Best-Practice Virus Management: Look to Germany

April 19, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , , , , , | Leave a comment

Best-Practice Virus Management: Look to Germany

By Shlomo Maital

Angela Merkel

   Sometimes, something happens and – we know exactly why we were put on this earth. Take Angela Merkel. Americans would call her a ‘lame duck’ chancellor, as she has indicated she will not run for re-election as head of her party, and a successor was already chosen (and then, resigned, and a new successor emerged). But meanwhile, she is still Chancellor, leading Germany at a critical time – and guess what – she gets it. [She obtained a doctorate in quantum chemistry in 1986 and worked as a research scientist until 1989].   Listening to an ignorant, spiteful, uneducated draft-dodging American President who does NOT get, focused solely on his rapidly-decreasing chances for re-election, it is very painful, after hearing Merkel.

     In part because of Merkel’s leadership, and in part because Germany is a very well-run organized country strong in science and technology, Germany today is best-practice in emerging from the coronavirus lockdown. New York Times’ Berlin bureau chief Katrin Bennhold explains why:

   “….3,000 households [were] chosen at random in Munich for an ambitious study whose central aim is to understand how many people — even those with no symptoms — have already had the virus, a key variable to make decisions about public life in a pandemic. The study is part of an aggressive approach to combat the virus in a comprehensive way that has made Germany a leader among Western nations figuring out how to control the contagion while returning to something resembling normal life.”

     Bennhold continues: “Other nations, including the United States, are still struggling to test for infections. But Germany is doing that and more. It is aiming to sample the entire population for antibodies in coming months, hoping to gain valuable insight into how deeply the virus has penetrated the society at large, how deadly it really is, and whether immunity might be developing   The government hopes to use the findings to unravel a riddle that will allow Germany to move securely into the next phase of the pandemic: Which of the far-reaching social and economic restrictions that have slowed the virus are most effective and which can be safely. The same questions are being asked around the world. Other countries like Iceland and South Korea have tested broadly for infections, or combined testing with digital tracking to undercut the spread of the virus.

   “Germany, which produces most of its own high-quality test kits, is already testing on a greater scale than most — 120,000 a day and growing in a nation of 83 million. Chancellor Angela Merkel, a trained scientist, said this week that the aim was nothing less than tracing “every infection chain.”   That high level of testing has helped her country slow the spread of the virus and keep the number of deaths relatively low. More people in Germany now recover from the virus every day than are infected by it. Every 10 people infected with the virus now pass it to seven others — a sharp decline in the infection rate for a virus that has spread exponentially.”

   “Nationally, the Robert Koch Institute, the government’s central scientific institution in the field of biomedicine, is testing 5,000 samples from blood banks across the country every two weeks and 2,000 people in four hot spots who are farther along in the cycle of the disease.   Its most ambitious project, aiming to test a nationwide random sample of 15,000 people across the country, is scheduled to begin next month.”

   “In the free world, Germany is the first country looking into the future,” said Prof. Michael Hoelscher, who heads up the Munich study, noting that a number of countries had already asked him for the protocol to be able to replicate it. “We are leading the thinking of what to do next.”   Mr. Hoelscher was co-author of what has become a widely influential research paper about how the virus can be transmitted before someone develops symptoms.   “There’s no doubt after reading this paper that asymptomatic transmission is occurring,” Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases in the United States, told CNN on Feb. 1, three days after the paper was published. “This study lays the question to rest. Asymptomatic transmission is what has made containment so difficult because a large number of infections are not detected.”

 

The Race to a COVID-19 Vaccine: Q&A

April 18, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , | Leave a comment

The Race to a COVID-19 Vaccine: Q&A

By Shlomo Maital

Where do we stand in the quest for a safe effective COVID-19 vaccine?

