Category: Covid-19 Vaccine

Novak Djokovic says his opposition to vaccinations may get in the way of his return to competitive tennis.

Personally I am opposed to vaccination and I wouldnt want to be forced by someone to take a vaccine in order to be able to travel, the world No 1 said in a live Facebook chat with several fellow Serbian athletes on Sunday. But if it becomes compulsory, what will happen? I will have to make a decision. I have my own thoughts about the matter and whether those thoughts will change at some point, I dont know.

Hypothetically, if the season was to resume in July, August or September, though unlikely, I understand that a vaccine will become a requirement straight after we are out of strict quarantine and there is no vaccine yet.

Last month, former world No1 Amelie Mauresmo said the rest of the 2020 tennis season may be wiped out. She added that action should not resume until a vaccine is available for Covid-19, something that most scientists believe is at least a year away.

International circuit = players of all nationalities plus management, spectators and people from the 4 corners of the world who bring these events to life. No vaccine = no tennis, the two-time grand slam winner said in a widely shared tweet.

This years Wimbledon championships have been cancelled for the first time since the second world war, while the French Open, originally due to start on 24 May, was rescheduled for the end of September, shortly after the end of the US Open.

Djokovic made a flying start to the 2020 season, winning the Australian Open in January for his 17th grand slam title and stretched his winning run to 18 matches before the pandemic brought sports events across the world to a halt.

So far the governing bodies of tennis have suspended all tournaments until 13 July. In addition, the womens Rogers Cup in Montreal, which had been due to be held in August, will not take place this year.

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Novak Djokovic's opposition to vaccination may stop his return to tennis - The Guardian

News Release

Friday, April 17, 2020

Health agencies, leading pharmaceutical companies to join forces to accelerate pandemic response.

The National Institutes of Health and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administrationand the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processesand/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. This is part of the whole-of-government, whole-of-America response the Administration has led to beat COVID-19.

We need to bring the full power of the biomedical research enterprise to bear on this crisis, said NIH Director Francis S. Collins, M.D., Ph.D. Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.

Coordinated by the FNIH, ACTIV government and industry partners will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19. The partnership is being developed with input from a steering committee managed by the FNIH which includes leaders from NIH, FDA and the research and development organizations of the companies.

COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic, said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop COVID-19. At Johnson & Johnson, we are committed to working closely with FNIH, IMI and are part of other important consortia to speed solutions to stop this pandemic.

Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone, said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer.We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.

The research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance which can be used to prioritize the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and efficiently.

Using the most advanced clinical trial methods to rapidly test multiple interventions will help get the answers we need as soon as possible to expedite potential prevention and treatment approaches to fight COVID-19, said FDA Commissioner Stephen M. Hahn, M.D. Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program to speed the development of safe and effective medical countermeasures.

ACTIV will have four fast-track focus areas, each of which will be led by a highly motivated working group of senior scientists representing government, industry and academia:

This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19, says Maria C. Freire, Ph.D., President and Executive Director, FNIH. Working in lock-step, the public and private sectors will maximize the chances of success and provide a roadmap to pre-emptively manage future threats.

About the Foundation for the National Institutes of Health: The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the worlds premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit fnih.org.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options - National Institutes of Health

As COVID-19 continues to spread throughout the country and the world, EpiVax, a biotechnology company based in Providence, is currently leading collaborative efforts to design a vaccine against the virus.

EpiVax has been dedicated to applying (their) tools to re-engineering therapeutic proteins and to designing new vaccines, according to their website. They are partnering with researchers from four organizations to work on the COVID-19 vaccine: Generex Biotechnology, the University of Georgia, Immunomic Therapeutics and an organization based in Belgium. Other researchers have reached out to the company to aid in collaborative efforts as well.

Bringing Potential Benefits

The candidate vaccines being developed by EpiVax are T-cell-based. Unlike other COVID-19 vaccines in the works that are B-cell-based, the T-cell vaccines do not stimulate antibodies, which are molecules created by the immune system to protect against infection. Some studies have proposed that in the case of COVID-19, antibody stimulation may exacerbate respiratory symptoms, said Katie Porter, EpiVaxs business development manager.

