Category: Corona Virus Vaccine

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COVID-19 hospitalizations fall across the state, even in southern Maine – Press Herald

June 14, 2020

Hospitalizations for COVID-19 continued to fall across the state over the past week, even in the parts of southern Maine that have continued to see significant numbers of people testing positive for the disease.

At Maine Medical Center, which has had nearly half of the states confirmed coronavirus inpatients through most of the crisis, the number of confirmed COVID-19 inpatients hovered at between eight and 11 over the week ending Thursday, down from a peak level of 35 hit on both April 7 and May 25. The inpatient count Tuesday and Wednesday was the lowest daily number there since March 22, at the beginning of the crisis.

At Portlands other major hospital, Mercy, the number of inpatients fell from five to zero during the period, down from five to eight the previous week and eight to 10 the week before that, which had been the busiest that hospital had experienced during the pandemic.

In Androscoggin County, hospitalizations have fortunately not been paralleling discouraging trends in new cases. The county saw a dramatic spike in new COVID-19 cases in mid-May going from a seven-day average of one case at the end of April to more than 15 on May 23 and over the past seven days has averaged a still-high nine cases a day, according to data from the Maine Center for Disease Control and Prevention.

Statewide, 29 people were hospitalized Thursday with COVID-19. Thats fewer than half of the 60 who were hospitalized with the disease just two weeks earlier.

Hospitalizations, when they occur, typically follow at least two weeks after exposure, but the countys two major hospitals have no seen a commiserate spike.

Central Maine Medical Center, however, averaged 1.7 COVID-19 inpatients a day over the past week and 0.7 patients a day the week before that. Lewistons other hospital, St. Marys, reporting for the first time, averaged 3.7 a day, roughly comparable to the week before, though an exact comparison could not be made because the older data included presumed COVID-19 cases, not just confirmed ones.

Dr. John Alexander, chief medical officer for CMMCs parent, Central Maine Health Care, said this is happening because testing expanded in May to include more younger and healthier people who are less likely to be hospitalized by the disease.

Because we had very limited testing capacity early on, we only wanted to test people who had a very high likelihood of both having the disease and having an adverse outcome, Alexander said. Now we are just testing exposures very widely.

Alexander also said the low levels of hospitalizations in the state are in large degree due to Mainers taking the disease seriously. As a state, we have understood and we have taken into action the guidance around masking, around social distancing and around essentially keeping each other safe, he said.

The data, for the week ending June 11, was collected directly from the hospitals by the Press Herald, which has been reporting the hospital-by-hospital trends weekly since April 18.

York Countys hospitals were also relatively quiet. Southern Maine Health Care Medical Center in Biddeford which has had the most pandemic inpatients overall after Maine Med averaged three COVID-19 inpatients a day for the week, down from 4.1 a day the week before. York Hospital in York had no COVID-19 inpatients for the second week running.

MaineGeneral in Augusta, the hospital which has had the fourth largest pandemic burden to date, fell to an average of one patient a day for the week, down from 3.1 patients the week before. Eastern Maine Medical Center in Bangor had no COVID-19 inpatients at all, and Mid Coast Hospital in Brunswick hasnt had such a patient since May 23.

Three smaller hospitals reported having a patient during the course of the week: Bridgton, Waldo in Belfast and Franklin Memorial in Farmington. The Press Heralds survey includes most of the states hospitals and accounts for the vast majority of the statewide hospitalizations reported by the Maine CDC each week.

In all cases, hospitalizations can end three ways: recovery, death, or transfer to another facility. The data does not include outpatients or inpatients who were suspected of having the virus but never tested.

Hospitalizations are a lagging indicator, because it typically takes two or three weeks after exposure for an acutely affected person to become sick enough to be admitted, but it is one metric that is not effected by how many people are tested.

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COVID-19 hospitalizations fall across the state, even in southern Maine - Press Herald

Coronavirus vaccine maker is also developing a promising …

June 11, 2020

The first coronavirus vaccines might be ready for public use in late 2020, assuming everything goes well during the last stages of human testing, but it will take years for pharmaceutical companies to manufacture enough of the vaccine to meet demand. Immunizing the global population might be even more challenging if COVID-19 immunity turns out to be short-lived. Dr. Anthony Fauci and other experts warned that protection could last between six and twelve months, which is the case for the four known human coronaviruses that cause common colds. If that turns out to be the case for SARS-CoV-2, then people could catch the disease again after the acquired immunity wanes.

