Covid -19: The Race for a Vaccine

The Race for a Vaccine: Covid-19

The race to save lives is underway. Scientists all over the world are speeding to develop a vaccine for COVID-19, a disease that has claimed more than half a million lives worldwide, and hs sickened millions of others. Vaccine development usually takes 10 to 15 years, and the long, involved process takes a tremendous amount of public and private involvement. At the current rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections that cause COVID-19 disease, though, the world does not have 10 to 15 years to wait.

COVID-19 Race for a vaccine

On July 18, 2020, the World Health Organization (WHO) reviewed 23 candidate vaccines in clinical evaluation. Many were still in Phase 1 to establish their safety and dosage at the time of the WHO review, while others were in Phase 2 to establish their performance under ideal and controlled performance. As of that mid-July WHO review, three clinical trials had entered Phase 3 for testing on large numbers of people, although one vaccine trial had not yet recruited candidates.

Why Must We Wait So Long?

Most vaccines in development never make it to licensing – in fact, many vaccine candidates never make to clinical evaluation on real humans because they fail to produce the desired immune response in the pre-clinical stages of testing in cell cultures and lab animals.

Regulators set a high bar for vaccination approval and often require years’ worth of safety data because, unlike medicines that treat diseases, vaccines are administered to healthy people to prevent illness. Releasing a vaccine could potentially do more harm than good, so many regulatory bodies set stiff guidelines for approval.

covid-19-race for A CURE

It is not yet clear what data federal regulators would accept as proof that a vaccine is safe and successful in the middle of the pandemic. On June 30, 2020, the U.S. Food and Drug Administration (FDA) said a vaccine must prevent COVID-19 or decrease the severity of illness in at least 50 percent of people who receive the vaccine. The FDA may consider some vaccine candidates for its Accelerated Approval pathway, but that the vaccine candidate must demonstrate an identifiable immune response or other measure that shows it is reasonably likely that the vaccine would provide clinical benefit. Regulators in other nations have not yet announced what they would consider acceptable criteria for approval, which creates a challenge for vaccine makers trying to gain approval.

More Challenges for Vaccine Makers

Vaccine makers also face challenges determining the best way to trigger the immune response. Vaccines typically work by exposing the body to the antigens of a particular pathogen to activate the immune system without causing disease. Made with weakened or inactivated form of the pathogen, these vaccines are often difficult to develop and produce quickly. Because of the urgent nature of the pandemic, researchers are looking for innovating ways to introduce antigens and otherwise activate an immune response to SARS-CoV-2. Four of the 23 vaccine candidates in clinical testing use an approach that involves engineering messenger RNA (mRNA) that tells human cells how to create the antigens themselves.

RACE FOR A VACCINE COVID-19

Moderna is one of those four companies. On July 15, 2020, the biotech company published data from an early-stage trial that shows its vaccine caused patients to generate an immune response by developing antibodies, although it caused some side effects. Supported by the National Institutes of Health, the study showed volunteers who receive the vaccine produced substantially more neutralizing antibodies than do most patients who have recovered from COVID-19. A second injection administered four weeks after the initial vaccination was necessary to produce a dramatic immune response. Vaccine experts were not impressed, however, concerned that the data was long on text and short on proof.

Other research teams, such as University of Oxford/AstraZeneca are using viral vector vaccines to speed up the process. Viral vector vaccines use a harmless virus as a kind of Trojan horse that carries the pathogen’s genetic material into cells in order to trigger an immune response. The team released more information about its coronavirus vaccine candidate, AZD1222, on July 20, 2020.

Developing a COVID-19 vaccine will be one of the most exciting and important events in human history, with the potential to save millions of lives around the world. Join us next month when we review the next leg of the race for a COVID-19 vaccine.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Most recently; Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Sources

https://coronavirus.jhu.edu/map.html

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

Autoimmune Disease, Inflammation & COVID-19

People with autoimmune disease face a number of challenges – their condition can cause pain, skin problems, digestive issues, weakness, muscle aches, stiff joints, and more. Autoimmune diseases and their treatments can weaken immune systems to leave patients vulnerable to infections. These conditions can also cause inflammation around the body, and even in vital organs, such as the lungs. In patients with COVID-19, an unhealthy immune response can damage the lungs to cause serious complications, including severe breathing problems.

Autoimmune Diseases and Inflammation

The immune system protects the body from disease and infection. In people with autoimmune disorders, though, the immune system can attack healthy body cells by mistake. There are more than 80 types of autoimmune diseases, according to the National Library of Medicine. Autoimmune diseases include rheumatoid arthritis, psoriasis, inflammatory bowel disease, lupus, Sjogren’s disease, multiple sclerosis, Hashimoto’s disease, Celiac disease and type 1 diabetes.
Some autoimmune diseases target just one organ, such the pancreas; other autoimmune conditions affect the entire body. Many of autoimmune diseases share similar symptoms. A large number of autoimmune conditions cause inflammation, characterized by redness, heat, pain and swelling. In fact, inflammation is the classic sign of an autoimmune disease.

