Tuesday Edition
November 10, 2020
Without reliable information, we rely on fear or luck.
Pfizer, BioNTech say Covid vaccine is more than 90% effective — ‘great day for science and humanity’
(see story below)
“We may have doses of the Pfizer and BioNTech vaccine that we are able to give to people by the end of November, the beginning of December, probably well into December.”
Dr. Fauci
Index
A. The Pandemic As Seen Through Headlines
B. Numbers & Trends
1. Cases & Tests
2. Deaths
3. Top 5 States in Cases, Deaths, Hospitalizations & Positivity
C. New Scientific Findings & Research
2. 7 Different “Disease Forms” Have Been Identified in Mild C19
3. Blood Pressure Medicines Do Not Increase C19 Risk
4. Recent Studies Cast Doubt on Cytokine Storms (!) ©
6. Enzyme targeted by coronavirus also influences gut inflammation
D. Vaccines & Testing
1. C19 vaccine from Pfizer and BioNTech is strongly effective
2. What does Pfizer’s ‘90% effective’ C19 vaccine actually mean?
3. COVID immunity could last over a year after taking Pfizer’s vaccine
4. Rapid Antigen Testing Not Reliable for Asymptomatic COVID Cases (!)
E. Improved & Potential Treatments
1. Llama Nanobodies Could Be a Powerful New Weapon Against C19
2. Aspirin to be tested as potential C19 treatment against blood clots
3. Death rates fall by more than a third for hospitalized C19 patients as treatments improve
F. Concerns & Unknowns
1. Irregular Heartbeat May Increase C19 Risk
2. C19 linked to worse stroke outcomes
3. Covid set to cause 400,000 surge in TB deaths as medics diverted
4. Researchers believe C19 can affect male fertility (!)
5. Many C19 patients later develop mental illness
6. More economic worries mean less caution about C19
G. The Road Back?
1. CDC: Teleworking may help us beat C19 (*)
H. Back to School!?
I. Projections & Our (Possible) Future
1. Top UK military commander Nick Carter fears C19 could spark third world war
J. Practical Tips & Other Useful Information
1. Is It Safe to Have Dinner Together Inside? (*)
2. C19 FAQs: Should I Purell My Nostrils? Can Lysol Disinfect The Air? (?!)
K. Johns Hopkins COVID-19 Update
L. Linked Stories
- FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior Coronavirus Infection
- Coronavirus Mutation Concern Verified by Largest C19 Viral Sequence Analysis in U.S.
- C19 Patient Zero: Data Analysis Identifies the “Mother” of All Coronavirus Genomes
- Plastic Film Protects Surfaces Against Novel Coronavirus on Contact – Eliminates 99.84% of Coronavirus Particles
- Significant psychological toll from New Zealand C19 lockdown
- Study reveals strategy to create C19 drugs to inhibit virus’s entry and replication
- Inside the Operation Warp Speed Effort to Get Americans a C19 Vaccine
Notes:
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- We do not endorse, and may not agree with, any opinion or view included in this update. We include a wide spectrum of opinions and views as we believe that it gives perspective on what people are thinking and may give insights into our future.
A. The Pandemic As Seen Through Headlines
(In no particular order)
- Global coronavirus cases exceed 50 million after 30-day spike
- Joe Biden warns of “dark winter”, unveils task force members
- US hospitalizations back to July highs
- Pfizer hits major milestone with coronavirus vaccine, data reveals
- Covid-19 vaccine from Pfizer and BioNTech results indicate that it is highly effective
- A possible vaccine breakthrough
- Dr. Fauci hails Pfizer-BioNTech news
- Russia says its COVID-19 vaccine also over 90% effective
- Biden Camp Celebrates Pfizer News, Warns Masks Better Option For Fighting COVID; Novovax Gets ‘Fast Tracked’
- COVID-19 vaccine distribution will start within 24 hours of approval
- Biden warns coronavirus vaccine won’t be ‘widely available’ for months
- Dr. Fauci: Moderna vaccine may have similar results as the Pfizer vaccine
- Novavax COVID vaccine gets ‘fast track’ status from FDA
- NY Bar Association Recommends Mandatory COVID-19 Vaccine With No Exemptions
- Joe Biden could enter White House amid COVID ‘apex,’ ex-FDA chief says
- FDA Approves Eli Lilly Antibody Drug For Emergency Use
- Dr. Fauci warns that widely used COVID tests may pick up ‘dead’ virus
- Dr. Fauci says he wants to stay in current role
- California hospitalizations spike
- California Governor hints at more restrictions
- Illinois reports 10,000+ new cases for fourth day
- Hospitalizations climb in the mountain west
- 100s Of UK Medics And Academics Urge Boris Johnson: COVID Data Is “Exaggerated” And Second Wave Talk Is “Misleading”
- German Doctors Urge Chancellor Merkel: Put An End To The COVID “Fear Machine”
- France, England making huge, anti-science mistake going back to total lockdown
- Europe at odds over what’s essential during new COVID-19 lockdowns
- New coronavirus lockdown in Greece requires people to text authorities before leaving home
- Denmark To Kill 17 Million Mink After COVID Mutation Found
- Nebraska issues mask order
- Utah governor announces statewide mask mandate ‘until further notice’
- Italy shuts down 4 regions as Europe tries lighter lockdowns
- Italian city shattered by COVID-19 sees hope in immunity
- Hungary and Portugal plan curfews and new restrictions as cases surge
- New Jersey announces new COVID-19 restrictions at bars, restaurants
- NYC ‘dangerously close’ to second coronavirus wave, mayor de Blasio says
- NYC to install mobile morgues as COVID-19 body count rises
- Navajo Nation experiencing ‘uncontrolled’ COVID-19 spread
- Shanghai reports first case in months
- Officials urged to probe mink farming amid COVID-19 mutation fears
- Nursing home resident says she ‘just wants to die’ over COVID isolation
- Federal Reserve Warns Assets Could Suffer “Significant Declines” If Covid Is Not Contained
- Zoom, Peloton shares tumble 15% on COVID vaccine news
- Morgan Stanley: With Little Or No Stimulus Coming, Pandemic Developments Become Critical For Markets
- South East Conference forced to change football schedule due to coronavirus
- Notre Dame fans storm field in potential COVID-19 nightmare
- Crowds get to celebrate Joe Biden’s victory — but no one else can gather in public?
- In a pandemic, smart companies are hiring unflappable military veterans
- Woman named ‘Corona’ says she gets threats, abuse
- ‘Lockdown’ named word of the year by Collins Dictionary
B. Numbers & Trends
Note: Unless otherwise noted, (i) all cases/deaths are confirmed cases/deaths that have been reported, (ii) all numbers reported in this update are as of the end of the most recent reporting period, and (iii) all changes reflect changes since the preceding day.
Sources: https://www.worldometers.info/coronavirus/ and https://covidtracking.com/
1. Cases & Tests
- Worldwide Cases:
- Total Cases = 51,223,588
- New Cases = 482,114
- New Cases (7 day average) = 554,969 (+1,001) (+0.2%)
Observations:
- Record high 7 day average of new cases
- New cases are increasing at a rapid rate (during the last month, the 7 day average has increased from 326,827 to 554,979, an increase of 69.8%)
- US Cases & Testing:
- Total Cases = 10,421,956
- New Cases = 125,689
- New Cases (7 day average) = 117,542 (+5,205) (+4.6%)
- Percentage of New Global Cases (based on 7 day average) = 21.2%
- Total Number of Tests = 159,284,960
- Percentage of positive tests (7 day average) = 9.7%
Observations:
- Record high 7 day average of new cases
- New cases are increasing at a very high rate (during the last month, the 7 day average has increased from 49,030 to 117,542, an increase of 239.7%) (!)
- 7 day average of positive test percentage is increasing at a rapid rate (during the last month, the 7 day average has increased from 5.3% to 9.7%, an increase of 83%)
2. Deaths
- Worldwide Deaths:
- Total Deaths = 1,268,910
- New Deaths = 6,770
- New Deaths (7 day average) = 7,965 (+149) (+1.9%)
Observations:
- Record high 7 day average of new deaths
- New cases are increasing at a rapid rate (during the last month, the 7 day average has increased from 5,351 to 7,965, an increase of 48.9%)
- As new cases are increasing at a faster rate than new deaths, further increases in new deaths can be expected
- US Deaths:
- Total Deaths = 244,448
- New Deaths = 641
- New Deaths (7 day average) = 1,000 (+17) (+1.7%)
- Percentage of Global New Deaths (based on 7 day average) = 12.6%
Observations:
- 7 day average of new deaths is increasing at a rapid rate (during the last month, the 7 day average has increased from 730 to 1,000, an increase of 37%)
- As new cases are increasing at a much higher rate than new deaths, further increases in new deaths can be expected
3. Top 5 States in Cases, Deaths, Hospitalizations & Positivity (11/9)
Observations:
- The positivity rate continues to rise across the country
- Nationally, the average 7-day positivity rate was 9.7% — up from 7.2% as of 10/26.
- More than 70% of all tests are now positive in ND, 54% in SD, and 48% in IA, and 41% in KS.
- Five states (NE, IS, WI, MO, MT) 7-day positivity rates greater than 30%
- Six states (IN, MN, WY, NV, CO, UT) had 7-day positivity rates greater than 20%.
- In total, 42 states have 7-day positivity rates greater than 5% (+5 states since 10/26)
- Hospitalizations in the US increased to 59,275, up 38% since 10/26.
- 43 states have had increases of hospitalized patients of more than 10% since 10/26
- 23 states have more than 1,000 hospitalized patients.
- 2 states (NC, VT) recorded a decline in the number of hospitalized patients compared to 10/26
4. U.S. Cases Top 10 Million
What to Know
- Total cases surpassed 10 million in the U.S. and 50 million globally.
- Governors instituted new restrictions as the U.S. reported nearly 106,000 new coronavirus cases Sunday.
- A vaccine developed by Pfizer and partner BioNTech has proved 90% effective at protecting people from C19. (Read a summary below)
Current Trends in the US
- Total confirmed coronavirus cases in the U.S. since the pandemic began surpassed 10 million on Monday, as the spread of the virus accelerated nationwide and after several record-breaking days of new infections over the past week.
- Newly reported cases in the U.S. exceeded 100,000 for a fifth day, according to data compiled by Johns Hopkins University, though Sunday’s tally was the lowest since Wednesday. The U.S. reported nearly 106,000 new coronavirus cases Sunday, down from more than 128,000 on Saturday. The number of new daily cases reported tends to be lower at the beginning of the week. The U.S., which has the most confirmed C19 cases of any country in the world, went from 9 million cases to 10 million in just 10 days. It took 14 days to record the previous million and 21 days to reach the prior million.
- The 10 million mark came as Pfizer and partner BioNTech SE said their vaccine proved to be more than 90% effective in the first 94 subjects who were infected by the new coronavirus and developed at least one symptom. The companies are on track to seek authorization from health regulators by the end of November, if pending data indicate the vaccine is safe.
- Meanwhile, the virus continued to spread rapidly in several states. Minnesota reported more than 5,900 new cases, a single-day record. New cases in Illinois rose by more than 10,000, a day after the state reported a daily record of over 12,000 infections. Other states, including Indiana, Michigan and Ohio, reported daily tallies near recent highs.
- In a press conference with Ohio Gov. Mike DeWine, hospital officials said the health and availability of their staff was of particular concern.
- “Everybody is having staffing challenges, and it’s not because they’re catching Covid[-19] in the hospital, it’s because they’re catching it in the community,” said Robert Wyllie, chief of medical operations at Cleveland Clinic.
- The nation’s seven-day moving average of newly reported cases, which helps smooth out irregularities in the data, rose to 108,498 as of Sunday, the latest in a series of record highs and the second time over 100,000. The 14-day moving average was 94,917. When the seven-day average is higher than the 14-day average, it suggests cases are rising.
- The seven-day average of new cases was outpacing the 14-day average in 49 states and Washington, D.C. Last week that was the case in 40 states and the district.
- As infection numbers rise, hospitalization levels are also climbing. As of Sunday, 56,768 people were in hospitals due to C19, a nearly 20% increase since Nov. 1 and the largest number since July 29, according to the Covid Tracking Project. Intensive-care units are also dealing with an upsurge: 11,108 people were being treated in ICUs around the country as of Sunday, the highest number since May 12.
- Arkansas hit a new high of concurrent hospitalizations attributed to C19 on Monday with 786 patients. The previous high occurred last Monday, with 672 patients.
- The nation’s death toll rose to more than 237,860, according to Johns Hopkins data. The U.S. recorded 457 fatalities for Sunday, after five consecutive days over 1,000. Sunday’s figure was higher than the 401 deaths reported a week earlier.