However, researchers studying new COVID-19 therapies arent placing all their eggs in the same basket. More than 130 teams are working on vaccines, but many hospitals are running trials with existing medicines that can be used to hasten recovery remdesivir is one such example. More importantly, other researches are looking at brand new drugs that can combine the best of both worlds. They can both treat existing COVID-19 patients and provide limited protection to people who havent contracted the disease.

The new drugs are known as monoclonal antibodies, which are drugs based on antibodies that can neutralize a pathogen. Several companies have identified human and animal antibodies that can prevent the SARS-CoV-2 virus from binding to the healthy human cells and invading them.

AstraZeneca announced on Tuesday that its going forward with six promising coronavirus-neutralizing antibodies of the more than 1,500 variations it had tested in lab conditions. The company licensed the antibodies from Vanderbilt University and evaluated their ability to inhibit the coronavirus. AstraZeneca signed an exclusivity deal for the six compounds and will combine two of them in a clinical trial set to start in the coming months.

The purpose of using both antibodies is to potentially increase the effectiveness of the resulting drug. The antibodies will target parts of the receptor-binding domain of the spike protein seen in the following illustration.

Schematic showing the spike protein of the novel coronavirus. Image source: AstraZeneca

By preventing the virus from interacting with cells via the spike protein, these drugs would stop a critical step in the replication of the coronavirus. Antibodies prevent the virus from creating hundreds of millions of copies of itself. As a result, monoclonal antibody therapies could help COVID-19 patients recover faster, and boost the immunity of patients who are likely to develop complications, including the elderly and people with existing health conditions.

Monoclonal antibodies are somewhat similar to vaccines when it comes to providing protection to people who have not been infected. The difference between the two is that vaccines teach the immune system to produce its own antibodies, and the immunity lasts longer. Monoclonal drugs only lend antibodies to a patient, and once they expire, the protection wears off. The protection would be shorter than vaccines, but it could still save lives.

AstraZeneca says that the candidates it chose for the human trial have an extended half-life, as theyre engineered using proprietary technology to extend their longevity in the body.

AstraZeneca infographic explains the process of developing monoclonal antibodies therapies for COVID-19. Image source: AstraZeneca

These drugs may be enough to supplement vaccines and other therapies, and could very well replace them if vaccines arent available. Not to mention that monoclonal antibody treatments might turn out to be easier to manufacture and distribute than vaccines. Before that happens, AstraZeneca and everyone else developing similar courses of treatment have to prove the drugs actually inhibit the virus. The company has signed agreements with academia and US government agencies on the project.

Separately, AstraZeneca partnered with the team behind the famous Oxford vaccine and plans to produce hundreds of millions of doses if the vaccine proves to be effective.

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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Coronavirus vaccine maker is also developing a promising ...

Coronavirus breakthroughs: How close are we to a vaccine?

June 11, 2020

Researchers from around the world are all racing to find a vaccine for COVID-19.

And theyre close a number of approaches are about to start human trials from Band-Aid-like microneedle stickers to traditional shots in the arm. Still, experts say, widespread vaccine use could be at least a couple of years away.

If everything went perfectly, well, [it would take] 18 months to two years minimum, says Dr. Kevin Tracey, president of the Feinstein Institutes for Medical Research at Northwell Health. More realistically, three to four years and that would still be fast.

Still, Tracey and other researchers on the front line of the pandemic have more hope lately.

We will beat this virus, whether its 18 months, two years or four years, he tells The Post. Our treatment protocols are improving every day.

Heres what we know so far.

One of the most promising COVID-19 vaccines is in the works from Moderna Therapeutics, a Cambridge, Massachussets, biotech company, and human trials have already begun bringing it one step closer to the necessary FDA approval.

The vaccine was developed at a rapid speed, partly due to China releasing the genetic sequencing for the novel coronavirus in January, giving scientists around the world a head start. Researchers were also able to refurbish previous vaccine research on another coronavirus, the Middle Eastern respiratory syndrome (MERS), and its outbreak in 2012.

Another vaccine on tap is from Novavax, a Maryland-based company that has reworked its previous vaccine research from the similar coronavirus, severe acute respiratory syndrome (SARS), and its outbreak in 2002-2004. According to TIME, Novavax has several candidates, that will be ready for testing on humans in the coming months.

University of Pittsburgh researchers also hope to start human clinical trials this spring for their newly developed vaccine that uses microneedle technology to administer the medication, rather than an actual needle. The vaccine was also based on previous research on MERS and SARS, and their work was recently published in the Lancet.

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, said co-senior author Dr. Andrea Gambotto, associate professor of surgery at the Pitt School of Medicine. We knew exactly where to fight this new virus.

