July 9, 2020

Managing Lab Protocols During the Pursuit of a Covid-19 Vaccine

Pursuit of Vaccine and Managing Lab Protocols during the Covid19 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

Covid19 The Pandemic (Almost) Nobody Saw Coming

Of all the changes 2020 had brought, almost nobody saw coronavirus disease 2019 (COVID-19) coming.

First reported in late December 2019 in Wuhan, China, the newly discovered coronavirus (2019-nCoV) quickly made its way around the globe, killing thousands and sickening hundreds of thousands more. There is quite a bit of information out there to disseminate we felt it time to give an overview and a few thoughts on Covid-19; as this situation is fluid we do expect to add more information in future posts.

On March 12, 2020, the World Health Organization declared COVID-19 a pandemic, meaning the disease had spread to multiple continents around the globe. Like other pandemics, COVID-19 seemed to move swiftly, taking governments, healthcare providers and citizens by surprise. 

Not everyone was blindsided, though – a handful of experts in global health, the biosciences, national security, emergency response and economics got together in October 2019 to talk about what would happen if a global pandemic suddenly hit the world’s population. The experts discussed how Americans and others around the world would fare if a novel and highly transmissible coronavirus outbreak reached pandemic proportions.

Just as its real-life counterpart did, the fictional coronavirus jumped between countries and continents via international air travel. In both accounts, the virus caused problems for health care systems, economies, and political leaders. The fictional scenario assumed governments would first try closing borders and banning travel, but by the time authorities enacted border closures and travel bans, carriers would have unknowingly transmitted the disease to others before developing symptoms. The experts also projected the travel bans would disrupt trade and worsen international cooperation.

The simulation provided a shocking glimpse into the near future, but in today’s rapid-fire news cycle, very few people took notice. When the predictions began to come true in the form of COVID-19, many people regarded the threat somebody else’s problem because it was occurring in another country and could never reach the shores of our nation. Others thought COVID-19 was nothing more than a seasonal influenza. They were wrong on both counts.

COVID-19 is Here, and it is More than Just a Flu

The first patient with COVID-19 walked into a U.S. emergency department on January 19, 2020. Today, thousands of Americans have tested positive for novel coronavirus.

COVID-19 is similar to the flu in many ways, and is significantly different in other ways. Both are infectious illnesses, for example, and both cause a dry cough and fever. Influenza causes aches, chills, fatigue, and headache and chills; these symptoms are less common with COVID-19. Flu symptoms come on suddenly, getting worse over a day or two. Symptoms of COVID-19 develop gradually, worsening over the course of several days.

COVID-19 is different from the flu in other ways:

  • Difficulty breathing and shortness of breath are the hallmarks of COVID-19 – they are also signs to seek immediate medical attention; flu does not cause shortness of breath and difficulty breathing
  • COVID-19 is more likely to kill than the flu – about 3.4 percent of people with COVID-19 have died and seasonal flu generally kills far fewer than 1 percent of those infected
  • Unlike the flu, there is no vaccine for COVID-19, and it will probably take a year to develop one
  • There is no treatment for COVID-19
  • Children, who are typically at high risk of contracting flu, are at lower risk for COVID-19 than are older adults

With a higher basic reproduction number, which is the number of infections one infected person can cause COVID-19, is more infectious than the flu. COVID-19 seems to have a basic reproduction number somewhere between 2 and 2.5, so the average person infected with the coronavirus spreads the disease to 2 to 3 other people. The basic reproduction number of seasonal influenza varies from year to year, but is often about 1.28.

COVID-19 is wreaking havoc on nearly every segment of the population, but it presents special danger to some. Director of the National Alliance on Mental Illness (NAMI) HelpLine Dawn Brown reported an increase in calls to the NAMI hotline. Callers expressed a wide variety of concerns, including feelings of depression and loneliness from social isolation, worries about job stability and income, fears of getting sick, grief over the death of a loved one, and homelessness. “Right now, the bigger concerns are around anxieties about the unknowns, you don’t know what you don’t know, and the people we serve tend to be a little more vulnerable to anxiety and panic.”

What Happens in the Future Depends Largely on What We Do Today

Arguably late to the situation, the U.S. government issued The President’s Coronavirus Guidelines for America, which directs citizens to listen to state and local authorities, stay home when sick, self-isolation measures, and good hygiene. States have issued a variety of public health emergency declarations, including the activation of National Guards, school and business closures, and limits on event sizes.

The medical community geared up quickly in response to the pandemic. Hospitals began enacting preparedness plans, clinicians developed treatment plans for critically ill patients, and researchers immediately turned their attention to developing a vaccine. Mayo Clinic announced the development of a new test that provides results in 24 hours.

The actions of individuals, families, businesses and communities will have the greatest influence in how the pandemic ends – they will also bear the brunt of its consequences. In even the best case scenario, hundreds or thousands of people in the United States could perish; new research suggests the number of deaths in the nation could exceed 2 million.

While nobody knows exactly how COVID-19 will change our lives, almost everyone can agree that the changes will be profound.

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:

http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/news/news/2020/3/who-announces-covid-19-outbreak-a-pandemic

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—3-march-2020

https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200306-sitrep-46-covid-19.pdf?sfvrsn=96b04adf_2

https://www.researchgate.net/publication/265345236_Estimates_of_the_reproduction_number_for_seasonal_pandemic_and_zoonotic_influenza_A_systematic_review_of_the_literature

https://www.whitehouse.gov/wp-content/uploads/2020/03/03.16.20_coronavirus-guidance_8.5x11_315PM.pdf

https://www.nga.org/coronavirus/#stateshttps://www.phe.gov/Preparedness/COVID19/Documents/COVID-19%20Healthcare%20Planning%20Checklist.pdf

https://jamanetwork.com/journals/jama/fullarticle/2762996

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

https://www.mprnews.org/story/2020/03/12/new-mayo-clinic-test-could-speed-detection-of-covid19

https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf