Making Sense of Medical Science (MSMS)

A medical scientist explains medical news for lay people

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Steve Clark, PhD is a retired university professor with a PhD in immunology and a past Special Fellow of the Leukemia Society of America. Clark has published dozens of papers based on his research and holds two drug patents. He taught medical and graduate students about cancer biology and genetics, and about research ethics. He also directed an NIH-funded PhD Graduate Program and chaired several executive-level faculty committees. Clark served on the University Chancellor’s Speaker’s Bureau. While retired, Clark has been blogging on the COVID pandemic, which is the subject of his next book.

  • CoV-2 Virus Budding Fom Lung Cells

    This is a colorized scanning electron microscope image of CoV-2-infected lung tissue that was recently published in the New England Journal of Medicine, by pediatric pulmonologist, Camille Ehre, at UNC-Chapel Hill. Human lung cells were cultured in a lab dish then infected with the virus. The image shows the great number of viral particles that can be released from infected cells in the respiratory tract. The dish contained about 1 million cells and Ehre noted that in just a couple of days, the virus produced by the cells exploded from about 1000 particles to 10 million.

    Virus

    • Lung cells are purple.
    • They are covered in hair-like cilia (blue) that clear mucus (yellow-green, of course) from the lungs.
    • Red particles are budding CoV-2 particles.

  • COVID-19 Is The Leading Cause Of Death And Accelerating

    Reuters reports that last week 17,000 people died from COVID-19, far surpassing the death rates of the former top two killers, heart disease and cancer, which kill about 12,000 people each week. There were 15,500 COVID-19 deaths the previous week, so the post-Thanksgiving surge is growing.

    The Dakotas and Iowa reported the most deaths per capita last week, while Rhode Island, Tennessee and Ohio had the highest number of new cases per capita. And according to the Johns Hopkins Tracker, the US has passed 300,000 total deaths.

    Across the US, ~12% of CoV-2 tests came back positive, compared to 10.5% the previous week. 32 states had a positive test rate of 10% or more with the highest rates reported in Iowa and Alabama at 50%.

    One conclusion from these data is that states that have the most lax restrictions, or most resistance to common-sense safe practices are bearing the brunt of the pandemic.

  • The Post-Thanksgiving Surge Is Underway

    As the pandemic surges, newly released data from the US Department of Health and Human Services show at least 200 hospitals across the country were at full capacity last week. One third of all hospitals have 90-100% occupancy of ICU beds, and coronavirus patients now take up almost 50% of all staffed ICU beds in the US–up from 37% in the first week of November. Hospitalizations in the US reached a record high of 107,248 on Thursday, Dec 10, according to the Covid Tracking Project.  This is the post-Thanksgiving surge we were warned would happen.

    Across the country, more hospitals are running out of health care workers and/or ICU beds, forcing some doctors to send patients out of state. This does not just affect COVID-19 patients, it affects anyone who needs hospital care. When hospitals run out of beds and staff, all patients are turned away, making difficulty in obtaining hospital care very egalitarian.

    Thursday was encouraging as an FDA committee recommended that a COVID-19 vaccine be authorized for emergency use. But it was also a day of loss. The single-day death toll from COVID-19 reached a record high of 3,124 according to Johns Hopkins University. That's more deaths than suffered in the 9/11 attacks. We are now suffering the equivalent of a 9/11 attack and more every day, and it is getting worse.

    A composite forecast from the US Centers for Disease Control and Prevention projects a total of 332,000 to 362,000 Covid-19 deaths by January 2, and up to 500,000 dead by April. That forecast combines modeling from 40 independent research groups. As I reported a few days ago in these pages, COVID-19 has now become the leading cause of death in the US.

    Yet, the mortality statistics do not tell the full story. Many more people who survive COVID-19 suffer long term health problems, usually neurological or cardio-pulmonary. This will continue to be a drain on health resources, finances, families, and lead to reduced life-spans in many long after the pandemic wanes. These problems also are common in younger, healthier survivors, and in those who only had mild disease. This is the long-term cost that too many people ignore.

  • Don’t Vaccinate Health Workers First

    The following is an excerpt of an opinion piece written by Joel Zivot, MD and published December 10 in MedPageToday. Zivot is an ICU doctor and Assistant Professor of Anesthesiology/Critical Care at Emory University School of Medicine.

    We are on the verge of a COVID-19 vaccine rollout and the current reality is that the on-hand supply will fall short. Healthcare workers have been put in the CDC's very first priority group, along with nursing home residents. I am puzzled by this. The question is, what is the expected result with this first wave of vaccinations?

    From the public perspective, one can imagine the desired result would be to reduce morbidity and mortality as fast as possible…

    When one considers the plan to start with vaccinating healthcare workers, the reality is the death rate will likely not slow in any appreciable way. This first wave of vaccinations is actually not configured to have a substantial impact on the current COVID-19 mortality rate….