- Reporting on fatalities varies by state, and deaths recorded on a certain day may have happened on a different date. However, the seven-day average of deaths has outpaced the 14-day average for 21 consecutive days, suggesting that deaths are increasing.
Source: https://www.wsj.com/livecoverage/covid-2020-11-09
C. New Scientific Findings & Research
1. Some People – Mainly Children – Have Pre-existing Coronavirus Antibodies That Could Help Protect Against C19
- Researchers at the Francis Crick Institute and University College London have found that some antibodies, created by the immune system during infection with common cold coronaviruses, can also target the coronavirus (SARS-CoV-2) and may confer a degree of protection against the new viral strain.
- In response to infection with a virus, the immune system creates antibodies to help fight it. These antibodies remain in the blood for a period after infection, and in the case of re-infection, they are able to tackle the virus again.
- In their paper, published in Science today (Friday, November 6, 2020), the scientists found that some people, notably children, have antibodies reactive to SARS-CoV-2 in their blood, despite not ever having being infected with the virus. These antibodies are likely the result of exposure to other coronaviruses, which cause a common cold and which have structural similarities with SARS-CoV-2.
- The researchers made this discovery while developing highly sensitive antibody tests for C19. To see how well their assay tests were performing, they compared the blood of patients with C19 to patients who had not had the disease. Surprisingly, they found that some people who had not been exposed to SARS-CoV-2 had antibodies in their blood that would recognize the virus. To confirm their findings, they analyzed over 300 blood samples collected before the pandemic, between 2011 and 2018.
- Nearly all samples had antibodies that reacted with common cold coronaviruses, which was expected given how everyone has been exposed to these viruses at some point in their lives. However, a small fraction of adult donors, about 1 in 20, also had antibodies that cross-reacted with SARS-CoV-2, and this was not dependent on recent infection with a common cold coronavirus.*
- Notably, such cross-reactive antibodies were found much more frequently in blood samples taken from children aged 6 to 16.
- Kevin Ng, lead author and post-graduate student in the Retroviral Immunology Laboratory at the Crick says: “Our results show that children are much more likely to have these cross-reactive antibodies than adults. More research is needed to understand why this is, but it could be down to children being more regularly exposed to other coronaviruses.”
- “These higher levels we observed in children could also help explain why they are less likely to become severely ill with C19. There is no evidence yet, however, that these antibodies prevent SARS-CoV-2 infection or spread.”
- In the lab, the researchers tested the antibodies they found in blood from uninfected people to confirm they are able to neutralize SARS-CoV-2. They found the cross-reactive antibodies target the S2 subunit of the spike protein on the surface of the virus.
- George Kassiotis, senior author and group leader of the Retroviral Immunology Laboratory at the Crick says: “The spike of this coronavirus is made of two parts or subunits, performing different jobs. The S1 subunit allows the virus to latch onto cells and is relatively diverse among coronaviruses, whereas the S2 subunit lets the virus into cells and is more similar among these viruses. Our work shows that the S2 subunit is sufficiently similar between common cold coronaviruses and SARS-CoV-2 for some antibodies to work against both.
- “It was previously thought that only antibodies to the S1 could block infection, but there is now good evidence that some antibodies to S2 can be just as effective. This is exciting as understanding the basis for this activity could lead to vaccines that work against a range of coronaviruses, including the common cold strains, as well as SARS-CoV-2 and any future pandemic strains.
- “But it is important to stress that there are still many unknowns which require further research. For example, exactly how is immunity to one coronavirus modified by exposure to another? Or why does this activity decline with age? It is not the case that people who have recently had a cold should think they are immune to C19.”
- A large study is now underway, in partnership with researchers at Imperial College London and University College London, to uncover the role that different antibodies and other immune defenses play in protection against C19 and how severely ill people become.
2. 7 Different “Disease Forms” Have Been Identified in Mild C19
- In a study recently published in the top journal Allergy, a team of MedUni Vienna scientists led by immunologist Winfried F. Pickl and allergologist Rudolf Valenta (both from the Center for Pathophysiology, Infectiology and Immunology) showed that there are seven “forms of disease” in C19 with mild disease course and that the disease leaves behind significant changes in the immune system, even after 10 weeks. These findings could play a significant role in the treatment of patients and in the development of a potent vaccine.
- In the study involving 109 convalescents and 98 healthy individuals in the control group, the researchers were able to show that various symptoms related to C19 occur in symptom groups. They identified seven groups of symptoms:
1) “flu-like symptoms” (with fever, chills, fatigue and cough),
2) “common cold-like symptoms” (with rhinitis, sneezing, dry throat and nasal congestion),
3) “joint and muscle pain”,
4) “eye and mucosal inflammation”,
5) “lung problems” (with pneumonia and shortness of breath),
6) “gastrointestinal problems” (including diarrhoea, nausea and headache), and
7) “loss of sense of smell and taste and other symptoms.”
- “In the latter group we found that loss of smell and taste predominantly affects individuals with a ‘young immune system’, measured by the number of immune cells (T lymphocytes) that have recently emigrated from the thymus gland. This means that we were able to clearly distinguish systemic (e.g., groups 1 and 3) from organ-specific forms (e.g. groups 6 and 7) of primary C19 disease,” says Pickl.
C19 fingerprint in the blood
- At the same time, the scientists established that C19 leaves behind long detectable changes in the blood of convalescents, very similar to a fingerprint. For example, the number of granulocytes, which are otherwise responsible in the immune system for fighting bacterial pathogens, is significantly lower than normal in the C19 group. Pickl explains: “However, both the CD4 and CD8 T cell compartment developed memory cells and CD8 T cells remained strongly activated. This indicates that the immune system is still intensively engaged with the disease several weeks after initial infection. At the same time, the regulatory cells are greatly diminished – and that is likely a dangerous mix, which could lead to autoimmunity.” Furthermore, increased levels of antibody-producing immune cells were detected in the blood of convalescents – the higher the fever of the affected patient during the mild course of the disease, the higher were the antibody levels against the virus.
- “Our findings contribute to a better understanding of the disease and help us in the development of potential vaccines, since we now have access to promising biomarkers and can perform even better monitoring,” the scientists emphasize. “Above all, the study shows that the human immune system “doubles up” when defending against C19 with the combined action of immune cells and antibodies – like the defense in a modern soccer team – and that the cells are also able to memorize certain “moves” on the part of the virus and respond to them. Now it is a matter of implementing these findings and using them for the development of highly-effective C19 vaccines.”
Source: https://scitechdaily.com/these-seven-different-disease-forms-have-been-identified-in-mild-covid-19/
3. Blood Pressure Medicines Do Not Increase C19 Risk
- There has been speculation that two types of medications used to treat high blood pressure and heart failure — angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) — may increase the risk of contracting C19.
- The researchers examined MEDLINE and EMBASE databases for studies that detailed patients treated with ACE inhibitors and/or ARB medications. They conducted two meta-analyses to evaluate the results of 17 trials: 1) to investigate the rate of COVID-19 positive cases, and 2) to determine the death rate among those hospitalized with COVID-19.
- Their analyses yielded these findings:
- Patients taking ACE inhibitors or ARBs did not have an increased rate of C19 infection; and
- Hospitalized C19 patients taking ACE inhibitors or ARBs did not have an increased rate of death.
- A sub-analysis was also done, focused on the studies including patients treated for hypertension. The results indicate taking ACE inhibitors and ARBs was associated with a lower death rate among hospitalized C19 patients with a history of hypertension.
- “Our study results confirm that patients already taking ACE inhibitors and ARBs should not discontinue taking them due to C19 infection,” said lead study author Yujiro Yokoyama, M.D., surgeon at St. Luke’s University Health Network’s Easton Hospital in Pennsylvania. “Both medications have proven benefits for heart and kidney disease, and this further confirms previous findings that ACE inhibitors do not pose additional risk with C19.”
Early in the COVID-19 pandemic, the American Heart Association issued a joint statement with the Heart Failure Society of America and the American College of Cardiology to address the use of ACE inhibitors and ARB medications among patients at risk for developing C19. The recommendations called for the continuation of ACE-i or ARB medications among patients already taking them for indications such as heart failure, hypertension or ischemic heart disease. Cardiovascular disease patients who are diagnosed with C19 should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared-decision making with their physician and health care team.
Source: https://scitechdaily.com/blood-pressure-medicines-do-not-increase-covid-19-risk/
4. Recent Studies Cast Doubt on Cytokine Storms
- Medical researchers are raising significant doubts about whether an agent of the human immune system causes some coronavirus patients to end up in the hospital with injured lungs and other organs, struggling to breathe. What remains is a continuing mystery about what causes certain people to die from C19, and how best to prevent that.
- A hypothesis that emerged early in the pandemic involves cytokine storms, an immune system response that is often invoked to explain severe viral infections, and to many doctors it seemed to make perfect sense: Patients who died from Covid were found to sometimes have little or no virus in their bodies. Their immune systems got rid of it. But in doing so, the hypothesis went, their body’s defenses went rogue, spewing out powerful compounds — cytokines and other drivers of inflammation — that fatally damaged tissues and organs in a storm.
- But in a number of recent studies, some researchers say, an agent suspected of causing the storms might not be the culprit or that such storms might not happen in the way doctors believed.
Not everyone agrees
- Dr. Randy Cron, a professor of pediatrics and medicine at the University of Alabama at Birmingham who has long studied cytokine storms, says some hospitalized C19 patients do experience these immune overreactions. But he agrees they are not identical to the reactions seen in other disorders, and much remains to be learned.
- The storm idea has so far centered on one cytokine, interleukin-6, or il-6. The belief that it might be the culprit in certain Covid deaths began with reports from China early in the course of the pandemic. Doctors there said a patient who fared poorly had high levels of il-6. The doctors tried using drugs that block il-6, and the patient recovered. Similar reports followed there and in Italy.
- A number of drugs that block il-6 are on the market to treat rheumatoid arthritis. They also can stop severe immune reactions in other situations, such as a cytokine release syndrome that can occur with some cancer treatments and with adult onset Still’s disease, a rare form of inflammatory arthritis. But, said Dr. John Stone, a professor of medicine at Harvard, “these are not infections.”
- Nonetheless, anti-il-6 drugs quickly became a standard of care at many hospitals treating Covid patients. The idea that they were quelling cytokine storms became widely accepted.
- “It is so easy to have your brain remember the cases that worked really well and ignore those that didn’t work well,” said Dr. Bruce Walker, an immunologist who is director of the Ragon Institute of Massachusetts General Hospital, M.I.T. and Harvard and was not involved in the new studies.
- Now rigorous studies are failing to find that anti il-6 drugs are effective. Other studies are finding that il-6 levels are not even highly elevated in Covid patients compared to levels in other critically ill patients.
- Three such studies, two published in JAMA Internal Medicine and one in the New England Journal of Medicine, found no evidence that a commonly used il-6 inhibitor, tocilizumab, a rheumatoid arthritis treatment, reduced the death rates in severely ill coronavirus patients. Roche, which makes tocilizumab, did its own tests in Covid patients and reported that its drug was not helpful.
One issue is with the very term, cytokine storm
- “It has no definition,” said Dr. Carolyn Calfee, an intensive care medicine specialist at the University of California in San Francisco. It is colorful and captured the imagination of doctors and much of the public, but with no definition there are no diagnostic criteria to show that such a thing is taking place.
- And even if there is, il-6 might be a bystander rather than a driver. Hundreds of cytokines are released when the immune system goes into action. They drive and suppress one another in complex feedback loops.
- “You take this thing like spaghetti that is connected in so many different ways,” Dr. Walker said. It is optimistic, he added, to think il-6 “will be the answer to everything.”
- Until recently, there were no systematic studies asking if il-6 levels really were unusually high in Covid patients.
- It turns out that they often are not, recent research suggests.
- Dr. Jonathan Parr, an infectious disease specialist at the University of North Carolina checked il-6 levels in his medical center’s Covid patients early in the pandemic. They were difficult to interpret but generally were well below those seen in other inflammatory syndromes, like sepsis, where they are 27 times higher.
- Dr. Calfee reviewed measurements reported in five studies with a total of more than 900 seriously ill coronavirus patients. Their il-6 levels ranged from normal to slightly higher.
- And even when cytokine levels are sky high, as in sepsis, drugs that squelch immune reactions do not help, Dr. Stone said. Failed sepsis studies go back to the late 1980s, he said, when researchers tested etanercept, a drug used to treat autoimmune diseases. It blocks another cytokine, tumor necrosis factor, which, like il-6 is released by white blood cells in sepsis patients.
- Etanercept turned out to increase the death rate in those patients.
