Recent Developments & Information
August 6, 2020
Without reliable information, we rely on fear or luck.
In a recent presentation to investors, Goldman Sach’s top economist projected in his base case that C19 vaccines will be widely available throughout US and Europe by middle to end of 2021 at the latest, but he also discussed the risk of all current vaccine candidates failing. For more information, see “How The Race For A COVID-19 Vaccine Could Go Horribly Wrong For The Market.”
A. The Pandemic As Seen Through Headlines
B. Numbers & Trends
1. Cases & Tests
3. Top 5 States in Cases, Deaths, Hospitalizations & Positivity (8/5)
4. US Testing
5. US Testing Compact
C. New Scientific Findings & Research
D. Vaccines & Testing
1. Potential C19 vaccine would protect obese adults less
2. Positive Vaccine News
E. Improved & Potential Treatments
1. Convalescent Plasma Reduced Death Rate Among C19 Patients by 50%
2. Designer antibodies could battle C19 before vaccines arrive
3. Which C19 treatments are showing promise? A list of potential drugs
F. Concerns & Unknowns
G. Back To School!?
1. Testing in Schools
2. A Tale of Two Cities
3. Kenya’s Radical School Solution
H. Projections & Our (Possible) Future
J. Practical Tips & Other Useful Information
K. Johns Hopkins COVID-19 Update (8/5)
- The Covid Tracking Project
- See How All 50 States Are Reopening (and Closing Again)
- City Health Dashboard
- Coronavirus Vaccine Tracker
- Could My Symptoms Be Covid-19?
- US Travel & Retail Supply Chain Updates
M. Linked Stories
Easing the long-term stress-related toll of C19 on children Decades of studies tell us that the kind of trauma and stress many children are experiencing during the C19 emergency has the potential to embed itself in children’s DNA, dramatically affecting their brains and other critical body systems and, as a result, their health across a lifetime.
The Strange Tale of Remdesivir and a Black-Market Cat Drug Cat owners are resorting to China’s underground marketplace to buy antivirals for a feline coronavirus. The use of the drug, known as GS-441524, is based on legitimate research from UC Davis. The feline coronavirus, eline infectious peritonitis, was thought to be incurable and 100% fatal to cats. GS-441524 is almost identical to remdesivir.
Experts cast doubt over claims by officials in the city of Osaka that a gargling medicine could help treat coronavirus patients, even as shelves across Japan were stripped clean of popular brands.
FDA’s Shifting Standards for Chinese Face Masks Fuel Confusion A FDA effort to address a shortage of protective masks has instead opened the floodgates to 3,500 Chinese manufacturers’ selling products of widely varying quality, potentially putting the public at risk and leaving some U.S. states with stockpiles of masks they no longer trust as protective gear
New NASA Research Projects Probe COVID-19 Impacts on Environment, Food & Water Supply NASA has initiated research projects focused on how the human response to the pandemic has affected our environment
A. The Pandemic As Seen Through Headlines
(In no particular order)
- FDA has warned consumers to avoid 115 hand sanitizers because products used the wrong type or amount of alcohol
- Trump campaign email urges supporters to wear facemasks
- Dr. Fauci says people without symptoms are driving infections in US
- Dr. Fauci says FDA won’t cut corners on approving vaccine
- Fauci expects tens of millions of coronavirus vaccine doses at start of 2021
- Latin America now has world’s highest coronavirus death toll
- Texas positivity rate hits 3-week high
- California new cases, deaths climb
- North Carolina ‘pauses’ reopening plans
- California has been “significantly” undercounting numbers for weeks
- NJ Governor says positivity rate is “too high”
- Florida cases top 500,000
- Department of Veterans Affairs coronavirus total tops 40,000
- In Oregon, 6.1% of tests are coming back positive, the highest rate since the early days of the pandemic
- As Cases Rise Fast, Mississippi Governor Mandates Masks And Delays Start Of School
- Young people fueling rise in coronavirus cases
- NYC Mayor de Blasio announces $10K fines, checkpoints for travelers flouting quarantine rules
- NYPD asks civilian staff to volunteer for de Blasio’s NYC checkpoints
- Chicago public schools to reopen online only this fall
- Teachers and their unions have been anything but heroes amid COVID-19
- In California, the virus reached what had been the last county without a confirmed case, Modoc, after a couple tested positive for it last week
- LA Mayor Threatens To Shut Off Water And Power At Homes Hosting Parties
- America’s slow, painful shift to enforcing mask mandates
- Houston latest city to fine residents who won’t wear a mask
- Virginia releases the first U.S. virus-exposure app to employ software from Apple and Google
- Czech Republic reports biggest jump in new cases since June
- Poland suffers record deaths
- WHO sends team of 43 to South Africa
- Uganda is Africa’s standout COVID success story
- WHO says first “confirmed” North Korea COVID cases “inconclusive”
- France suffers biggest jump in new cases in 2 months
- Queensland, Australia bars travelers from all Eastern states
- On Verge Of Six-Week Shuttering, Australian Small Businesses Beg: We Can’t Survive Another Lockdown
- Coronavirus deaths in Iran three times the official numbers, leaked report claims
- Germany has begun to see cases tick up again, and began requiring tests for travelers who enter the country from coronavirus “hot spots.”
- In Japan, a pandemic policy that denies re-entry to many permanent and long-term residents has upended many lives
- Afghanistan’s health ministry said that about one-third of the country’s population, or roughly 10 million people, have probably been infected by the virus and recovered
- Johnson & Johnson will receive $1 billion from the U.S. government to fund development and distribution of its experimental vaccine
- US Government And Yale Hold Trials On How Best To “Persuade” Americans To Take COVID-19 Vaccine
- “We were not built for a situation like this”: Many medical facilities in poor American communities lack intensive-care units, exacerbating the toll of the virus
- “Our House Is On Fire, We Need Help” – COVID-19 Deaths Pile Up In Texas Rio Grande Borderland
- Churchgoer spreads COVID-19 to at least 91 people after attending service
- Sturgis motorcycle in South Dakota rally expected to draw 250,000 people amid pandemic
- US Cruise Operators Halt Voyages Until Oct. 31 After 2 Ships Hit By Outbreaks Amid Restart
- Trump: ‘Teachers in a certain age group’ should stay home in fall due to COVID-19
- Joe Biden scraps plans to accept nomination at DNC over COVID-19 fears
- Dr. Fauci family needs security amid harassment, death threats
- Since the pandemic hobbled the U.S. economy, the cost of groceries has shot up at the fastest pace in decades
- Most people are more stressed than ever about bills since the pandemic began
- 400,000 NYC families could lose homes as eviction pause lifts, federal aid stalls
- Trump ready sign executive orders on evictions, unemployment if Dems don’t bend
- Black SUVs line up for laid-off employees outside NBCUniversal offices
- Yale University student demands tuition reimbursement for ‘offering inferior online classes’ during the pandemic – raising prospect of class action suit against Ivy League school
- Students in Mexico will only take classes broadcast on television or the radio when school begins this month
- Clorox wipes won’t be fully restocked in stores until 2021
- Robot Uses Face Scanning AI To Ask People To Wear A Mask
- UConn becomes first major college football team to cancel season
- ‘Big 10’ Releases Shortened 2020 Football Schedule After UConn Cancels Football Season
- Ultra-Wealthy Northeast Town Sees Surge In COVID-19 Cases After ‘Secretive’ Teen Parties
- Americans are thankful for ‘little joys’ more than ever these days
- People in Japan panic buy gargling medicine after governor touts anti-virus effect
- Walmart announces free drive-in movies
- ‘Mask mouth’ is a seriously stinky side effect of wearing masks
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.