From studies on other coronaviruses, we have learned that often the antibodies are not long-lived, so they do not hold up their defense against invading viruses for extended periods of time as the virus evolves, said Lalit Beura, assistant professor of molecular microbiology and immunology, whose research involves T-cells. Having another arm of the immune system in the form of a T-cell-focused vaccine is helpful.

EpiVax: Starting with Sequencing

There are people who are concerned that were working with the actual virus in Providence, but that is not the case, Porter said. Rather, EpiVax is using a digital representation. After determining the viruss genome, the researchers selected the amino acid sequences that form the COVID-19 SARS-CoV-2 proteins that T-cells recognize and used a computer-based technology they developed to determine the regions of these proteins that instigate the greatest immune system response. The researchers will use these short protein segments to design vaccine candidates.

EpiVax has created three designs for the collaborators to use for their distinct, biological methods of delivering the vaccine. These designs include a set of distinct, short peptides, a string of connected peptides and a modified protein. Peptides are composed of the same molecules as proteins but are shorter. We are working with various collaborators on a daily basis to provide them with the best design options for their platform technology, Porter said. For instance, the Generex collaborators are using a set of peptides while the University of Georgia collaborators will be using the modified protein model consisting of the full viral protein.

While each of these organizations is working on their own projects, they all share a common goal of developing a vaccine. EpiVax has begun delivering its protein designs to its collaborators and optimizing the strains for their mechanism. For the company, sharing their sequencing and initial design work with collaborators who can help create an eventual vaccine is important because we have the ink, and we need to give it to someone with the pen so that together we can write, Porter said.

University of Georgia: Modifying the Protein Model

Ted Ross, director of the Center for Vaccines and Immunology, Georgia Research Alliance Eminent Scholar and professor of infectious diseases at the University of Georgia, and two other investigators at the university will engineer the modified protein sequences that EpiVax is designing. Then they will run trials in animal models mice and ferrets by infecting them with the altered peptides to determine whether they produce a better immune response than the wild type viruss proteins do. If this is the case, the researchers plan to expose these animals to SARS-CoV-2 to ensure that this potential vaccination is effective. The groups expectation is to have this data ready by the middle of this summer.

Ross and his group have also been working on developing a universal flu vaccine, a vaccine that could potentially be used for all influenza viruses without requiring constant changes. Perhaps we could use those (same) techniques to eventually create a universal coronavirus vaccine, Ross said.

Generex Biotechnology: Modifying the Peptide Model

Generex Biotechnology, another therapeutics company, is modifying the peptides provided by EpiVax. They are first synthesizing the peptides predicted by EpiVaxs analysis using their Ii-Key technology. An li-Key facilitates the attachment of a four-amino-acid-long peptide to a part of the COVID-19 virus. This technology serves as a sort of flag on the virus, providing a way to artificially activate the T-cells more quickly than would happen in a typical immune response.

The researchers plan on conducting their studies by testing the modified peptides, determined by EpiVax and optimized by Generex, using blood cells from COVID-19-recovered patients. They hope to complete these studies in three to four months prior to testing the potential vaccine in live animals and people.

It is a two-fold process, said Eric von Hofe, chief scientific officer of NuGenerex Immuno-Oncology, a subsidiary of Generex. The team will be looking for a T-cell response to these peptides, as well as the generation of antibodies. After starting and completing trials in animal models, Generex hopes to begin clinical trials with about 200 volunteers that will receive the peptide-based vaccine to determine whether this produces the desired immune response and to ensure the safety of the vaccine.

The biggest advantage is that peptides represent the minimal unit required to produce an immune response while reducing safety concerns associated with other proposed COVID-19 vaccines that are RNA- and DNA-based and have the potential to insert into a persons DNA, von Hofe said. But none of these types of vaccines have been approved yet for the treatment of infectious diseases, he added.

Fundamentals of Funding

Despite the preliminary successes the companies have seen thus far, funding remains a critical part of the picture. Funding often pushes back the timeline, or worse, cancels hopes of a trial continuing. EpiVaxs and Generexs earlier research on vaccine candidates for the H1N1 and SARS pandemics were halted largely due to funding limitations.