Another vaccine trial that has been approved by the FDA for human testing is by Inovio Pharmaceuticals which is backed by Bill and Melinda Gates. Like the others, the vaccine is a spin-off of a previously developed MERS vaccine that already had a promising phase 1 study.

Going from mice to humans to worldwide use doesnt happen overnight. Some vaccines take decades before theyre used if ever.

Tracey notes that the flu and polio vaccines took decades to develop, and when it comes to viruses like COVID-19, there is a two-arm approach to drug research: You can try to find a vaccine to treat a wide population or you can treat the virus head-on, like with HIV, for example. After all these years, there is still no HIV vaccine, but scientists have found drugs that treat the virus.

When it comes to vaccine development, once the human testing phase begins, scientists first have to determine if the vaccine causes an antibody response, Tracey tells The Post. Next, scientists have to see if the produced antibodies are effective against the virus. Then, of course, researchers have to make sure the antibodies arent dangerous.

Some people make good antibodies and some people make bad ones, and some people can make both, Tracey says. Bad antibodies can make the infection worse.

For example, if you immunize 1,000 people with a vaccine that protects 900 of them, but it makes 100 people worse, thats a disaster, Tracey says.

You cant make the clock run faster, Tracey says. You cant rush these things. A vaccine is going in healthy people. It has to have almost zero side effects.

The CDCs website is clear: There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.

But the agency does list two therapies under investigation to treat COVID-19.

First, the controversial hydroxychloroquine and chloroquine, which are taken orally and have been used in the past for the treatment of malaria and some inflammatory conditions, is also being studied as a treatment of patients with mild, moderate and severe COVID-19, according to the CDC. But theres only anecdotal evidence that the medicine could combat the coronavirus, and federal officials dont recommend taking the drug in an uncontrolled environment.

Its potential side effects include everything from fatal heart arrhythmia to vision loss, ear-ringing, vomiting, mood changes, skin rashes and hair loss.

A second drug, Remdesivir, manufactured by the California-based biotech company Gilead Sciences, has been in creation for a decade. It was once seen as a potential Ebola treatment but those trials were unsuccessful. Results from the first clinical trial testing Remdesivir administered through an IV for COVID-19 are expected this month.

The CDC says but does not name that there are numerous other treatments in the works.

One such treatment is the Japanese flu drug, favipiravir, which is already being used as a treatment in Turkey and Japan. Made by Fujifilm, the drug was found to improve lung function in 91% of patients in a Chinese study. On Tuesday, three Massachusetts hospitals received FDA approval to launch the first clinical trials of the drug.

Another promising treatment comes from researchers at Johns Hopkins, who have developed a therapy that uses blood plasma from recovered patients. Last week, the FDA approved a clinical trial for Johns Hopkins to test the therapy as a preventive measure on healthy people. The university is also waiting on FDA approval for another trial this time, on patients who are slightly or moderately ill to see if the serum will keep them out of ICUs and help bring them back to health, according to the university.

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Coronavirus breakthroughs: How close are we to a vaccine?

AstraZeneca is aiming to produce 2 billion doses of a coronavirus vaccine and it could be ready by September – CNBC

June 11, 2020

Pharmaceutical company AstraZeneca is aiming to produce 2 billion doses of a coronavirus vaccine, including 400 million for the U.S. and U.K. and 1 billion for those in low- and middle-income countries.

It plans to start distributing the vaccine to the U.S. and U.K. in September or October, with the balance of deliveries likely to be made by early 2021, according to AstraZeneca CEO Pascal Soriot, on a call with journalists Thursday.

AstraZeneca said it had signed a licensing deal with the Serum Institute of India to provide 1 billion doses to low- and middle-income countries, with 400 million of those shots set to be delivered by the end of 2020, according to a press release Thursday.

The vaccine, named AZD1222, was originally developed by Oxford University in the U.K. and AstraZeneca is working with pharmaceutical industry partners to manufacture and distribute the drug.

Soriot said the distribution was dependent on clinical trials taking place by August. Clinical trials and manufacturing are set to occur concurrently, which is an unprecedented move for the pharmaceutical industry because of the risk of producing a drug that might not work.

"We are very focused and very committed. When you have something like this with this sort of pandemic and the tremendous impact it has on people, the economy, et cetera, you can't second-guess what's going to happen. You can't spend your time figuring out is it going to work or not going to work, you just have to commit. We come in and make a bet on some of these things," Soriot said on the call.

