FDA and their physician. Red tape is being broken down so patients who could benefit from potential treatments are getting them as quickly as possible.
We have heard a lot of concern about patient costs. Are treatments and vaccines going to be affordable to patients?
It is too early to tell, but we do not anticipate that we will have affordability challenges or questions. This is a public health crisis, and we fully expect that companies are going to price products with that in mind.
What about research funding -- is there enough of it, and is it in the hands of those who can put it to the best use?
Funding for the trials that are happening now, particularly for the NIH, is not a significant challenge, thanks to all the efforts that are happening right now on the Hill, and thanks to other funding that is being diverted from traditional trials that cannot immediately use them.
So, funding on the clinical trials side is moving rather quickly and we have been in conversations with the Gates Foundation, which has a $125 million initiative, and with Mastercard and Wellcome Trust. Seeing the private philanthropy side step up is also quite promising.
I will say that we are going to need significant funding to ramp up manufacturing once we have an FDA-approved therapy on the market or evidence supporting an existing therapy that has a different indication. The manufacturing needs are quite real, and we need to be sure we are prepared for that. But for the clinical trials, particularly those that are run by the NIH, the funding seems to be flowing.
And finally, for individual investigators at universities, obviously they are looking for funding to scale their efforts as they typically do.
FasterCures has a long history around patient engagement and advocacy. In what ways are patients being engaged with this type of research?
There is a lot of work happening to get patients mobilized into clinical trials, and we are seeing significant participation on that front. As you see in the Seattle region, patients are quite willing to step into clinical trials, and they are quite eager to see what they can do to help ensure we can get a treatment or a vaccine quickly to market.
We are communicating and working quite closely with our disease foundations, which represent a significant portion of the community of patients that have very complex care needs. These are individuals who have chronic diseases and underlying medical conditions that make them the most vulnerable to COVID-19. Whats important for that population is getting the right information and education to them so they understand how they can protect themselves during this time and continue following the appropriate treatment protocols for their existing conditions.
Can you talk about the state of collaboration among researchers, companies and the federal government?
Yes. One example is the Biomedical Advanced Research and Development Authority, which recently issued a call to companies that want to work with them to submit applications that is wonderful to see. We see a lot of collaboration already happening between university research institutions here in the US in collaboration with those abroad. We see NIH mobilizing their trial networks quite quickly to start clinical trials to collect evidence for treatment protocols.
Data is being shared. Even on Twitter, different scientific communities are really creating great opportunities to discuss and share data and studies in advance of being published.
So, there is a lot that is happening on the collaboration front. What we still need is greater coordination of the academic scientific community so we ensure we are not duplicating efforts. We need to have really good quarterbacking behind the scenes, whether FDA or NIH working in collaboration with the scientific community, to make sure teams have the appropriate standards, and even a master protocol for clinical trial design, which would be quite helpful during this time.
Scientists have been warning us for decades that our world was primed for a pandemic like this. What effect will this experience have on funding for emerging infectious diseases moving forward?
This is a reality check, right? The world that we predicted would happen has now come before us.
And so, my hope is that this motivates funders and policymakers to plan for long-term responses, so we are not responding continually in a crisis situation. I am quite hopeful we can get the right funding to BARDA for them to develop platform technologies and other solutions that will be helpful to turn the capability of R&D quite readily to whatever virus shows up.
We have seen a lot of quick action on the part of BARDA and others that are working in collaboration with them, but what we want to see is longer-term funding directed to BARDA, to the NIH and other parts of the federal government -- DOD and others -- that can really help us establish longer-term platforms. Now is the time to fund these agencies at sufficient levels.
Melissa Turner is director of content for health care and life sciences at SmartBrief. For more content like this delivered straight to your inbox, check out SmartBrief's Life Sciences newsletters, covering medical devices, drug development and regulation, biotech and more.
Researchers in the Mork Family Department of Chemical Engineering and Materials Science are working on a vaccine and treatments for the COVID-19 coronavirus. IMAGE/CDC
As the worldwide spread of the COVID-19 virus continues, with countries facing lockdowns and hospitals dealing with unprecedented demand, a research team at the USC Viterbi School of Engineering is working around the clock on a new vaccine.
The team is also looking at isolating the human antibodies that can successfully fight the viral infection, in order to create working therapeutic treatments to improve recovery times for COVID-19 patients.
The research is led by Pin Wang, Zohrab A. Kaprielian Fellow in Engineering and Professor of Chemical Engineering and Materials Science and Biomedical Engineering. Wangs lab specializes in the emerging field of immunobioengineering, which uses engineering tools to better understand the immune system and to develop novel molecular and cellular immunotherapies.
