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A Series of Recently Published Papers Report the Development of SARS-CoV2 Neutralizing Antibodies and Passive Immunity toward COVID19

Curator: Stephen J. Williams, Ph.D.

 

Passive Immunity and Treatment of Infectious Diseases

The ability of one person to pass on immunity to another person (passive immunity) is one of the chief methods we develop immunity to many antigens.  For instance, maternal antibodies are passed to the offspring in the neonatal setting as well as in a mother’s milk during breast feeding.  In the clinical setting this is achieved by transferring antibodies from one patient who has been exposed to an antigen (like a virus) to the another individual.   However, the process of purifying the most efficacious antibody as well as its mass production is limiting due to its complexity and cost and can be prohibitively long delay during a pandemic outbreak, when therapies are few and needed immediately.  Regardless, the benefits of developing neutralizing antibodies to confer passive immunity versus development of a vaccine are evident, as the former takes considerable less time than development of a safe and effective vaccine.  For a good review on the development and use of neutralizing antibodies and the use of passive immunity to treat infectious diseases please read the following review:

Margaret A. Keller1,* and E. Richard Stiehm. Passive Immunity in Prevention and Treatment of Infectious Diseases. Clin Microbiol Rev. 2000 Oct; 13(4): 602–614. doi: 10.1128/cmr.13.4.602-614.2000

ABSTRACT

Antibodies have been used for over a century in the prevention and treatment of infectious disease. They are used most commonly for the prevention of measles, hepatitis A, hepatitis B, tetanus, varicella, rabies, and vaccinia. Although their use in the treatment of bacterial infection has largely been supplanted by antibiotics, antibodies remain a critical component of the treatment of diptheria, tetanus, and botulism. High-dose intravenous immunoglobulin can be used to treat certain viral infections in immunocompromised patients (e.g., cytomegalovirus, parvovirus B19, and enterovirus infections). Antibodies may also be of value in toxic shock syndrome, Ebola virus, and refractory staphylococcal infections. Palivizumab, the first monoclonal antibody licensed (in 1998) for an infectious disease, can prevent respiratory syncytial virus infection in high-risk infants. The development and use of additional monoclonal antibodies to key epitopes of microbial pathogens may further define protective humoral responses and lead to new approaches for the prevention and treatment of infectious diseases.

TABLE 1

Summary of the efficacy of antibody in the prevention and treatment of infectious diseases

Infection
Bacterial infections
 Respiratory infections (streptococcus, Streptococcus pneumoniaeNeisseria meningitisHaemophilus influenzae)
 Diphtheria
 Pertussis
 Tetanus
 Other clostridial infections
  C. botulinum
  C. difficile
 Staphylococcal infections
  Toxic shock syndrome
  Antibiotic resistance
  S. epidermidis in newborns
 Invasive streptococcal disease (toxic shock syndrome)
 High-risk newborns
 Shock, intensive care, and trauma
Pseudomonas infection
  Cystic Fibrosis
  Burns
Viral diseases
 Hepatitis A
 Hepatitis B
 Hepatitis C
 HIV infection
 RSV infection
 Herpesvirus infections
  CMV
  EBV
  HSV
  VZV
 Parvovirus infection
 Enterovirus infection
  In newborns
 Ebola
 Rabies
 Measles
 Rubella
 Mumps
 Tick-borne encephalitis
 Vaccinia

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A Great Explanation of Active versus Passive Immunity by Dr. John Campbell, one of the pioneers in the field of immunology:Antibodies have been used for over a century in the prevention and treatment of infectious disease. They are used most commonly for the prevention of measles, hepatitis A, hepatitis B, tetanus, varicella, rabies, and vaccinia. Although their use in the treatment of bacterial infection has largely been supplanted by antibiotics, antibodies remain a critical component of the treatment of diptheria, tetanus, and botulism. High-dose intravenous immunoglobulin can be used to treat certain viral infections in immunocompromised patients (e.g., cytomegalovirus, parvovirus B19, and enterovirus infections). Antibodies may also be of value in toxic shock syndrome, Ebola virus, and refractory staphylococcal infections. Palivizumab, the first monoclonal antibody licensed (in 1998) for an infectious disease, can prevent respiratory syncytial virus infection in high-risk infants. The development and use of additional monoclonal antibodies to key epitopes of microbial pathogens may further define protective humoral responses and lead to new approaches for the prevention and treatment of infectious diseases.