    The best way to reduce mortality is to staunch the flood of hospital admissions. If the hospital had fewer COVID admissions, this would accomplish two things. First, it would ease the burden on the healthcare workers. I speak from experience as an ICU doctor working this from the beginning. So much of what we do is COVID and we have had to expand services in a way that has stretched us very thin…

    Second, if we target the high-risk group for serious COVID-19 morbidity and mortality, we will begin to also reduce morbidity and mortality overall…

    The idea behind vaccinating healthcare workers is to avoid a crippling level of healthcare worker absenteeism. This sounds reasonable. In my experience, yes, healthcare workers have gotten sick with COVID-19, but on the whole, this group has actually done well in protecting itself and is not the population at the crest of the wave of mortality. Until we target the highest risk groups, we will continue to lose lives to COVID-19…

    That's why I respectfully disagree with the CDC that healthcare workers be among the first in line to receive the COVID-19 vaccine.

    Recently in the U.K., the National Health Service reconsidered its original plan to vaccinate healthcare workers first, and instead will focus on nursing home residents and staff. It is true that healthcare workers have fallen sick and some have died, yet they make up a very small proportion of patients in ICUs and of deaths.

    Vaccinating healthcare workers won't unclog the ICU and thus will not make healthcare workers' jobs any easier…

    But what if we started with Medicare and Medicaid recipients, a group that covers the populations at highest risk: the elderly, the disabled and the poor? The vaccine program could be administered by family doctors who can reach out directly to their Medicare/Medicaid patients and ask them to come in to the office or the clinic…

    The hospital is clogged with patients and empty of families. This combination is eroding the resolve of the healthcare worker. When the hospital begins to unclog as we target the real priority populations — those at highest risk of otherwise becoming hospital patients — the clog will give way and the families will return. When this happens, ICUs will return to something closer to normal for healthcare workers — to the benefit of all.

  • The Statistics Get Grimmer

    As of 8 AM Monday EST, the COVID-19 toll is 14,761,732 total cases and 282,345 total deaths, up nearly 1.4 million cases and nearly 15,500 deaths versus this time a week ago.

    That makes COVID-19 the leading cause of death for Americans by a considerable margin, topping heart disease and cancer, which each kill roughly 12,000 people in the U.S. each week.

    And still people think the inconvenience of wearing a face mask and socially isolating is a bigger problem!

  • And It Begins–Thanks To A Turkish Couple And Their German Biotech Company

    The U.K. just became the first western country to approve a Covid-19 vaccine. The vax was developed by Pfizer and BioNTech. It is an RNA vaccine that is 95% effective. The shot will be available in Britain next week with 50 hospitals preparing to administer it and 800,000 doses ready to be delivered from a Pfizer production facility in Belgium. The country has ordered enough doses of the two-shot vax for 20 million people, less than one-third of the population. This is the first human coronavirus vaccine and the very first RNA vaccine.

    It took only 10 months for Germany’s BioNTech and its US partner, Pfizer to develop the vaccine that was granted emergency-use authorization in the UK on Wednesday—beating the previous Western record for vaccine development by more than three years. Yet, for BioNTech’s founders, Ugur Sahin and Özlem Türeci, the husband-and-wife team behind the endeavor, it was the outcome of three decades of work, starting long before the coronavirus first appeared in humans last winter. It began 30 years ago in rural Germany when two young physicians, the children of Turkish migrants and freshly in love, pledged to invent a new treatment for cancer, not vaccines for a virus.

    By the time the pandemic broke out, Dr. Sahin had already spent years studying how mRNA could be delivered into the body to help it defend against threats like cancer. In January, just days before the illness was first diagnosed in Europe, he designed a version of the RNA vaccine on his home computer. Sahin was born in Turkey in 1965. He moved to Germany four years later when his father was recruited to work at a Ford factory near Cologne as part of a policy to rebuild postwar Germany with foreign labor. Dr. Türeci’s father, a surgeon, came to Germany around the same time to work at a Catholic hospital. After initially considering becoming a nun, she eventually followed in her father’s footsteps and became a physician. When the two met at Homburg University in the 1990s, they shared frustration as young physicians about the dearth of options faced by cancer patients for whom chemotherapy was no longer working. The couple wrote their doctoral dissertations on experimental cancer therapies. Christoph Huber, then head of the hematology and oncology department of the Johannes‐Gutenberg University in Mainz and now a BioNTech nonexecutive director, persuaded them to join his faculty. There they began researching new treatments based on programming the body’s own immune system to defeat cancer like it does an infectious disease. Hence the carryover to using their technology to treat a real infectious disease.