COVID-19 and Inflammation

The virus, known as SARS-CoV-2 or simply “coronavirus,” causes a wide variety of symptoms associated with COVID-19 disease. Most notably, the virus causes cough, fever, and shortness of breath. Coronavirus is highly contagious, already infecting at least 2 million people in the United States by the middle of June 2020, and claiming the lives of 113,000. While people with autoimmune disorders are not more likely to contract coronavirus than are the rest of the general population, they are more likely to develop severe complications if they do contract COVID-19 if they have a suppressed immune system due to their autoimmune disease or treatment for their autoimmune disorder. One of the most serious complications of COVID-19 is severe inflammation throughout the body, including the lungs, heart and brain. The body reacts to the presence of the SARS-CoV-2 virus with a robust inflammatory response; health professionals now regard this excessive inflammatory response as a hallmark symptom of COVID-19.
The excessive immune response triggered by SARS-CoV-2 can cause hyper-inflammation of the lungs and of other organs. Severe inflammation of the lungs can prevent the proper exchange of oxygen and carbon dioxide, which makes it difficult for patients to get the oxygen they need.

How Autoimmune Diseases Cause Inflammation

Special receptors cover the exterior surface of body cells. Proteins bind to these receptors to change the way the cell works. A specific type of protein, known as cytokines, binds to certain receptors to regulate the body’s immune response. Cytokines are mediators, which mean they trigger and control a body response. Specifically, cytokines mediate the inflammation response to tissue injury or infection. In other words, cytokines promote inflammation as a response to tissue injury or infection. There are several types of cytokines, and each type can work alone, work together, or work against each other to regulate the immune response. A special type of cytokine, known as interleukin or IL, may play an important role in the immune response in COVID-19 patients. There are 40 interleukins, IL-1 through IL-40, and each performs a function. Interleukins normally help the immune system fight off viruses and bacteria in the body, but an overactive immune system can cause interleukins to attack the body instead. This can lead to chronic inflammatory conditions.
In a significant physiological event, known as a cytokine storm, can cause the release of a flood of interleukin that leads to widespread and dangerous inflammation. Research shows that COVID-19 can cause a cytokine storm that releases IL-6, IL-1, IL-12, and IL-18. The excessive number of cytokines can damage tissue and could lead to the breakdown of the protective lining in the lungs and blood vessels. The breakdown and weakening of this protective lining can allow fluid and proteins to leak from blood vessels and into the tiny air sacs of the lungs. This fluid displaces air, which prevents the air sacs from filling with oxygen. The resulting lack of oxygen causes the patient to experience shortness of breath, and puts the patient at a higher risk for complications and a more severe case of COVID-19. Inflammation related to autoimmune disease can have serious consequences for patients. This is especially true for those who contract COVID-19. To View Frank Magliochetti Press Releases Please CLICK HERE Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.
This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg
Mr. Frank Magliochetti MBA Managing Partner Parcae Capital www.parcaecapitalcorp.com www.frankmagliochetti.com

SOURCES:

https://medlineplus.gov/autoimmunediseases.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.htmlhttps://www.ncbi.nlm.nih.gov/books/NBK499840/https://www.medscape.com/answers/2500114-197455/what-is-the-role-of-interleukin-il-inhibitors-in-the-treatment-of-coronavirus-disease-2019-covid-19

Managing Lab Protocols and the Pursuit of a Vaccine during the Covid-19 Outbreak

Vaccine Pursuit and Managing Lab Protocols during the Covid-19 Pandemic

On April 22, 2020, the Director-General of the World Health Organization (WHO) said, “To be clear, WHO’s advice is to find and test every suspected case, not every person in a population.”

While testing every person is not essential to controlling COVID-19, finding and testing every suspected case is. As the COVID-19 outbreak sweeps across the globe, the world turns to laboratories for answers. Laboratory scientists are responding by providing doctors with ways to diagnose COVID-19 and by pursuing the development of a vaccine that could someday stop the pandemic in its tracks. Until a vaccine is found, social distancing and testing are the best ways to control the spread of the disease.

The 2019 novel coronavirus, now named SARS-CoV-2, has sickened millions of people with COVID-19. By the end of April 2020, the United States had by far the highest number of confirmed cases and deaths in the world, according to Johns Hopkins University.

Testing is the only way to determine the case fatality rate (CFR), which is the ratio between confirmed deaths and confirmed cases. Testing is also the best way to assess the overall effectiveness of preventive measures and vaccines. Determining the CFR requires time and reliable data to confirm cases and deaths based on trusted laboratory testing. Strict adherence to proven and accepted laboratory protocols provides the most accurate data possible.