Oxford University's Jenner Institute has worked with the Oxford Vaccine Group to develop the AZD1222 vaccine that includes a protein of the SARS CoV-2 virus strain, which causes the coronavirus disease known as Covid-19. It is currently testing the drug in around 10,000 adult volunteers. So far it has been "safe and well-tolerated," according to AstraZeneca's press release.

Asked whether the vaccine will work, Soriot said, "The chance of the vaccine working I would say we all have pretty good hope from what we've seen so far, but we can't be sure of course," adding that the company is creating a comprehensive database of safety information and expects to eventually have clinical trials with more than 50,000 volunteers taking part.

Trials are running concurrently with manufacturing to make the vaccine available as early as possible, according to Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, which is working with AstraZeneca on the drug's production. "Obviously, if the vaccine is successful, placing that early bet on the manufacturing gives a huge payoff because you end up with tens or even hundreds of millions of doses that become available at the earliest possible moment," he said on the call with journalists Thursday.

"We believe we can get the vaccine to hundreds of millions of people around the world, importantly, including those in the countries with the lowest income. So our goal is really to not leave anybody behind," Soriot said.

On Thursday, governments and businesses said they would give $8.8 billion to a vaccine allianceknown as Gavi, which is backed by the Bill & Melinda Gates Foundation. The foundation and the World Health Organization have created a mechanism known as the Access to Covid-19 Tools Accelerator to make sure the vaccine is distributed fairly.

Correction: A quote in this story has been updated and extended to more accurately reflect the comments made byAstraZeneca CEO Pascal Soriot.

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AstraZeneca is aiming to produce 2 billion doses of a coronavirus vaccine and it could be ready by September - CNBC

Fauci: US government to fund and conduct studies on three possible coronavirus vaccines – KMBC Kansas City

June 11, 2020

The U.S. government will fund and conduct key studies on three experimental coronavirus vaccines, Dr. Anthony Fauci, the nation's top infectious disease expert, tells CNN.Phase 3 trials, which typically involve tens of thousands of people and measure whether a vaccine is safe and effective, will begin with one by Moderna in July, then an Oxford/AstraZeneca vaccine in August and one by Johnson & Johnson in September.The funding and trial timing were first reported by the Wall Street Journal. CNN has reached out to the companies for comment."The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer," Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. "This is good news for the overall coronavirus vaccine effort."Each Phase 3 trial is expected to take place at more than 50 sites, mostly in the United States, but possibly in other countries, too. The trials, which are expected to include about 30,000 people, will begin only after there's enough evidence of safety and efficacy from earlier trial stages.The U.S. government might also plan Phase 3 trials for additional coronavirus vaccines currently in development. According to the World Health Organization, there are 10 vaccines currently in human trials and 126 more in development.Fauci said the funding decision came from the Department of Health and Human Services, in consultation with the National Institute of Health and other agencies. He also said that the testing plans still track with the timeline that he has suggested in the past: a vaccine at scale by the end of the year or early next year.Last week, Fauci said the U.S. should have 100 million doses of one candidate coronavirus vaccine by the beginning of 2021, but many doctors caution that is an ambitious goal. He has also said there will be "more than one winner" in the COVID-19 vaccine field on Tuesday.The number of confirmed coronavirus cases in the U.S. is nearing two million, and more than 112,000 Americans have died.

The U.S. government will fund and conduct key studies on three experimental coronavirus vaccines, Dr. Anthony Fauci, the nation's top infectious disease expert, tells CNN.

Phase 3 trials, which typically involve tens of thousands of people and measure whether a vaccine is safe and effective, will begin with one by Moderna in July, then an Oxford/AstraZeneca vaccine in August and one by Johnson & Johnson in September.

The funding and trial timing were first reported by the Wall Street Journal. CNN has reached out to the companies for comment.

"The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer," Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. "This is good news for the overall coronavirus vaccine effort."

Each Phase 3 trial is expected to take place at more than 50 sites, mostly in the United States, but possibly in other countries, too. The trials, which are expected to include about 30,000 people, will begin only after there's enough evidence of safety and efficacy from earlier trial stages.

The U.S. government might also plan Phase 3 trials for additional coronavirus vaccines currently in development. According to the World Health Organization, there are 10 vaccines currently in human trials and 126 more in development.

Fauci said the funding decision came from the Department of Health and Human Services, in consultation with the National Institute of Health and other agencies. He also said that the testing plans still track with the timeline that he has suggested in the past: a vaccine at scale by the end of the year or early next year.

Last week, Fauci said the U.S. should have 100 million doses of one candidate coronavirus vaccine by the beginning of 2021, but many doctors caution that is an ambitious goal. He has also said there will be "more than one winner" in the COVID-19 vaccine field on Tuesday.