- Dr. William Fischer, a pulmonary and critical care physician at the University of North Carolina, said the idea of a cytokine storm “comes up in every severe viral infection.” Examples include AIDS, Ebola, flu, Lassa fever, SARS and MERS, he said.
- But, he said, “it can be difficult to tease apart what drives pathology — whether it’s just the virus or both the virus and the very immune response that is needed to clear the virus.”
- “The next step should be a randomized clinical trial,” in which patients are randomly assigned to receive the experimental treatment or not. Instead, Dr. Fischer said, trials, if they started at all, tended to begin after tens of thousands of patients had already gotten the drugs, which muddied the ability to prove safety and effectiveness.
So if not for this cytokine storm, what could be injuring the patients?
- Inflammation from a variety of immune system overreactions may play a role, researchers said. One piece of evidence is that the steroid, dexamethasone, which broadly suppresses the immune system, can reduce the death rate.
- But il-6 is not the only possible driver of a damaging immune response, Dr. Stone said. Other inflammatory chemicals such as ferritin appear and so does CRP, a protein that is a sign of inflammation.
- Many Covid patients also suffer from blood clots, which themselves might be damaging lungs and other organs.
- Dr. Walker cites another possibility. He was an author of a study that found that the virus can destroy germinal centers, places in lymph nodes where antibodies are produced. The result can be fewer antibodies and less effective ones.
- And it still remains possible that administering anti-il-6 drugs may help if done earlier or later during a patient’s illness.
- “We need randomized clinical trials to answer these hard questions,” Dr. Stone said.
- Dr. Calfee said the new findings should be teaching doctors a lesson.
- “We have to be really humble about biologic complexity,” she said.
- For now, Dr. Walker said, he and many others are sadder but wiser about using anti il-6 drugs to treat Covid patients.
- “All of us were hopeful that this would work,” he said. “It was definitely worth a try.”
Source: https://www.nytimes.com/2020/11/08/health/covid-cytokine-storm.html
5. What are cytokines?
- Cytokines are molecules that allow your cells to talk to each other, and are crucial for healthy immune system function. Too many cytokines, however, can have a negative effect and result in what’s known as a “cytokine storm.”
- These small signaling molecules are produced by many different immune cells, such as neutrophils (some of the first cells to travel to an infection site), mast cells (responsible for allergic reactions), macrophages, B-cells and T-cells, according to a 2014 review published in the journal Frontiers in Immunology.
- Cytokines radiate out from cells “kind of like a Wi-Fi signal,” said Joyce Wu, an immunobiologist at the University of Arizona in Tucson. They then bind to specific receptors on both immune and non-immune cells, and may signal the cell to adjust how it grows or behaves. Nearly every organ of the body contains cells with cytokine receptors.
- Chemokines are cytokines that act like a beacon directing immune cells where to go. In this way, chemokines help immune cells find and destroy whatever harmful invader has entered the body.
- While cytokines typically come from immune cells, they can also come from non-immune cells, said Mandy Ford, an immunologist at Emory University in Atlanta, Georgia. Endothelial cells, which are the cells lining the inside of blood vessels, and epithelial cells, which are the cells covering the surface of organs, skin and other tissue, can also send cytokines around the body.
How do cytokines work?
- When a pathogen, or harmful invader enters the body, immune cells, cytokines and organs respond by working together like an orchestra, Ford said. The first immune cell to notice the pathogen is like the conductor. That cell directs all the other cells by creating and sending out messages (cytokines) to the rest of the organs or cells in the body (the orchestra members), which then respond as directed.
- “The initiation of cytokine secretion tells the rest of the immune cells, and also non-immune cells in the body that there is a pathogen present, and an immune response should be occurring,” Ford said.
- One of the immune responses cytokines may elicit is inflammation. Cytokines help inflame tissue by directing the cell walls of blood vessels to become more porous by reducing cell-to-cell contact, Ford said. Blood vessels will then leak blood into the surrounding tissue, allowing immune cells to travel via the leaked fluid to the damaged area, and start the healing process.
- While cytokine production mainly occurs when the body is infected by a pathogen, cytokine-induced inflammatory responses also happen when tissues are physically damaged, such as if you tripped and cut your knee on the sidewalk.
Are cytokines part of the innate or adaptive immune system?
- Our immune system can be divided into two categories: the innate immune system and the adaptive immune system. The innate immune system refers to the immunity that you’re born with, which targets general health threats, while adaptive immunity refers to acquired immunity, which targets more specific pathogens.
- Cytokines are “at the crossroads of bridging the communication between the innate and adaptive immune responses,” Ford said. That’s because the amount and type of cytokines that cells secrete differ depending on the type of pathogen, and those differences help the immune system appropriately tailor its response to be innate or adaptive. Certain cytokines can stimulate either the innate immune system, adaptive one, or a mix of both depending on the infection.
- Cytokines can also direct brain cells to release chemicals that tell your body that you’re sick, prompting you to rest and avoid activities that could further expose you to pathogens. “Tiredness, lethargy, malaise and just that kind of achy feeling is the impact of cytokines on our bodies,” Ford said.
- Without cytokines, the innate immune system wouldn’t know when to activate because there would be no indication of a threat. Once activated, innate immune cells don’t secrete cytokines intended for any specific receptors at first, Ford said. Rather, secreted cytokines will target the entire body, causing fever, achy joints and fatigue, according to a 2007 study published in the journal International Anesthesiology Clinics. The adaptive immune system will eventually secrete specific cytokines that target and activate T-cells in order to fine-tune the immune response toward the specific introduced pathogen, reported a 2010 study from The Journal of Allergy and Clinical Immunology.
- Cytokines signal the adaptive immune system to activate when the innate immune system fails to subdue an infection. While the innate immune system is good at warding off general health threats, it may fail to destroy foreign pathogens. Cytokines direct the adaptive immune system to produce pathogen-specific antigens that quickly identify the pathogen so the immune system can destroy it.
- The cytokine response is slow, and for good reason, Wu said. A 2020 editorial published in the journal JAMA Internal Medicine describes how a rapid immune response in which loads of cytokines are released would cause hyperinflammation, which can lead to shock and organ damage. The slow initial response of the innate immune system prevents the release of too many cytokines at one time, avoiding collateral damage to the body, according to a 2007 study published in the journal Nature Public Health Emergency Collection. The fine-tuned T-cell response can then attack the infection without causing excess harm to the body.
When are cytokines a bad thing?
- Cytokines help your body fight off and kill infections, but too many cytokines overwhelm the body and create what is known as a “cytokine storm.” It’s a “simple analogy to a weather-type storm where it’s too much of a good thing,” Ford said.
- A cytokine storm may occur when too many pathogens enter the body at once, or if the body secretes the wrong type of cytokine early in the immune response, in which case the excessive cytokines can’t accurately direct the immune system to clear out the pathogen. Because nearly every organ has cytokine receptors, almost every part of the body is susceptible to the negative effects of a cytokine storm.
- A normal release of cytokines causes blood vessel walls to become leakier in order to promote healing of damaged tissue via inflammation, but too many cytokines may cause blood vessels to become overly porous and result in low blood pressure. That, in turn, depletes organs of oxygen and could eventually cause death, Ford said.
- Patients with sepsis or uncontrolled bacterial infections typically experience a cytokine storm, and it’s also a symptom of some diseases, such as C19, as described in the JAMA Internal Medicine editorial. A cytokine storm is essentially an uncontrolled immune response that leads to reduced oxygen in the blood, fluid build-up in the lungs, difficulty breathing, and many of the other symptoms observed in C19 illnesses, Ford said.
- Whether induced by C19 or not, cytokine storms can also cause neurological issues. The brain is naturally protected from harmful chemicals thanks to the blood-brain barrier. But cytokines are much smaller than cells, so they can slip through the brain’s protective membrane. Cytokine storms have been known to cause symptoms such as headache, migraine, decreased appetite, increased need for sleep and overwhelming fatigue, according to a 2009 review published in the journal Psychiatry.
Treating C19 cytokine storms
- Some research suggests that cytokine storms are a major reason for illness and death among C19 patients, according to the JAMA Internal Medicine editorial. A 2020 study published in the journal Clinical Infectious Diseases found the cytokine inhibiting drug tocilizumab has been shown to reduce mortality in C19 patients on ventilators by 45%.
- Cytokine levels can also influence the care C19 patients receive. The presence and amount of certain cytokines can predict the survivability of C19 cases, reported a recent study published in Nature Medicine. This can help doctors create an effective treatment protocol depending on cytokine severity. Although the mechanisms underpinning the severity of C19 are still poorly understood, a recent review published in the journal Cardiorenal Medicine found that properly timed anti-inflammatory strategies may help reduce the severity of cytokine storms and can improve a patient’s health when infected.
Source: https://www.livescience.com/what-are-cytokines.html
6. Enzyme targeted by coronavirus also influences gut inflammation
- An enzyme that helps C19 infect the body also plays a role in inflammation and patient outcomes in inflammatory bowel disease (IBD), according to a new study led by Cedars-Sinai. The findings raise the possibility that anti-inflammatory drug therapies for IBD may aid recovery from coronavirus.
- The multisite study, led by Cedars-Sinai and published today in the journal Gastroenterology, focused on angiotensin-converting enzyme 2 (ACE2), which normally plays a crucial health role by activating a hormone that helps regulate blood pressure. But in C19 infections, the coronavirus (SARS-CoV-2) binds to ACE2 and uses it to invade and infect cells, “hijacking” them to spread the virus.
- To learn more about how ACE2 affects the body, investigators examined its role in Crohn’s disease and ulcerative colitis – two types of IBD that can cause inflammation and scarring (fibrosis) in the digestive tract along with diarrhea, cramping and loss of appetite.
- “We chose these disorders because C19, while known for attacking the lungs, frequently causes gastrointestinal symptoms,” said Dermot P. McGovern, MD, PhD, the Joshua L. and Lisa Z. Greer Chair in Inflammatory Bowel Disease Genetics and senior author of the new study. “It was important for us to understand how C19 might affect IBD patients who are treated with anti-inflammatory medications. Also, there is increasing evidence that the GI tract may serve as an alternate route for uptake of SARS-COV-2 in general.”
- By examining records of nearly 1,000 patients at Cedars-Sinai, Washington University in St. Louis, Missouri, and multiple other centers across North America, the team found that levels of ACE2 in the small bowel were lower in Crohn’s patients and higher in the colons of ulcerative colitis patients than they were in patients without IBD. The differing ACE2 levels were associated with poorer outcomes and more severe disease in the IBD patients.
- “We saw that the effect of ACE2 depended on both its specific location in the gastrointestinal tract and the specific disease involved,” said McGovern, professor of Medicine and Biomedical Sciences. “So, this enzyme was a double-edged sword.”
- In both types of IBD, treatment with infliximab, an anti-inflammatory drug, normalized the levels of ACE2 and was associated with improved disease outcomes in patients. This finding suggests these drugs, commonly used in autoimmune diseases, also might improve outcomes in C19, the investigators said, “Overall, our study supports the potential paradoxical function of ACE2 in inflammation and C19,” McGovern explained. “Individuals with higher ACE2 expression may be at increased risk of infection with SARS-CoV-2. But judging from our discoveries of how ACE2 works in IBD, this enzyme likely has anti-inflammatory and anti-fibrotic functions that also could help certain C19 patients recover from the virus.”
Source: https://www.eurekalert.org/pub_releases/2020-11/cmc-cet110520.php
D. Vaccines & Testing
1. C19 vaccine from Pfizer and BioNTech is strongly effective
- Pfizer and partner BioNTech said Monday that their vaccine against C19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.
- The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic C19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.
- The Phase 3 study is ongoing and additional data could affect results.
- In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.
- “I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
- Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
- Nor is there any information yet on whether it prevents people from carrying the virus that causes C19, SARS-CoV-2, without symptoms.
- Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data. Gruber said that he believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizer’s pneumonia vaccine, Prevnar, or a flu shot.
- The results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech have been given no other details about how the vaccine performed by the independent monitors overseeing the study.
- Initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally. by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer has said it is confident those issues can be managed.
- Although the estimate of the efficacy of the vaccine could change as the study is completed, it is close to a best-case scenario. That also bodes well for other vaccines in the late stages of testing, including those developed by Moderna, AstraZeneca, and Johnson & Johnson.
- “If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” said Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.
- “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
- Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.
- The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a C19 vaccine to produce data — including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion.
- The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted C19. If fewer than six volunteers in the group who received the vaccine had developed C19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of C19 — individuals with at least one symptom and a positive test result — had been reported.
- That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.