Still, the companies believe that this time around, it will not be as much of a barrier. If our trials are successful, Im sure that there will be opportunities to take a vaccine candidate even further, Porter said. There is government and other funding available, but there are many people trying to get it. We have many collaborations in place to move a COVID vaccine forward, so chances for success are very good.

Von Hofe highlighted the importance of reaching out to government officials, as well as voting for political candidates who will support vaccine research. Public interest is acute in the midst of a pandemic and then fades away, von Hofe said. But with the last 20 years having brought a handful of pandemics, now it is pretty clear that the regular emergence of pandemic or potentially pandemic viruses will not be going away, he added. Whatever happens with COVID-19, we will have learned a lot that will be applicable to whatever potential pandemic may come next; it is clear that we need to be better prepared.

While the timeline for this COVID-19 vaccines development remains indefinite, according to EpiVaxs website, were in the race to have the vaccines in clinical trials by the fall, Porter said.

The rest is here:

Providence-based EpiVax collaborates on ongoing research for a COVID-19 vaccine - The Brown Daily Herald

WASHINGTON (AP) Three potential COVID-19 vaccines are making fast progress in early-stage testing in volunteers in China and the U.S., but its still a long road to prove if theyll really work.

Chinas CanSino Biologics has begun the second phase of testing its vaccine candidate, Chinas Ministry of Science and Technology said Tuesday.

In the U.S., a shot made by the National Institutes of Health and Moderna Inc. isnt far behind. The first person to receive that experimental vaccine last month returned to a Seattle clinic Tuesday for a second dose.

NIH infectious disease chief Dr. Anthony Fauci told The Associated Press there are no red flags so far and he hoped the next, larger phase of testing could begin around June.

More on the Virus Outbreak:

A third candidate, from Inovio Pharmaceuticals, began giving experimental shots for first-step safety testing last week in the U.S. and hopes to expand its studies to China.

Initial tests focus on safety, and researchers in both countries are trying out different doses of different types of shots.

But moving into the second phase is a critical step that allows vaccines to be tested in many more people to look for signs that they protect against infection.

Last week, CanSino filed a report showing it aimed to enroll 500 people in this next study, comparing two doses of the vaccine to dummy shots. As of Monday, 273 of the volunteers had been injected, state media said.

Looking ahead, Fauci said if the new coronavirus continues to circulate widely enough over the summer and fall, it might be possible to finish larger studies slightly sooner than the 12 to 18 months hed originally predicted maybe toward mid to late winter of next season.

Please let me say this caveat: That is assuming that its effective. See, thats the big if, Fauci stressed. Its got to be effective and its got to be safe.

During a news conference in China, authorities also cautioned that the studies must be done properly.

Although we are in an emergency, we cannot lower the standards of safety and effectiveness in the reviews of vaccines, said Wang Junzhi, a Chinese biopharmaceutical expert. The public is paying huge attention.

The World Health Organization this week counted more than five dozen other vaccine candidates in earlier stages of development being pursued around the world. Many research groups are teaming up to speed the work; in an announcement Tuesday, vaccine giants Sanofi and GSK became the latest to partner on a candidate.

On the WHOs list are a wide variety of ways to make vaccines -- so if one approach doesnt pan out, hopefully another one will.

CanSinos vaccine is based on a genetically engineered shot it created to guard against Ebola. The leading U.S. candidates use a different approach, made from copies of a piece of the coronavirus genetic code.

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AP camera operator Borg Wong contributed to this report from Beijing.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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Search for a COVID-19 vaccine heats up in China, US

Lars Hagberg/The Canadian PressA sign for the University of Waterloo is seen here on April 29, 2019, in Waterloo, Ont. Waterloo is one of several universities in Canada working on a COVID-19 vaccine.

Researchers at the University of Waterloo say they are developing a new nasal sprayCOVID-19 vaccine that can be delivered non-invasively.

In anews releasepublished Thursday, the public research university in southwestern Ontario says the vaccine will work by using bacteriophage, which allows it to replicate within bacteria in the body.