The number of confirmed coronavirus cases in the U.S. is nearing two million, and more than 112,000 Americans have died.

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Fauci: US government to fund and conduct studies on three possible coronavirus vaccines - KMBC Kansas City

Coronavirus news and updates: 2 million cases confirmed in the US; COVID-19 spreading in several states; the pandemic and your retirement – USA TODAY

June 11, 2020

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Coronavirus news and updates: 2 million cases confirmed in the US; COVID-19 spreading in several states; the pandemic and your retirement - USA TODAY

2020 Outlook on the Worldwide COVID-19 Market – Events That Pushed Share Prices Up – GlobeNewswire

June 11, 2020

Dublin, June 11, 2020 (GLOBE NEWSWIRE) -- The "COVID-19 Pipelines - Cell Therapies, Diagnostics, Treatments, & Vaccines" report has been added to ResearchAndMarkets.com's offering.

This comprehensive report provides coverage of the rapidly evolving pandemic, with an emphasis on the emerging role of cell therapies in the prevention and management of the COVID-19.

While there is not yet an approved treatment for COVID-19, the scientific, medical, and regulatory agencies are making heroic efforts to bring out new medicines. Numerous COVID-19 product categories have emerged, including vaccines, antibodies, antivirals, repurposed drugs, RNA-based drugs, and cell-based therapies, as well as other approaches, such as enzymes, peptides, and glycoproteins. This report explores each of these product development categories in detail, presenting the products under development and timelines for them to come to market. Special attention is given to the critical role of cell-based therapies in the management of the global pandemic.

To accelerate the development of therapies against COVID-19, the repurposing of existing drugs is being explored by numerous market competitors. For example, Barcitinib is being explored because of its anti-inflammatory effect and possible ability to reduce viral entry. A specific dose of the anti-HIV combination, Lopinavir-Nitonavir, is now in clinical trials with Arbidol or Ribavirin. Remdesivir, developed by Gilead Sciences, was earlier tested in patients with Ebola virus and has shown promise in animal models for MERS and SARS. Remdesivir has reached Phase III in the U.S. and China.

Favipiravir, a purine nucleoside leading to inaccurate viral RNA synthesis, was previously developed by Toyama Chemical of Japan and has now been approved for a clinical trial as a drug for the treatment of COVID-19. Chloroquine has shown itself to be effective in treating COVID-19 in China. Dozens of companies are rushing vaccine development and proceeding toward clinical trials. As select examples, the U.S. NIH initiated a Phase I trial in Seattle evaluating an investigational vaccine (mRNA-1273) created by NIAID scientists and their collaborators at Moderna, Inc. Sanofi and Regeneron launched a Phase II/II trial in New York evaluating the IL-6 targeted Kevzara. Inovio Pharmaceuticals is advancing its vaccine into human trials within the U.S. and intends to produce one million doses of it by the end of the year.

Globally, the healthcare industry is using every weapon in its armory to suppress the threat from the virus, including the use of living therapies such as natural killer (NK) cells, T-cells, stem cells, and exosomes. While many novel approaches are being investigated, stem cells - mesenchymal stem cells (MSCs) in particular - are showing intriguing potential for the treatment of COVID-19.

COVID-19 Market Trends

The aim of this report is to gather existing research on COVID-19, reveal key insights, and position the reader to identify emerging market opportunities related to the Coronavirus pandemic. It provides comprehensive coverage of the outbreak, highlights global competitors involved in the fight against COVID-19, and presents product development pipelines, diagnostic testing approaches, vaccine development programs, regulatory approvals, and importantly, trend rate data for COVID-19 scientific publications, patents, and clinical trials on a worldwide basis.

With the rapidly developing nature of this global pandemic, you don't have the time to do the research. Claim this global strategic report to become immediately informed, without sacrificing hours of unnecessary research or lacking awareness of critical COVID-19 events.