Managing Laboratory Protocols during the COVID-19 Outbreak

Managing laboratory protocols during the SARS-CoV-2 outbreak is challenging because, as with the outbreak of any novel virus, researchers are entering uncharted territories. Virologists had a limited understanding of transmission patterns, clinical features, severity, and risk factors for COVID-19 infection at the start of the pandemic. To address those unknowns, WHO established Four Early Investigation Protocols, which are now known as the WHO Unity Studies.

The protocols rapidly and systematically collect and store data that will be critical in refining recommendations for case definition and surveillance, and for characterizing the key epidemiological features of COVID-19. The protocols will also help the medical community gain a greater understanding of the spread, severity and spectrum of the disease, as well as its impact on the community. Information gained from the data will help guide countermeasures, such as case isolation and contact tracing.

Rapid detection of COVID-19 cases is essential for controlling the emergence of this rapidly spreading illness and for understanding the key epidemiological features of the disease, but rapid detection requires wide availability of diagnostic testing.

Within a month of the first outbreak in China, the Centers for Disease Control and Prevention (CDC) developed a real time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test that can diagnose COVID-19. The CDC provides instructions for the use of real-time rT-PCR assays for the in vitro qualitative detection of coronavirus in sera and respiratory specimens. FIND also maintains a list of SARS-CoV-2 tests in development or commercially available for COVID-19, and WHO maintains a list of COVID-19 in-house PCR protocols assays.

Challenges of managing laboratory protocols

Even with reliable assays, managing laboratory protocols during COVID-19 is challenging. The pandemic has disrupted the supply chain for many laboratories, for example. Personal protection equipment (PPE) is scarce, for example, and there have been shortages of SARS-CoV-2 PCR reagents.

Biosafety is also a major concern, as keeping lab workers safe is a high priority. The CDC has released biosafety guidelines for labs working with Coronavirus: Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). These guidelines include essential information on virus isolation, waste management, and decontamination. The EPA also released an expanded COVID-19 disinfectant list on March 13, 2020, but social distancing is far more effective than disinfection for controlling viral transmission. Unfortunately, social distancing is much more difficult than disinfection in a typical laboratory, where technicians work side by side and in close proximity to specimens.

While the protocols are far from perfect, and disruptions in the supply chain can slow testing, laboratory protocols will continue to play an important role in preventing the spread of COVID-19 until a vaccine is found.

Pursuit of a COVID-19 Vaccine

The best way to defeat COVID-19 is to develop a vaccine, of course, but vaccine development can often take 10 to 15 years. Vaccines for respiratory viruses are also elusive. Two toddlers died in 1966 from respiratory syncytial virus (RSV), for example, and vaccines for the parainfluenza viruses (PIVs) and metapneumovirus (MPVs) are still not available.

There are 120 projects working towards a vaccine; only five have received approval for clinical trials in humans. University of Oxford researchers began Phase I human trials of ChAdOx1 nCoV-19 in late April. In this trial, half of the roughly 1100 participants receive ChAdOx1 nCoV-19 vaccine, while the control group receives the common meningitis vaccine, MenACWY. The first two volunteers, one from the test group and one from the control, received their inoculations on April 23, 2020.

Fast tracking the development of this vaccine or others could potentially save thousands or millions of lives, providing the vaccine undergoes sufficient testing to ensure its safety and efficacy. It is possible to get a licensed vaccine in one and a half to two years, and even possible to get a vaccine into use much sooner. Reliable laboratory testing will help researchers determine if their vaccines are working.

Many of the battles against the COVID-19 outbreak will be fought in laboratories in the United States and around the world. Widespread testing will play an important role in reducing deaths associated with coronavirus and improving the health and well-being of people across the globe.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://coronavirus.jhu.edu/map.htmlhttps://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations

https://www.cdc.gov/coronavirus/2019-ncov/lab/index.htmlhttps://www.finddx.org/covid-19-2/pipeline/

https://www.who.int/docs/default-source/coronaviruse/whoinhouseassays.pdf?sfvrsn=de3a76aa_2

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fhealthcare-supply-ppe.html

https://asm.org/Articles/Policy/2020/March/ASM-Expresses-Concern-about-Test-Reagent-Shortageshttps://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.htmlhttps://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2

https://www.labconscious.com/blog/2020/3/17/laboratory-sustainablity-in-the-coronavirus-crisishttps://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://cvi.asm.org/content/23/3/189https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547785

https://www.cbsnews.com/news/coronavirus-vaccine-covid-19-human-clinical-trial-oxford-england/

http://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stagehttps://www.drugbank.ca/drugs/DB15656