1. Cases & Tests
- Total Cases = 18,965,479 (+1.5%)
- New Cases = 271,406 (+12,765) (+4.9%)
- New Cases (7 day average) = 255,453 (-2,538) (-1.0%)
- Number of new cases is 17,767 less than one week ago
- 7 day average of new cases has declined for 2 consecutive days
- 7 day average of new cases has been generally declining since 7/30, declining approx. 4,500, or 1.7% over last 6 days
- 1,000,000+ cases every 4 days (based on 7 day average)
US Cases & Testing:
- Total Cases = 4,973,568 (+1.1%)
- New Cases = 55,148 (-1,098) (-2.0%)
- Percentage of New Global Cases = 20.3%
- New Cases (7 day average) = 58,024 (-1,453) (-2.4%)
- Total Number of Tests = 62,381,295
- Percentage of positive tests (7 day average) = 7.9%
- Number of new cases has declined 23,298 since 7/24, a decrease of 29.7%
- Number of new cases is 10,175 less than one week ago
- Number of new cases drops to 3rd highest globally, behind India & Brazil
- 7 day average of cases has declined for 11 consecutive days
- 7 day average of the percentage of positive tests has been relatively stable during the last week
- Total Deaths = 710,287 (+1.0%)
- New Deaths = 6,838 (+212) (-3.2%)
- New Deaths (7 day average) = 5,799 (-27) (-0.5%)
- 12th highest number of new deaths
- 7 day average of new deaths have been steadily increasing since 7/1
- Total Deaths = 161,061 (+0.8%)
- New Deaths = 1,311 (-50) (-3.7%)
- Percentage of Global New Deaths = 19.2%
- New Deaths (7 day average) = 1,107 (-23) (-2.0%)
- Number of new deaths is 154 less than one week ago
- Number of new deaths 2nd highest globally, behind Brazil
- 7 day average of new deaths has been relatively flat since 8/1
Source: Worldometer & The Covid Tracking Project
3. Top 5 States in Cases, Deaths, Hospitalizations & Positivity (8/5)
- While the US C19 incidence continues to slowly decrease at the national level, mortality remains elevated. The US is now averaging 1,078 deaths per day, a slight increase from the previous day.
- Notably, Texas (194 deaths per day), Florida (184), California (133), Georgia (59), Mississippi (30), North Carolina (29), Ohio (27), Nevada (15), Arkansas (9), and Oklahoma (8) are reporting increasing daily C19 mortality. Arizona’s C19 mortality (62 deaths per day) may have reached a peak, but further data is needed to characterize the longer-term trend.
Source: Worldometer, The Covid Tracking Project & Johns Hopkins COVID-19 Updates
4. US Testing
- US coronavirus testing capacity has increased dramatically since the early months of the pandemic, up to more than 800,000 tests per day, but numerous problems and barriers remain to achieving a robust and reliable testing system.
- Last month, the US government unveiled a plan to provide nursing homes and long-term care facilities across the country with machines capable of performing rapid, on-site coronavirus tests. As we have covered previously, these types of facilities are among the highest risk settings for rapid transmission, severe disease, and death, largely due to prolonged close contact between patients and staff, older populations, and high prevalence of underlying health conditions. Rapid testing would provide the ability to quickly identify and isolate patients to mitigate transmission risk and to monitor staff to ensure infectious individuals do not have contact with high-risk patients.
- Reportedly, coronavirus “Testing Czar” ADM Brett Giror noted that the program would only provide a limited supply of testing kits to go along with the machines and that individual facilities will be required to acquire their own test kits. The facilities will be expected to use funds from emergency funding previously provided by the federal government, but the US government has reportedly made arrangements with manufacturers to ensure easy and affordable access to the test kits as well as technical support.
- Another major barrier is disparities in the availability of testing in underserved communities, particularly for communities of color. One study, conducted by ABC News and FiveThirtyEight, found that testing availability and wait times can vary widely. In particular, the researchers found that “people of color, especially Blacks and Latinos, are more likely to experience longer wait times and understaffed testing centers.”
- The study analyzed the expected testing demand and number of sites in communities nationwide and found that testing sites in and near Black and Hispanic communities were likely to face higher demand than sites located in White neighborhoods. Similarly, the sites located in lower-income neighborhoods were expected to serve more patients than those in higher-income neighborhoods. Higher patient demand can lead to longer wait times, which may be more difficult for lower-income individuals who may have more difficulty taking time away from work and family.
- These types of disparities contribute to the disproportionate effect of C19 on racial and ethnic minority communities across the US. The study did not account for other factors, such as the testing capacity or throughput of individual testing sites, which could affect wait times.
Source: Johns Hopkins COVID-19 Updates
5. US Testing Compact
- In a bipartisan agreement, 7 US states are collaborating to invest in 3.5 million diagnostic tests in an attempt to increase testing capacity and decrease delays in obtaining test results. The governors of Louisiana, Maryland, Massachusetts, Michigan, North Carolina, Ohio, and Virginia agreed to pool financial resources to encourage manufacturers of rapid diagnostic tests to increase their production and sales capacity. The governors maintain that these rapid tests will alleviate some of the strain on states’ traditional testing infrastructure and private laboratories. Crucially, these states determined their collaboration was necessary to ensure sufficient access to diagnostic test capacity in the absence of a coordinated national plan.
- In collaboration with the Rockefeller Foundation, which has agreed to provide supplemental funding, the states participating in the compact will each receive 500,000 tests. Maryland Governor Larry Hogan worked with the Rockefeller Foundation to establish the deal through his position as the co-chair of the National Governors Association. The Rockefeller Foundation stated that speed of testing should be prioritized over sensitivity at this stage in the pandemic, particularly considering that numerous reports that diagnostic test results can still take several days.
- The participating governors are currently in talks with 2 manufacturers of rapid diagnostic tests, Becton Dickinson (BD) and Quidel. The BD test uses a proprietary handheld device and can return results within 15 minutes. The BD system is already used in healthcare and pharmacy settings across the US, further decreasing access issues. Similarly, Quidel system point-of-care devices that can return results within 15 minutes. Quidel reported that more than 43,000 of their systems are already in use in healthcare facilities around the world. In addition to the multi-state testing compact, BD and Quidel are supplying rapid diagnostic tests to support the HHS strategy to increase testing in nursing homes in hotspot areas.
Source: Johns Hopkins COVID-19 Updates
C. New Scientific Findings & Research
1. Scientists Uncover Biological Signatures of the Worst C19 Cases
- Scientists are beginning to untangle one of the most complex biological mysteries of the coronavirus pandemic: Why do some people get severely sick, whereas others quickly recover?
- In certain patients, according to a flurry of recent studies, the virus appears to make the immune system go haywire.
- Unable to marshal the right cells and molecules to fight off the invader, the bodies of the infected instead launch an entire arsenal of weapons — a misguided barrage that can wreak havoc on healthy tissues, experts said.
- “We are seeing some crazy things coming up at various stages of infection,” said Akiko Iwasaki, an immunologist at Yale University who led one of the new studies.
- Researchers studying these unusual responses are finding patterns that distinguish patients on the path to recovery from those who fare far worse. Insights gleaned from the data might help tailor treatments to individuals, easing symptoms or perhaps even vanquishing the virus before it has a chance to push the immune system too far.
- “A lot of these data are telling us that we need to be acting pretty early in this process,” said John Wherry, an immunologist at the University of Pennsylvania who recently published a study of these telltale immune signatures. As more findings come out, researchers may be able to begin testing the idea that “we can change the trajectory of disease,” he said.
- When a more familiar respiratory infection, like a flu virus, tries to gain a foothold in the body, the immune response launches a defense in two orchestrated acts. First, a cavalry of fast-acting fighters flocks to the site of infection and tries to corral the invader, buying the rest of the immune system time to mount a more tailored attack.
- Much of the early response depends on signaling molecules called cytokines that are produced in response to a virus. Like microscopic alarms, cytokines can mobilize reinforcements from elsewhere in the body, triggering a round of inflammation.
- Eventually, these cells and molecules leading the initial charge will stand down, making way for antibodies and T cells — specialized assassins built to home in on the virus and the cells it has infected.
- Rather than bowing out gracefully, the cytokines that drive the first surge never stop sounding the alarm, even after antibodies and T cells arrive on the scene. That means the wildfire response of inflammation may never get snuffed out, even when it’s no longer needed.