   More than 2.2 million persons worldwide have contracted the virus and of those, 154,783 have died. That is a 6.8% death rate. But wait – there are far far more cases worldwide than those we know about. Deaths are certain; cases are a guess. If we use a 1% to 1.5% death rate, we can guess that between 10 million and 15 million persons worldwide have contracted the illness. Only an effective vaccine will put a clear end to this crisis, in which COVID-19 is already the #1 cause of death in the US.

     This Q&A is based on an informative survey published in a reputable website, livescience.com, by staff writer By Nicoletta Lanese, two days ago:   (Warning: this blog is long, 1895 words…sorry).

* https://www.livescience.com/coronavirus-covid-19-vaccine-timeline.html

   When will a vaccine be ready?

     “Here’s why it probably can’t be developed any sooner than 12 to 18 months.

     “More than 60 candidate vaccines are now in development, worldwide, and several have entered early clinical trials in human volunteers, according to the Some groups aim to provoke an immune response in vaccinated people by introducing a weakened or dead SARS-CoV-2 virus, or pieces of the virus, into their bodies. The vaccines for measles, influenza, hepatitis B and the vaccinia virus, which causes smallpox, use these approaches, according to the U.S. Department of Health & Human Services. Although tried-and-tested, using this approach to develop these conventional vaccines was labor-intensive, requiring scientists to isolate, culture and modify live viruses in the lab.

   That initial process of just creating a vaccine can take 3 to 6 months, “if you have a good animal model to test your product,” Raul Andino-Pavlovsky, a professor in the Department of Microbiology and Immunology at the University of California, San Francisco, told Live Science. “

   Are there short cuts? How fast is the US working on a vaccine?

   “The first COVID-19 vaccine to enter clinical trials in the United States, for example, uses a genetic molecule called mRNA as its base. Scientists generate the mRNA in the lab and, rather than directly injecting SARS-CoV-2 into patients, instead introduce this mRNA. By design, the vaccine should prompt human cells to build proteins found on the virus’ surface and thus trigger a protective immune response against the coronavirus. Other groups aim to use related genetic material, including RNA and DNA, to build similar vaccines that would interfere with an earlier step in the protein construction process. But there’s one big hurdle for mRNA vaccines. We can’t be sure they will work. As of yet, no vaccine built from a germs’ genetic material has ever earned approval, Bert Jacobs, a professor of virology at Arizona State University and member of the ASU Biodesign Institute’s Center for Immunotherapy, Vaccines and Virotherapy, told Live Science. Despite the technology having existed for almost 30 years, RNA and DNA vaccines have not yet matched the protective power of existing vaccines, National Geographic reported.

   In this high-stakes competition, is there also collaboration?

   “Assuming these unconventional COVID-19 vaccines pass initial safety tests, “will there be efficacy?” Jacobs said. “The animal models suggest it, but we’ll have to wait and see.”  “Because of the emergency here, people are going to try many different solutions in parallel,” Andino-Pavlovsky said. The key to trialing many vaccine candidates at once will be to share data openly between research groups, in order to identify promising products as soon as possible, he said.

   Could a COVID-19 vaccine be potentially dangerous and do damage?

    For sure.

   “Designing a vaccine that grants immunity and causes minimal side effects is no simple task. A coronavirus vaccine, in particular, poses its own unique challenges. Although scientists did create candidate vaccines for the coronaviruses SARS-CoV and MERS-CoV, these did not exit clinical trials or enter public use, partly because of lack of resources, Live Science previously reported.   “One of the things you have to be careful of when you’re dealing with a coronavirus is the possibility of enhancement,” Fauci said in an interview with the journal JAMA on April 8. Some vaccines cause a dangerous phenomenon known as antibody dependent enhancement (AED), which paradoxically leaves the body more vulnerable to severe illness after inoculation.    Candidate vaccines for dengue virus, for example, have generated low levels of antibodies that guide the virus to vulnerable cells, rather than destroying the pathogen on sight, Stat News reported. Coronavirus vaccines for animal diseases and the human illness SARS triggered similar effects in animals, so there’s some concern that a candidate vaccine for SARS-CoV-2 might do the same, according to an opinion piece published March 16 in the journal Nature. Scientists should watch for signs of AED in all upcoming COVID-19 vaccine trials, Fauci said. Determining whether enhancement is occurring could happen during initial animal studies, but “it is still unclear how we will look for AED,” Jacobs said.