Key Topics Covered:

1. REPORT OVERVIEW

2. CORONAVIRUS: STRUCTURE, INFECTION, REPLICATION, SYMPTOMS2.1 Start of the Outbreak2.2 The Symptoms of COVID-192.3 Progression of COVID-192.4 The Incubation Period for COVID-192.5 Duration of the Disease2.6 Case Fatality Rate2.7 Modes of COVID-19 Transmission2.8 Clinical Case Management

3. GLOBAL STATISTICS ON COVID-193.1 The Steady Increase in Global Number of Confirmed Cases3.2 Top Five Most Affected Countries3.4 The Ebb and Flow of COVID-19 Cases3.5 Africa Spared the Worst of the Pandemic3.6 Number of Laboratory Tests Conducted by Select Countries3.7 Top Four Countries with Number of COVID-Tests

4. FUNDING FOR COVID-19 RESEARCH4.1 Contributions to WHO for COVID-19 Appeal4.1.1 Contingency Fund for Emergencies4.2 National Institutes of Health (NIH) Funding for COVID-19 Research4.3 Funding for COVID-19 Research from U.S. Stimulus Bill

5. PUBLISHED SCIENTIFIC PAPERS ON COVID-195.1 Published Papers by Category5.2 Notable Journal Articles

6. PATENTS OF SARS AND MERS WITH POSSIBLE RELEVANCE TO COVID-196.1 Types of SARS and MERS Patents6.2 Key Proteins Described in the Patents and their Roles in Viral Infection6.3 Patents and Potential Drug Candidates Related to Key Protein Targets6.4 Patents of Existing Drugs with Potential Applications for COVID-196.5 Selected Patents Related to Small Molecule Drug Candidates6.5.1 Compounds with Potential Effects on Key Proteins of COVID-196.5.2 Small Molecules Identified by Structure Similarity and Therapeutic Usage6.6 Distributions of Biologics Patents Related to SARS and MERS6.6.1 Patents of SARS Antibodies6.7 Distribution of Patents of Vaccines Related to SARS/MERS6.8 Distribution of RNAi Patents related to SARS/MERS

7. CLINICAL TRIALS LANDSCAPE FOR COVID-197.1 COVID-19 Clinical Trials by Country/Region7.2 Clinical Trials by Study Type7.2.1 Types of Interventions in the Ongoing COVID-19 Clinical Trials7.2.1.1 Proposed Pharmacological Interventions in COVID-19 Clinical Trials7.2.1.2 ATMPs under Investigation in COVID-19 Trials7.3 COVID-19 Clinical Trials by Stage of Development7.3.4 COVID-19 Clinical Trials by Funding Type7.3.4.1 Industry-Sponsored Clinical Trials against COVID-197.4 Upcoming Readouts from Ongoing COVID-19 Clinical Trials

8. COVID-19'S NEGATIVE/POSIVE IMPACTS ON HEALTHCARE INDUSTRY8.1 Negative Impacts8.1.1 Disruption of Big Clinical Trials by COVID-19 Pandemic8.1.2 15-Fold Increase in Clinical Trial Suspensions8.1.3 Specific Examples of Clinical Trials Threatened by COVID-198.1.4 Delayed Readouts due to COVID-198.1.5 Shortages of Patients for Phase III due to COVID-198.1.6 Most Hit Pivotal Trials8.1.7 Threat to Trials of Near-Term Blockbusters8.1.8 COVID-19's Deleterious Effects on Elective Procedures8.1.9 COVID-19 Infected Cardiovascular Companies8.1.10 Delayed Acquisitions due to COVID-198.1.11 Stalling of Biotech Flotations by COVID-198.1.12 Financial Damages to the Pharmaceutical Industry due to COVID-198.2 Positive Impacts8.2.1 Sizeable Opportunities for Some Collaborations8.2.2 COVID-19 Market Movers8.2.3 COVID-19 Events that Pushed the Share Prices up8.2.3.1 Johnson & Johnson8.2.3.2 Gilead Sciences8.2.3.3 Roche8.2.3.4 Sanofi8.2.3.5 BioNTech8.2.3.6 Moderna8.2.3.7 Vir Biotechnology8.2.3.8 Takeda8.2.3.9 CytoDyn8.2.4 COVID-19-Related Stock Risers

9. MEDICINES IN DEVELOPMENT FOR COVID-199.1 The First Medicine to Reach the Market9.1.1 Spectrum of Drugs9.1.2 Difficulties in Making a Drug in Time9.1.2.1 Bargain Search9.1.2.2 Three Stages in Development9.1.2.3 Massive Demand9.1.3 Generic for Remdesivir9.1.4 Concern about Access to COVID-19 Medicine9.2 FDA's CTAP to Accelerate COVID-19 Drug Development9.2.1 CTAP's Activities in a Snapshot