 

However, developing successful neutralizing antibodies can still be difficult but with the latest monoclonal antibody technology, as highlighted by the following papers, this process has made much more efficient.  In addition, it is not feasable to isolate antibodies from the plasma of covalescent patients in a scale that is needed for a worldwide outbreak.

A good explanation of the need can be found is Dr. Irina Robu’s post Race to develop antibody drugs for COVID-19 where:

When fighting off foreign invaders, our bodies make antibodies precisely produced for the task. The reason vaccines offer such long-lasting protection is they train the immune system to identify a pathogen, so immune cells remember and are ready to attack the virus when it appears. Monoclonal antibodies for coronavirus would take the place of the ones our bodies might produce to fight the disease. The manufactured antibodies would be infused into the body to either tamp down an existing infection, or to protect someone who has been exposed to the virus. However, these drugs are synthetic versions of the convalescent plasma treatments that rely on antibodies from people who have recovered from infection. But the engineered versions are easier to scale because they’re manufactured in rats, rather than from plasma donors.

The following papers represent the latest published work on development of therapeutic and prophylactic neutralizing antibodies to the coronavirus SARS-CoV2

1.  Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody.

Pinto, D., Park, Y., Beltramello, M. et al. Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Nature (2020).                                                                            https://doi.org/10.1038/s41586-020-2349-y

Abstract

SARS-CoV-2 is a newly emerged coronavirus responsible for the current COVID-19 pandemic that has resulted in more than 3.7 million infections and 260,000 deaths as of 6 May 20201,2. Vaccine and therapeutic discovery efforts are paramount to curb the pandemic spread of this zoonotic virus. The SARS-CoV-2 spike (S) glycoprotein promotes entry into host cells and is the main target of neutralizing antibodies. Here we describe multiple monoclonal antibodies targeting SARS-CoV-2 S identified from memory B cells of an individual who was infected with SARS-CoV in 2003. One antibody, named S309, potently neutralizes SARS-CoV-2 and SARS-CoV pseudoviruses as well as authentic SARS-CoV-2 by engaging the S receptor-binding domain. Using cryo-electron microscopy and binding assays, we show that S309 recognizes a glycan-containing epitope that is conserved within the sarbecovirus subgenus, without competing with receptor attachment. Antibody cocktails including S309 along with other antibodies identified here further enhanced SARS-CoV-2 neutralization and may limit the emergence of neutralization-escape mutants. These results pave the way for using S309- and S309-containing antibody cocktails for prophylaxis in individuals at high risk of exposure or as a post-exposure therapy to limit or treat severe disease.

 

2.  Potent neutralizing antibodies against SARS-CoV-2 identified by high-throughput single-cell sequencing of convalescent patients’ B cells

Yunlong Cao et al.  Potent neutralizing antibodies against SARS-CoV-2 identified by high-throughput single-cell sequencing of convalescent patients’ B cells. Cell (2020).

https://doi.org/10.1016/j.cell.2020.05.025

Summary

The COVID-19 pandemic urgently needs therapeutic and prophylactic interventions. Here we report the rapid identification of SARS-CoV-2 neutralizing antibodies by high-throughput single-cell RNA and VDJ sequencing of antigen-enriched B cells from 60 convalescent patients. From 8,558 antigen-binding IgG1+ clonotypes, 14 potent neutralizing antibodies were identified with the most potent one, BD-368-2, exhibiting an IC50 of 1.2 ng/mL and 15 ng/mL against pseudotyped and authentic SARS-CoV-2, respectively. BD-368-2 also displayed strong therapeutic and prophylactic efficacy in SARS-CoV-2-infected hACE2-transgenic mice. Additionally, the 3.8Å Cryo-EM structure of a neutralizing antibody in complex with the spike-ectodomain trimer revealed the antibody’s epitope overlaps with the ACE2 binding site. Moreover, we demonstrated that SARS-CoV-2 neutralizing antibodies could be directly selected based on similarities of their predicted CDR3H structures to those of SARS-CoV neutralizing antibodies. Altogether, we showed that human neutralizing antibodies could be efficiently discovered by high-throughput single B-cell sequencing in response to pandemic infectious diseases.