- “It’s normal to develop inflammation during a viral infection,” said Catherine Blish, a viral immunologist at Stanford University. “The problem comes when you can’t resolve it.”
- This sustained signaling may result in part from the body’s inability to keep the virus in check, Dr. Iwasaki said. Many who struggle to recover from their illness seem to harbor the pathogen long after other patients have purged it, perhaps goading the immune system into prolonging its frantic inflammatory siege.
- Plenty of other viruses, including those that cause AIDS and herpes, have evolved tricks to elude the immune system. Recent evidence hints that the new coronavirus might have a way of delaying or muffling interferon, one of the earliest cytokine defenses the body mounts.
- The failure of this first line of defense may dupe the immune system into sounding its alarm bells even louder, dragging out the response into something destructive. “It’s an enigma,” said Avery August, an immunologist at Cornell University. “You have this raging immune response, but the virus continues to replicate.”
- And the quality of these cytokines may matter as much as the quantity. In a paper published last week in Nature Medicine (here), Dr. Iwasaki and her colleagues showed that patients with severe C19 appear to be churning out signals that are better suited to subduing pathogens that aren’t viruses.
- Although the delineations aren’t always clear-cut, the immune system’s responses to pathogens can be roughly grouped into three categories: type 1, which is directed against viruses and certain bacteria that infiltrate our cells; type 2, which fights parasites like worms that don’t invade cells; and type 3, which goes after fungi and bacteria that can survive outside of cells. Each branch uses different cytokines to rouse different subsets of molecular fighters.
- People with moderate cases of C19 take what seems like the most sensible approach, concentrating on type 1 responses, Dr. Iwasaki’s team found. Patients struggling to recover, on the other hand, seem to be pouring an unusual number of resources into type 2 and type 3 responses, which is kind of “wacky,” Dr. Iwasaki said. “As far as we know, there is no parasite involved.”
- It’s almost as if the immune system is struggling to “pick a lane,” Dr. Wherry said.
- This disorientation also seems to extend into the realm of B cells and T cells — two types of immune fighters that usually need to stay in conversation to coordinate their attacks. Certain types of T cells, for instance, are crucial for coaxing B cells into manufacturing disease-fighting antibodies.
- Last month, Dr. Wherry and his colleagues published a paper in Science (here) finding that, in many patients with severe C19, the virus had somehow driven a wedge between these two close-knit cellular communities. It’s too soon to tell for sure, but perhaps something about the coronavirus is preventing B and T cells from “talking to each other,” he said.
- These studies suggest that treating bad cases of C19 might require an immunological reset — drugs that could, in theory, restore the balance in the body and resurrect lines of communication between bamboozled cells. Such therapies could even be focused on specific subsets of patients whose bodies are responding bizarrely to the virus, Dr. Blish said: “the ones who have deranged cytokines from the beginning.”
- But that’s easier said than done. “The challenge here is trying to blunt the response, without completely suppressing it, and getting the right types of responses,” Dr. August said. “It’s hard to fine-tune that.”
- Timing is also crucial. Dose a patient too early with a drug that tempers immune signaling, and they may not respond strongly enough; give it too late, and the worst of the damage may have already been done. The same goes for treatments intended to shore up the initial immune response against the coronavirus, like interferon-based therapies, Dr. Blish said. These could stamp out the pathogen if given shortly after infection — or run roughshod over the body if administered after too long of a delay.
- So far, treatments that block the effects of one cytokine at a time have yielded mixed or lackluster results — perhaps because researchers haven’t yet identified the right combinations of signals that drive disease, said Donna Farber, an immunologist at Columbia University.
- Steroids like dexamethasone, on the other hand, are like “big hammers” that can curb the activity of multiple cytokines at once, Dr. Farber said. Early clinical trials have hinted at dexamethasone’s benefits against severe cases of the coronavirus, and more are underway. Such broad-acting treatments have their downsides. But, she added, “it seems that’s a good strategy, until we know more.”
2. Common colds train the immune system to recognize C19
- Previous infections with common cold viruses can train the immune system to recognize the coronavirus, according to a new study.
- The study, published Aug. 4 in the journal Science, found that immune cells known as T cells that recognize common cold coronaviruses also recognize specific sites on the coronavirus — including parts of the infamous “spike” protein it uses to bind to and invade human cells.
- This existing immune system “memory” may explain why some people have milder C19 infections compared with others; however, the authors stress that this hypothesis is “highly speculative” and requires more research to confirm. That’s because it’s unknown exactly how big a role T cells play in fighting C19 — T cells are just one part of a complex menagerie of molecules and cells that makes up our immune system.
- “We have now proven that, in some people, preexisting T-cell memory against common cold coronaviruses can cross-recognize SARS-CoV-2, down to the exact molecular structures,” study co-lead author Daniela Weiskopf, assistant professor at La Jolla Institute for Immunology in La Jolla, California, said in a statement.
- It’s possible that this “immune reactivity may translate to different degrees of protection” against C19, study co-lead author Alessandro Sette, a professor at La Jolla Institute for Immunology, said in the statement. “Having a strong T-cell response, or a better T-cell response may give you the opportunity to mount a much quicker and stronger response.”
- Previous studies have shown that upwards of 50% of people never exposed to C19 have T cells that recognize the coronavirus. This ability has been seen in people around the world, in the Netherlands, Germany, the United Kingdom and Singapore. Scientists hypothesized that this existing immunity could be due to previous infections with other coronaviruses, specifically those that cause common cold infections.
- In the new study, the researchers analyzed blood samples collected from people between 2015 and 2018, well before C19 first emerged in Wuhan, China.
- These blood samples contained T cells that reacted to more than 100 specific sites on the coronavirus. The researchers showed that these T cells also reacted to similar sites on four different coronaviruses that cause common cold infections.
- “This study provides very strong direct molecular evidence that memory T cells can ‘see’ sequences that are very similar between common cold coronaviruses and the coronavirus,” Sette said.
- In addition to binding to the spike protein, the T cells also recognized other viral proteins beyond the spike.
- Currently, most C19 vaccine candidates target the spike protein, but the new findings suggest that including other proteins in a vaccine, besides the spike, might harness this T cell cross reactivity and potentially enhance the vaccine’s potency, the researchers said, although much more research would be needed to show this.
- The authors note that their findings of cross-reactivity with T cells are different from what has been seen with neutralizing antibodies — another weapon of the immune system that blocks a pathogen from infecting cells. Neutralizing antibodies against common cold viruses are specific to those viruses and don’t show cross-reactivity with the coronavirus, according to previous studies, the authors said.
3. Study Finds 98 “Long-Term” C19 Symptoms, Including Baldness
- Epidemiologists readily admit that viruses are chock full of puzzles. And C19 is no exception. Earlier today, Dr. Fauci himself lamented the fact that nearly half of those who get the virus don’t see symptoms, which is one reason why young people have been so reckless, purportedly helping to spread the virus.
- And in a study published recently by the University of Indiana School of Medicine happened on a surprising finding: those who suffer from long-term symptoms of the coronavirus – a group that the researchers nicknamed “long haulers” after a Facebook group where many go for help – can experience all kinds of surprising symptoms, including baldness (for both men and women).
- The study was conducted by a doctor at the Indiana University School of Medicine and the grassroots C19 survivor group Survivor Corps using a Facebook poll that was shared with a group of “long haulers”, whom the researchers thanked for sharing their time and experience.
- The CDC has identified only 17 persistent C19 symptoms, but the survey of more than 1,500 patients found 98 possible symptoms, according to Dr. Natalie Lambert, an associate research professor who worked on the study.
- “The new symptoms our study identified include severe nerve pain, difficulty concentrating, difficulty sleeping, blurry vision and even hair loss,” Lambert said in a written statement.
- While the CDC guidelines are helpful for the vast majority of C19 sufferers, for those who are severely affected by the virus, a much broader world of potential symptoms opens up. Many of these symptoms aren’t included on the CDC’s list of common C19 symptoms. And until now, the medical community hadn’t really recognized these symptoms as potentially tied to the coronavirus.