- In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of C19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
- Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of C19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
- This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
- Gruber said that there will not be another interim analysis conducted in the study. He also said that Pfizer’s estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.
- But Gruber said he now expects that by the time of the planned meeting of the FDA’s vaccine advisory committee in December, the study’s efficacy portion could be completed, having reached 164 cases of C19.
- He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.
- The study has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
- Bourla, Pfizer’s CEO, said the results mark “a great day for science and humanity,” in a statement, saying they provide “initial evidence of our vaccine’s ability to prevent C19.” He added: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
2. What does Pfizer’s ‘90% effective’ C19 vaccine actually mean?
- Pfizer’s C19 vaccine candidate is touting an efficacy rate that’s far higher than the latest flu shot, according to company and federal data.
- The vaccine is so far 90% effective, the company announced Monday — which is well above the typical efficacy of the seasonal flu shot, which was 29% effective in the 2018-2019 influenza season, according to the CDC.
- In the 2015-2016 season, the flu vaccine was 48% effective, but that number steadily dropped to 40% in 2016-2017, 38% in 2017-2018 and 29% in 2018-2019, CDC data shows.
- Preliminary numbers from the 2019-2020 flu season show the latest vaccine was 39% effective.
- Those numbers mean only 39% of people who were vaccinated in 2019-2020 didn’t catch the flu.
- With Pfizer’s coronavirus vaccine, a 90% effectiveness rate means the overwhelming majority of those who received the shot ended up developing protective antibodies within 28 days, which will at least temporarily ward off the infection, the company said.
- A study published Thursday, which is awaiting peer review, found antibody immunity lasts at least six months and scientists are already probing whether a C19 vaccine will need to be done annually like the influenza booster, NBC reported.
- While there is not currently a market-ready vaccine for C19, Pfizer expects to have 50 million doses of BNT162b2 — the scientific marker for the shot — ready by the end of 2020 and up to 1.3 billion doses available in 2021, the company said.
- A 90% effectiveness rate is well above the 50% required for a coronavirus vaccine by the Food and Drug Administration and is inching closer to the high rates of immunity offered by the measles and polio vaccines.
- The polio vaccine, which first became available in 1955, is 90% or more effective if a person receives two doses, and 99 to 100% effective if a person receives three, according to the CDC.
- Forms of the measles vaccine, which became available in the early 1960s, is 93% effective when one dose is taken and 97% effective when two doses are completed, the CDC said.
- Pfizer’s coronavirus vaccine currently requires two doses of the booster, the company said.
- The efficacy rate of vaccines like the flu immunization are generally determined in two ways — a randomized controlled trial (RCT) and a variety of observational studies, the CDC explains on its website.
- The RCT is typically double-blind and done with two sets of volunteers — a cohort of people who receive the actual vaccine and another who receive a placebo. Neither group typically knows which one they receive. Then scientists determine the efficacy of the immunization by measuring the frequency of the illness in the people who received the shot and those who received the placebo, the CDC said.
- In the observational studies, a variety of probes occur, including comparing how often the illness occurred among people who were inoculated and those who weren’t, according to the CDC.
Source: https://nypost.com/2020/11/09/what-does-pfizers-90-effective-covid-19-vaccine-actually-mean/
3. COVID immunity could last over a year after taking Pfizer’s vaccine
- Immunization against C19 with the new Pfizer vaccine would hopefully last for at least a year, one of its developers said Monday.
- The head of the German firm BioNTech, which developed the vaccine with Pfizer, said research already shows that patients who had the coronavirus and consequently developed high levels of antibodies against it would have at least that much protection against reinfection — and vaccinated people should be no different.
- On the heels of the companies’ stunning announcement Monday that studies show their late-stage vaccine is 90% effective, BioNTech CEO Ugur Sahin told Reuters he is “optimistic that the immunization effect can last for at least a year.”
- The drug honcho added that current research shows the vaccine must be stored at a temperature of -94 degrees Fahrenheit at its central location before being shipped out — and then can last up to five days at refrigerator temps.
- “By December, we expect more data [on its potential storage], and if those results allow us to keep the vaccine in a fridge for longer than five days, maybe two weeks, that would again simplify things” in terms of distribution, Sahin said.
Source: https://nypost.com/2020/11/09/immunization-from-covid-19-vaccine-will-hopefully-last-a-year-ceo/
4. Rapid Antigen Testing Not Reliable For Asymptomatic COVID Cases
- As if there wasn’t enough confusion and broad misunderstanding going around about Covid, the states of Louisiana and Oregon are now warning against using rapid, low cost antigen tests in asymptomatic people to try and determine whether or not they are positive with coronavirus. Oh, and so is the Food and Drug Administration…
- The appeal of these tests is that they can be spread widely and cheaply, giving the illusion of control over the virus to individuals and organizations that use them for quick blanket testing.
- But these tests could “miss some infections that can be picked up by costlier gold-standard assays, and can incorrectly return positive results,” according to Bloomberg.
- As a result, the state is not recommending the tests to people without symptoms, who have not been exposed to someone with a positive test. The Louisiana Department of Health also says that people who undergo antigen tests should be made aware of its limitations.
- Joseph Kanter, interim assistant secretary for the state’s Office of Public Health, said: “On the one hand, we have technology and testing platforms like this one which are new and likely valuable. And everybody has an interest in getting them to people that could benefit from them as quick as possible. On the other hand, we don’t have great data on them yet.”
- The Oregon Health Authority has also warned against using the tests in asymptomatic people without confirmed C19 exposure.
- Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, commented that antigen tests for one time use risks the chance of missing infections: “For people looking to one-time use of Covid antigen tests as a way to go back to normal, we’re not in that situation now. This is one more layer of protection as we try to reopen and get through the rest of the pandemic.”
- On Tuesday, the FDA also warned about the tests, saying they can produce “incorrect positive results”. Nursing homes and other care settings have reported false positives from antigen tests, the FDA noted.
- These warnings apply to tests like Abbot’s $5 BinaxNOW test that the U.S. government is spending $750 million on. Now, state health officials are reportedly “increasingly concerned that people without symptoms should be screened with more costly but more reliable polymerase chain reaction assays”.
- Jeff Engel, a senior adviser at the Council of State and Territorial Epidemiologists, said: “HHS made this purchase without any studies on the novel use in which they’re deploying these tests. I think that’s careless.”
- It’s also one of the infinite reminders that government is not only an abhorrent allocator of other peoples’ capital, but is also flailing wildly in trying to control a virus that is casually making its way across the globe regardless of what preventative measures we take.
- HHS official Brett Giroir responded: “We do support asymptomatic testing being used. That is the only way that you’re going to screen millions of people a month.”
- Abbot responded: “Widespread, affordable rapid antigen testing helps slow the virus’s spread, and tests like BinaxNOW, when used as intended, can detect those most likely to be infectious.”
E. Improved & Potential Treatments
1. Llama Nanobodies Could Be a Powerful New Weapon Against C19
- Researchers at the University of Pittsburgh School of Medicine describe, in the journal Science, a new method to extract tiny but extremely powerful coronavirus (SARS-CoV-2) antibody fragments from llamas, which could be fashioned into inhalable therapeutics with the potential to prevent and treat C19.
- These special llama antibodies, called “nanobodies,” are much smaller than human antibodies and many times more effective at neutralizing the SARS-CoV-2 virus. They’re also much more stable.
- “Nature is our best inventor,” said senior author Yi Shi, Ph.D., assistant professor of cell biology at Pitt. “The technology we developed surveys SARS-CoV-2 neutralizing nanobodies at an unprecedented scale, which allowed us to quickly discover thousands of nanobodies with unrivaled affinity and specificity.”
- To generate these nanobodies, Shi turned to a black llama named Wally—who resembles and therefore shares his moniker with Shi’s black Labrador.
- Shi and colleagues immunized the llama with a piece of the SARS-CoV-2 spike protein and, after about two months, the animal’s immune system produced mature nanobodies against the virus.
- Using a mass spectrometry-based technique that Shi has been perfecting for the past three years, lead author Yufei Xiang, a research assistant in Shi’s lab, identified the nanobodies in Wally’s blood that bind to SARS-CoV-2 most strongly.
- Then, with the help of Pitt’s Center for Vaccine Research (CVR), the scientists exposed their nanobodies to live SARS-CoV-2 virus and found that just a fraction of a nanogram could neutralize enough virus to spare a million cells from being infected.
- These nanobodies represent some of the most effective therapeutic antibody candidates for SARS-CoV-2, hundreds to thousands of times more effective than other llama nanobodies discovered through the same phage display methods used for decades to fish for human monoclonal antibodies.
- Shi’s nanobodies can sit at room temperature for six weeks and tolerate being fashioned into an inhalable mist to deliver antiviral therapy directly into the lungs where they’re most needed. Since SARS-CoV-2 is a respiratory virus, the nanobodies could find and latch onto it in the respiratory system, before it even has a chance to do damage.
- In contrast, traditional SARS-CoV-2 antibodies require an IV, which dilutes the product throughout the body, necessitating a much larger dose and costing patients and insurers around $100,000 per treatment course.
- “Nanobodies could potentially cost much less,” said Shi. “They’re ideal for addressing the urgency and magnitude of the current crisis.”
- In collaboration with Cheng Zhang, Ph.D., at Pitt, and Dina Schneidman-Duhovny, Ph.D., at the Hebrew University of Jerusalem, the team found that their nanobodies use a variety of mechanisms to block SARS-CoV-2 infection. This makes nanobodies ripe for bioengineering. For instance, nanobodies that bind to different regions on the SARS-CoV-2 virus can be linked together, like a Swiss army knife, in case one part of the virus mutates and becomes drug-resistant.
- “As a virologist, it’s incredible to see how harnessing the quirkiness of llama antibody generation can be translated into the creation of a potent nanoweapon against clinical isolates of SARS-CoV-2,” said study coauthor and CVR Director Paul Duprex, Ph.D.
Source: https://scitechdaily.com/llama-nanobodies-could-be-a-powerful-new-weapon-against-covid-19/
2. Aspirin to be tested as potential C19 treatment against blood clots
- Thousands of coronavirus patients in Britain will be given aspirin as part of a trial to determine whether the painkiller can reduce the risk of dangerous blood clots.
- The cheap and widely available drug has been added to a list of potential treatments to be tested as part of the Randomised Evaluation of C19 therapy (Recovery) trial, one of the biggest in Britain.
- People infected with coronavirus seem to have hyper-reactive platelets, the cell fragments that help stop bleeding, which means that they are at higher risk of potentially deadly blood clots, scientists say.
- Experts hope that aspirin, an anti-platelet agent which is commonly used as a blood thinner, can reduce the possibility of clotting complications.
- “Aspirin is widely used to prevent blood clots in many other conditions, including heart attack, stroke, and pre-eclampsia in pregnant women,” said Prof Martin Landray, co-chief investigator of the trial.
- “But enrolling patients in a randomised trial such as Recovery is the only way to assess whether there are clear benefits for patients with C19 and whether those benefits outweigh any potential side-effects such as the risk of bleeding.”
- At least 2,000 patients are expected to get 150mg of aspirin daily along with the usual regimen. Data from those patients will be compared with at least 2,000 other patients who receive the standard C19 treatment on its own.
- Small daily doses of aspirin have been found to reduce the risk of certain cancers. As a blood thinner, it increases the risk of internal bleeding, and taking too much over a long period of time has been associated with kidney damage.
3. Death rates fall by more than a third for hospitalized C19 patients as treatments improve
- Two large recent studies show that people hospitalized for C19 in March were more than three times as likely to die as people hospitalized for COVID–19 in August.
- The first study used data from three hospitals in New York City. The chance of death for someone hospitalized for the coronavirus in those hospitals dropped from an adjusted 25.6% in March to 7.6% in August. The second study, which looked at survival rates in England, found a similar improvement.
Continuous, significant improvement
- In March, out of 1,724 people hospitalized for C19 in the three New York hospitals, 430 died. In August, 134 were hospitalized and five died. This change in the raw numbers could be driven by who was arriving at the hospital – if only older people were getting sick, the death rate would be higher, for example – but the researchers controlled for this in their calculations.
- To better understand what was causing this decrease in hospitalization death rate, the researchers accounted for a number of possible confounding factors, including the age of patients at hospitalization, race and ethnicity, the amount of oxygen support individuals needed when they got to the hospital and such risk factors as being overweight, smoking, high blood pressure, diabetes, lung disease and so on.
- No matter what their specific situation, a person hospitalized in March for C19 was more than three times as likely to die as one hospitalized in August.
- The study in England looked at hospitalized coronavirus patients who were sick enough to go to a high-dependency unit (HDU) – one where they were monitored closely for oxygen needs – or the intensive care unit (ICU). As in the New York study, the researchers also accounted for confounding factors, but they calculated survival rates instead of mortality rates.