    In 2001, the couple set up their first company, Ganymed Pharmaceuticals GmbH, to develop an antibody treatment for cancer. Türeci was the CEO and Sahin was in charge of research. One day in 2002, they left their laboratory around lunchtime, got married and returned to work. It was a honeymoon among test tubes and incubators.

    The earliest and most important backers of the couple were Andreas and Thomas Strüngmann, twin brothers and billionaire investors who poured more than $241 million into the couple’s enterprises since 2001. In 2008, Sahin and Türeci founded BioNTech to expand their research from antibody treatments into mRNA therapies. Ganymed was sold for $1.4 billion in 2016 and the couple reinvested the proceeds into BioNTech. The BioNTech team includes scientists from 60 nations, half of them women scientists.

    On Saturday, Jan. 25, after reading a study Sahin set to work on his computer, designing the template for 10 possible coronavirus vaccines, one of which would become BNT162b2, the vaccine authorized in the U.K. on Wednesday. That same day, BioNTech refocused its work from cancer to combating a virus that didn’t yet have a name and hadn’t yet been diagnosed in Europe. The following Monday, Sahin reorganized his staff into seven-day shifts, asked key workers to cancel their holidays and stop using public transport to protect him from the coming pandemic that Sahin predicted. The newly dubbed Lightspeed Project would develop a vaccine in months rather than years using RNA technology platforms the company had developed to fight other diseases. It was a risky and visionary endeavor.

    BioNTech already had been working with Pfizer to develop a flu vaccine based on the mRNA technology. So when Sahin needed a partner to organize clinical trials, manufacture the product, and help distribute it he approached Pfizer. In March, the two companies signed a cooperation deal, and in April, the first human trials began. Now, the second day of December, the vaccine has been approved and inoculations will begin a few days!

    As an interesting aside: Ugur Sahin’s brother, Mustafa Sahin, MD was a research fellow in my cancer research laboratory at the University of Wisconsin.

    And so it begins….

  • The Coronavirus Arrived In The US Weeks Earlier Than Thought

    The CoV-2 virus and the illness that it causes, COVID-19, were first identified in Wuhan, China, in December 2019, but it wasn't until Jan. 20 that the first confirmed COVID-19 case, in a traveler who just returned to Seattle from China, was found in the US. However, new findings published in the journal Clinical Infectious Diseases show that the virus had infected people in the US much earlier.

    The CDC found coronavirus antibodies in 106 out of 7,389 blood donations collected between Dec. 13 and Jan. 17 from residents in nine states. The presence of antibodies in a person's blood means they were exposed to the coronavirus.

    Coronavirus antibodies were found in 39 samples from California, Oregon, and Washington as early as Dec. 13 to Dec. 16. Antibodies were also found in 67 samples from Connecticut, Iowa, Massachusetts, Michigan, Rhode Island, and Wisconsin in early January, weeks before the first confirmed COVID-19 case appeared in the US. This means that the virus was widely spreading throughout the US weeks, if not months before the first COVID-19 case was confirmed in the US. This is consistent with a recent report from the UCLA medical center that where was an unexpected 50% spike in patients with respiratory illness beginning in December.

    In other words, evidence strongly supports the notion that the virus was widely spreading around the US and the world before health officials and the public were aware of it.

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  • A Third Vaccine Also Shows Success!

    Two RNA vaccines developed and produced by Pfizer/BioNTech and Moderna/NIH have already reported highly significant protection against SARS-CoV-2 with negligible side effects. The Pfizer vaccine has been submitted to the FDA for approval, which should be quickly forthcoming. Moderna will soon submit its vaccine for FDA approval.

    Now, a third and different type of two-shot vaccine developed by the UK’s AstraZeneca and the University of Oxford also reports 90% efficacy. It also showed minimal adverse effects that are expected from the immune reaction to any vaccine. Unlike the RNA vaccines, this one is a crippled adenovirus engineered to express the CoV-2 spike protein and offers some advantages over the RNA vaccines. First, it can be produced and marketed at a fraction of the cost of the RNA vaccines. Second, it only needs refrigeration storage, not a freezer like the Moderna vaccine, and not an ultracold freezer like the Pfizer vaccine requires. These advantages mean that this vaccine will be more readily available for third-world countries that do not have freezer storage capability. Also, AstraZeneca plans to produce its vaccine in multiple countries, from India to Brazil to Japan and to Australia, and beyond which will facilitate its international distribution.  