- In the report, the authors wrote that “the mismatch between the health problems people are experiencing and the information that they can find from official health sources is noticeable and a potential cause for concern,” outlining the motivation for their study.
- To be sure, media reports have documented a degree of versatility in virus symptoms. Some seriously ill patients experienced damage to their hearts along with the lungs and the vascular system – these symptoms, and the puzzle they presented for epidemiologists, were widely reported.
- But the team from the Indiana University School of Medicine wrote that other symptoms, including “brain, whole body, joints, eye, and skin symptoms are also frequent-occurring health problems for people recovering from C19”, they wrote in the study.
- Another finding of the survey is that many “long haulers” who suffer from these extended symptoms report high levels of pain – 26.5% reported painful symptoms.
D. Vaccines & Testing
1. Potential C19 vaccine would protect obese adults less
- In a new report from CNN and Kaiser Health News, researchers pointed out that other prominent vaccines dating back to 1985 — like those for the flu and hepatitis A and hepatitis B — have not worked as well in providing immunity for obese adults.
- “Will we have a COVID vaccine next year tailored to the obese? No way,” Raz Shaikh, an associate professor with the University of North Carolina’s nutrition department, told Kaiser on Wednesday.
- That said, those with obesity are still highly encouraged to obtain vaccinations.
- “The influenza vaccine still works in patients with obesity, but just not as well,” the University of Alabama’s Director of Diabetes Research Dr. Timothy Garvey explained.
- In the United States, over 40% of American adults are considered obese, and the CDC has cautioned they face an increased risk if they contract C19.
- While obesity has long been recognized as a significant risk factor for death from things like cardiovascular disease and cancer, immunologists have found obesity also negatively impacts the body’s immune response, Kaiser reported.
- “Obesity is a serious global problem, and the suboptimal vaccine-induced immune responses observed in the obese population cannot be ignored,” a Mayo Clinic Vaccine Research Group noted in a 2015 study published in the journal Vaccine and cited by Kaiser.
- While people with high Body Mass Index (BMI) measurements have historically been excluded from drug trials — reportedly because of chronic conditions that would interfere with the results — today’s clinical trials for a C19 vaccine do not have a BMI exclusion, according to Dr. Larry Corey, who oversees the phase III trials sponsored by the National Institutes of Health.
2. Positive Vaccine News
- Novavax, the little-known Maryland company that received $1.6 billion from the federal government to produce an experimental coronavirus vaccine, announced encouraging results in two preliminary studies on Tuesday.
- In one study, 56 volunteers produced a high level of antibodies against the virus without any dangerous side effects. In the other, researchers found that the vaccine strongly protected monkeys from coronavirus infections.
- There are other vaccines that are further along with clinical trials, but Novavax’s stands out because it is protein-based — the same proven technology used for existing vaccines against diseases like shingles — which could make it safer and easier to manufacture in large amounts.
- Our colleague Carl Zimmer, a science writer and author of “A Planet of Viruses,” thinks there will be a number of coronavirus vaccines that will turn out to be safe and effective. “I think that there will be a patchwork,” he told us. India, China, and Russia, could all end up with their own successful vaccines, he said, and “there may be vaccines that are better for old people and other groups.”
- Despite the promising initial results, it won’t be possible to say whether the Novavax vaccine is safe and effective until the company conducts a large-scale study — known as Phase 3 — comparing people who get vaccinated to people who get a placebo.
Source: New York Times Coronavirus Updates
E. Improved & Potential Treatments
1. Convalescent Plasma Reduced Death Rate Among C19 Patients by 50%
- Hospitalized C19 patients who received transfusions of blood plasma rich with antibodies from recovered patients reduced their mortality rate by about 50%, according to researchers running a large national study.
- The researchers presented their data analysis Saturday in a webinar for physicians interested in learning about so-called convalescent plasma, with data slides that were reviewed by The Wall Street Journal. The researchers said they saw signs that the treatment might be working in patients who received high levels of antibodies in plasma early in the course of their illness. They based their conclusions on an analysis of about 3,000 patients.
- Patients who at three days or less after diagnosis received plasma containing high levels of antibodies against the coronavirus had a mortality rate of 6.6% at seven days after the transfusion. That compared with a mortality rate of 13.3% for patients who got plasma with low levels of antibodies at four days or more after diagnosis. That indicates reduced mortality of about 50%, the researchers said.
- At 30 days after transfusion, the mortality rate was reduced by about 36%, investigators reported.
- The sharing of the data comes as the FDA is nearing a decision to authorize emergency use of convalescent plasma for treating people infected with the coronavirus. The FDA can’t comment on whether it would take such action, a spokeswoman said.
- The data were submitted to the FDA, which is sponsoring an expanded-access program led by the Mayo Clinic in Rochester, Minn. The Mayo Clinic organized the webinar.
- The data haven’t been published in a journal or subject to peer review. At the webinar presentation, investigators said the conclusions are their own and don’t represent an official government endorsement of efficacy of convalescent plasma.
- The FDA can’t comment on the conclusions of the investigators, a spokeswoman said, adding that, as with other medical products, the FDA is assessing “all of the available evidence that could potentially support the use of convalescent plasma for the management of C19.”
- There is a long history of using convalescent plasma to treat people during large viral outbreaks, including the 1918 influenza pandemic and the 2014 Ebola outbreak in West Africa.
- Many doctors and hospitals are treating hospitalized C19 patients with convalescent plasma under compassionate-use protocols or as part of studies.
- The Mayo-led expanded-access program was set up to allow broad and quick access to convalescent plasma, and to ensure the safety of using antibodies from someone who recovered from the coronavirus to improve the immune response of a newly infected individual.
- Investigators said they initially thought a few thousand people might receive convalescent plasma through the expanded-access program. More than 53,000 C19 patients have received it to date.
- As the number of patients in the study multiplied, investigators began to wonder whether they could detect signs it was working, according to Michael Joyner of the Mayo Clinic, the principal investigator of the expanded-access study.
- As part of the analysis, the investigators contacted individual blood-collection centers around the country, which retain small amounts of plasma collected from recovered patients. The investigators analyzed the samples and correlated each one to the outcome of individual patients in the study who received them.
- Expanded-access studies don’t meet the scientific gold standard of a randomized controlled trial for proving whether a drug or treatment works. Investigators in the Mayo program can’t say with certainty whether plasma caused the improved outcomes because every patient in the study receives it.
- Four former heads of the FDA wrote an opinion piece in the Washington Post earlier this week stating that although convalescent plasma is a promising treatment and many patients have been treated with it, issues remain about when and how to use it and “we are not much closer to definitively answering those questions.”
- “Convalescent plasma is not available in unlimited supply. Patients who get it are selected for some reason. Lots of those reasons can also affect patient outcomes,” said Mark McClellan, former head of the FDA and one of the authors of the opinion piece.
- “There are many examples of observational studies no matter how well done that got answers that were wrong when randomized trials were done,” said Dr. McClellan, director of the Margolis Center for Health Policy at Duke University.
- Randomized controlled clinical trials of convalescent plasma therapy are under way, including several studies examining its potential effectiveness in outpatient clinics. At present, only hospitalized patients have access to convalescent plasma.
- Donald Berry, a professor in the department of biostatistics at the University of Texas MD Anderson Cancer Center, who isn’t involved in the convalescent plasma study and reviewed the slides at the Journal’s request, said the data are promising.
- “I agree there is a signal of efficacy,” Dr. Berry said. “It is pointing in the right direction.”
- The FDA is conducting additional studies to make sure any early signal of efficacy remains robust, the investigators said.
2. Designer antibodies could battle C19 before vaccines arrive
- While the world is transfixed by the high-stakes race to develop a C19 vaccine, an equally crucial competition is heating up to produce targeted antibodies that could provide an instant immunity boost against the virus.
- Clinical trials of these monoclonal antibodies, which could both prevent and treat the disease, are already underway and could produce signs of efficacy in the next few months, perhaps ahead of vaccine trials. “If you were going to put your money down, you would bet that you get the answer with the monoclonal before you get the answer with a vaccine,” says Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID).