   Are there specific dangers in developing a COVID-19 vaccine?

   A successful coronavirus vaccine will snuff the spread of SARS-CoV-2 by reducing the number of new people infected, Andino-Pavlovsky said. COVID-19 infections typically take hold in so-called mucosal tissues that line the upper respiratory tract, and to effectively prevent viral spread, “you need to have immunity at the site of infection, in the nose, in the upper respiratory tract,” he said.  These initial hotspots of infection are easily permeated by infectious pathogens. A specialized fleet of immune cells, separate from those that patrol tissues throughout the body, are responsible for protecting these vulnerable tissues. The immune cells that protect mucosal tissue are generated by cells called lymphocytes that remain nearby, according to the textbook “Immunobiology: The Immune System in Health and Disease” (Garland Science, 2001).

   “It’s like your local police department,” Andino-Pavlovsky told Live Science. But not all vaccines prompt a strong response from the mucosal immune system, he said. The seasonal influenza vaccine, for example, does not reliably trigger a mucosal immune response in all patients, which partly explains why some people still catch the respiratory disease after being vaccinated, he said.

   “Even if a COVID-19 vaccine can jumpstart the necessary immune response, researchers aren’t sure how long that immunity might last, Jacobs added. While research suggests that the coronavirus doesn’t mutate quickly, “we have seasonal coronaviruses that come, year in [and] year out, and they don’t change much year to year,” he said. Despite hardly changing form, the four coronaviruses that cause the common cold keep infecting people — so why haven’t we built up immunity?

Could the COVID-19 virus pose special problems?

   “Perhaps, there’s something odd about the virus itself, specifically in its antigens, viral proteins that can be recognized by the immune system, and that causes immunity to wear off. Alternatively, coronaviruses may somehow fiddle with the immune system itself, and that could explain the drop-off in immunity over time, Andino-Pavlovsky said. To ensure a vaccine can grant long-term immunity against SARS-CoV-2, scientists will have to address these questions. In the short term, they’ll have to design experiments to challenge the immune system after vaccination and test its resilience through time, Jacobs said. In a mouse model, such studies could take “at least a couple of months,” he said. Scientists cannot conduct an equivalent experiment in humans, but can instead compare natural infection rates in vaccinated people to those of unvaccinated people in a long-term study. “When you have the luxury, you look at this for five years, 10 years to see what happens,” Andino-Pavlovsky added.

How will they ensure that a COVID-19 vaccine is safe?

     “Unlike an antiviral treatment for COVID-19 that can be given to patients already infected with the virus, a vaccine must be tested in diverse populations of healthy people. “Because you give it to healthy people, there’s an enormous pressure to make sure it’s absolutely safe,” Andino-Pavlovsky said. What’s more, the vaccine must work well for people of many ages, including the elderly, whose weakened immune systems place them at heightened risk of serious COVID-19 infection. “Initially, safety studies will be done in small numbers of people,” likely fewer than 100, Jacobs said. A vaccine may be approved based on these small studies, which can take place over a few months, and then continually monitored as larger populations become vaccinated, he added. “That’s just my guess.”

   [Note: The high and growing death toll from COVID-19 may justify some speed-up and short-cuts].

   So what are the various stages that a vaccine must undergo, before it can be mass produced?