- Looking at 21,082 hospitalizations in England from March 29 to June 21, 2020, the authors found a continuous improvement in survival rates of 12.7% per week in the HDU and 8.9% per week in the ICU. Overall, between March and June the survival rate improved from 71.6% to 92.7% in the HDU and from 58% to 80.4% in the ICU. These increases in survival after hospitalization for the coronavirus in England mirrored the changes in New York City.
Better treatments and better care are responsible
- The main reason researchers think coronavirus patients are doing better is simply that there are now effective treatments for the virus that didn’t exist in March.
- I am a practicing infectious disease doctor at the University of California, San Francisco, and I have witnessed these improvements firsthand. Early on, my colleagues and I had no idea how to treat this brand-new virus that burst onto the scene in late 2019. But over the spring, large studies tested different treatments for C19 and we now use an antiviral called remdesivir and a steroid called dexamethasone to treat our hospitalized coronavirus patients.
- Along with these new treatments, physicians gained experience and learned simple techniques that improved outcomes over time, such as positioning a patient with low oxygen in a prone position to help distribute oxygen more evenly throughout the lungs. And as time has gone on, hospitals have become better prepared to handle the increased need for oxygen and other specialized care for patients with the coronavirus.
- Though improvements in care and effective drugs like remdesivir and dexamethasone have helped greatly, the virus is still very dangerous. People with severe cases can suffer prolonged symptoms of fatigue and other debilitating effects. Therefore, other treatments should be and are still explored.
Public health measures help too
- Treatments have undoubtedly gotten better. But the authors of the New York City study specifically mention that public health measures not only led to the plummeting hospitalization rates – 1,724 in March vs. 134 in August – but might have helped lower death rates too.
- My own research proposes that social distancing and face coverings may reduce how much virus people are exposed to, overall leading to less severe cases of COVID–19. It is important to continue to follow public health measures to help us get through the pandemic. This will slow the spread of the virus and help keep people healthier until a safe and effective vaccine is widely available.
Source: https://www.livescience.com/amp/covid-19-death-rates-falling-treatments.html
F. Concerns & Unknowns
1. Irregular Heartbeat May Increase C19 Risk
- Previous studies have shown higher death rates in C19 patients with evidence of heart damage. Heart damage can manifest as abnormal heart rhythms such as atrial fibrillation and atrial flutter. Atrial fibrillation is the most common form of heart arrhythmias and is an independent risk factor for death, especially in critically ill patients.
- This study reviewed the prevalence and outcomes of hospitalized C19 patients with atrial fibrillation and atrial flutter. Researchers reviewed medical records of 435* patients in the Yale Cardiovascular COVID Registry, who were adults, ages 18 and older (mean age 68.2 years; >50% were male) hospitalized between March and June 2020 in the Yale New Haven Health System. *Please note: This news release includes updated data compared to the abstract.
- The data for the first 435 patients included in the registry revealed that 7.8% patients were diagnosed with atrial fibrillation/flutter for the first time in their lives, and 15.9% of the patients had a prior history of these types of arrhythmia. Overall, about one fifth of the patients had an episode of atrial fibrillation/flutter during hospitalization.
- Additional analysis on the outcomes of the patients with atrial fibrillation/flutter showed that patients with a prior history of atrial fibrillation/flutter had a significantly higher risk of death or ICU mortality, independent of other health issues related to the heart, kidneys and lungs.
- Data also indicated in-hospital atrial arrhythmias were significantly associated with even higher risk of death and ICU mortality, as well as multi-organ failure, such as respiratory failure and renal failure.
- “Our study suggests that the combination of C19 and atrial arrhythmias may create a pathologic synergy that markedly increases the risk for major adverse cardiac events and death,” said Zaniar Ghazizadeh, M.D., a lead author of the study and an internal medicine resident at Yale New Haven Hospital/Yale School of Medicine in New Haven, Connecticut. “C19 places patients at a high risk for abnormal heart rhythms that are, in turn, associated with markedly worse outcomes including death and multi-organ failure. Patients and physicians need to monitor for these arrhythmias closely and treatments needs to be timely.”
Source: https://scitechdaily.com/irregular-heartbeat-may-increase-covid-19-risk/
2. C19 linked to worse stroke outcomes
- People who experience strokes while infected with C19 appear to be left with greater disability after the stroke, according a study led by UCL and UCLH researchers.
- Having C19 at stroke onset was also associated with more than double the mortality rate of other stroke patients, according to the findings published in the Journal of Neurology, Neurosurgery & Psychiatry.
- The researchers found evidence that people of Asian descent might be more likely to experience C19-associated ischaemic strokes (those caused by blockage of blood vessels supplying the brain) than those in other groups in the UK.
- Lead researcher Dr Richard Perry (UCL Queen Square Institute of Neurology and National Hospital for Neurology and Neurosurgery, UCLH) said: “By comparing characteristics and outcomes of strokes experienced by people with and without C19, we found that there were differences between the groups, suggesting that C19 exerts an influence over the presentation of stroke.
- “Some of the differences relate to what other studies are uncovering about C19, in that it might make blood stickier and more likely to clot.”
- The findings build on previous studies led by UCL researchers which have also suggested that some people with C19 are experiencing neurological symptoms, and that the infection may increase the risk of stroke.
- The researchers reviewed evidence from 86 people who had a stroke in England or Scotland and had C19 at stroke onset, between March and July this year, and compared them to 1,384 stroke cases during the same period in people who did not have any evidence of C19.
- Evidence of infection was determined by a positive coronavirus test within four days of admission or suspected C19 at the time of admission and confirmed on testing at any point during the subsequent 10 days.
- The researchers found that ischaemic stroke patients who also had C19 were only half as likely to leave hospital without any disability as those without C19. The researchers do not yet have data on how long these excess disabilities might persist.
- Ischaemic strokes in C19 patients were around twice as likely to be caused by the blockage of more than one large blood vessel in the brain (18% vs 8%), which the researchers say suggests evidence of abnormal blood clotting. They also found that the C19 associated strokes were more severe, with an average stroke severity (NIHSS) score of 8, compared to 5 in the control group.
- Levels of D-dimers, a protein marker for the stickiness of blood, were also higher in C19 related ischaemic stroke than in other ischaemic strokes. The new findings fit with other studies showing that people with C19 appear to have sticky blood that is more liable to clot.
- The researchers found differences by ethnicity, as people of Asian descent were overrepresented (by more than double) in the C19 group than White or Black patients.
- Dr Perry said: “Our study suggests that C19 has had more impact on strokes in the Asian community than in other ethnic groups. We cannot say from our data whether this is because people of Asian descent are more likely to catch C19, or whether Asian patients with C19 are more likely to have ischaemic strokes, or both.”
- Co-author Professor David Werring (UCL Queen Square Institute of Neurology and National Hospital for Neurology and Neurosurgery, UCLH) added: “Our findings suggest that in some people, C19 may influence stroke risk through its effect on excessive blood clotting or inflammation, and may also influence the characteristics and outcome of the stroke, including greater severity with a higher chance of multiple large vessel blood clots.
- “Our findings support testing people for C19 if they come into hospital with a stroke, and further research is needed to determine whether treatments (such as the use of early full dose anticoagulation) should differ depending on this test result.”
Source: https://www.eurekalert.org/pub_releases/2020-11/ucl-clt110520.php
3. Covid set to cause 400,000 surge in TB deaths as medics diverted
- Scientists have warned that several hundred thousand extra deaths from tuberculosis are likely to occur this year as a result of C19’s effect on global health services.
- In many countries – including South Africa, India and Indonesia – doctors and health workers have been shifted from tracking TB cases to tracing people infected with C19. Equipment and budgets have also been reassigned, an investigation by the World Health Organisation (WHO) has revealed.
- As a result, millions of TB diagnoses have been missed, and according to the WHO this is likely to result in 200,000 to 400,000 excess deaths from the disease this year alone, with a further million new cases occurring every year after that for the next five years.
- “This is just one example of the very difficult choices that had to be taken to contain C19,” said Thomas Kenyon, chief health officer of Project Hope, the humanitarian NGO. “It was obviously crucial that we tackle the pandemic but we cannot forget that we have other killers in our midst. We are going to have to be innovative in addressing them.”
- TB is the world’s leading cause of death from infectious disease, topping both HIV and malaria. It is contagious and is caused by a bacterium known as Mycobacterium tuberculosis, which commonly attacks the lungs but can affect any part of the body, from the bloodstream to the brain.
- Humanity has lived with the threat of TB for millennia. The ancient Egyptians knew of its dangers and it is believed that Nefertiti and her Pharaoh husband Akhenaten both died from tuberculosis in around 1330 BC.
- In modern times TB has become a global scourge and it is believed that about 10 million people are infected with the disease each year, while about 1.5 million people die from it. The WHO says the planet is now in the grip of global TB epidemic, which it has pledged to defeat by 2030. The condition can be treated using a six-month drug regime – provided a diagnosis is made in time. Major efforts to contain the disease began in 2015. At first, efforts to contain it were successful and the number of deaths began to fall. This decline has slowed recently. One problem has been the spread of antibiotic-resistant strains of TB, particularly in nations that made up the former Soviet Union.
- With the arrival of C19, the global battle against TB received a further setback. According to the WHO, problems have arisen not just because key staff have been reallocated from TB tracing to Covid testing but also because critically important equipment and materials have been redeployed. In addition, some countries have cut inpatient and outpatient care for TB sufferers.
- A particular problem has arisen in relation to a test called GeneXpert, which is efficient at identifying the molecular signature of Mycobacterium tuberculosis in people with TB. The test is also very good at identifying individuals who have C19.
- “Many countries have changed to using GeneXpert machines for C19 testing instead of diagnostic testing for TB,” reported WHO, which said it had also found numerous examples of staff reassignment and reallocation of budgets from TB to Covid work.
- In India, Indonesia, the Philippines and South Africa – which account for 44% of all global TB cases – this led to large drops in the number of people diagnosed with the disease between January and June this year. “As a result, the global number of TB deaths could increase by around 0.2–0.4 million in 2020 alone,” the WHO report predicts.
- It adds that C19 is likely to affect the world’s TB epidemic in two other key ways: GDP per capita and undernutrition. “Modelling has suggested that the number of people developing TB could increase by more than one million per year in the period 2020–2025. The impact on livelihoods resulting from lost income or unemployment could also increase the percentage of people with TB and their households facing catastrophic costs.”
- This point was backed by Kenyon. “We have to face the fact that we are going to get a lot of deaths caused directly by Covid, but we also have to realize we are going to get a lot of deaths caused indirectly by the disease,” he said.
4. Researchers believe C19 can affect male fertility
- A new study by the University of Miami Miller School of Medicine has discovered potential impacts C19 can have on male fertility and sexually transmitted diseases.
- Researchers looked at tissue from autopsies of six men who died from the C19 infection and found the virus was still in their testicles.
- They also found C19 in the testicles of a 28-year-old male patient who had the coronavirus and recovered without showing symptoms.
- “We also identified the presence of the virus in a man who underwent a testes biopsy for infertility but had a previous history of C19,” said Dr. Ranjith Ramasamy, an associate professor and director of reproductive urology at the Miller School.
- “So the patient tested negative and was asymptomatic after having C19 but still showed the presence of the virus inside the testes. The finding is novel, remarkable, and certainly worthy of further exploration,” added Dr. Ramasamy.
- The study went on to question how much of the virus is needed to be present in the testes to be detected in semen, and which can be sexually transmitted.
- “I’m fairly certain, just like mumps, about 20 to 30% of men are going to have some sort of affected fertility in their future,” Dr. Ramasamy said.
- More research must be conducted in order to fully understand how testis tissue responds to C19, but this current study is a step forward in better understanding the virus.
- Dr. Ramasamy recommended that men of all ages who had C19 and are suffering from testicular pain, should see a urologist.
- “Testicular pain along with other symptoms could be a sign that C19 has entered the testis, and if men are thinking about fertility and/or low testosterone either at present or in the future, they should get their testosterone levels evaluated with a blood test and sperm parameters evaluated with a semen analysis,” according to Dr. Ramasamy.
Source: https://nypost.com/2020/11/09/researchers-believe-covid-19-can-affect-male-fertility/
5. Many C19 patients later develop mental illness
- 20% of coronavirus patients later develop a new mental illness, according to a study.
- The most common disorders experienced by C19 survivors within 90 days of their diagnoses are anxiety, depression and insomnia, according to the study published in The Lancet Psychiatry journal.