To create the vaccine, Wang and his team have engineered a hybrid virus, the core of which is based on that of the vesicular stomatitis virus (VSV); a family of viruses which include rabies among others. The surface of the hybrid virus is then covered with spike proteins derived from the COVID-19 virus.
Pin Wang, Zohrab A. Kaprielian Fellow in Engineering and Professor of Chemical Engineering and Materials Science and Biomedical Engineering.
The reason that this hybrid virus can be a good vaccine format, is that by having the COVID-19 surface protein, this can hopefully trick our immune system into recognizing it, Wang said. That way we can induce the neutralizing antibody to stop the virus from infecting us in future.
We are hoping well have a very potent product, compared to other vaccine platforms, he said.
This type of vaccine is known as a vectored vaccine, and does not contain the harmful components of original viruses, and thus has safety benefits as opposed to vaccine forms using live-attenuated viruses.
Wang said the vaccine research was also looking into how our cells immune response works to combat the virus so that this process can be replicated in the development of therapeutics to manage COVID-19.
If we can immunize animals like mice, then we can isolate the B cells that that can generate antibodies; antibodies that can neutralize the virus, Wang said.
So say a patient is infected by the disease, we could directly infuse the antibodies into the patient to block the virus, he said.
Wang and his team have been in the early stages of vaccine development for the last month and have started to see positive results in the lab. Researchers around the world are concurrently working on various approaches to a vaccine across different vaccine platforms.
We recognize that this virus has a very different life cycle to other viruses and affects a very broad population, Wang said. So its important for the research community to test all different kinds of vaccine platforms. So that we can ensure at least one of them will work.
Wang said that it was important in the lifecycle of vaccine development that adequate time is taken to conduct rigorous human trials, which can take around 18 months.
We also need to demonstrate that this vaccine data can generate sufficient immunity to block COVID-19, so that takes time, Wang said.
We know its time-sensitive and everyone wants to get a vaccine as soon as possible, but we dont want to generate something that may cause harm to populations, he said.
WANGS RESEARCH TEAM HAS CREATED A VECTORED VACCINE BASED ON AN ENGINEERED HYBRID VIRUS THAT CONTAINS COVID-19 SURFACE PROTEINS TO TRIGGER AN IMMUNE RESPONSE. IMAGE/PIXABAY
Given current health and safety requirements, Wang and his team have also faced the unusual challenge of needing to conduct globally-important, time-sensitive lab-based research while maintaining adequate levels of social distancing.
Wang said that his lab had stopped all other experiments so that the team can focus on this program, and has organized for no more than two researchers to be in the lab at the same time.
We are making sure that even in the lab environment we are keeping our distance, Wang said. We always try to schedule things so some start early in the morning, and other people will come in a little later, so that people are not working at the same time.
But you know that researchers are really determined. Everyone in my team feels this is important and are determined to work on this as much as possible, Wang said.
An international academic-industry partnership has secured the funding necessary to develop a vaccine for the SARS-CoV-2 virus, which is responsible for the2019 coronavirus disease (COVID-19) pandemic.
The international, intergovernmental organizationCoalition for Epidemic Preparedness Innovations(CEPI) is committing nearly $5 million to a consortium led byInstitut Pasteurin Paris, in collaboration withThemisin Vienna and theUniversity of Pittsburgh Center for Vaccine Research(CVR), to develop a SARS CoV 2 vaccine and take it through phase I clinical trials in humans.
There are virologists all around the world who have been trained for this moment, said CVR director and Jonas Salk Chair for Vaccine ResearchPaul Duprex. We have colleagues in many parts of the world who collaborate and work with us to share information and share knowledge because this is important.
Duprex and colleagues are developing a SARS-CoV-2 vaccine using a measles vectormeaning a measles vaccine engineered to express SARS-CoV-2 proteins on its surfaceto generate immunity to the virus.
Measles is an attractive vector becausethe measles vaccine has proven safe and effectivefor billions of children over the past 40 years.
Our versatile, plug-and-play manufacturing technology affords us the advantage of accelerating the discovery and development of a vaccine candidate against the highly infectious and pandemic coronavirus, saidErich Tauber, CEO of Themis.
And creating new measles vector vaccines is a well-established process. Chikungunya, dengue, Ebola, HIV-1, Lassa, MERS, RSV, SARS, West Nile and Zika all have experimental measles vector vaccines. Several of these have even advanced through clinical trials.
We are delighted to continue our long-lasting collaboration with Themis and CEPI that has already delivered high potential vaccine candidates for Chikungunya, nearing phase 3, and Lassa fever in phase 1, both emerging infectious diseases representing a threat to global health, saidStewart Cole, president of the Institut Pasteur.