3. A human monoclonal antibody blocking SARS-CoV-2 infection

Wang, C., Li, W., Drabek, D. et al. A human monoclonal antibody blocking SARS-CoV-2 infection. Nat Commun 11, 2251 (2020). https://doi.org/10.1038/s41467-020-16256-y

Abstract

The emergence of the novel human coronavirus SARS-CoV-2 in Wuhan, China has caused a worldwide epidemic of respiratory disease (COVID-19). Vaccines and targeted therapeutics for treatment of this disease are currently lacking. Here we report a human monoclonal antibody that neutralizes SARS-CoV-2 (and SARS-CoV) in cell culture. This cross-neutralizing antibody targets a communal epitope on these viruses and may offer potential for prevention and treatment of COVID-19.

Extra References on Development of Neutralizing antibodies for COVID19 {Sars-CoV2} published this year (2020)  [1-4]

  1. Fan P, Chi X, Liu G, Zhang G, Chen Z, Liu Y, Fang T, Li J, Banadyga L, He S et al: Potent neutralizing monoclonal antibodies against Ebola virus isolated from vaccinated donors. mAbs 2020, 12(1):1742457.
  2. Dussupt V, Sankhala RS, Gromowski GD, Donofrio G, De La Barrera RA, Larocca RA, Zaky W, Mendez-Rivera L, Choe M, Davidson E et al: Potent Zika and dengue cross-neutralizing antibodies induced by Zika vaccination in a dengue-experienced donor. Nature medicine 2020, 26(2):228-235.
  3. Young CL, Lyons AC, Hsu WW, Vanlandingham DL, Park SL, Bilyeu AN, Ayers VB, Hettenbach SM, Zelenka AM, Cool KR et al: Protection of swine by potent neutralizing anti-Japanese encephalitis virus monoclonal antibodies derived from vaccination. Antiviral research 2020, 174:104675.
  4. Sautto GA, Kirchenbaum GA, Abreu RB, Ecker JW, Pierce SR, Kleanthous H, Ross TM: A Computationally Optimized Broadly Reactive Antigen Subtype-Specific Influenza Vaccine Strategy Elicits Unique Potent Broadly Neutralizing Antibodies against Hemagglutinin. J Immunol 2020, 204(2):375-385.

 

For More Articles on COVID-19 Please see Our Coronavirus Portal on this Open Access Scientific Journal at:

https://pharmaceuticalintelligence.com/coronavirus-portal/

and the following Articles on  Immunity at

Race to develop antibody drugs for COVID-19
Bispecific and Trispecific Engagers: NK-T Cells and Cancer Therapy
Issues Need to be Resolved With ImmunoModulatory Therapies: NK cells, mAbs, and adoptive T cells
Antibody-bound Viral Antigens

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Race to develop antibody drugs for COVID-19

Reporter: Irina Robu, PhD

Even at the record pace vaccines are moving, the first vaccine for COVID-19 might not be available until next year. And even if it is available, it will take longer for enough people within the population to be vaccinated in order to achieve herd immunity and curb the spread. Companies such as Regeneron, Eli Lily, Amgen and Vir Biotechnology are leading the race to produce therapies that could give patients infected with COVID-19 short term protection. However, several experts believe that developing antibody drugs are vital.
At this time, Gilead’s antiviral drug remdesivir, which seems to help hasten recovery from COVID-19, but not entirely. There is no guarantee that these injectable biologic drugs won’t solve the pandemic. Yet, many believe that in combination with mass testing and tracing measures, these injectable biologic drugs could be a critical tool for keeping the disease in check.

When fighting off foreign invaders, our bodies make antibodies precisely produced for the task. The reason vaccines offer such long-lasting protection is they train the immune system to identify a pathogen, so immune cells remember and are ready to attack the virus when it appears. Monoclonal antibodies for coronavirus would take the place of the ones our bodies might produce to fight the disease. The manufactured antibodies would be infused into the body to either tamp down an existing infection, or to protect someone who has been exposed to the virus.

However, these drugs are synthetic versions of the convalescent plasma treatments that rely on antibodies from people who have recovered from infection. But the engineered versions are easier to scale because they’re manufactured in rats, rather than from plasma donors.

Yet, what brands antibodies unique in comparison to vaccines or antiviral drugs is their potential to both treat and protect against viral infections and could work as a short-term preventative for healthcare workers who are at high risk of contracting COVID-19 or as a treatment for people who are already sick. But it is up to creators to figure out exactly when is the best time is to interfere with an antibody drug. More persuasively, antibodies will deliver the greatest value for the people at the highest risk like healthcare workers or people who are old or immuno-compromised.