- “People have been worried that C19 survivors will be at greater risk of mental health problems, and our findings … show this to be likely,” said Paul Harrison, a professor of psychiatry at Britain’s Oxford University.
- The study looked at the electronic health records of over 62,000 coronavirus patients in the US.
- The study group was twice as likely to suffer from a new mental illness than other groups of patients during the same period, researchers said.
- “This is likely due to a combination of the psychological stressors associated with this particular pandemic and the physical effects of the illness,” said Michael Bloomfield, a consultant psychiatrist at University College London who was not directly involved with the study.
Source: https://nypost.com/2020/11/09/many-covid-19-patients-later-develop-mental-illness-study-finds/
6. More economic worries mean less caution about C19
- Workers experiencing job and financial insecurity are less likely to follow the CDC’s guidelines for C19, such as physical distancing, limiting trips from home and washing hands, according to a Washington State University study.
- The researchers, who surveyed 745 workers in 43 states, also found that state unemployment benefits and C19 policies affected the connection between economic concerns and compliance with C19 precautions.
- The study shows that a scarcity mindset can play a role in how well people are able to focus on responding to the pandemic, said Tahira Probst, a WSU psychology professor and lead author in the study published recently online in the Journal of Applied Psychology.
- “We all have a finite set of resources at our disposal, whether it’s money, time or social support, and individuals who have fewer of those resources appear less able to enact the CDC-recommended guidelines,” said Probst. “The extent to which economic stressors will impact that behavior is in part a function of where we live. Having a fall back, a strong safety net to catch you, seemed to help mitigate the risk factors of job insecurity that was otherwise associated with less adherence to the guidelines.”
- In states with lower unemployment benefits, job insecurity was associated with a 7% decline in compliance with C19 prevention behaviors.
- State-imposed C19 mandates also had a positive effect on compliance but seemed to primarily benefit the financially secure workers more. In states that had fewer restrictions on behavior that could spread the disease, workers were less likely to follow the CDC’s recommendations, whether the respondents were financially secure or insecure.
- However, in states with a stronger response, including measures such as stay-at-home orders and shutting down non-essential businesses, financially secure employees had 13% higher enactment of the prevention behaviors compared to workers who felt more financially insecure.
- These differences could have significant public health ramifications, the authors argue, since research suggests that even modest reductions in social contacts among adults can reduce infection and eventual death rates.
- “It’s important to acknowledge as a society that there are certain segments of the population, namely the economically secure, that are better equipped to follow the CDC recommendations to prevent the spread of C19,” said Probst. “This is a red flag since precarious work and financial strain can also co-occur with other C19 risk factors and pre-existing health disparities.”
- The researchers recruited survey participants using Amazon’s Mechanical Turk, an online crowdsourcing platform. The authors acknowledge that the demographics of that sample skewed more male, 62%, and more college-educated, 68%, than the general U.S. population which is about 50% male and 35% college-educated. However, using the platform did allow the researchers to survey groups of workers representing most states in the U.S. The respondents’ median household income of $50,000-$59,000 was also close to that of the United States’ median of $60,293.
- The data for this study were collected in April, the month after the World Health Organization officially declared the pandemic on March 11. Probst and her colleagues are continuing to follow up with this survey group every 1-2 months to collect a total of seven waves of survey data. The researchers are looking to see if the disparities related to economic stress and protective behaviors translate into greater C19 infection rates.
Source: https://www.eurekalert.org/pub_releases/2020-11/wsu-mew110620.php
G. The Road Back?
1. CDC: Teleworking may help us beat C19
- Looking to go back into the office anytime soon? Evidence is starting to mount against it, according to a new report from the Centers for Disease Control and Prevention (CDC).
- The data released Friday revealed that, in July, of 248 people, those who worked from home for two weeks before developing symptoms of any sort were less likely to be infected with coronavirus.
- In other words, coronavirus-infected people were more likely to report going into school or offices in the two weeks leading up to illness.
- This conclusion was upheld even after accounting for those who work in critical sectors, like health care and education, for example.
- “Businesses and employers should promote alternative work site options, such as teleworking, where possible, to reduce exposures to SARS-CoV-2,” reads the CDC report. “Where telework options are not feasible, worker safety measures should continue to be scaled up to reduce possible worksite exposures.”
- The report drew from a multi-state case study of 314 symptomatic adults in total; 153 tested positive for the virus while 161 tested negative. Participants answered questions about employment status, telework status and community exposures, among other questions.
- (Not all participants answered the question about telework status, which explains the discrepancy in totals.)
- Further, of coronavirus-infected participants, only 35% reported being able to telework full-time or part-time, while 53% of people who tested negative reported teleworking. Meanwhile, 65% of coronavirus-infected people were going into the office or school regularly.
- “This investigation provides evidence of the potential health benefits of teleworking associated with the C19 pandemic,” authors added.
- However the study also further confirmed socioeconomic disadvantages related to the virus. Teleworkers were more likely to be White, have a college degree, earn over $75,000 and have health insurance, the agency wrote.
- Finally, the percentage of people who reported teleworking in the study is higher than the national estimate, which was 26% during July, per the agency. Authors also noted several limitations, including that the findings “might not be representative of the U.S. population,” due to people who declined to partake.
Source: https://nypost.com/2020/11/09/teleworking-may-help-us-beat-covid-19-cdc-finds/
H. Back to School!?
1. The Colleges with No C19
- AVA MCDONALD STRODE across her college’s campus on the way to the library, happy to spend the fall back in idyllic Bronxville, New York, after what has been a tumultuous year. The sophomore’s classmates lounged on blankets. Some talked at a distance. Others pored over books. Except for their masks, everything at Sarah Lawrence College appeared to be just as it was before the coronavirus pandemic swept the globe.
- For the venerable liberal arts college’s 1,400 or so students, the campus has felt like a safe haven where they could live without fear of catching or spreading C19. As of this writing, Sarah Lawrence has had only five cases of the virus, a minuscule number compared to other colleges and universities across the United States, several of which exceed 1,000 cases on their campuses.
- In contrast to the pandemic drama playing out at colleges and universities across the country, a handful of schools, including Sarah Lawrence, have kept the disease at bay. Some of these schools are public, others private. All have created their own small public health infrastructures, sharing cohesive public health messaging and implementing C19 testing regimens to stop the virus from spreading on their campuses.
- Only about 35% of the undergraduate student body now lives on campus, down from 84% last year. Most of these students are freshmen. They had to provide their C19 test results within two weeks of arrival, and they have continued to undergo what Judd calls “surveillance testing” at monthly intervals throughout the semester.
- Every dorm room houses a single student instead of the usual double or triple occupancy, and the school has kept several rooms empty to be used for quarantines. The school also reworked the pedestrian traffic flow, adjusting the entrances and exits of buildings to make social distancing easier. All the buildings are locked, too: only people with key cards can enter, as McDonald does almost every day.
- Even though her classes as a writing major are all online, McDonald hasn’t been cooped up in her room. She picks up grab-and-go meals at the campus center, and when the weather is good, she studies at a desk outside. Life on campus has felt far from lonely. As a resident advisor, McDonald helps keep her residents on track with pandemic safety protocols even while making sure they haven’t become isolated from the rest of campus.
- “The activities council does an event almost every day either in person or online,” McDonald says. “I would end my night by going to the open mic, for example, where a bunch of students just get on a Zoom call, and everyone performs whatever they want to share.”
- The school attributes its success at keeping coronavirus at bay not to the students’ strict adherence to the rules, but to the campus’s camaraderie. “A key part for us was active communication with our students about caring for each other as a community,” says Judd.
Three degrees of separation
- The coronavirus saga played out differently on James Madison University’s bucolic Shenandoah Valley campus in Virginia. When junior Joseph Dwyer arrived to help the football team as a trainer this summer, he felt confident the school had the situation under control. He lived in a dorm with the team. They wore masks and followed the guidelines from the U.S. Centers for Disease Control and Prevention.
- When the rest of the students arrived in September, everything changed. The university’s plan quickly went off the rails for its 22,000 person student body, of which 30 percent live on campus in a typical year.
- “There was no testing. They didn’t take temperatures anywhere,” Dwyer says. “They tried to space the desks six feet apart, but there wasn’t enough room for that.”
- One week-long stretch in early September brought about 80 coronavirus cases a day as more than one of every two C19 tests came back positive. As numbers mounted, Dwyer stayed in his room. By the time the school sent everyone home on September 7, less than three weeks after residence halls opened, the campus had recorded more than 1,060 total cases.
- While Dwyer has seen pictures of his classmates at parties on Instagram, the kinesiology major says that most people he knows were staying in their apartments at the time. “I haven’t seen more than maybe five other people that I don’t live with,” he says. Dwyer has since dropped his classes for the semester. He is one of thousands who have done so, as enrollment is down across the country. (James Madison University declined requests for comment.)
- Still, Dwyer is indignant toward the widespread blame laid on college students for outbreaks at their schools. Superspreader events, like fraternity parties, might include only a few dozen students, but they can have an outsized domino effect. In society at large, superspreader events can spark infections in communities. As few as 10 percent of infected people are responsible for spreading 80 percent of cases. In colleges, that effect is amplified by a formerly positive trait: the interconnectedness of campus life.
- Almost all students are connected by a shared classmate, says Kim Weeden, a social science professor at Cornell University. At a mid-size school like Cornell, 92 percent of the student body is connected by three degrees of separation or fewer, according to a study by Weeden and Benjamin Cornwell, the chair of sociology at Cornell.
- “A lot of colleges and universities spend an enormous effort trying to connect students to each other across interests, across class lines, across all sorts of lines,” Weeden says.
- People at a university are so interconnected that, without any preventative measures in place, it is likely that every student and staff member at a mid-size university of 20,000 students would catch coronavirus within a single semester, even if the school had no cases when the semester began. We know that because Philip Gressman, a mathematics professor at the University of Pennsylvania, and Jennifer Peck, a professor of economics at Swarthmore University, put various campus coronavirus scenarios to the test in a new mathematical model.
- “If everything goes right,” Gressman explains, “if there’s a low level of transmission in the surrounding community, if all the students are wearing masks basically all the time, if you’re cutting large classes to limit crowd size, if you’re doing a robust testing and contact tracing program—the combination of all of these things and a little bit of luck works, even if students are still taking classes in person.”
- In the real world, though, everything seldom goes right. Students can only control their own actions, and even the university can’t regulate transmission in the community that surrounds them. Of the colleges that haven’t experienced major coronavirus outbreaks, “many of those places have had the advantage of being relatively isolated,” explains Sarah Fortune, a professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.
- By isolation, Fortune doesn’t mean a school has to be in a rural area. Rather risk can vary based on how freely people from the community move on campus. Schools situated in what Fortune calls porous communities, where there is more movement between the school and the surrounding area, have faced the threat of more serious outbreaks. If a college is less porous and it has established a solid testing program to help keep it COVID-free, then the student body could, in theory, be more relaxed, says Fortune. “The places that are more porous, where there is definitely transmission into the campuses from the outside community, these are the places that have to attend much more behavioral risk mitigation strategies.”
- Both Cornell’s mathematical model and Fortune’s research suggest a testing scheme that rapidly reacts to the presence of C19 is the best strategy for controlling the spread of coronavirus on campus and in the world at large. Those kinds of decisions come from the top.
Solving problems before they happen
- College officials can help prevent coronavirus cases among their student body—even when no one is on campus. In North Carolina, sophomore Ashleigh Fields continues with her studies online, far from the nation’s capital and Howard University, where she is enrolled. Other than track practice, during which she leaps borrowed hurdles in a nearby field, the journalism major has stayed focused on her academics and freelance writing. She’s eager to return to her school and the District of Columbia in the spring.
- “Howard is very lively,” says Fields. “You never truly have to go looking for an opportunity because one will approach you. You could be talking to your friends and meet someone creative who’s making a movie, and then they want you as an actor.”
- Even with her excitement to rejoin campus life, Fields knows that it might not be possible with the pandemic going on. As a historically Black university situated in a metropolis of about 700,000 people, nearly half of whom are people of color as well, Howard University has a unique risk profile. Black Americans who contract C19 are more than twice as likely to die than their white counterparts. The school’s administration has taken that into account for every aspect of its pandemic strategy.
- “Given our student and faculty population, we would have to be very careful,” says Howard University’s president, Wayne A. I. Frederick, about the potential for on-campus activities. “If we don’t feel we could do that safely, we will not bring them back to campus until there’s widespread distribution of a vaccine, which would be the ultimate way to decrease the spread of the virus.”