The DNA-based vaccine is being designed to work in the nasal cavity and lower respiratory tract. It would target tissues in the body to stimulate a virus-like particle (VLP) response, which would trigger an immune system response.

When complete, our DNA-based vaccine will be administered non-invasively as a nasal spray that delivers nanomedicine engineered to immunize and decrease COVID-19 infections, University of Waterloo Prof. Roderick Slavcev,who specializes in designing vaccines, pharmaceuticals and gene-therapy treatments, said in a statement.

Researchers say the VLP will look like the disease that causes COVID-19, but its actually harmless. It would bind to the same receptors that the virus targets, limiting the potential for infection.If successful, the spray will help the body in two ways: by building immunity to the virus while limiting the severity of the infection, serving as both a therapeutic and a vaccine.

Multiple professors and university teams are chipping in with their expertise to help with the research. The university says every aspect of the vaccine is being specifically engineered to fight COVID-19 and still must be tested.

A grant from the Natural Sciences and Engineering Research Council of Canada is helping fund this work, which has yet to be peer reviewed.

Earlier this week, Health Canada approved Spartan Biosciences portable COVID-19 test. The handheld DNA analyzer from the Ottawa-based company is the size of a cup of coffee and can produce results within an hour without relying on a laboratory. The federal government and the government of Ontario have already ordered these tests called the Spartan Cube.

On the vaccine front, Waterloo is one of many areas in Canada where COVID-19 research is ongoing.

Vaccines are also being developed by research teams at Dalhousie University, McMaster University, the University of Alberta, Laval University, the University of British Columbia, the University of Saskatchewan, the University of Manitoba and Western University. Companies such as Medicago,Entos Pharmaceuticals and AbCellera Biologics are also conducting research work in Canada.

In March,Quebec City-based Medicago said it could begin human trials of a vaccine as soon as July or August.

Vaccines must be properly tested in laboratories before they can be approved for human use, a process which could take months to years. Earlier this month, Prime Minister Justin Trudeau said estimates from health experts on when a new COVID-19 vaccine might be ready range from six to 18 months.

With files from Daniel Tencer and The Canadian Press

Also on HuffPost:

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Canadian Researchers Working On Nasal Spray COVID-19 Vaccine

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Another COVID-19 Vaccine Looks Promising

According to the World Health Organization, there are 70 vaccines being developed worldwide for COVID-19, with three already in human clinical trials. The furthest along is one by CanSino Biologics and the Beijing Institute of Biotechnology, which is in Phase II. The others are by U.S. companies, Inovio Pharmaceuticals and Moderna. Another institution, the University of Pittsburgh, also announced that in laboratory tests their COVID-19 vaccine, delivered via a fingertip-sized patch, showed positive results in laboratory mice, producing antibodies specific to SARS-CoV-2 at enough amounts to neutralize the virus. The research was published in EBioMedicine, published by The Lancet.

We had previous experience on SARS-CoV in 2003 and MERS-COV in 2014, said co-senior author Andrea Gambotta, associate professor of surgery at the Pitt School of Medicine. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We know exactly where to fight this new virus. Thats why its important to fund vaccine research. You never know where the next pandemic will come from.

It uses a more traditional process than the mRNA one being used by Moderna. The virus is being called PittCOVacc, and uses laboratory-manufactured pieces of viral protein to build immunity. Its a process similar to that used in seasonal flu shots. They also leveraged a new technique to deliver the drug, called a microneedle array, to increase the potency of the vaccine. The fingertip-sized patch has 400 tiny needles that deliver the spike protein pieces into the skin. It goes on like a Band-Aid. The needles are built from sugars and the antigens, and they just dissolve.

We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient, said Louis Falo, co-senior author and professor and chair of dermatology at Pitts School of Medicine and UPMC. And its actually pretty painlessit feels kind of like Velcro.

They are currently submitting an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) and hope to begin Phase I human clinical trials in the next few months.