10. EMERGING VACCINE TREATMENTS FOR COVID-1910.1 Protein Sub-Unit Vaccines in Development against COVID-1910.2 RNA-Based Vaccines10.3 Non-Replicating Viral Vector Vaccines10.4 DNA Vaccines in Development for COVID-1910.5 Inactivated Virus Vaccines in Development for COVID-1910.6 Virus-like Particle Vaccines in Development for COVID-1910.7 The Nearest Vaccine10.8 Additional COVID-19 Vaccine Projects10.9 CEPI's Call for Vaccine Fund10.10 Clinical Trial Costs for Developing a Viral Vaccine10.11 The Usual Pattern of Revenue Generation by Viral Vaccines10.11.1 Historical Sales of Vaccines for Previous Pandemics10.11.2 Historic Sales of H1N1 Influenza Vaccines10.12 Recent Vaccine Collaborations10.13 Companies Capable of Producing Vaccines on a Global Scale10.14 Big Pharma in COVID-19 Vaccines

11. ANTIBODY THERAPIES IN DEVELOPMENT FOR COVID-19

12. ANTIVIRAL DRUGS IN DEVELOPMENT FOR COVID-1912.1 Estimated Cost of COVID-19 Antiviral Therapeutic Development12.2 A Competitor for Gilead12.3 Remdesivir: The First to Reach the Market12.3.1 Hints of a Hope from Remdesivir Results12.3.2 Interim Data for Remdesivir12.3.3 Sales Forecast for Remdesivir12.4 Structure of Remdesivir12.4.1 Mechanism of Action of Remdesivir12.5 Additional COVID-19 Therapeutic Projects

13. REPURPOSED DRUG CANDIDATES AGAINST COVID-19

14. CELL-BASED THERAPIES IN DEVELOPMENT FOR COVID-1914.1 Brief Descriptions of Stem Cell-Based Clinical Trials for COVID-1914.1.1 NCT04313322 (Stem Cells Arabia)14.1.2 NCT04366063 (Royan Institute)14.1.3 NCT04252118 (Beijing 302 Hospital)14.1.4 NCT04346368 (Guangzhou Institute of Respiratory Disease)14.1.5 NCT04331613 (Chinese Academy of Sciences)14.1.6 NCT04390139 (Banc de Sang i Teixits)14.1.7 NCT04355728 (Camillo Ricordi)14.1.8 NCT04299152 (Tianhe Stem Cell Biotechnologies, Inc)14.1.9 NCT04269525 (ZhiYong Peng)14.1.10 NCT04390152 (BioXcellerator)14.1.12 NCT04362189 (Hope Biosciences)14.1.13 NCT04371393 (Icahn School of Medicine/Mesoblast, Inc)14.1.14 NCT04365101 (Celularity Incorporated)14.1.15 NCT04367077 (Athersys, Inc)14.2 MSCs: The Most SuiTable Cells to be used Against COVID-19

15. MEDICAL DEVICES IN DEVELOPMENT FOR COVID-1915.1 The Scramble for Mechanical Ventilators15.2 Ventilator Shortages

16. COMMERCIALLY AVAILABLE DIAGNOSTICS FOR COVID-1916.1 PCR Tests (Viral RNA Tests)16.2 Serology Tests (Antibody Tests)16.3 Antigen Tests16.3.1 Number of EUAs Granted to Viral RNA Tests and Antibody Tests16.3.2 Specific Issues with Antibody Tests16.3.3 Roche's Antibody Test: Maximum Sensitivity and Specificity16.4 The First COVID-19 Antigen Test16.5 At-Home COVID-19 Sample Collection Kit16.6 Top Ten COVID-19 Diagnostic Companies16.7 The Deluge of Testing Options

17. MARKET ANALYSIS17.1 Global COVID-19 Vaccine Market17.2 Global Market for Antiviral Drugs against COVID-1917.3 Global Market for Diagnostic Tests for COVID-1917.3.1 Global Market for COVID-19 Testing Kits by Technology17.4 COVID-19 Addressable Personal Protection Equipment (PPE) Market17.5 Estimated COVID-19 Addressable Critical Care Device Market17.6 Global Market for Other COVID-19-Related Medical Supplies17.6.1 Market Shares of Face Masks by Type of Material17.6.2 Global Market Share for Hand Sanitizers by Type17.7 Global COVID-19 Treatment Market