Scientists at all three institutions are already working on creating the vaccine, and CVR scientists are hard at work designing animal testing protocols that require special biocontainment measures for safe handling of potentially lethalairborne pathogens like SARS-CoV-2.
The CVRsRegional Biocontainment Laboratories(RBL) are state-of-the-art facilities for research on biodefense and emerging infectious diseases. TheNational Institute of Allergy and Infectious Diseaseshas supported this network of labs since 2003, with the mandate that the CVR will respond rapidly to global outbreaks, such as COVID-19, by developing animal models and testing candidate vaccines. CVR is one of a short list of sites in the U.S. to havereceived samples of SARS-CoV-2from theCenters for Disease Control and Prevention.
You have to be the right laboratory who can handle the virus in the right way with the right expertise to safely, carefully, methodically and rigorously understand the disease, Duprex said. All of our efforts will be directed to address this rapidly changing public health emergency, Duprex said. We are delighted to be part of this multinational, world-class consortium.
The research team anticipates that by April theyll have a candidate vaccine ready for animal testing in Paris and Pittsburgh. This will be complemented by the development of an aerosol model of COVID-19 disease at CVR. By the end of the year a total of 60-80 human volunteers in two sites in Europe will have gotten the vaccine. At the same time, Themis will be generating a stockpile of the candidate vaccine in anticipation of a phase II trial starting early next year.
CEPI and their partners will help to accelerate the vaccine through the regulatory process, potentially through anEmergency Use Listingwith theWorld Health Organization.
It is clear that an effective vaccine against COVID-19 is crucial if we are to beat this virus, said Richard Hatchett, CEO of CEPI. By investing in a range of partners and vaccine technologies, we are giving ourselves the best chance of developing a vaccine that can stop COVID-19 in its tracks.
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New Delhi: Over 20 research institutes are working overnight to develop vaccines for the treatment of the highly infectious novel coronavirus, said a top government official.
The National Institute of Virology (NIV), Pune, and the Indian Council of Medical Research (ICMR) are among these research institutes.
According to Renu Swarup, Secretary, Department of Biotechnology (DBT), which functions under the Ministry of Science and Technology, the government has received over 7,000 tech-based proposals from private companies and individuals across the country to fight Covid-19.
In an interview to ThePrint, Swarup further said the government is dealing with several aspects from scaling up production of low-cost Covid-19 testing kits and ventilators to expediting research for the development of vaccine to fight the novel coronavirus.
We are working on several aspects right now. First is scaling up the manufacturing capacity of those start-ups and incubators, who have made low-cost testing kits and ventilators. They got early approval from the NIV and ICMR also. Eight to nine companies are in the process to get approval for their kits and ventilators, said Swarup.
We are also supporting those companies who got approval for commercial production of testing kits and ventilators. Besides, all IIT-incubators have been asked to focus on research and development of portable ventilators, on genome sequencing and on isolation of the strain of the novel coronavirus from blood samples, she added.
Also read: How do you test for coronavirus? All you want to know about testing kits, process, results
Swarup said IIT-Kanpur and IIT-Roorkee incubation centers are working on making portable ventilators.
We are also supporting three indigenous companies in scaling up their manufacturing capacity of providing ventilators at a fast pace. A Mysuru-based firm is also ramping up its capacity to make more ventilators. It is working with the NITI Aayog, DBT, DRDO (Defence Research and Development Organisation) to manufacture more ventilators, she said.
The DBT is also supporting private companies to procure local components to manufacture ventilators because there is a problem in sourcing them from outside now (in the wake of the lockdown), she added.
An ICMR official told ThePrint ventilators and testing kits are extremely essential if the outbreak reaches the third stage.
India, with less than 1 lakh intensive care units and a bed ratio of 1:1,000, will be at risk if outbreak reaches the third stage. The unique nature of the disease requires 3-4 week of recovery and 21-day ventilator support, said the official.
Ventilators are the next level weapon after a test kit, which is required in sufficient numbers in case of a mass outbreak, he added.
Swarup said the coronavirus research consortium, which has experts from the ICMR, DBT, NIV, are working to develop a vaccine for Covid-19.
We are researching new molecules for treatment. We are researching repurposed drugs to treat patients. More than 45 drugs have been identified that may be effective and research is going on. Several DBT institutions are working to see which formulations can work effectively against Covid-19, she said.
We are also sharing our research with international consortium, which are working on vaccine development. But in any case, it will take time. They are at the animal trial stage and it will reach stage three of human trail not before year end, she added.
Over 7,000 technological solutions were received by the government as part of its COVID-19 Solution Challenge.