Genetic Mechanisms of Inflammatory Bowel Disease

Researchers at Children's Hospital of Philadelphia identified a genetic variant that causes the development of inflammatory bowel disease (IBD). The pathway is linked to other immune disorders. More than 240 genetic regions are already associated with IBD, but each region has multiple markers and not all are causative. The researchers focused on the single nucleotide polymorphism (SNP) rs1887428, located on the promoter region of the JAK2 gene. The protein coded by the gene controls the production of blood cells. The team found that two transcription factors, RBPJ and CUX1, recognize the DNA sequence altered by the rs1887428 SNP, and while it only has mild influence on JAK2 expression, it was amplified by other proteins in the JAK2 pathway.

Possible Mechanism of Link Between Obesity and Breast Cancer

Breast cancer (and other cancers) and obesity are associated, but the reason for that link isnt well understood. Researchers from the University of Louisville published research suggesting that the fatty acid binding protein family, especially FABP4, plays a critical role. Fat tissue produces FABP4 within fat cells, which processes and distributes water-insoluble long-chain fatty acids. Normally, some FABP4 enters the bloodstream, but the higher fat volume, the more FABP4 is secreted. They believe two mechanisms are in play. Within cells, FABP4 increases in certain tumor-associated macrophages, which accumulate in tumors and promote cancer growth. And second, when elevated levels of FABP4 circulate outside the fat cells, it promotes breast cancer by directly interacting with breast cancer cells.

Using Cellular Machinery Without the Cells to Develop Drugs

Northwestern University and ShanghaiTech University leveraged cell-free synthetic biology to produce a drug that kills SARS-CoV-2 in cell cultures. They indicate they could create the new drug by taking the molecular machinery out of cells and using that machinery to make a product in a safe, cheap and quick way. The molecule is called valinomycin. By using this method, they were able to increase production yields more than 5,000 times in only a few quick design cycles.

Glucose Metabolism Linked to Alzheimers Disease

Researchers with the National Institutes of Healths National Institute on Aging conducted the largest study so far on proteins related to Alzheimers and identified proteins and biological processes that regulate glucose metabolism that are associated with Alzheimers. The study was published in the journal Nature Medicine.

The study was part of the Accelerating Medicines Partnership for Alzheimers Disease (AMP-AD). The investigators assayed the levels and analyzed the expression patterns of more than 3,000 proteins in brain and cerebrospinal fluid samples collected at centers across the U.S.

This is an example of how the collaborative, open science platform of AMP-AD is creating a pipeline of discovery for new approaches to diagnosis, treatment and prevention of Alzheimers disease, said Richard J. Hodes, NIA director. This study exemplifies how research can be accelerated when multiple research groups share their biological samples and data resources.

The study involved analyzing protein expression patterns in more than 2,000 human brain and almost 400 cerebrospinal fluid samples taken from both healthy individuals and Alzheimers patients. They analyzed how the protein modules relate to Alzheimers and other neurodegenerative diseases. They observed changes in proteins related to glucose metabolism and an anti-inflammatory response in glial cells in brain tissues from both Alzheimers patients and people with documented brain pathology who were cognitively normal. This also would seem to support increasing evidence that brain inflammation is involved in the disease as well.

In Alzheimers patients, they found that how cells extract energy from glucose is increased in both the brains and spinal fluid of Alzheimers patients. The proteins observed were also elevated in preclinical Alzheimers patients, which is to say, people with brain pathology of the disease who had not shown cognitive decline.

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Research Roundup: Another Promising COVID-19 Vaccine and More - BioSpace

I certainly dont trust the government, but neither am I credulous (see above). And its not just me. Last year, in 2019, a Pew poll found that only seventeen percent of Americans state they can trust the government just about always or most of the time, being three percent and fourteen percent, respectively. Eighty-three percent of Americans are not anti-vaccine, and to conflate government mistrust with it, thereby smearing what can be fairly termed as almost all Americans, is partisanship parading as scientific objectivity.