“Any potential vaccine will need to pass a safety trial, known as a Phase 1 trial, which also helps determine the needed dose. The next step is a larger trial in 100 to 300 people, called a Phase 2, which looks for some biological activity, but can’t say for sure if the drug is effective. If a vaccine candidate prompts a promising immune response in Phase 2 clinical trials, after passing safety tests in Phase 1, it’s possible that the FDA could approve such a vaccine for emergency use “before the 18-month period that I said,” Fauci said in the JAMA interview.  “If you get neutralizing antibodies,” which latch onto specific structures on the virus and neutralize it, “I think you can keep moving forward on it,” Jacobs said. Normally, a vaccine would then enter Phase 3 clinical trials, which include hundreds to thousands of people.

   “So adding up these steps, each of which will likely take 3 to 6 months, it’s very unlikely we would be able to find a vaccine that is safe and effective in less than 12 months — even if many of these steps could be done in parallel.

    Can it be mass-produced? How?

“Then comes the issue of manufacturing billions and billions of doses of a new vaccine whose ingredients we don’t yet know. Bill Gates has said that the Gates Foundation will fund the construction of factories for seven coronavirus vaccine candidates, equipping the sites to produce a wide variety of vaccine types, Business Insider reported.

   [Neanderthal Conservative groups have attacked Gates, making false and inflammatory claims about him].

“Even though we’ll end up picking at most two of them, we’re going to fund factories for all seven, just so that we don’t waste time in serially saying, ‘OK, which vaccine works?’ and then building the factory,” Gates said. Even if a fairly promising vaccine surfaces by 2021, and can be mass-produced, the search won’t end there. “Especially with trying to get something out this quickly, we may not get the best vaccine out there right away,” Jacobs said. Ideally, an initial vaccine will grant immunity for at least one to two years, but should that immunity wane, a longer lasting vaccine may have to be deployed. Historically, so-called live attenuated vaccines that contain a weakened virus tend to perform most reliably over extended periods of time, Andino-Pavlovsky said.      

     “That may be what we need in the long run,” he said. And research into coronavirus immunity should continue, regardless, “not only for COVID-19, but for the next coronavirus that comes.  

Compassionate Capitalism: Filling in the Details

April 18, 2020 in Global Crisis Blog, Innovation Blog | Tags: | Leave a comment

Compassionate Capitalism: Filling in the Details

By Shlomo Maital

   In an earlier blog, I proposed that businesses adopt a new formula for free-enterprise capitalism: Price at cost. I called this “compassionate capitalism”, suitable for this new era of unprecedented unemployment, hardship and economic collapse. The goal: Preserve jobs, keep businesses alive, but help the people stretch their diminishing incomes.

   My close friend in Vietnam, Tran Luong Son, reports that the idea is resonating in his country, but there remain many practical questions. Let me try to answer some of them. In general, I propose to launch a voluntary group of visionary business leaders, willing to embrace C c (the capital C is for compassion, the small ‘c’ is for capitalism), and to commit to a small number of Cc principles.

Can you outline a clear simple methodology for applying Cc?

  1. Open an Excel sheet for each of your products and services.
  2. Begin with variable costs (costs of production and distribution). Wages: lower than pre-plague but reflecting the needs and productivity of workers; senior management take proportionately bigger cuts. Materials: Take into account second sourcing – businesses that used a single source are, in many cases, in trouble.
  3. Cost of capital: This is an opportunity cost. The risk-adjusted return on capital has declined, but is recovering. Use again the principle of fairness: Owners of capital need a return on their money, but not as high as pre-plague. They too must take cuts, as do wage-earners.
  4. Fixed costs: Governments are part of this. They need to contribute as well, by reducing income and profit taxes and property taxes. Many governments have job-preservation schemes, to replace unemployment insurance with partial wage subsidies.
  5. Prioritize: Apply the McCabe principle. Tom McCabe was the legendary CEO of Scott Paper, making it a great global company. He had every senior manager put this plaque on the wall: Whom do we serve? 1. Customers 2. Our community 3. Our country 4. Our employees. 5. Our shareholders.   Shareholders last???? McCabe had a simple answer. Of course. If you serve the other four well, you will best serve your shareholders, in the long run.   This applies more than ever now. In Cc compassionate capitalism, serve your customers, your community and your country, and your employees. They come first. This is what capitalism should look like, if we are to sustain it.
  6. Use the “value sharing” principle.   When I taught this to MBA students, there was blood on the floor. They were taught to profit maximize. This is more than obsolete, it is immoral in today’s plague-ridden world.