- “Antibodies have the potential to be an important bridge until the vaccine is available,” says Ajay Nirula, a vice president at Eli Lilly, one of several large companies investing in them. Likely to be more effective than the repurposed drugs now available, such as remdesivir and dexamethasone, antibodies could protect the highest risk health care workers from becoming infected while also lessening the severity of C19 disease in hospitalized patients. But making monoclonals involves growing lines of antibodymaking B cells in bioreactors, raising concerns they could be scarce and expensive. On 15 July, Lilly, AbCellera, AstraZeneca, GlaxoSmithKline, Genentech, and Amgen jointly asked the U.S. Department of Justice (DOJ) whether they could share information about manufacturing their monoclonals without violating antitrust laws, “to expand and expedite production.”
- Soon after the pandemic began, researchers in industry and academia began to identify, design, tweak, and conduct lab tests of monoclonal antibodies against the coronavirus. Most work by binding to and “neutralizing” the viral surface protein, or spike, that initiates an infection. On 29 May, Lilly, working with AbCellera, launched the first human study of a monoclonal antibody—a phase I trial testing its safety and tolerability in hospitalized C19 patients. Other safety trials followed, from Lilly’s Chinese partner Junshi Biosciences and Regeneron, which developed a cocktail of three monoclonals that works against Ebola.
- Regeneron is now testing the efficacy of its C19 cocktail, which combines a spike antibody from a person who recovered and one from a mouse given the spike protein, in three large-scale, placebo-controlled trials. A prevention trial run in coordination with NIAID’s C19 Prevention Trials Network (CoVPN), an arm of the Trump administration’s Operation Warp Speed, will recruit 2000 people who live in a house with a confirmed C19 case. One treatment study run by the company aims to enroll nearly 2600 hospitalized people with severe C19, whereas another, about half that size, will test the antibodies in infected people with mild or moderate symptoms. Lilly has launched its own trials, including a phase III, placebo-controlled study in 2400 residents or staff of long-term care facilities, run with the help of CoVPN.
- “We should be able to see an efficacy signal very quickly” from these trials, says Amy Jenkins, who heads the Pandemic Prevention Platform (P3) program at the Defense Advanced Research Projects Agency, which for 2 years has invested in speeding the development of monoclonal antibodies for pandemics. Although Jenkins hesitates to make a firm prediction, she says the November-December time frame is “realistic and conservative.” That is likely earlier than any vaccine will prove safe and effective, researchers say.“I would be reluctant to say [that] would be any earlier than the end of the year,” Fauci said at a press conference about the launch of NIAID’s first C19 vaccine trial on 27 July.
- Regeneron’s Christos Kyratsous notes that vaccine trials must wait a few weeks for a person’s immune system to develop appropriate responses to shots and further weeks for “the event”—a chance exposure to the coronavirus. This means those trials require time and many people. In contrast, for the antibody treatment trials, “your event has already happened,” Kyratsous says. And in the prevention studies, the household contacts of C19 cases will be much more likely to be exposed than people who typically join a vaccine study.
- Immunologist Dennis Burton, whose group at Scripps Research has isolated highly potent monoclonal antibodies against SARS-CoV-2 that they hope to move into human studies, says he is optimistic that monoclonals will protect people from infection for months with a single shot. “It’s much easier to take care of a few incoming virus particles than to try and resolve or cure an ongoing infection.” The same logic holds for treatment. “Hit the virus hard and early,” Burton says.
- Kyratsous says even if monoclonal antibodies don’t beat vaccines to the finish line, they still might have a role to play against C19. “We’re going to need both approaches in the long run,” Kyratsous says. Vaccines are rarely 100% effective, and many people may decline a vaccine or not skip immunization for other reasons. What’s more, he notes, the elderly or people who are immune compromised may not mount robust immune responses after being vaccinated.
- Supplies of monoclonal antibodies may be limited, however, in part because of modest investment. Operation Warp Speed, for example, has committed $8 billion to six different C19 vaccines; for monoclonals, the government has invested about $750 million, much of it in Regeneron, which will produce somewhere between 70,000 and 300,000 doses before it even has efficacy data. Lilly says it will have 100,000 doses by the end of the year.
- If the antibodies work, a study from the Duke University Margolis Center for Health Policy estimates the United States alone could require nearly 40 million doses next year. But no one knows how far those doses would stretch, says Janet Woodcock, who is on leave from running the drug evaluation and research division of the Food and Drug Administration to lead Warp Speed’s therapeutic effort. “Unlike with vaccines, it is hard to project the number of treatment courses that will be available,” Woodcock says. Prevention, which would be a single intramuscular shot, requires less product than the intravenous infusions used in treatment, she notes, but the amount needed depends on a person’s weight.
- Although how to prioritize vaccine distribution has already sparked extensive debate, no such discussion has yet taken place about monoclonal antibodies. But DOJ acknowledged the supply concerns on 23 July, giving the six companies that had petitioned it the green light to share production information.
- Regeneron is not part of that group, but Kyratsous is optimistic about meeting the need. “The good thing with some of these biologics is you can ramp up production fairly fast,” he says. Nirula agrees. “If we have success in these clinical trials, we will have a lot of drug available,” he says.
- The cost of monoclonals, especially for the higher doses needed for treatment, could split the world into the haves and have-nots. “It’s unlikely that that treatment will get down to a price point in the near future that it would be easily affordable globally,” says Seth Berkley, who leads Gavi, the Vaccine Alliance, and also heads an international C19 vaccine effort.
- Jenkins says a key aim of the P3 project, which has provided four groups with $96 million in seed money, has been to develop monoclonal antibodies that can be made by the body itself, instead of in large fermentation tanks. The idea, which has not yet been tested in humans, is to inject people with DNA or messenger RNA that encodes a desired antibody, allowing their own cells to make it. “We think we can bring down the cost of monoclonal antibodies,” Jenkins says.
- Regardless of cost, evidence that monoclonals work as preventives could benefit everyone by giving vaccinemakers a clear sign that antibodies against the surface protein of coronavirus are enough to protect a person. This, in turn, could provide a strong indicator for evaluating the worth of a candidate vaccine short of actual efficacy data. “It will be earthshaking to the vaccine field in a positive way,” says Myron Cohen of the University of North Carolina, Chapel Hill, who leads testing of monoclonal antibodies for CoVPN. “It provides a thousand opportunities to move forward faster.”
3. Which C19 treatments are showing promise? A list of potential drugs
- The race is on to find a treatment that works to quash the coronavirus — as the deadly disease continues to spread across the globe.
- Here’s a list of the most promising treatments and potential vaccines for the coronavirus.
- The experimental antiviral drug, made by Gilead Sciences, was the first to get emergency-use authorization from the FDA. It was initially developed to treat Hepatitis C and RSV, a virus that can cause potentially serious respiratory infections, and works by stopping viruses from replicating by inserting itself into infected genes.
- Remdesivir was recently shown to have reduced the risk of death for severely ill coronavirus patients by 62% during a clinical study. An earlier study also found that remdesivir helped coronavirus patients recover more quickly.
- Several US hospitals began using the widely available steroid to treat C19 patients in June after a preliminary study by British researchers found that the inexpensive drug lowered the risk of death by about a third in patients requiring mechanical breathing assistance or oxygen.
- The anti-inflammatory is used to treat edema, tumors in the spine and brain and eye inflammation. It is also used as a treatment for certain types of autoimmune diseases and cancers including leukemia, lymphoma and multiple myeloma.
- But dexamethasone may do more harm than good for patients with milder cases of coronavirus, however. The National Institutes of Health does not recommend using the drug on those who do not require supplemental oxygen or a ventilator.
- Critically ill patients have also bounced back quicker thanks to RLF-100, or aviptadil, a synthetic form of a natural peptide that protects the lung. The treatment was just granted fast-track emergency use designation in the US by the FDA.