Originally posted here:

How the Anti-Vaccine Community Is Responding to Covid-19 - Undark Magazine

Antibodies from recovered patients and biotech companies could help

Editors note: The Economist is making some of its most important coverage of the covid-19 pandemic freely available to readers of The Economist Today, our daily newsletter. To receive it, register here. For our coronavirus tracker and more coverage, see our hub

DURING THE flu pandemic of 1918-19 doctors at an American naval hospital developed a treatment which, according to the American Journal of Public Health, had a decided influence in shortening the course of the disease and in lowering the mortality. It involved clotting and then centrifuging blood from people who had got over the disease so as to separate out the antibodies it contained, then giving those antibodies to patients in dire need.

Since then antibody-rich convalescent plasma (CP) has been used as a treatment for various diseases, including SARS and the pandemic strains of H1N1 and H5N1 influenza. Now covid-19 has joined the list. A recent study in Wuhan found that severely ill covid-19 patients treated with CP did significantly better than patients matched with them by age, gender and severity of infection had done earlier in the epidemic.

Michael Joyner of the Mayo Clinic, which leads a CP research effort in America, expects randomised control trials to begin in a few weeks. They will not just look at CPs potential as a treatment, but also as a prophylactic. If that worked, it would be a sort of halfway house on the road to a vaccine.

Even though CP donors get the other components of their bloodcells, platelets and the likereturned to them after the antibodies have been removed, the process is still something of a palaver, requiring a lot of medical attention. Despite the fact that various companies are trying to make a go of it, it is hard to see it scaling up all that far. But there is an alternative. Antibodies are proteins, and that means a bit of genetic engineering will allow cell lines at biotechnology and pharma companies to mass produce them. The resulting product should be less prone to contamination, more consistent, and easier to scale up than CP.

This approach has already been successful against Ebola. Regeneron, an American biotech company, developed a cocktail of three antibodies which recognised different parts of the proteins coat. Trials in the Democratic Republic of Congo showed this therapy to be better than remdesivir, a drug designed to block the Ebola vaccines reproduction which is now, as it happens, being tested as a medicine for covid-19.

Regeneron is now making a pair of antibodies that target the SARS-CoV-2 spike protein. It hopes to have produced enough to start trials soon. As with CP, it is possible that such antibodies may temporarily confer immunity on the uninfected, as well as helping the infected fight the disease.

Dig deeper:For our latest coverage of the covid-19 pandemic, register for The Economist Today, our daily newsletter, or visit our coronavirus tracker and story hub

This article appeared in the Briefing section of the print edition under the headline "Survivors as saviours"

Excerpt from:

Some benefits of a covid vaccine could come early - The Economist

Scientists around the world are racing to find ways out of the new coronavirus pandemic. Some are working to develop new drugs and vaccines, while others are looking to see whether therapies we already have may help against COVID-19.

In the latter category, researchers have dusted off one intriguing compound in our collective medicine cabinet a century-old vaccine to fight tuberculosis, a bacterial disease that affects the lungs. A couple of early analyses, which have yet to be peer-reviewed, have found that countries that require this vaccine, called Bacillus CalmetteGurin (BCG), seemed to have been hit less severely, in terms of both number and severity, by the coronavirus that causes the disease COVID-19.

Could this vaccine be protecting people from COVID-19? The short answer is: We don't know. But several clinical trials around the world are now examining whether this vaccine could protect against this new foe.

Related: 13 coronavirus myths busted by science

"I was originally quite skeptical" that the studies could tease apart all of the other factors that could be causing some countries to be hit harder with COVID-19 than others, said Paula Cannon, a distinguished professor of molecular microbiology and immunology at the University of Southern California's Keck School of Medicine, who is not a part of any of these studies. Among those factors are the quality of the healthcare system, measures put in place to fight the disease and testing capacity. Still, it is a "provocative idea" and the "data is tantalizing," Cannon said.

Dozens of countries, including Japan and China, require children typically newborns to receive the BCG vaccine as protection against tuberculosis, an infection that is typically more common in lower-income countries. Other countries, such as Spain, France and Switzerland, used to require the vaccine but stopped because the risk of catching the disease in those countries lessened, according to one of the preprint studies published in medRxiv on March 28. Other countries, such as the U.S., Italy and the Netherlands never had such a universal vaccine policy for the BCG vaccine.