Over the years of research, it is shown that some vaccines are only effective in a part of population. But making a vaccine takes time, and they don’t kick in immediately. So, proving the monoclonal antibodies can treat patients with COVID-19 disease can be much faster and easier than showing a preventive benefit. As with vaccines, antibodies would have to succeed in much longer tests to fully show they can prevent infections. Vaccine aside, the only treatments granted emergency use by the FDA thus far are the antiviral remdesivir and the generic malaria pill hydroxychloroquine.

Regeneron, Amgen, Vir and Eli Lilly are each using different methods to screen for and develop their antibodies. The initial experiments may lead to different type of products where one type of antibody versus a cocktail of two or three. The antibodies are designed to mimic the ones our bodies make versus those that are modified in some way to improve their properties. Modifying an antibody could help it last longer, but make it look more foreign to the immune system, which could lead to potential problems.
What makes antibodies unique compared to vaccines or antiviral drugs is their potential to both treat and protect against viral infections. The idea is that an antibody drug will bind to the “spike” protein SARS-CoV-2 uses to crack open cells, and prevent the virus from entering. The fastest path to success for an antibody is possible through a drug that has to be given intravenously in a hospital or clinic, rather than through an auto-injector a patient could self-administer.

SOURCE

https://www.biopharmadive.com/news/coronavirus-antibody-drug-trials/577778/

As We Wait For a Vaccine, Scientists Eye Antibodies

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The Seasonality of COVID-19

Reporter: Irina Robu, PhD

There are several similarities between SARS-CoV-2 and SARS-CoV, because both viruses share a high degree of homology to SARS-like coronaviruses isolated from bats. The entire genome of SARS-CoV-2 has 86% similarity with SARS-CoV. COVID-19, SARS-CoV-2 has a higher transmissibility than SARS-CoV, where more patients with COVID-19 have mild symptoms that contribute to spread because the patients are usually missed and not isolated.

Even in terms of disease dynamics, the similarities include transmission route via respiratory droplets. The angiotensin-converting enzyme 2 (ACE2), found in the lower respiratory tract of humans, has been identified as the receptor used for cell entry for both SARS-CoV and SARS-CoV-2.

So even though the viruses seem similar, there are some strong differences as well. Patients reports from China, Europe and United states show that some patients have also cardiac issues. The scientist do not truly understand what is happening at this point, whether people are having heart attacks (myocardial infarction) or whether the virus is actually invading the heart tissue to cause inflammation (myocarditis)

The great concern is that many people are asymptomatic with this condition, have no symptoms. This is what makes the virus so complicated is because you can have a group of patients severely sick and in the intensive care unit and in some cases, there are older individuals and some with underlying diabetes and heart disease, hypertension, renal disease.

Even though, the US has a large number of cases of over one million and at least 84,000 deaths, but due to undertesting, the true numbers of cases are probably far higher. The big unknown is that there is no clear understanding what is going to happen in the next coming months or years with the virus. However, the investigation models indicate that the virus has a probably of returning seasonally in the coming years.

Yet, people have to be mindful and recognize that even if we begin relaxing social distancing and transmission diminishes, that it could come back in these periodic waves, as suggested by the model.

SOURCE

https://www.medpagetoday.com/infectiousdisease/covid19/86049?xid=nl_mpt_DHE_2020-04-21

Seasonality of SARS-CoV-2: Will COVID-19 go away on its own in warmer weather?

 

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Powerful AI Tools Being Developed for the COVID-19 Fight

Curator: Stephen J. Williams, Ph.D.

 

Source: https://www.ibm.com/blogs/research/2020/04/ai-powered-technologies-accelerate-discovery-covid-19/

IBM Releases Novel AI-Powered Technologies to Help Health and Research Community Accelerate the Discovery of Medical Insights and Treatments for COVID-19

April 3, 2020 | Written by: 

IBM Research has been actively developing new cloud and AI-powered technologies that can help researchers across a variety of scientific disciplines accelerate the process of discovery. As the COVID-19 pandemic unfolds, we continue to ask how these technologies and our scientific knowledge can help in the global battle against coronavirus.

Today, we are making available multiple novel, free resources from across IBM to help healthcare researchers, doctors and scientists around the world accelerate COVID-19 drug discovery: from gathering insights, to applying the latest virus genomic information and identifying potential targets for treatments, to creating new drug molecule candidates.