- An inhalable form of interferon beta, a protein that’s produced by the body battling a viral infection, helped reduced the odds of patients developing serious cases of coronavirus by 79%, according to a preliminary study of a Phase II clinical trial released last month. The treatment, developed by UK company Synairgen, was inhaled directly into the lungs.
- More than 165 coronavirus vaccines are currently being developed — and 27 have reached human trials, according to the New York Times.
- The Trump administration has been doling out serious amounts of funding for various potential vaccines that are being developed by firms including Moderna, Johnson & Johnson and AstraZeneca. The goal is to deliver 300 million doses of an effective coronavirus vaccine by January.
- Moderna reached Phase III of its human trial after a study found that monkeys who were injected with its candidate — mRNA-1273 — built immunity against C19. Primates that were given two doses of the vaccination developed high levels of antibodies and were able to fight off the virus.
- A vaccine that’s being developed by Johnson & Johnson had similar results in monkeys.
- Pfizer has also been working on four experimental vaccines with German-based BioNTech, including one that helped volunteers in phase I and II trials develop antibodies against the coronavirus.
- Novavax is also developing a vaccine — NVX-CoV2373. The US government committed $1.6 billion to the biotech company last month to help it kickstart production and fund a Phase 3 clinical trial with up to 30,000 participants that is slated to begin in the fall.
F. Concerns & Unknowns
1. Pregnant women face special risks from C19
- Yalda Afshar hears the worries every day from her patients: Will C19 hit me harder because I’m pregnant? If I’m infected, will the virus damage my baby? Afshar, a high-risk obstetrician at Ronald Reagan University of California (UC), Los Angeles, Medical Center, understands the women’s concerns better than most: Her first child is due in October.
- Data on pregnancy and C19 are woefully incomplete. But they offer some reassurance: Fetal infections later in pregnancy appear to be rare, and experts are cautiously optimistic that the coronavirus won’t warp early fetal development. But emerging data suggest some substance to the other worry of Afshar’s patients: Pregnancy does appear to make women’s bodies more vulnerable to severe C19. That’s partly because of pregnant women’s uniquely adjusted immune systems, and partly because the coronavirus’ points of attack—the lungs and the cardiovascular system—are already stressed in pregnancy.
- The prescription for caregivers is simple, says David Baud, an expert on emerging infectious diseases and pregnancy at Lausanne University Hospital: “Protect your pregnant patients. The first ones who need the masks are pregnant women. The first to avoid social contact should be pregnant women.”
- The best U.S. data available so far were published by the CDC late in June. Among 91,412 women of reproductive age with coronavirus infections, the 8207 who were pregnant were 50% more likely to end up in intensive care units (ICUs) than their nonpregnant peers. Pregnant women were also 70% more likely to need ventilators, although they were no more likely to die.
- CDC’s data only offer a partial view, however. Pregnancy status was only available for 28% of the 326,000 U.S. women of reproductive age whose coronavirus infections had been reported to CDC by early June.
- A second paper, published by the Public Health Agency of Sweden last month in Acta Obstetricia et Gynecologica Scandinavica, used a more complete data set. Using data for all of Sweden during 4 weeks in March and April, researchers calculated infected pregnant women’s rate of ICU admission compared with that of infected, nonpregnant women of reproductive age. The study was small: Only 13 coronavirus-infected pregnant women and 40 nonpregnant infected women were admitted to Swedish ICUs in that time frame. But, Baud says, “From my point of view, it is the most robust data.”
- The results were sobering: The researchers found that pregnant or immediately postpartum women with C19 were nearly 6 times as likely to land in ICUs as their nonpregnant, C19–infected peers.
- It’s well known that pregnancy boosts the risk of serious disease from respiratory viral infections. During the H1N1 flu epidemic of 2009, pregnant women accounted for 5% of U.S. deaths, although they constituted about 1% of the population. One study found pregnant women with severe acute respiratory syndrome (SARS), which is caused by a virus that’s a close cousin of the coronavirus (SARS-CoV-2), were significantly more likely to be admitted to the ICU and to die than nonpregnant peers.
- Viral infections can be more severe in pregnant women in part because “the entire immune system is geared toward making sure not to create any antifetal immune response,” says Akiko Iwasaki, an immunologist at the Yale School of Medicine. “The mother has to compromise her own immune defense in order to preserve the baby’s health.”
- At the same time, the immune system is far from inactive in pregnancy, and “the really significant immune response to the infection certainly has the potential to cause complications,” says Carolyn Coyne, a virologist at the University of Pittsburgh.
- In addition, the coronavirus strikes the lungs and the cardiovascular system, which in pregnancy are already strained. “As the uterus grows there is less and less room for the lungs. That’s why pregnant women often feel short of breath. And that affects your pulmonary function,” says Denise Jamieson, chair of obstetrics and gynecology at Emory University School of Medicine.
- To supply the fetus, pregnant women also need extra oxygen and blood to ferry it: up to 50% more by late pregnancy. This may multiply the stress that C19 has been shown to put on the cardiovascular system. “The heart is already working for two,” Baud says. “And if you are a virus known to induce vessel change, inflammation, this will increase the workload of the heart even more.”
- Malavika Prabhu, a maternal and fetal medicine specialist at Weill Cornell Medicine, adds that later in pregnancy, “with so much blood going around and the organs more metabolically active, all that extra fluid can go in places it shouldn’t go—including filling your lungs with fluid.”
- Finally, pregnant women’s blood has an increased tendency to clot, thought to be due to their need to quickly staunch bleeding after delivering a baby. But the coronavirus itself can have a similar effect. “COVID is thought to increase your likelihood of clotting, and then pregnancy further increases your likelihood of clotting,” Jamieson says.
- Elevated dangers to the mother don’t end with delivery, according to work by Prabhu and colleagues in the journal BJOG last month. They followed all 675 pregnant women admitted for delivery at three New York hospitals during 4 weeks in late March and April. After giving birth, nine of 70 infected women, or about 13%, had at least one of three complications that doctors watch for after delivery: fever, low blood oxygen, and hospital readmission. Among 605 noninfected women, 27, or 4.5%, had one of these problems. “Many diseases are unmasked in the postpartum period. We learned that C19 is one of those,” Prabhu says. She noted that 79% of the pregnant women who tested positive when admitted were asymptomatic.
- Experts all say better data are desperately needed to understand and address the risks to pregnant, coronavirus-infected women. Jamieson notes that registries gathering data on pregnant women infected with H1N1 influenza in 2009 and with Zika in 2015 and 2016 were abandoned after those epidemics passed. “We really need investment in a long-term, well-funded surveillance system that captures pregnancy outcomes.”
- With a colleague at UC San Francisco, Afshar is co–principal investigator of the Pregnancy Coronavirus Outcomes Registry now collecting data from more than 1100 U.S. pregnant women. She hopes it will begin to answer urgent questions such as the impact on mother and fetus of drugs being given to fight C19; how infection influences a mother’s immune status; and whether and how anticlotting drugs ought to be used in pregnant women with C19.
- “It has been very strange to counsel women and their families, and witness their stress, and not be able to give them evidence-based recommendations,” Afshar says. “I lose sleep for every woman I take care of, to make sure I am doing the right thing for her. And it’s just the same, I would say, for myself.”
2. The Hidden Danger of Masks
- Face masks have become a cultural symbol. To resist them “is nothing more than selfish, libertarian nonsense masquerading as a comic-book defense of freedom,” Thomas Friedman of the New York Times proclaims. Yet the science is far less certain than the moralism.
- The question of how well masks prevent transmission and infection requires far more study. The decision to wear a mask would seem to be cost-free, apart from minor discomfort. But absolutism about masks and disregard for scientific uncertainties may promote a false sense of security that encourages risky behavior—including massive political protests.
- In February, the CDC recommended against wearing face masks and instead urged Americans to “take everyday preventive actions” like staying home when sick and washing hands. These recommendations were guided by the government’s desire to conserve medical masks for health-care workers.
- The CDC changed its recommendation in April based on lab tests showing that cloth masks reduce the distance that large respiratory droplets travel after a cough. Like the flu, C19 is believed to be transmitted mainly through these large droplets.