But scientists have long known that "almost by lucky accident," the BCG vaccine doesn't just protect against tuberculosis, it also helps fight other viruses, respiratory infections in particular, Cannon said. The vaccine, "in some sort of unexpected and magical way, is like a broad immune booster," she said.

For example, one study conducted in Guinea-Bissau in West Africa found that children who were vaccinated with BCG had about a 50% reduction in overall mortality, largely because the vaccine reduced respiratory infections and sepsis, or blood poisoning, according to the medRxiv study. Other studies, mostly conducted in animals, have found similar broad-spectrum protections from the BCG vaccine.

The BCG vaccine is made up of weakened forms of live Mycobacterium bovis, closely related to the bacteria that causes tuberculosis. It was first developed in the 1920s in Paris and later shipped all over the world.

Now, countries from Japan to Denmark have their own BCG vaccines, made using different formulations of live bacteria and each one has varying degrees of immune boosting ability, said Dr. Ofer Levy, the director of the precision vaccines program at Boston Children's hospital and a professor at Harvard Medical School.

Typically, live vaccines provide a "strong and long-lasting immune response" and sometimes even "lifelong protection" against the germ, whereas inactivated forms of vaccines, such as those in flu shots don't provide immunity that's "as strong," according to the U.S. Department of Health and Human Services.

While most vaccines prompt one arm of the immune system the adaptive immune system to create antibodies that target very specific pathogens, the BCG vaccine taps into the other arm, the innate immune system. This system doesn't discriminate against pathogens and releases immune cells rather quickly to fight any foreign substance. The BCG vaccine thus boosts the body's production of non-specific immune cells.

The medRxiv study and another preliminary study recently published in Research Gate came to similar conclusions: there seemed to be a correlation between countries that require BCG vaccines and a reduced spread and severity of COVID-19 cases. For example, Portugal which has required BCG vaccines for infants has over 16,000 cases of COVID-19 but only 535 deaths whereas neighboring Spain has over 169,000 cases and over 17,000 deaths.

Similarly, Ireland, with 9,655 cases and only 334 deaths, requires the BCG vaccination, whereas the U.K. with 89,554 cases and 11,346 deaths no longer does. Based on these numbers, Ireland has a fatality rate 3.5% whereas the U.K. has a fatality rate of 12.7%. Of course, there are big population number differences across these countries, along with other variables that could affect death and infection rates.

These preliminary studies are "very flawed," because many factors such as differences in wealth and testing ability, can affect the outcomes Levy told Live Science. But the authors are "doing the best they can in a very difficult situation." While there's no direct evidence that BCG vaccines will reduce people's risk of developing COVID-19, "I'm enthusiastic about the hypotheses," Levy said.

It's difficult to draw firm conclusions, but there's enough scientific evidence to prompt clinical trials, and his team is looking into starting one in the U.S, he said. Clinical trials analyzing the protective effects of the vaccine against COVID-19 are already underway in other countries, including Australia and the Netherlands.

"I'm kind of puzzled," by the implication that the BCG vaccine might be able to protect for such a long period of time once someone has received it as a baby, Cannon said. Indeed, it's not clear how long the BCG vaccine effects can last.

The second study, which also has not been peer-reviewed, analyzed how countries with re-vaccination policies or booster shots fared in the COVID-19 pandemic. That study found that countries without re-vaccination policies had a 5.2% case fatality rate, versus a0.6% case fatality rate in countries that required re-vaccination.

"The big kind of asterisk, if you like, against all of these studies, is that they are really dealing with massively incomplete information," Cannon said. "We're all guessing what the true infection rates and the case fatality rates are because there isn't widespread uniform testing in every country."

Still, "I applaud the authors for at least, you know, doing what they could with the available data and providing some very provocative hypotheses," she said. "The good news is they're very testable."

In another world, we would be doing animal experiments to test this hypothesis. In this world, amid the coronavirus pandemic, we don't have time for that, she said. But the BCG vaccine has a "very safe track record," and likely can be tried in those who aren't old and who don't have weakened immune systems (since this is a live vaccine, it can potentially cause more side effects for older people or those with weakened immune systems), she added.