Though some of the resources are still in exploratory stages, IBM is making them available to qualifying researchers at no charge to aid the international scientific investigation of COVID-19.

Today’s announcement follows our recent leadership in launching the U.S. COVID-19 High Performance Computing Consortium, which is harnessing massive computing power in the effort to help confront the coronavirus.

Streamlining the Search for Information

Healthcare agencies and governments around the world have quickly amassed medical and other relevant data about the pandemic. And, there are already vast troves of medical research that could prove relevant to COVID-19. Yet, as with any large volume of disparate data sources, it is difficult to efficiently aggregate and analyze that data in ways that can yield scientific insights.

To help researchers access structured and unstructured data quickly, we are offering a cloud-based AI research resource that has been trained on a corpus of thousands of scientific papers contained in the COVID-19 Open Research Dataset (CORD-19), prepared by the White House and a coalition of research groups, and licensed databases from the DrugBankClinicaltrials.gov and GenBank. This tool uses our advanced AI and allows researchers to pose specific queries to the collections of papers and to extract critical COVID-19 knowledge quickly. Please note, access to this resource will be granted only to qualified researchers. To learn more and request access, please click here.

Aiding the Hunt for Treatments

The traditional drug discovery pipeline relies on a library of compounds that are screened, improved, and tested to determine safety and efficacy. In dealing with new pathogens such as SARS-CoV-2, there is the potential to enhance the compound libraries with additional novel compounds. To help address this need, IBM Research has recently created a new, AI-generative framework which can rapidly identify novel peptides, proteins, drug candidates and materials.

We have applied this AI technology against three COVID-19 targets to identify 3,000 new small molecules as potential COVID-19 therapeutic candidates. IBM is releasing these molecules under an open license, and researchers can study them via a new interactive molecular explorer tool to understand their characteristics and relationship to COVID-19 and identify candidates that might have desirable properties to be further pursued in drug development.

To streamline efforts to identify new treatments for COVID-19, we are also making the IBM Functional Genomics Platform available for free for the duration of the pandemic. Built to discover the molecular features in viral and bacterial genomes, this cloud-based repository and research tool includes genes, proteins and other molecular targets from sequenced viral and bacterial organisms in one place with connections pre-computed to help accelerate discovery of molecular targets required for drug design, test development and treatment.

Select IBM collaborators from government agencies, academic institutions and other organizations already use this platform for bacterial genomic study. And now, those working on COVID-19 can request the IBM Functional Genomics Platform interface to explore the genomic features of the virus. Access to the IBM Functional Genomics Platform will be prioritized for those conducting COVID-19 research. To learn more and request access, please click here.

Drug and Disease Information

Clinicians and healthcare professionals on the frontlines of care will also have free access to hundreds of pieces of evidence-based, curated COVID-19 and infectious disease content from IBM Micromedex and EBSCO DynaMed. Using these two rich decision support solutions, users will have access to drug and disease information in a single and comprehensive search. Clinicians can also provide patients with consumer-friendly patient education handouts with relevant, actionable medical information. IBM Micromedex is one of the largest online reference databases for medication information and is used by more than 4,500 hospitals and health systems worldwide. EBSCO DynaMed provides peer-reviewed clinical content, including systematic literature reviews in 28 specialties for comprehensive disease topics, health conditions and abnormal findings, to highly focused topics on evaluation, differential diagnosis and management.

The scientific community is working hard to make important new discoveries relevant to the treatment of COVID-19, and we’re hopeful that releasing these novel tools will help accelerate this global effort. This work also outlines our long-term vision for the future of accelerated discovery, where multi-disciplinary scientists and clinicians work together to rapidly and effectively create next generation therapeutics, aided by novel AI-powered technologies.

Learn more about IBM’s response to COVID-19: IBM.com/COVID19.