     a) Estimate the value your product or service creates, by the average amount your clients would be willing to pay for it, if you ‘squeezed’ them at the maximum. ($). b) estimate the cost of providing the product or service, taking into account maximum productivity and hidden costs (opportunity cost of capital – see above). c) set the price as close as you can to cost, while sustaining the business and its jobs. To maximize client margin (the net value your clients get from your product). These days, ‘value’ is way down, for most products and services, because our income and disposable income are way down. If you still manage to generate ‘client margin’ (net value for clients), you will have loyal customers for three generations or for a century. We customers will not forget who served us (McCabe principle) and who ripped us off.

   Capitalism can no longer afford to maximize ‘company margin’. The game today is to maximize ‘client margin’.

Remdesivir: Grasping at Straws!

April 17, 2020 in Uncategorized | Tags: , , | Leave a comment

Remdesivir: Grasping at Straws!

By Shlomo Maital

     There is a massive amount of fake news circulating now about COVID-19, some of it racist, pernicious and dangerous. There is also well-meaning news, reports that want to bring hope but in fact are simply grasping at straws.

     A report now viral, emanating from the University of Chicago, is about how an anti-viral drug developed by a pharma company, Gilead, has helped seriously ill COVID-19 patients.

     Remdesivir is an antiviral medication; a nucleotide analog, specifically an adenosine analogue, which inserts into viral RNA chains, causing their premature termination. It is being studied during 2020 as a possible post-infection treatment for COVID-19 illness.

A U of Chicago doctor participated in an internal hospital video in which she reported that when seriously ill patients administered remdesivir, many recovered.

The video reached some hospital employees, who leaked it to journalists. That led to a highly optimistic report.

This is not a clinical test. There is no protocol, and no placebo (sugar pill given to some patients).

   The drug, made by Gilead Sciences, was tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to Covid-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).

     We are all desperate for some good news. But grasping at straws is not going to help. The journalists who reported this “scoop” should have told us exactly what the source was, an internal chatty ‘gossip’ video of the kind that circulates in most hospitals.

     The journalist who DID inform us was the CNN medical correspondent, is Elizabeth Cohen, who has serious training and deep scientific knowledge. She has a Master’s degree in public health. Her colleague is Dr. Sanjay Gupta, a neurosurgeon; together they comprise “the horse’s mouth” and to mix a metaphor, a horse’s mouth that does NOT grasp at straws.

Does the Novel Coronavirus Mutate?

April 16, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , , , , , | Leave a comment

Does the Novel Coronavirus Mutate?

By Shlomo Maital

     Writing in today’s New York Times, Nathaniel Lash and Tala Schlossberg try to answer the key question, does the novel coronavirus mutate? If so, how and when?

   Here is why it is important for us to know this.   The pandemic crisis will end only when we have a vaccine, produced in billions of doses. The vaccine will work by stimulating the body to produce antibodies that neutralize the virus by binding to it in a very specific way. If the virus can mutate to defeat the vaccine, then the vaccine will not stop working. The key is the “spike protein” – the protein the virus makes that penetrates the cell walls and lets the virus invade (and kill) it. Those are the spikes you see in the graphic illustrations of corona. Vaccines can defeat the spike.

   Here is what the authors of the article have found:

   “Among the thousands of samples of the long strand of RNA that makes up the coronavirus, 11 mutations have become fairly common. But as far as we know, it’s the same virus infecting people all over the world, meaning that only one “strain” of the virus exists, said Peter Thielen, a molecular biologist with the Johns Hopkins Applied Physics Laboratory.   Only one of those common mutations affects the “spike protein,” which enables the virus to infect cells in the throat and lungs. Efforts to produce antibodies that block the spike protein are central to many efforts to develop a vaccine. Since the spike protein has changed little so far, some scientists believe that’s a sign that it can’t alter itself very much and remain infectious.”