18. CELL THERAPY COMPANIES JOINING FORCES AGAINST COVID-1918.1 Aspire Health Science18.2 Athersys, Inc.18.3 AlloVir18.4 Bonus BioGroup, Ltd.18.5 Caladrius Biosciences18.6 Capricor Therapeutics18.7 Celularity18.8 Celltex Therapeutics Corporation18.9 Citius Pharmaceuticals, Inc.18.10 Cynata Therapeutics18.11 FibroGenesis18.12 GC LabCell18.13 Global Institute of Stem Cell Therapy and Research (GIOSTAR)18.14 Healios KK18.15 Hope Biosciences18.16 Kimera Labs, Inc.18.17 Lattice Biologics, Ltd.18.18. Lineage Cell Therapeutics, Inc.18.19 Mesoblast, Ltd.18.20 NantKwest, Inc.18.21 Orbsen Therapeutics18.22 Organicell18.23 Pluristem Therapeutics, Inc.18.24 Tianhe Stem Cell Biotechnologies, Inc.18.25 The Cure Alliance18.26 Vitro Biopharma

19. OTHER COMPANIES/INSTITUTIONS SPONSORING TRIALS FOR COVID-1919.1 AlloVir and Baylor College of Medicine19.2 Biostar Stem Cell Research Institute19.3 CAR-T (Shanghai) Biotechnology, Co., Ltd19.4 Orgenesis' Cell-Based Vaccine19.5 Peking University19.6 REMSTEM's Phase I/IIa for COVID-1919.7 University of Miami-COVID-19 Research Programs19.8 Wuhan Hamilton Biotechnology

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2020 Outlook on the Worldwide COVID-19 Market - Events That Pushed Share Prices Up - GlobeNewswire

COVID-19 virus has properties that have never been found in nature before – WION

June 9, 2020

Norwegian and British vaccine scientists have published unequivocal evidence that SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic, is man-made.

The authors state two conclusions: (1) the mutations that would normally be seen in the course of animal to human transmission have not occurred in SARS-CoV-2, indicating that it was fully pre-adapted for human infection and (2) SARS-CoV-2 has insertions in its protein sequence that have never been detected in nature and contribute to its infectivity and pathogenicity.

That is, SARS-CoV-2 has a receptor binding domain specifically designed for the human angiotensin converting enzyme-2 receptor (ACE2) found in lungs, kidneys, intestines and blood vessels.

In addition, SARS-CoV-2 has a furin polybasic cleavage site not found in any closely-related bat coronaviruses as well as other artificially inserted charged amino acids that enhance the virus ability to bind to and enter human cells by forming salt bridges between the virus and the cell surface.

Those modifications are key to understanding the unique transmissibility and potency of SARS-CoV-2.

The authors explain that the COVID-19 pandemic is revealing neurological, haematological and immunological pathogenicity, which cannot be explained by infectivity via the ACE2 receptor alone.

There have been wide-ranging clinical observations such as a loss of taste and smell, sore throat, dry cough, headache and severe gastrointestinal pain with diarrhoea.

SARS-CoV-2 binding to the bitter/sweet receptors in the upper respiratory tract provides a perfect location for transmission by coughing.

According to the authors, oral and upper respiratory infection can lead to transmission to the lower respiratory tract, gastrointestinal effects and a cascade of inflammation-producing immunological responses.

The wide-spread systemic release of the virus, due to its co-receptor enhancement, could explain the multiple clinical findings on the cardiovascular system, immunological T-cells, cells associated with neuropathological conditions and, finally, the severe hypoxia seen in advanced cases of the disease.

As the authors correctly note, the development of an effective vaccine cannot be accomplished without an objective analysis of the structure of SARS-CoV-2, its mode of action and its origin.

That effort has been hampered by Chinas refusal to fully disclose the information it possesses, in conjunction with a politically-motivated scientific misinformation campaign by Beijing to avoid responsibility, by some Western scientists with a vested interest in the outcome and by an uninformed and servile media.

That includes the editorial decisions of scientific and medical journals, which seem to favour, overwhelmingly, the narrative that the COVID-19 pandemic is just another naturally-occurring outbreak, even to the extent of censoring opposing views.

Until now, the cover-up of the true origin of the COVID-19 pandemic has been successful.

No less than the Office of the Director of National Intelligence in the United States has blindly accepted the scientific conventional wisdom promoted by the Chinese Communist Party, issuing the following April 30, 2020 statement:

The Intelligence Community also concurs with the wide scientific consensus that the COVID-19 virus was not manmade or genetically modified.

Remarkedly, there has never been conclusive scientific evidence to support that claim, yet many appear content endorsing the naturally-occurring narrative, mostly out of ignorance or an unwillingness to accept the ugly truth.

That ugly truth is - China manufactured SARS-CoV-2 and, through a combination of hubris, incompetence and recklessness, unleashed it on the world.

(Disclaimer: The opinions expressed above are the personal views of the author and do not reflect the views of ZMCL)

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COVID-19 virus has properties that have never been found in nature before - WION

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