- Howard’s decision to go fully online came with a great deal of planning as well. The school made sure students with economic insecurity could stay in the apartment complex near campus, and they have kept the campus food pantry open through the crisis given most Howard students hail from the surrounding area. Securing these necessities helps the students focus on their studies and reduces their exposure to the coronavirus by lowering their need to travel outside the home for public resources, such as WiFi access at a cafe. As of now, only 21 of Howard’s roughly 10,000 students have tested positive for coronavirus.
- Although the school’s strategy differs from Sarah Lawrence’s in several major ways, one factor is the same: their thorough organization. Both schools researched their student populations, relied on science, and shared clear public health messages that told their students exactly how to guard themselves and their classmates against the virus.
- “A college administration’s actions are hugely important,” Fortune says. Despite appearances, the number of coronavirus cases at most colleges remains low. At schools that have successfully stifled transmission, like her own Harvard University, she says, they “have a whole public health infrastructure. You just cannot believe the commitments that they have made to public health and the health of their communities.”
Source: https://www.nationalgeographic.com/science/2020/11/the-colleges-with-no-coronavirus/
I. Projections & Our (Possible) Future
1. Top UK military commander Nick Carter fears C19 could spark third world war
- The coronavirus pandemic is creating a “real risk” of a third world war, the UK’s most senior military commander warned Sunday.
- General Sir Nick Carter told Sky News that the economic devastation already sparked by the pandemic has sparked regional conflicts that too closely mirrored ones that led to the previous two world wars.
- “I think we are living at a moment in time where the world is a very uncertain and anxious place,” he told the UK broadcaster, while also predicting armies of the future would be manned in part by robots.
- “I think the real risk we have, with quite a lot of regional conflicts that are going on at the moment, is you could see escalation lead to miscalculation, and that is a thing I think we have to guard against,” he warned.
- Without specifying the regional conflicts he was most concerned about, he told Sky that if left unchecked they could easily “lead to an escalation.”
- That means “more people perhaps get involved, more weaponry gets involved and before you can contain it, it leads the sides ending up in a full-blown war,” he warned.
- “We have to remember that history might not repeat itself, but it has a rhythm,” he said.
- “If you look back at the last century, before both world wars, I think it was unarguable that there was escalation that led to the miscalculation which ultimately led to war at a scale we would hopefully never see again,” he told Sky.
- Asked whether he was saying the threat of another world war was real, Carter said, “I am saying it’s a risk and I think we need to be conscious of those risks.”
- Carter gave his stark warning on Remembrance Sunday in the UK, saying that recalling the huge sacrifices made was more important than ever.
- “If you forget about the horror of war then the great risk I think is that people might think going to war is a reasonable thing to do,” he said.
- Carter also predicted that within 10 years armies could be filled with robot soldiers.
- “I mean, I suspect we could have an army of 120,000, of which 30,000 might be robots, who knows?” he predicted.
J. Practical Tips & Other Useful Information
1. Is It Safe to Have Dinner Together Inside?
- Americans have been told that if we want to socialize, the safest way to do it is outdoors, the better to disperse the droplets that spew from our mouths whenever we do anything but silently purchase grapefruit. But in many parts of the country, this is the last month that the weather will allow people to spend more than a few minutes outside comfortably. And next month, America will celebrate a holiday that is marked by being inside together and eating while talking loudly to old people.
- Federal and local officials have offered little guidance on whether and how people should be socializing this winter. That has left even medical experts confused about what’s safe, and what’s not. About a month ago, Megan Ranney, an emergency physician who teaches at Brown University, was trying to decide whether to take her son to his favorite restaurant for his ninth birthday. The family has not dined out since the pandemic hit the U.S. But Ranney’s son really, really wanted to go.
- “And I was trying to think in my brain, Is it safe for us to go outside? What if we’re inside and we’re in a private room?” Ranney told me. “It’s just, it’s too complicated to figure it out on your own.”
- No indoor gathering will be perfectly safe. Although many states have allowed indoor public settings such as gyms and restaurants to reopen at least in some capacity, experts don’t recommend spending a lot of time indoors with others, especially in situations where masking isn’t possible. The odds of catching the coronavirus are about 20 times higher indoors, and private, indoor gatherings have been linked to several coronavirus outbreaks. In June, a surprise birthday party in Texas resulted in 18 coronavirus cases. In July, a house party in Michigan led to 43 cases, and a family gathering in North Carolina led to 40 cases because the attendees “went about their daily lives” before they started showing symptoms. In some places, in-home gatherings are now responsible for the majority of new coronavirus cases. A recent Centers for Disease Control and Prevention report showed how a chain of family gatherings in Chicago led to three deaths.
- But it’s unrealistic to expect Americans to stay inside all winter without seeing anyone. Even if people could do that without going batty, it’s likely that, with January feeling endless and no stay-at-home order in place, people will take their chances. “Making a rule that says zero indoor gatherings until we have a vaccine is totally impractical,” says Julia Marcus, an infectious-disease epidemiologist at Harvard Medical School.
- In the absence of such a rule, “we have a mishmash of risk communication and guidelines from different entities,” Marcus told me, “and people are continuing to muddle through. It’s funny, because now I’m sitting here thinking, What are the rules in my city? I actually don’t know.”
- Beyond “stay at home” and “it’s okay to go out now,” government officials aren’t explaining the relative risks clearly and widely enough for everyone to understand. Ever since states publicized their “reopenings,” some people have seen unrelated people only from a six-foot distance and outside. Others are throwing indoor weddings. Often, these people live in the same city.
- Given this information vacuum, researchers like Ranney and some public-health workers have launched their own efforts to help people decide what types of social activities are safe, based on where they live.
- In a few phone calls, I too was able to figure out whether socializing indoors is okay. But not everyone is a health reporter.
- Here’s what to consider before you host that dinner party inside your dining room on a nippy October day: If you make it small, and primarily comprising people under 60, that’s safer. If your guests can stay six feet apart, even better—though consider that this is not likely to happen once they have had a few glasses of wine and the board games come out.
- Perhaps the most important factor is the level of so-called community transmission: how many new C19 cases are in your immediate area. Caitlin Rivers, an assistant professor at the Johns Hopkins Bloomberg School of Public Health, told me she wouldn’t be comfortable at an indoor dinner party right now, no matter what. But if you were going to risk it, it’s safer in areas that are seeing only five to 10 new cases a day per 100,000 people, and have a test-positivity rate less than 5 percent. Tom Tsai, a health-policy professor at Harvard, puts this number slightly higher, at 25 cases per 100,000.
- But this community-transmission number is hard for most people to keep track of. Part of the problem is that Americans no longer have a centralized source for news. Though interest in TV news has picked up recently, the three major evening newscasts get only about half the viewers today as they did in the 1980s. Some newspapers run transmission numbers on their front pages, but many Americans live in news deserts, and only 29 percent of Americans get a newspaper either digitally or in print. People tend to get news from social media, which will often circulate stories of national interest but not, say, the case numbers in a given county. Health departments can post things on social media, but how many people follow their local health department on Facebook?
- Rivers told me that to find the community transmission rate and other information, people should be checking their local public-health department’s website. But after more than a decade of severe budget cuts, many health departments don’t have the money to make snazzy, user-friendly websites with constantly updating figures.
- A number of websites show the levels of community transmission by county, such as one Tsai worked on, at GlobalEpidemics.org, but they are not widely known among the general public. (According to this map, in the county where I live, for example, it would be safe to gather indoors according to Rivers’s standards, because there are only eight new cases a day per 100,000 people. But in my parents’ county in Texas, which has just over 10 cases, it would be less safe.)
- In Chicago, the public-health department has developed a tool that can help people decide whether a gathering is safe through questions such as “Is everyone healthy?” and “Can you always keep a 6-foot distance?” Commissioner Allison Arwady has also been hosting regular Facebook Lives in which she answers questions from the public, and she hosts a weekly press conference in which she often highlights stories of individuals who caught the coronavirus at a small gathering. She’s running focus groups with Black and Latino Chicagoans to test messages that might resonate with them. But, she acknowledges, not every health department has the money or manpower to do all this.
- Together with her colleagues at Brown-Lifespan Center for Digital Health, Ranney has developed a free app called My COVID Risk that will allow users to input the type of activity they want to do, whether it’s indoors or outdoors, how many people will be there, what protective measures they’ll take, and where they live, along with other factors. The app will then generate a relative risk of catching the coronavirus during that activity—from “very low” to “very high”—using community-level data from The New York Times’ coronavirus map. People can modify their risk level by reducing the number of people, for example, or adding a mask requirement. “Given the lack of clear national guidelines on what’s safe and not safe, our hope is that this will fill a void for the average American who’s really struggling to judge the safety of various activities,” Ranney told me.
- With Americans befuddled as to which risks are acceptable, social media has overflowed with posts shaming people who appear to be in the company of other people. But these witch hunts miss the point that people generally don’t want to kill their friends and relatives. Most people want to do the right thing. But they can’t do it if they don’t know what it is.
Source: https://www.theatlantic.com/politics/archive/2020/10/it-safe-have-dinner-together-inside/616568/
2. C19 FAQs: Should I Purell My Nostrils? Can Lysol Disinfect The Air?
- Each week, we answer frequently asked questions about life during the coronavirus crisis. If you have a question you’d like us to consider for a future post, email us at goatsandsoda@npr.org with the subject line: “Weekly Coronavirus Questions.”
- When I get in my car, I always use a squirt of hand sanitizer for my hands. With the tips of my forefinger and thumb, I then rub some of the sanitizer just inside my nostrils. Does this have any helpful or detrimental effect?
- Wait, what? Well, good for you for remembering the hand sanitizer for your hands. The Centers for Disease Control and Prevention says keeping your hands clean is always important to reduce infection but especially so now to help prevent the spread of C19.
- But … not in your nose, says Leana Wen, an emergency physician and public health professor at George Washington University who previously was Baltimore’s health commissioner. “Putting hand sanitizer on your nostrils isn’t a barrier to breathing in the virus.”
- If your hands come in contact with the virus — say by touching a steering wheel that someone with C19 sneezed on, “then using hand sanitizer can kill the virus from your hands and keep it from entering your body if you touch the mucus membranes in your nose, eyes or mouth,” Wen says. “But hand sanitizer on, or in, your nose, won’t keep you from inhaling in virus particles which can attach to mucus membranes deep inside your nose and throat. “
- Your best bet is the whole combination of protective measures: frequent washing or hand sanitizing your hands, especially if you come in contact with an item or surface that someone else might have touched, physical distancing and wearing a mask.
- With so many people using hand sanitizer, some popular brands can be hard to find. But don’t just settle for any brand: The Food and Drug Administration has found that some hand sanitizers contain hazardous ingredients such as methanol or wood alcohol, which “can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.” Check this FDA website to see if the brand you have or are planning to buy is on its list of hand sanitizers to avoid.
- And as long as we’re talking about hand sanitizer, here are some refresher tips you might have forgotten since the beginning of the pandemic, courtesy of the CDC and University of Pennsylvania:
- Use an alcohol-based hand sanitizer that contains at least 60% alcohol, a recommended percentage for wiping out viral particles.
- Squeeze out enough sanitizer to cover all surfaces on your hands.
- After applying sanitizer, rub your hands together until they feel dry — about 20 seconds.
- Don’t rinse or wipe off the hand sanitizer before it’s dry or it may not work well against germs.
- Hand sanitizer does have a shelf life, so get a new bottle when this one reaches its expiration date.
- Consider storing that sanitizer in the purse or any carrying case you typically bring with you when you get in the car. Sanitizer can evaporate from heat if left in the car, and you may find yourself with none to use when you need it.
- We want to plan a birthday party for 13 people. We are all committed to wearing masks and social distancing. Would it help to spray Lysol in the rooms every 30 to 60 minutes to help with disinfecting the air?
- The only time we wouldn’t have on a mask is to eat.
- We hate to be a literal party pooper, but, in a word, no, says Steve Bennett, senior vice president of scientific and regulatory affairs at the Household & Commercial Products Association, the trade association for cleaning products such as Lysol.
- “A disinfectant spray is actually designed for surface use, so spraying it in the air will not be effective in protecting indoor guests from C19,” Bennett says. He adds that there are no sprayable household products currently registered with the Environmental Protection Agency that can be used to disinfect the air. (And as we reported in an earlier FAQ: “Portable air cleaners can limit the spread of the virus via long-range airborne particles by capturing most of those particles in a HEPA filter and cleaning the air at a rate of up to six times per hour.”)
- It would be nice to think we could spray away the virus, but the problem with disinfecting spray is that “it only lasts in the air for a few seconds and then falls to the ground, or evaporates, ending any protection,” says James Malley, a professor of civil and environmental engineering at the University of New Hampshire in Durham. So even if you sprayed the air with disinfectant, it wouldn’t linger long enough to be effective in the next moment if anyone who’s contagious (and not showing symptoms) has resumed talking or breathing in the indoor space.