Under the initiative, individuals and companies can submit their tech-based ideas for strengthening the fight against coronavirus.
Several tech giants such as Microsoft, Intel, Amazon, Google have pitched ideas for making artificial intelligence-based solutions to detect suspected cases of coronavirus using the ICMR data. Ideas to manufacture low-cost ventilators, low-cost test kits and herbal sanitisers also came, the DBT secretary told ThePrint.
Swarup said all these ideas are being vetted.
A committee headed by K. VijayRaghavan, principal scientific adviser to the government, is evaluating the ideas and the DBT will support the selected research proposal, she added.
The DBT has also invited proposals from companies working in the field of research and development to manufacture ventilators, testing kits, for which it will provide the required funding, the DBT secretary added.
Also read: By failing to scale up testing coronavirus, India may have lost crucial time
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Sean Diehl likens the development of a new vaccine to the construction of a house. Before workers can turn a shovelful of dirt or hammer a nail, an architect must create a blueprint that shows how the building's thousands of components fit together and in what order.
Similarly, vaccine researchers trying to stop the spread of a deadly virus must start by mapping its messenger RNA. Decoding that genetic blueprint allows them to construct a safe and reliable vaccine that, they hope, will provide immunity for decades.
This time, researchers are racing to devise a vaccine that will stop a pandemic that's already upon us, using a never-before-tried method. It's akin to erecting a storm shelter using a new construction technique just as a Category 5 hurricane makes landfall.
Diehl is an assistant professor in the Department of Microbiology and Molecular Genetics at the University of Vermont's Larner College of Medicine. Since 2008, he's collaborated with the college's Vaccine Testing Center on projects involving infectious diseases, autoimmune disorders and vaccine development. In the past few years, Diehl's laboratory has focused on developing new protections against rotavirus, which is one of the most common and deadly causes of childhood diarrhea, and two mosquito-borne viruses dengue and Zika which infect tens of millions of people worldwide each year.
The 44-year-old Shelburne resident agreed to an interview with Seven Days months before the novel coronavirus made headlines. Since then, Diehl has joined the global effort to develop a vaccine against COVID-19.
On that front, researchers are already working at breakneck speed. They began in late December, when health authorities in Wuhan, China, first reported the outbreak of a viral pneumonia of unknown origin. On January 12, Chinese health authorities and the World Health Organization announced that they had mapped the entire sequence of the new coronavirus genome and shared it with researchers around the world.
On March 16, the National Institutes of Health announced the launch of a Phase 1 clinical trial to evaluate an experimental COVID-19 vaccine. In that study, being conducted at the Kaiser Permanente Washington Health Research Institute in Seattle, 45 healthy volunteers, ages 18 to 55, were injected with different doses of an experimental vaccine to evaluate its safety and efficacy in inducing immune responses.
Diehl is not involved in the Washington study. But, using the expertise he gained from researching dengue and Zika vaccines, he explained how a COVID-19 vaccine will be developed, how long it could last and how we can create more effective versions in the future.
"This is a brand-new approach," he said of the experimental coronavirus shot. "There is no current vaccine that's ever been developed this way."
How long before the public can be immunized? That's difficult to say. Diehl wouldn't offer a prediction beyond saying that "there are some aggressive timelines being talked about."
Ordinarily, vaccines involve years of research before human trials begin. But advanced genetic technologies and reductions in bureaucratic red tape could significantly shorten that timeline for COVID-19, with some estimates saying a vaccine could be available as early as this fall.
Several methods are used to create a vaccine, Diehl said. Under normal circumstances, the most common is to start with an attenuated, or weakened, version of a virus. Scientists inject this weaker version into laboratory animals, typically mice and nonhuman primates, hoping to trigger an immune response that doesn't make the animal sick. Only after long and rigorous study do vaccine developers request approval from the U.S. Food & Drug Administration to move on to human trials.
Consider the lengthy path that brought researchers to a vaccine for just one of four serotypes, or strains, of dengue (known as "Dengue 1, 2," etc.). Versions of the deadly virus are found in more than 100 countries around the world, posing a risk to about 40 percent of the world's population, or 3 billion people. According to the U.S. Centers for Disease Control and Prevention, as many as 400 million people are infected with dengue each year, of whom 100 million get sick and 22,000 die.
Though dengue's mortality rate is about 0.1 percent, comparable to seasonal flu, Diehl pointed out that its symptoms are much worse. "Dengue" may derive from the Spanish word for fastidious or careful, which describes the gait of a patient suffering from the disease.
The disease causes a very high fever that progresses into terrible joint, muscle and bone aches hence its nickname, "breakbone fever." Patients feel that their eyes are about to pop out of their heads.