    Getting a vaccine out to the several billion people around the world is a daunting challenge. Having multiple vaccines produced in various sites around the world should facilitate the distribution to all countries. A global program called Covax has an ambitious effort to deploy vaccines around the world, getting dozens of countries to join and securing deals for 700 million doses so far. AstraZeneca has agreed to supply the initiative, while a collaboration including the Serum Institute of India agreed to accelerate the production of the AstraZeneca or, soon to come, Novavax shots for low- and middle-income nations, priced at only $3 per dose. Another Covax pact with pharma companies Sanofi and GlaxoSmithKline Plc, which are developing their own vaccines, followed last month. The program, led by the World Health Organization, the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance, expects more deals in the coming weeks. Pfizer/BioNTech, along with Moderna/NIH, are also in talks with Covax.

    AstraZeneca/Oxford has easily been the most active company in reaching supply accords around the world. It has assembled an unprecedented global network of manufacturing and distribution partners, and has promised to provide 3.2 billion doses of its vax. More than 50 lower- and middle-income countries in regions including Latin America, Africa, the Middle East, Asia and Eastern Europe would receive AstraZeneca/Oxford’s shot, which will be provided at cost during the current pandemic. The company is poised to be the dominant vaccine supplier to the developing world and it is forgoing any profit to do so.

    Trial results for other vaccines produced by Novavax Inc. and Johnson and Johnson are expected soon. The Milken Institute tracks a total of 199 vaccines in development around the world. That means we can soon expect results from 194 more vaccines.

    A final note: Some folks with a conspiratorial mindset have pointed out that these positive vaccine results presented just after the November 3rd US election is evidence that the election was rigged. They assume that the vaccine results were delayed in order to prevent giving Trump a bump. But, these folks have to explain why and how German and British pharma and biotech companies, and universities, which had no input from the US, were involved in that conspiracy.

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  • Pfizer Applies For FDA Approval

    Pfizer announced that today it will seek approval for its anti-CoV-2 vaccine. If approved, the vaccine can be distributed as early as December. Given the urgency, the FDA is expected to move quickly.

    The final numbers, released last Wednesday, showed that of the 170 subjects in the trial who caught COVID-19, 162 had received the placebo, meaning that the vaccine was 95% effective. It also was 94% effective in people 65 and older. Nine of the 10 subjects who came down with severe COVID-19 had received the placebo, meaning that the vaccine protects against severe disease.

    This is a momentous vaccine. It will be the first RNA vaccine and, by far, the fastest to be developed and distributed, which will revolutionize vaccinology. This moved rapidly for several reasons. 1) The RNA vaccine platform had already been developed and it was just a matter of inserting the genome sequence for the viral spike protein into it. 2) RNA vaccine technology greatly speeds vax development since it completely avoids the need to grow massive amounts of virus iteslf. 3) Genome sequencing is now done very rapidly. The Chinese published the CoV-2 genome sequence in just a few weeks after the new virus was identified. 4) Pfizer began mass production of the vaccine while it was still in the experimental stage and not yet approved, thereby eliminating the typical delay required to ramp up production capability. 5) Trump’s Operation Warp Speed pre-planned for the massive storage and distribution effort that will be needed so that as soon as approval is granted, the already manufactured vaccine can immediately be distributed.

    After approval, vaccine for about 25 million people will be immediately available for distribution and the US is scheduled to receive half of that. 1.3 billion doses are expected to be produced next year, which will enough to vaccinate 650 million people. In the US, it is likely that the first doses will go to health-care workers, followed by those at high risk, people in nursing homes, and prisoners. The general public probably will not get access until the spring or summer. The US has agreed to pay Pfizer and BioNTech nearly $2 billion for 100 million doses, enough to vaccinate 50 million people at no charge to them.

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  • Nasal Spray To Prevent CoV-2 Infection?

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    A November 5 preprint showed that a nasal spray was 100% effective in preventing infection in an animal CoV-2 infection model. The spray contained a small piece of the SARS-CoV-2 spike protein designed to block the ability of the virus to enter human cells in the respiratory tract.

    Ferrets were given the nasal spray and then placed in cages with an infected partner to see if the virus would transfer to the treated animal. After 24 hours, 100% of the animals that received a sham spray were infected while none of the animals that received the experimental nasal spray were infected. This not only shows that the spray seems to work, it also confirms that sinus exposure to the virus is the primary route of infection–at least in ferrets. It shows that saliva exchange, sharing food and water, etc., are not as important routes of infection.

    While very encouraging, this also is very preliminary. We need to learn how long such protection lasts, whether it works early after infection, whether it works in humans, and assess its safety profile in humans.

    Such a pre-exposure, or even early post-exposure prophylactic, would be very helpful to high risk people, front-line health care workers, teachers, nursing home residents, and many others. If it works, it could provide a relatively inexpensive and readily available prophylaxis and complement the vaccines that will likely be soon approved. Since it seems that only about 50% of the US are willing to get an anti-CoV-2 vaccine, which is not sufficient to confer herd immunity, a preventive measure like this nasal spray could go a long way in reducing the R0 value for CoV-2 to <1.