Source: https://www.ibm.com/blogs/research/2020/04/ai-powered-technologies-accelerate-discovery-covid-19/

DiA Imaging Analysis Receives Grant to Accelerate Global Access to its AI Ultrasound Solutions in the Fight Against COVID-19

Source: https://www.grantnews.com/news-articles/?rkey=20200512UN05506&filter=12337

Grant will allow company to accelerate access to its AI solutions and use of ultrasound in COVID-19 emergency settings

TEL AVIV, IsraelMay 12, 2020 /PRNewswire-PRWeb/ — DiA Imaging Analysis, a leading provider of AI based ultrasound analysis solutions, today announced that it has received a government grant from the Israel Innovation Authority (IIA) to develop solutions for ultrasound imaging analysis of COVID-19 patients using Artificial Intelligence (AI).Using ultrasound in point of care emergency settings has gained momentum since the outbreak of COVID-19 pandemic. In these settings, which include makeshift hospital COVID-19 departments and triage “tents,” portable ultrasound offers clinicians diagnostic decision support, with the added advantage of being easier to disinfect and eliminating the need to transport patients from one room to another.However, analyzing ultrasound images is a process that it is still mostly done visually, leading to a growing market need for automated solutions and decision support.As the leading provider of AI solutions for ultrasound analysis and backed by Connecticut Innovations, DiA makes ultrasound analysis smarter and accessible to both new and expert ultrasound users with various levels of experience. The company’s flagship LVivo Cardio Toolbox for AI-based cardiac ultrasound analysis enables clinicians to automatically generate objective clinical analysis, with increased accuracy and efficiency to support decisions about patient treatment and care.

The IIA grant provides a budget of millions NIS to increase access to DiA’s solutions for users in Israel and globally, and accelerate R&D with a focus on new AI solutions for COVID-19 patient management. DiA solutions are vendor-neutral and platform agnostic, as well as powered to run in low processing, mobile environments like handheld ultrasound.Recent data highlights the importance of looking at the heart during the progression of COVID-19, with one study citing 20% of patients hospitalized with COVID-19 showing signs of heart damage and increased mortality rates in those patients. DiA’s LVivo cardiac analysis solutions automatically generate objective, quantified cardiac ultrasound results to enable point-of-care clinicians to assess cardiac function on the spot, near patients’ bedside.

According to Dr. Ami Applebaum, the Chairman of the Board of the IIA, “The purpose of IIA’s call was to bring solutions to global markets for fighting COVID-19, with an emphasis on relevancy, fast time to market and collaborations promising continuity of the Israeli economy. DiA meets these requirements with AI innovation for ultrasound.”DiA has received several FDA/CE clearances and established distribution partnerships with industry leading companies including GE Healthcare, IBM Watson and Konica Minolta, currently serving thousands of end users worldwide.”We see growing use of ultrasound in point of care settings, and an urgent need for automated, objective solutions that provide decision support in real time,” said Hila Goldman-Aslan, CEO and Co-founder of DiA Imaging Analysis, “Our AI solutions meet this need by immediately helping clinicians on the frontlines to quickly and easily assess COVID-19 patients’ hearts to help guide care delivery.”

About DiA Imaging Analysis:
DiA Imaging Analysis provides advanced AI-based ultrasound analysis technology that makes ultrasound accessible to all. DiA’s automated tools deliver fast and accurate clinical indications to support the decision-making process and offer better patient care. DiA’s AI-based technology uses advanced pattern recognition and machine-learning algorithms to automatically imitate the way the human eye detects image borders and identifies motion. Using DiA’s tools provides automated and objective AI tools, helps reduce variability among users, and increases efficiency. It allows clinicians with various levels of experience to quickly and easily analyze ultrasound images.

For additional information, please visit http://www.dia-analysis.com.

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Promises on Covid-19 Vaccines

Reporter: Irina Robu, PhD

Vaccines play a vital role in keeping us healthy. Currently, scientists are racing through development at speeds never before seen. Even if the stages of vaccine development could be compressed and supplies could be quickly manufactured, it could take months or longer before people can have access to it.

The World Health Organization closely monitors Covid-19 vaccines which are designed in academic laboratories without having the commercial production capacity. Whereas China has widespread vaccine production capacity and other developing countries including India, Indonesia, and Brazil are amongst the world’s largest vaccine producers and exporters, a sizable amount of the manufacturing capacity belonging to pharmaceutical companies that sell vaccine in North America and Europe is based in the United States.

Assuming a vaccine can be developed rapidly, the production of some vaccine candidates could be easily ramped up than others it is conceivable that they could use the existing plants to produce more vaccines. Production of this type of candidate could reach hundreds of millions of doses within about a year, yet any vaccines would require longer time to reach those output levels.