- Like Bennett, Malley says disinfectant sprays are really meant for cleaning surfaces such as kitchen countertops or doorknobs — though he prefers disinfecting wipes. With wipes, you can be sure you’ve disinfected the entire surface because “you can visually see what has gotten wet and what hasn’t,” he says. With spray disinfectant, it can be harder to distribute the product across a surface and harder to tell where you’ve already sprayed. If you do choose to use wipes, Malley has a tip: To ensure a surface is fully disinfected, wait for the surface to dry before touching it.
K. Johns Hopkins COVID-19 Update
November 9, 2020
1. Cases & Trends
Overview
- The WHO C19 Dashboard reports 50.27 million cases and 1.25 million deaths as of 8:45am EST on November 9. The WHO surpassed 50 million cumulative cases today, and the following timeline will provide some context for the trajectory of the C19 pandemic:
- 1 case to 1 million cases – 90 days
- 1 million to 5 million – 48 days
- 5 million to 10 million – 38 days
- 10 million to 20 million – 44 days
- 20 million to 30 million – 37 days
- 30 million to 40 million – 31 days
- 40 million to 50 million – 21 days
- The pandemic continues to accelerate globally, now increasing by 10 million cases every 3 weeks. The WHO has already reported more than 677,000 new cases today, which would easily be a new record high for single-day incidence. The WHO reported a new record high for weekly incidence, with more than 3.5 million new cases (a 4% increase over the previous week), as well as a new record high for C19 mortality, with 52,718 deaths (a 16% increase over the previous week). This exceeds the first peak mortality in mid-April, and C19 mortality has accelerated steadily for 3 consecutive weeks.
- Total Daily Incidence (change in average incidence; change in rank, if applicable)
- USA: 109,184 new cases per day (+27,585)
- France: 53,344 (+14,000; ↑ 1)
- India: 46,335 (+712; ↓ 1)
- Italy: 32,253 (+6,031)
- Poland: 23,789 (+5,758; ↑ 3)
- United Kingdom: 22,443 (-574; ↓ 1)
- Spain: 20,451 (+111)
- Russia: 19,650 (+2,093; ↑ 1)
- Germany: 18,120 (+2,811; ↑ 1)
- Czech Republic: 10,455 (-1,480; new)
- Per Capita Daily Incidence (change in average incidence; change in rank, if applicable)
- Andorra: 1,032 daily cases per million population (-423)
- Czech Republic: 976 (-138; ↑ 1)
- Switzerland: 948 (+116; ↑ 3)
- Montenegro: 931 (+494; new)
- Liechtenstein: 888 (+191; ↑ 4)
- Luxembourg: 844 (-201; ↓ 2)
- France: 817 (+214; ↑ 3)
- Belgium: 704 (-521; ↓ 6)
- Armenia: 676 (-30; ↓ 1)
- Austria: 657 (+203; new)
- Brazil fell out of the top 10 in terms of total daily incidence. The US is the first country to average more than 100,000 new cases per day, and its daily incidence increased by 33% compared to the previous week. After an increase of more than 35% over the previous week, France surpassed India as #2 globally in terms of total daily incidence. The entire top 10 in terms of per capita daily incidence is in Europe. Austria and Montenegro entered the top 10, and Slovenia fell out of the top 10. Montenegro’s daily incidence more than doubled compared to the previous week, and it jumped all the way to #3 globally on a per capita basis.
United States
- The US CDC reported 9.81 million total cases and 236,547 deaths. The US reported a new record high daily incidence over the weekend, with 132,830 new cases reported on Saturday (corresponding to data through Friday), which is more than 75% higher than any single day during the previous 2 peaks. Additionally, the average daily incidence is nearly 100,000 new cases per day, almost triple the low reported in mid-September, and we expect the US to surpass 10 million cases in the next 2-3. Daily mortality also continues to increase, now up to 968 deaths per day. If it continues on this trajectory, the US could once again exceed 1,000 daily deaths in the next several days.
- More than half of all US states have reported more than 100,000 cumulative cases, and more than one-third have reported more than 200,000 cases:
> 900,000: California, Texas
> 800,000: Florida
> 500,000: New York
> 400,000: Illinois
> 300,000: Georgia
> 200,000: Alabama, Arizona, Indiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Wisconsin
- The Johns Hopkins CSSE dashboard reported 10.02 million US cases and 237,742 deaths as of 1:30pm EST on November 9.
2. US ELECTION
- The result of the 2020 US presidential election was announced this weekend. After several days of continual updates from “battleground” states as they counted ballots, it became apparent that the former Vice President Joe Biden and Senator Kamala Harris defeated President Donald Trump and Vice President Mike Pence. The outcome will not become official until states certify their results and the Electoral College votes on December 14—and President Trump’s campaign and other Republican officials have already filed a number of lawsuits contesting the election outcome in closely contested states—but President-Elect Biden is already working on the transition, including his C19 response plan.
- Most notably, President-Elect Biden announced the members of his C19 taskforce, a team of 13 former government officials and other experts representing various aspects of medicine and public health. The taskforce will be led by Dr. Marcella Nunez-Smith, Yale physician and researcher; Dr. Vivek Murthy, former US Surgeon General; and Dr. David Kessler, former FDA Commissioner, and these experts will help President-Elect Biden’s transition team prepare to take immediate action after taking office in January 2021. In addition to the C19 response, many experts are anticipating that President-Elect Biden will quickly make a number of changes to existing US policies enacted by President Trump’s administration once he assumes the office of President, including a reversal of President Trump’s decision to withdraw from the WHO.
- One of the most pressing questions in terms of the election outcome is how President Trump, the US Congress, and other aspects of the US C19 response will function during the “lame duck” period between now and Inauguration Day in January. In particular, the Congress and the White House had been negotiating a C19 economic stimulus package in the weeks leading up to the election, but they were not able to finalize a deal.
- Some experts have highlighted the critical need for such a package—to support individuals and families, small businesses, schools, healthcare and public health systems, and state and local governments—but there does not appear to be much optimism that the federal government will be able to agree to a funding package before 2021. Senate Majority Leader Mitch McConnell has stated that a C19 stimulus package is among his top priorities; however, he also stated that recent economic data indicate that a smaller package is warranted, likely in conflict plans supported by Democrats.
- Beyond the presidential election results, several other interesting C19-related stories emerged from the US election. Analysis conducted by NPR found that support for President Trump increased in counties that were more severely affected by C19, compared to the 2016 election. In particular, the voting margin in favor of President Trump in 2020 increased for counties with higher per capita C19 mortality. Notably, among counties in the top 25% of per capita mortality, two-thirds reported increased support for President Trump in the 2020 election. The drivers of individuals’ voting decisions are extremely complex.
- In North Dakota, a Republican candidate that died from C19 during the campaign was elected to the state’s House of Representatives. David Andahl reportedly had underlying health conditions, and he died of the disease on October 5. The election results have not yet been certified, but there appears to be conflict between North Dakota’s Governor and Attorney General regarding how to fill the vacant seat.
- President Donald Trump’s Chief of Staff, Mark Meadows, reportedly tested positive for SARS-CoV-2. A report by the Associated Press indicates that Mr. Meadows attended an election night gathering at the White House in the days before his positive test, although the exact timing of the test is unclear. Like a number of previous examples at the White House, the attendees reportedly did not wear face masks or practice recommended physical distancing at the event. Mr. Meadows is one of at least 5 White House staff members to test positive over the past week or so, approximately 1 month after a previous outbreak at the White House.
3. US TESTING KITS
- The US CDC conducted an internal investigation of reliability issues with early SARS-CoV-2 diagnostic tests in the US, in particular that the test kits developed by the CDC’s Respiratory Viruses Diagnostic Laboratory. According to a report by NPR, the investigation determined that the final quality control test for the CDC-developed test kits suggested that the test would fail 33% of the time, but “laboratory officials” decided to release them anyway.
- Additionally, the CDC investigation identified “a lack of appropriate recognized laboratory quality standards, and organizational problems” at the laboratory. According to the NPR report, the director of the Respiratory Viruses Diagnostic Laboratory is no longer working in that laboratory, and “the CDC has effectively removed all the leadership from the division of viral diseases that oversaw the lab.” The lack of adequate testing capability and capacity early in the US epidemic was a major challenge in terms of identifying the scope of transmission early in the epidemic, and the delays associated with the CDC diagnostic test kit was a major contributor to national testing shortages early in the epidemic.
4. PFIZER VACCINE
- Pfizer Pharmaceuticals and BioNTech announced interim efficacy results from the Phase 3 clinical trial of their candidate SARS-CoV-2 vaccine. According to press releases issued by both companies, preliminary analysis of trial data shows that the vaccine could be 90% efficacious. The study has enrolled 43,538 participants, including 38,955 who have received both doses of the vaccine (as of November 8). The preliminary analysis was conducted by an external and independent Data Monitoring Committee. At the time of the analysis, 94 C19 cases had been reported among participants. The available data indicate that the vaccine demonstrates at least a 90% efficacy 7 days after the second dose—corresponding to 28 days after the first dose. No serious adverse events have been reported so far among trial participants.
- While these preliminary results are encouraging, additional data is still needed to better characterize both the vaccine’s efficacy and safety before Pfizer can apply for an Emergency Use Authorization (EUA) from the US FDA. A senior official for Pfizer indicated that the trial could potentially complete the efficacy portion (ie, based on detecting 164 total cases) by December, but negotiations are ongoing with the FDA regarding the required duration of safety monitoring.
- Additionally, the preliminary results were only reported via a press release, and the full datasets have not been published publicly and have not been subjected to peer review. Pfizer also aims to determine the vaccine’s efficacy in preventing severe C19 disease and as post-exposure prophylaxis (PEP). Pfizer has reported that 50 millions doses of the vaccine could be available by the end of the year and 1.3 billion doses in 2021.
5. WORLD HEALTH ASSEMBLY
- Starting today and lasting until November 14, WHO Member States are gathering virtually for the 73rd World Health Assembly (WHA). This will be the second virtual WHA meeting to take place, after the scaled-back meeting held May 18-19. Key topics for the current meeting include the Pandemic Influenza Preparedness (PIP) Framework, the Global Vaccine Action Plan for meningitis, draft Immunization Agenda for 2030, polio eradication, and reflections on the efforts of the WHO Health Emergencies Programme, likely including the C19 response.
- A statement issued last week by the WHO also noted that the week-long session will discuss a 10-year plan for addressing neglected tropical diseases and the WHO Global Code of Practice for Recruitment of Health Personnel, which was first adopted in 2010. After the conclusion of the virtual WHA, the Executive Board will resume its 147th session.
- Convening the 73rd WHA has not been without controversy, however. Taiwanese officials, with support from the US and officials from 25 European countries, have expressed “strong regret and dissatisfaction” that Taiwan has not been invited to participate in the meeting. Taiwan is not officially recognized as a country by the WHO, and while Taiwan has participated in previous WHA meetings, “China has objected to Taiwan’s inclusion in the WHA since Taiwanese President Tsai Ing-wen was elected.”
- In response to calls for Taiwan’s inclusion, the Chinese government reportedly stated that Taiwan can only participate in the WHA if it acknowledges that it is part of China, the principal source of conflict between China and Taiwan. Notably, Taiwan has demonstrated tremendous success in terms of containing C19. Taiwan continues to detect and report imported cases, but it has not reported a domestic C19 case in more than 200 days. The Taiwanese government and Taiwan CDC likely have many lessons to share with other countries, based on their experience and success in containing their epidemic, but it remains uncertain whether they will be able to do so in a high-profile forum like the WHA.
6. MARDI GRAS
- The Mardi Gras Carnival festival in New Orleans, Louisiana (US)—much like Carnival/Carnivale festivals in many other countries—is not traditionally known for being conducive to social or physical distancing. The large crowds and dozens of parades, concerts, and other celebrations spread across more than a month that are typically associated with the festival, held annually in January and February, are necessitating major changes for 2021 in order to mitigate C19 risks.
- In anticipation of continued C19 activity during the 2021 Mardi Gras festivities, the city of New Orleans is working with festival organizers to develop appropriate restrictions and protective measures to enable Mardi Gras to take place in 2021, even if not in the traditional form. New Orleans Mayor LaToya Cantrell directed the city’s Mardi Gras Advisory Committee to submit recommendations for C19 policies and procedures by December 5, approximately a month before the start of Carnival season. Prospective measures include mask use, symptom screening, and live television broadcasts of parades. Additionally, committee members are considering policies to limit alcohol consumption and discourage parade floats from throwing “high value” items to spectators in order to reduce crowding.