   So – we have a small piece of good news. The measles vaccine, for instance, was developed in 1950. And it is still effective. Measles hasn’t mutated in a manner that neutralizes the vaccine. Evolution is powerful – but apparently it cannot surmount EVERY obstacle. So hopefully the same will apply to the COVID-19 vaccine – and we will bid this insidious deadly enemy good-bye, with an effective vaccine… until the next one.

Viral Shedding Peaks – BEFORE Symptoms!

April 16, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , , | Leave a comment

Viral Shedding Peaks – BEFORE Symptoms!

By Shlomo Maital

The late Li Wenliang, China’s hero doctor who warned us

   A very large number of research papers are now emerging from China, by Chinese scientists and scholars, related to biology, medicine, education, and other areas. China is sharing with the world what it has learned.

   Yesterday’s Nature Medicine features a very important article by a large group of Chinese researchers, which shows this:

     “We report temporal patterns of viral shedding in 94 patients with laboratory-confirmed COVID-19 and modeled COVID-19 infectiousness profiles from a separate sample of 77 infector–infectee transmission pairs.

     We observed the highest viral load in throat swabs at the time of symptom onset, and inferred that infectiousness peaked on or before symptom onset. We estimated that 44% (95% confidence interval, 25–69%) of secondary cases were infected during the index cases’ pre-symptomatic stage, in settings with substantial household clustering, active case finding and quarantine outside the home. Disease control measures should be adjusted to account for probable substantial presymptomatic transmission.”

   Meaning?   Three rather scary words: substantial pre-symptomatic transmission. We spread the coronavirus even before we feel symptoms.

     This is why social distancing will need to be enforced for quite some time, until tests are widely available and can provide results within hours. If you have no symptoms, then anybody can be a carrier and spreader. Anybody.

     Finally, we are learning about this insidious enemy – is anyone expressing some gratitude to the Chinese for sharing?

         Well, a small gesture – here are the names of the researchers who co-authored this paper: Xi He, Eric H. Y. Lau, Peng Wu, Xilong Deng, Jian Wang, Xinxin Hao, Yiu Chung Lau, Jessica Y. Wong, Yujuan Guan, Xinghua Tan, Xiaoneng Mo, Yanqing Chen, Baolin Liao, Weilie Chen, Fengyu Hu, Qing Zhang, Mingqiu Zhong, Yanrong Wu, Lingzhai Zhao, Fuchun Zhang, Benjamin J. Cowling, Fang Li & Gabriel M. Leung

 

 

A Vaccine is Coming – from Pittsburgh: Again!

April 16, 2020 in Uncategorized | Tags: , , , , , | Leave a comment

A Vaccine is Coming – from Pittsburgh

By Shlomo Maital

Univ. of Pittsburgh “Cathedral of Learning”

   Before the good news about a COVID-19 vaccine – a piece of history.

     In 1947, native New Yorker Jonas Salk accepted an appointment to the University of Pittsburgh School of Medicine. In 1948, he undertook a project funded by the National Foundation for Infantile Paralysis to determine the number of different types of poliovirus. Salk saw this was a golden opportunity to extend this project towards developing a vaccine against polio. He built a research team and devoted himself to this work for the next seven years. The field trial set up to test the Salk vaccine involved 20,000 physicians and public health officers, 64,000 school personnel, and 220,000 volunteers.   Over 1.8 million schoolchildren took part in the trial.

    On March 26, 1953, Salk announced on a national radio show that he had successfully tested a vaccine against poliomyelitis, the virus that causes the crippling disease of polio. In 1952—an epidemic year for polio—there were 58,000 new cases reported in the United States, and more than 3,000 died from the disease. Dr. Salk was celebrated as the great doctor-benefactor of his time.