An RNA vaccine project is being developed by Pfizer and BioNTech, began testing four possible vaccines in a compressed Phase ½ trial in the US on May 5, 2020. In addition, Moderna signed a deal with pharmaceutical company Lonzo to produce 1 billion doses of the vaccine in the U.S. and in Switzerland. Nevertheless, of who gets vaccines, it is believed that most new vaccines will require at least two doses to be effective, so any estimates of numbers of doses available in the autumn will need to be divided by two to find out how many people could expect to be vaccinated. The public, both in US and abroad need clear communications about realistic times to COVID-19 vaccine access. Yet when vaccines do start to become available, demand will be enormous and supply will be minimal.

SOURCE

Mounting promises on Covid-19 vaccines are fueling false expectations, experts say

https://www.the-scientist.com/news-opinion/covid-19-vaccine-frontrunners-67382

https://www.biospace.com/article/moderna-vaccine-clinical-trial-moves-into-2nd-round-of-dosing/

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Blood Clots Tied to Coronavirus Problems

Reporter: Irina Robu, PhD

Frequent complications of COVID-19 include purple rashes, swollen legs, clogged catheters and sudden death. Anyone with a severe illness is at risk of developing clots, but hospitalized patients with COVID-19 appear to be more susceptible. Blood clots in the deep veins of the body can occur due to injury/damage, inactivity, surgery, chemotherapy for cancer. Injuries like bone fractures or muscle tears can cause damage to blood vessels, leading to clots. Yes, due to long periods of inactivity, gravity causes blood to stagnate in the lowest areas of your body.

Yet, blood clots can form a variety of reasons. One of the most known blood clots that form in veins is pulmonary embolism caused by deep vein thrombosis. In some cases, a pulmonary embolism can be difficult to diagnose when you have an underlying lung or heart condition. It is possible that anything that gets in the bloodstream and then lodges in the smaller pulmonary arteries can be a pulmonary embolism.

Research from Netherlands and France suggest that clots appear in 20% to 30% of critically ill COVID-19 patients. Researchers have a few credible hypotheses to explain the phenomenon and they are starting to launch studies aimed at gaining mechanistic visions. But with the death toll rising, they are also scrambling to test clot-curbing medications. Common anticoagulant blood thinners such as warfarin and enoxaparin don’t reliably avert clotting in people with COVID-19 and young people are dying of strokes caused by the blockages in the brain. It is indicated that patients in the hospital have extremely elevated levels of a protein fragment called D-dimer, which is generated when a clot breaks down. High levels of D-dimer appear to be a powerful predictor of mortality in hospitalized patients infected with coronavirus.

Jeffrey Laurence, a hematologist at Weill Cornell Medicine in New York City studied lung and skin samples from three people infected with COVID-19 and found that the capillaries were clogged with clots. Even with all the research, how clotting occurs is still a mystery. One probability is that SARS-CoV-2 is unswervingly attacking the endothelial cells that line the blood vessels, which harbor the same ACE2 receptor that the virus uses to enter lung cells. This is confirmed by researchers from University Hospital Zurich in Switzerland and Brigham and Women’s Hospital in Boston, Massachusetts, who observed SARS-Cov-2 in endothelial cells inside kidney tissue.

Clotting can also be affected by the virus effects, because in some people COVID-19 prompts immune cells to release a torrent of chemical signals that ramps up inflammation. As the virus appears to activate the complement system, it then sparks clotting which acts a defense mechanism. People with the COVID-19 disease who become hospitalized usually have a number of risk factors for clotting such as high blood pressure, diabetes and/or genetic predisposition to clotting.

While researchers initiate how clotting occurs in people with COVID-19, they’re hurrying to test new therapies meant at preventing and busting clots. Blood-thinning medications are usually the standard of care for patients in the intensive-care unit and patients with COVID-19 are no exception. Similar trials are planned for scientists at Beth Israel Deaconess Medical Center have started enrolment for a clinical trial to evaluate an even more powerful clot-busting medication, tissue plasminogen activator. TPK is a drug more potent that carries higher risks of serious bleeding than do blood thinners. Scientists anticipate that these trials and others will deliver the data required to help physicians to make difficult treatment decisions.

SOURCE

https://www.scientificamerican.com/article/blood-clots-are-mysteriously-tied-to-many-coronavirus-problems/?fbclid=IwAR2SsBh00fkPjSqgCYyFpwCu6FlZbmnsYtSDYHqZ7xW_Dw2yP7f9HaLUhTE

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via Dr. Giordano Featured in Forbes Article on COVID-19 Antibody Tests in Italy and USA

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