- Media figures and public-health officials have also observed that countries where face-mask use is more prevalent have lower infections. In June, the New York Times ran a story with the headline “Is the Secret to Japan’s Virus Success Right in Front of Its Face?” Its answer: Yes. But this piece drew conclusions based on mere correlations. According to a YouGov survey in late June, face-mask use was higher in the U.S. (59%) than in countries with fewer infections, including Taiwan (57%), France (54%), Canada (35%), Netherlands (9%) and Denmark (2%). And Japan (77%) and Hong Kong (83%) have experienced recent infection spikes.
- A study in the Journal of the American Medical Association this month reported that a universal mask policy for health-care workers and patients at the Mass General Brigham hospital system reduced C19 infections. The positive test rate among health-care workers peaked at 21.32% in March, declined to 14.65% after masks were mandated for workers, and dropped further, to 11.46%, in late April after the mask mandate extended to patients.
- But these numbers roughly track the overall positive test rate in the state. The study notes that the improvements “could be confounded by other interventions inside and outside of the health care system, such as restrictions on elective procedures, social distancing measures, and increased masking in public spaces, which are limitations of this study.”
- The only way to ascertain the efficacy of face masks in the real world is to do randomized trials. So far there have been only a dozen examining the efficacy of masks in preventing respiratory illnesses, and conclusions have been difficult to draw because of poor compliance by study participants. None of the six trials published over the past decade found that masks alone had a significant effect on the spread of the flu or similar illnesses in health-care workers or the general population.
- The only trial with reusable cloth masks suggested they’re ineffective. They could even increase the risk. In the 2015 study, hospital workers in Vietnam who were given cloth masks were 13 times as likely to develop influenza-like illnesses as those given surgical masks. Face masks are speculated to be more useful in preventing C19 because many infected people are asymptomatic. But some three-fourths of flu cases are also asymptomatic, and most people who develop symptoms are infectious for a couple of days first.
- A new independent analysis of cloth masks’ efficacy on the CDC website notes that the mask in the Vietnam trial was “a locally manufactured, double-layered cotton mask”—similar to what many Americans buy today—and that higher infection rates among wearers “may have been because the masks were not washed frequently enough or because they became moist and contaminated.”
- “Cloth masks may give users a false sense of protection because of their limited protection against acquiring infection,” the researchers write. “Taking a mask off is a high-risk process because pathogens may be present on the outer surface of the mask and may result in self-contamination during removal.”
- This is an important caveat: Fiddling with masks can be more dangerous than not wearing one at all. The American Academy of Pediatrics recommends that “elementary students should wear face coverings if the risk of touching their mouth or nose is not greater than the benefit of reducing the spread of C19.” But the point is lost amid simplistic moralizing about selfish libertarians.
- While mask mandates provide a comfort level that is needed to get people back to work and resume economic activity, they may also induce a false sense of security. In early April, as the Trump administration was debating whether to change its guidance on masks, Deborah Birx of the White House virus task force warned that “we don’t want people to get an artificial sense of protection because they’re behind a mask” or “send a signal that we think a mask is equivalent” to social distancing and good hygiene.
- Liberal politicians—who railed against antilockdown protests in the spring—have dismissed concerns that leftist demonstrations could spread infection, because participants are wearing masks. But not all are, and many masks aren’t fitted correctly. Protesters probably don’t wash them regularly. And masks don’t eliminate the risk of contagion when large numbers of people are crowded for long periods while talking loudly and breathing heavily.
- Masks have benefits, but moralism can be harmful to public health.
Source: The Hidden Danger of Masks – WSJ
3. New cancer diagnoses fell sharply as the coronavirus pandemic first hit
- By almost every measure, far fewer cancers are being diagnosed during the coronavirus pandemic, whether the decline shows up in screening mammograms and colonoscopies or in other tests ordered after troubling symptoms prompt a doctor’s visit.
- A research letter published Tuesday in JAMA Network Open notes a steep downward slope in newly identified cases of six common cancer types, based on weekly numbers from Quest Diagnostics. The clinical laboratory’s data add to similar analyses conducted in May and July from the electronic medical records vendor Epic and a July report from the COVID and Cancer Research Network on trends in cancer-related patient encounters.
- Compared to Quest’s baseline period from January 2019 through February 2020, during the seven weeks from March 1 through April 18, the mean weekly number of newly diagnosed cancer patients plunged 46.4% for all six types: breast, colorectal, lung, gastric, pancreatic, and esophageal. The biggest drop was 51.8% in breast cancer and the smallest decrease was 24.7% in pancreatic cancer.
- “Patients didn’t have the opportunity to have routine screens because they were told not to go to their doctors for routine visits,” said Harvey Kaufman, Quest’s senior medical director and an author of the study. “And if they had some mild symptoms, they waited or ignored them. The key is that during the real lockdown periods, people who have screenings didn’t have routine visits.”
- Patients whose doctors ordered tests for any cause and entered the code for a new cancer diagnosis in that order were included in the Quest analysis, picking up more results than from screening mammograms and colonoscopies alone. Its tests represent a range from 16% of lung cancers to 42% of breast cancers detected in the U.S., as tallied against the national SEER registry. Three-quarters of all Quest patients, in both the baseline and pandemic period, were women and the mean age was 66. Other demographic information, such as race, is not collected by Quest in test orders from physicians so no further breakdown is available.
- At the outset of that seven-week timeframe when the pandemic first hit the U.S., federal health officials and cancer societies urged patients to stay home and postpone routine medical care, including mammograms and colonoscopies or other tests that might have inadvertently found cancer. Health systems overwhelmed by C19 patients or preparing for a surge in cases — or both — asked those whose care could wait to delay what they could.
- Skipping cancer screenings, although prudent at the time, sparked alarm from Ned Sharpless, who directs the National Cancer Institute. He warned in a June editorial in Science that delayed cancer diagnosis could lead to as many as 10,000 extra deaths over 10 years in breast and colorectal cancer alone, in effect trading one public health crisis for another.
- “We’re very worried about the consequences of … delaying therapy on our patients,” Sharpless told STAT then. “We can’t delay cancer care forever.”
- In the spring, Epic reported that screening appointments for cancers of the cervix, colon, and breast plummeted between 86% and 94% in March. In July, screenings were still down but by far less, from 29% to 36% in these three cancers.
- The COVID and Cancer Research Network found a significant decrease in all cancer-related patient encounters as a result of the pandemic, defining an encounter as screening, an initial diagnosis, a second opinion, or the start of treatment. Across 20 different U.S. provider institutions with more than 28 million patients, the researchers found an overall drop of 74% in new cases of breast, lung, prostate, colorectal, and hematologic cancers and melanoma in April 2020 compared to April 2019. That report was published in the Journal of Clinical Oncology on July 27. In the network, 43% of patients are seen at institutions in the South, 22% in the Midwest, 18% in the Northeast, and 17% in the West.
- Quest’s Kaufman said the company has seen geographic shifts in testing as cases rise and fall across the U.S. and patients stay home. “Our volume in Florida at the moment is slightly softer because a pandemic is hitting Florida hard,” he told STAT on Monday.
- The debate over whether early detection causes overtreatment or saves lives has not been settled, but cancer centers want patients to come back.
- Dana-Farber Cancer Institute is encouraging patients to get their delayed screening or other care. Oncologist Andrew Wagner wasn’t surprised by the drop in cancer diagnoses reported by Quest and others, calling it a reflection of a risk-benefit assessment when the risk of exposure to the coronavirus in a hospital outweighed the benefit of screening. But now that safety measures are in place, that balance has shifted in favor of screening tests and other medical visits.
- “I think what is really critically important is that people do feel safe to return to health care environments where we do now have the appropriate equipment in place and screening procedures in place,” he said.
- So far, Wagner hasn’t seen evidence of patients’ cancers being diagnosed at a later stage than if they had been tested earlier.