   Fast forward.   A press release from the NIH: https://www.nih.gov/news-events/nih-research-matters/microneedle-coronavirus-vaccine-triggers-immune-response-mice

   “After the identification of SARS-CoV-2, the genome sequence of the new coronavirus was rapidly released to the public by scientists in China. Several weeks later, National Institute of Health-funded scientists produced a detailed picture of the part of the virus, called the spike protein, that allows it to infect human cells. This spike protein is currently the target of several vaccine development efforts. And we see the graphic version of the corona ‘spikes’ everywhere…

   “Researchers led by Drs. Louis Falo, Jr. and Andrea Gambotto from the University of Pittsburgh have been working to develop vaccines for other coronaviruses, including the one that causes Middle East Respiratory System (MERS). They adapted the system they had been developing to produce a candidate MERS vaccine to rapidly produce an experimental vaccine using the SARS-CoV-2 spike protein.

   The team developed a method for delivering their MERS vaccine into mice using a microneedle patch. Such patches resemble a piece of Velcro, with hundreds of tiny microneedles made of sugar. The needles prick just into the skin and quickly dissolve, releasing the vaccine. Since the immune system is highly active in the skin, delivering vaccines this way may produce a more rapid and robust immune response than standard injections under the skin.

   “When delivered by microneedle patch to mice, three different experimental MERS vaccines induced the production of antibodies against the virus. These responses were stronger than the responses generated by regular injection of one of the vaccines along with a powerful immune stimulant (an adjuvant). Antibody levels continued to increase over time in mice vaccinated by microneedle patch—up to 55 weeks, when the experiments ended.

   “Using knowledge gained from development of the MERS vaccine, the team made a similar microneedle vaccine targeting the spike protein of SARS-CoV-2. The vaccine prompted robust antibody production in the mice within two weeks.

   “The vaccinated animals haven’t been tracked for enough time to see if the long-term immune response is equivalent to that observed with the MERS vaccines. The mice have also not yet been challenged with SARS-CoV-2 infection. However, the findings are promising in light of results from the similar MERS vaccine.

   “The components of the experimental vaccine could be made quickly and at large-scale, the researchers say. The final product also doesn’t require refrigeration, so it could be produced and placed in storage until needed. The team has now begun the process of obtaining approval from the U.S. Food and Drug Administration to launch a phase 1 trial within the next several months.

   “Much work still needs to be done to explore the safety and efficacy of this candidate vaccine. “Testing in patients would typically require at least a year and probably longer,” Falo says. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take.”

OK – it works in mice. Now for humans. A vaccine is on the way – and it may emerge again from Univ. of Pittsburgh.

 

   

 

 

 

 

The End of the Beginning

April 15, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , , , | Leave a comment

The End of the Beginning

By Shlomo Maital

   There is evidence that, to quote Winston Churchill, “we are not at the beginning of the end, but..at the end of the beginning.” Here are the daily totals of new cases worldwide, thanks to worldometer.com, and next to them, the % daily change:

3-Apr 101736
4 84821 -16.6 %
5 71502 -15.7
6 74044 3.6
7 85116 15.0
8 84447 -0.8
9 85638 1.4
10 94629 10.5
11 80963 -14.4
12 72523 -10.4
13 71572 -1.3
14 73969 3.3

What this looks like, is a kind of ‘plateau’ levelling off — as the coronavirus spread globally, some countries were afflicted early, others later. So countries will reach their ‘apex’ at differing times… (the US is still not there yet)…. And this will produce a kind of plateau worldwide.

   The reason this is important, is this — countries will begin to emerge from their ‘lockdown’ at different times, some sooner than others. Denmark is opening its kindergartens, China is sending Wuhan back to work in part.

       But in terms of public health, we need to see this as a global system. If there are hot pockets in one country, no country is safe – because a return to normality will restart flights and travel. And we still do not fully understand the duration or extent of coronavirus immunity for those who had it.