The human immune system is like an orchestra, "it's massively interconnected and what the BCG vaccine seems to do is maybe it gives like a little bit of extra control to the conductor," Cannon said. "So in the symphony of immune attack against respiratory viruses, the orchestra is able to go full blast, straightaway, all together, in sync, rather than kind of playing catch up."

Originally published on Live Science.

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Could a 100-year-old vaccine protect against COVID-19? - Livescience.com

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In GlobalDatas Coronavirus Disease (Covid-19): Pipeline and Clinical Trial Analysis April 2020 thematic report, 1,561 visitors of GlobalDatas Pharmaceutical Technology website responded to the question How confident are you that Pharma/Biotech Companies will be able to develop an effective vaccine for Covid-19 within the next 12 months? A strong majority (80%) were optimistic about the development of a vaccine, with 52% being very confident, 28% somewhat confident, and only 20% who expressed no confidence at all. However, considering that vaccines typically take years to develop, expectations surrounding the potential availability of a Covid-19 vaccine should be tempered.

Covid-19 therapeutics could be available within a matter of months, as off-the-shelf solutions may already be available and ready for clinical trials. Assuming rapid trial initiation, these trials could produce readouts in a matter of weeks. Data are already available for multiple candidate therapies, including chloroquine/hydroxychloroquine, ritonavir + lopinavir, remdesivir, and favipiravir, among others. Notably, these data have been produced less than five months after the discovery of the virus, demonstrating that short studies for Covid-19 treatments can indeed be completed quite rapidly, although the data are less clear than desired. However, it is unrealistic to expect vaccines to follow a similar timeframe for multiple reasons.

Vaccines work by training the immune system to respond to components of pathogens, and accordingly must be highly specific to the pathogen of interest. As the virus responsible for Covid-19 is new, its components are poorly understood, making it difficult to decide which parts might be more immunogenic and thus more likely to lead to a successful vaccine. While several vaccines have entered clinical trials, such as Modernas messenger ribonucleic acid (mRNA) vaccine mRNA-1273, the amount of time dedicated to the R&D of these candidates has been substantially shorter than other vaccines that have entered clinical trials. Part of the reason these vaccines were able to enter Phase I studies so quickly is because they rely on new vaccine technologies, such as DNA, mRNA, or adenoviral vector-driven vaccines, which can be developed rapidly relative to older technologies. However, no vaccine using these technologies has ever been commercialised, and data supporting their efficacy is thin. As such, enthusiasm surrounding their likelihood of success may be met with disappointment.

Prophylactic vaccines confer active immunity against a potentially disease-causing pathogen. Even if a vaccine is effective, the protection it confers must be measured against time because exposure to the pathogen could take weeks, months, or even years. This means that the endpoint for the time after immunisation needs to be longer rather than shorter in order to ensure that the pathogen is likely to have been encountered. If a trial is too short, an immunised patient might not be exposed to the disease, which could either make it difficult to differentiate the treatment from placebo or could confer a false sense of efficacy, as the rate of disease in the vaccinated group would be lower.

Even if a vaccine were to rapidly demonstrate efficacy in both Phase I and II trials, there would need to be significant manufacturing efforts initiated prior to proof of efficacy. Waiting for trial results could significantly delay the delivery of the vaccine to the public. However, increasing production prior to the release of the trial results is risky due to the possibility of failure to meet endpoints, so most developers usually avoid this option. The availability of a vaccine will likely depend heavily on the geography where it is developed and who is recommended to receive it upon licensure. For example, a Covid-19 vaccine developed in the US might initially be recommended for older patients in the US who are at increased of disease, while younger patients and those in other regions might have to wait for later releases of the vaccine.

While it is technically possible for a Covid-19 vaccine to be available in 12 months, there are multiple factors that suggest this to be closer to wishful thinking than anything remotely certain.

Figure 1: Industry Perspective on Vaccine Development. Credit: GlobalData

GlobalData is this websites parent business intelligence company.

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Covid-19 vaccine will be developed within 12 months, poll participants said - Pharmaceutical Technology