Dengue is a particularly complicated disease to combat because of its four serotypes; an immunity to one offers no protection against the other three. If a person contracts Dengue 1 in, say, the Dominican Republic, they may recover without even knowing they were infected. However, if that person later travels to Puerto Rico and contracts Dengue 2, they have a greater chance of getting sick from the second exposure.
"For dengue," Diehl said, "it's taken, so far, 20 years and several billion dollars to get to the point of [having] the one vaccine that's on the market right now, for a very limited use."
What does this mean to researchers racing for a coronavirus vaccine? Speaking in "really broad brushstrokes," Diehl said, the way genetic material is encoded in the coronavirus is "very similar" to the coding of dengue. Both viruses have one long, continuous string of nucleic acid, or mRNA, that is "read" as a series of letters representing its chemical components: adenine (A), guanine (G), cytosine (C) and urasil (U).*
In the case of dengue, that string is 10,000 letters long. In COVID-19, Diehl said, it's 29,289.*
Working with a much longer string of information naturally presents more challenges. But, Diehl said, COVID-19 researchers don't need a full understanding of how all 29,289 letters of the genome function. The novel approach they're using to develop a vaccine is focused on the 3,000 to 5,000 letters that they believe may induce an early protective immune response. If they can pinpoint those letters, they will, in effect, buy themselves more time.
By now, most people who are following news of the unfolding pandemic have seen images of the COVID-19 virus, which resembles a fuzzy tennis ball riddled with darts or crowns. Those darts, which are called spike proteins, enable the virus to attach itself to a target cell, pass along its genetic material and reproduce.
A vaccine is essentially useless, Diehl said, if it triggers an immune response "post-fusion," or after the virus binds to the cell. The aim of this experimental vaccine is to induce an immune response before fusion happens.
"If we can block that," he said, "the virus has nowhere to go, and it dies."
The good news: Vaccine developers now have machines that can rapidly synthesize and mass produce the crucial 3,000- to 5,000-letter sequences that can be used to induce a pre-fusion immune response.
The bad news: That immune response won't last for long, because the mRNA used to produce it is an unstable molecule that degrades quickly in the body. "A good vaccine will last decades. This is probably single years," Diehl said.
That may be enough, though. Here's where Diehl joins the global effort: He has submitted a protocol seeking permission to collect and study blood samples from patients who have recovered from COVID-19. Once researchers better understand how all of the nucleotides work together, he said, they can move on to developing vaccine "versions 2.0, 3.0 and beyond" that will induce "immune memory."
It's no surprise that Diehl uses construction metaphors to describe the microscopic workings of cells and viruses; his father, who's now retired, worked for years in construction. To his mother, a nurse, Diehl attributes his desire to work in a public health field and help others.
A native of Rome, N.Y., Diehl earned a bachelor's degree in chemistry at the State University of New York Geneseo. There, he developed an interest in immunology, and a professor suggested he pursue a doctoral degree. The first member of his family to attend a four-year college, Diehl hadn't known until then that students could get funding to pursue graduate degrees.
Earning his PhD at UVM, Diehl met his now-wife, Sandra. When he completed the degree, they moved to the Netherlands, where Sandra was born and raised.
After spending 2003 to 2008 at the University of Amsterdam, Diehl returned to Vermont and joined the faculty at UVM, where he's been ever since. Sandra works as a pediatric nurse at the UVM Medical Center. The couple has two daughters, Jill, 11, and Vera, 9.
Diehl admitted that it's frustrating to see vaccines demonized by the public when he knows how much "blood, sweat and tears" go into making them. He sees them as a "miracle product" that saves lives. "And then some people just choose not to believe in them."
What keeps him interested in immunology?
"The fact that we'll never figure it all out," he said. Unlike the study of many processes in the human body, such as the cardiopulmonary system, immunology is constantly evolving and discovering new cell types. And those discoveries almost always have real-world health applications, whether it's combating an autoimmune disorder or working to end a global pandemic. Given its complexity, COVID-19 could keep researchers busy for years to come.
"At the root of it," Diehl said, "I always know that there's so much still to be learned."
Correction March 26, 2020: This article originally misidentified one of the components in the coronavirus mRNA, and the number of letters in the string.
Link/share: www.kingcounty.gov/covid/schools
On March 12, 2020 Washington State Governor Jay Inslee announced that all schools in King, Snohomish, and Pierce counties will close from Tuesday, March 17 through Friday, April 24. The decision was made in response to the spread of COVID-19 in the Washington counties hit hardest by the virus. With this in mind, weve created resources for child cares and families for how to care for children while school is out (see below).