 

How to Emerge from Lockdown: Speed (in Testing) is Vital!

April 15, 2020 in Global Crisis Blog, Innovation Blog | Tags: , , , | Leave a comment

How to Emerge from Lockdown: Speed is Vital!

By Shlomo Maital

   Question: how does coronavirus resemble standup comedy?

   Answer: For both, timing is crucial.

As countries begin to emerge from lockdown (Denmark has opened its kindergartens, because 90% of families with children have both parents working), fears arise whether this is wise. One answer is, yes, but…   The diagram above shows how emergence can best be done. And everything, EVERYthing, depends on timing and speed —

  • test for virus among those with symptoms, and some who are asymptomatic,
  • get the results super-fast, within hours (this is possible with some tests),
  • track those in contact with persons testing positive,
  • lock down those with the virus, and
  • do this again and again.

 

     All this depends on revising current testing procedures (some results have been lost, some take 6-8 days for results, far too long to be useful). Timing and speed are crucial. Why? Because, in the 6 days it takes now for results to be provided, the person potentially infected can infect many many other people, even unknowingly.

       Does your country have test results within minutes or even hours? There are such tests. We need millions of them.

What Do We NOT Know?! (about the novel coronavirus)!

April 14, 2020 in Uncategorized | Tags: , , | Leave a comment

What Do We NOT Know?!

By Shlomo Maital

  After more than four months of nonstop news/debate/discussion around COVID-19, it is astonishing how much we do not know. And as the saying goes, what you don’t know that you don’t know — is the worst; it can literally kill you.

   So here is my attempt to list, what it is we don’t know, that we NEED to know, about this tiny virulent enemy and hopefully, scientists are working on it.

  • For those who get COVID-19 and recover, are they immune? For life? For a short time? How long does the immunity last?
  • Like many viruses, can this novel coronavirus mutate quickly and attack those who contracted an older version? Are COVID-19 cases in the US characterized by the same genetically-identical virus as say in China, or different? If so, how different? And does it matter?
  • Intubation: Are we in too much of a hurry to put people on intubation (ventilators)? If such a small percentage of those intubated, survive, should we rethink this? And how different are the various kinds of ventilators (those used by anesthetists, oxygen ventilators, standard ventilators, etc.)?
  • Why are the death rates (those who die from COVID-19, as a % of those who are seriously ill, or in general % of those who contract the virus) different, radically, between one country and another?   How much of this is due to ICU expertise?
  • How exactly does COVID-19 spread?   As aerosol (tiny droplets that hang in the air for hours?)   As big droplets (that fall to the ground fairly quickly)?  
  • Are there drugs proven to be effective against COVID-19? What about the recently-approved anti-influenza drugs? Xofluza, Tamiflu, Relenza, Rapivab ? And, of course, hydroxychloroquine? (which seems to have severe heart side-effects among some patients).
  • Why are African-Americans more afflicted than Caucasians? Men more than women?
  • Will there be a second wave? And a third? How will we know in time?
  • How soon will we have a proven vaccine, and how quickly can doses be produced, to inoculate billions of people? How much will it cost? Can it be provided for free? How can the many companies working on a vaccine, in many countries, work together, to save time and save lives?
  • What countries have managed the COVID-19 crisis best, and what can be learned from them? There have been many variations on lockdown, ranging from easy (Sweden) to draconian (China, Singapore).   Which works best?
  • Somewhere, as we speak, a new virus is brewing and mutating somewhere; this is not the last pandemic. Can we organize a world-spanning organization (broader in span than WHO, with far more resources) that will be ready to tackle the next pandemic quickly and efficiently? With massive resources?  

 

I’m certain there are a thousand more things we do not know. Add your own questions… for each question above, there are multiple answers online, and many of them are fake or conspiratorial.   This simply adds to the fog.

Blog entries written by Prof. Shlomo Maital

Shlomo Maital

Pages