- “This delay of a few months probably does not have a significant impact on patients. But we don’t like to delay screening tests,” he said. “It does depend a lot on the biology of the tumors, where some can be really slow-growing, small tumors and a few months has no impact, and then other, more rapidly growing ones where it could make an impact. So we hope we don’t see that. But it’s certainly possible.”
G. Back to School!?
1. Testing in Schools
- A commentary published in Science argues that a major shift in testing strategy is necessary to resume in-person classes in US schools. The current US testing protocol largely relies on diagnostic testing individuals who may be sick, but it may be necessary to implement programs to test students regularly in order to increase the chance of identifying infectious individuals and limit the number of exposed individuals.
- This kind of testing program would test everyone, possibly every few days, regardless of whether they are believed to be infected or even exposed. This would necessitate substantially increased testing capacity, but several pre-print studies evaluate options to utilize tests that return faster results, even if they are not quite as accurate as existing diagnostic tests.
- A modeling study published in JAMA: Network Open evaluated various testing strategies in the context of a simulated college student population. The simulated scenario involved 10 initial asymptomatic infections out of a total population of 5,000 students and evaluated various testing protocols, including a range of testing frequencies and test characteristics.
- The researchers found that testing all students every 2 days using a test with low sensitivity (70%) but high specificity (98%), in conjunction with isolating individuals with positive tests, could be a viable option to mitigating transmission risk at schools with in-person classes. The model illustrated that testing frequency may be a more important factor than test sensitivity, in terms of limiting cumulative incidence for C19 outbreaks.
Source: Johns Hopkins COVID-19 Updates
2. A Tale of Two Cities
- Chicago, the nation’s third-largest school district, will begin the academic year remotely, after teachers and parents opposed a hybrid plan that would have sent children into classrooms two days a week.
- “When we announced the potential for a hybrid model some weeks ago, we were in a very different place in the arc of the pandemic,” Mayor Lori Lightfoot said. The city’s reported coronavirus cases have steadily increased in recent weeks, to more than 250 a day.
- Chicago’s shift leaves New York City as the only major school system in the country that is still planning to offer in-person classes this fall. But New York — which has some of the lowest viral transmission rates in the country — is confronting a torrent of logistical issues and political problems.
- There are not yet enough nurses to staff schools, and ventilation systems in aging buildings are in urgent need of upgrades. There may not even be enough teachers available to offer in-person instruction. Some teachers are threatening to stage a sickout — teacher strikes are illegal in New York — and their union has indicated it might sue over reopening.
- “The entire country is watching how New York City handles this,” Eliza Shapiro, who covers education for The New York Times, told us. “If the city can pull off a safe reopening, it could provide a blueprint for scores of other districts trying to figure this out. But if the city halts or delays its plan, or has to close schools quickly after they open in September, it could be a warning shot to other districts.”
Source: New York Times Coronavirus Update
3. Kenya’s radical school solution
- Faced with the mounting challenges of reopening schools, Kenya chose a drastic option: cancel the entire academic year and make students repeat their grades. The decision was made not just to contain the virus, but to also level the playing field for students who lack access to remote learning.
- “It was a sweeping move that surprised many students, parents and educators but came as a relief to others who were worried that their children might fall behind,” Abdi Latif Dahir, the East Africa correspondent for The Times, told us.
- For most students, particularly those from poor and rural households, following lessons was not possible once schools started teaching online. “By the time they go to class next year, a lot of these kids who were at home and didn’t have access to these facilities will just not be able to compete,” Abdi said.
Source: New York Times Coronavirus Update
H. Projections & Our (Possible) Future
1. The Coronavirus Is Never Going Away
- The coronavirus that causes C19 has sickened more than 16.5 million people across six continents. It is raging in countries that never contained the virus. It is resurging in many of the ones that did. If there was ever a time when this coronavirus could be contained, it has probably passed. One outcome is now looking almost certain: This virus is never going away.
- The coronavirus is simply too widespread and too transmissible. The most likely scenario, experts say, is that the pandemic ends at some point—because enough people have been either infected or vaccinated—but the virus continues to circulate in lower levels around the globe. Cases will wax and wane over time. Outbreaks will pop up here and there.
- Even when a much-anticipated vaccine arrives, it is likely to only suppress but never completely eradicate the virus. (For context, consider that vaccines exist for more than a dozen human viruses but only one, smallpox, has ever been eradicated from the planet, and that took 15 years of immense global coordination.) We will probably be living with this virus for the rest of our lives.
- Back in the winter, public-health officials were more hopeful about the coronavirus, a closely related coronavirus, emerged in late 2002 and infected more than 8,000 people but was snuffed out through intense isolation, contact tracing, and quarantine. The virus was gone from humans by 2004. SARS and the coronavirus (SARS-CoV-2) differ in a crucial way, though: The new virus spreads more easily—and in many cases asymptomatically. The strategies that succeeded with SARS are less effective when some of the people who transmit C19 don’t even know they are infected. “It’s very unlikely we’re going to be able to declare the kind of victory we did over SARS,” says Stephen Morse, an epidemiologist at Columbia University.
- If not, then what does the future of C19 look like? That will depend, says Yonatan Grad, on the strength and duration of immunity against the virus. Grad, an infectious-disease researcher at Harvard, and his colleagues have modeled a few possible trajectories. If immunity lasts only a few months, there could be a big pandemic followed by smaller outbreaks every year. If immunity lasts closer to two years, C19 could peak every other year.
- At this point, how long immunity to C19 will last is unclear; the virus simply hasn’t been infecting humans long enough for us to know. But related coronaviruses are reasonable points of comparison: In SARS, antibodies—which are one component of immunity—wane after two years. Antibodies to a handful of other coronaviruses that cause common colds fade in just a year. “The faster protection goes away, the more difficult for any project to try to move toward eradication,” Grad told me.
- This has implications for a vaccine, too. Rather than a one time deal, a C19 vaccine, when it arrives, could require booster shots to maintain immunity over time. You might get it every year or every other year, much like a flu shot.
- Even if the virus were somehow eliminated from the human population, it could keep circulating in animals—and spread to humans again. The coronavirus likely originated as a bat virus, with a still-unidentified animal perhaps serving as an intermediate host, which could continue to be a reservoir for the virus. (SARS also originated in bats, with catlike palm civets serving as an intermediate host—which led officials to order the culling of thousands of civets.) Timothy Sheahan, a virologist at the University of North Carolina at Chapel Hill, wonders if, with the coronavirus so widespread across the globe, humans might be infecting new species and creating new animal reservoirs. “How do you begin to know the extent of virus spread outside of the human population and in wild and domestic animals?” he says. So far, tigers at the Bronx Zoo and minks on Dutch farms seem to have caught C19 from humans and, in the case of the minks, passed the virus back to humans who work on the farm.
- The existence of animal reservoirs that can keep reinfecting humans is also why scientists don’t speak of “eradication” for these viruses. The Ebola virus, for example, probably comes from bats. Even though human-to-human transmission of Ebola eventually ended in the West African epidemic in 2016, the virus was still somewhere on Earth and could still infect humans if it found the right host. And indeed, in 2018, Ebola broke out again in the Democratic Republic of the Congo. Ebola can be contained through contact tracing, isolation, and a new vaccine, but it cannot be “eradicated.” No one is quite sure why SARS has never reemerged from an animal reservoir, but this coronavirus could well follow a different pattern.
- In the best-case scenario, a vaccine and better treatments blunt C19’s severity, making it a much less dangerous and less disruptive disease. Over time, the coronavirus becomes just another seasonal respiratory virus, like the four other coronaviruses that cause a sizable proportion of common colds: 229E, OC43, NL63, and HKU1. These cold coronaviruses are so common that we have likely all had them at some point, maybe even multiple times. They can cause serious outbreaks, especially in the elderly, but are usually mild enough to fly under the radar. One endgame is that SARS-CoV-2 becomes the fifth coronavirus that regularly circulates among humans.
- In fact, virologists have wondered whether the common-cold coronaviruses also got their start as a pandemic, before settling in as routine viruses. In 2005, biologists in Belgium studied mutations in the cold coronavirus OC43, which likely evolved from a closely related coronavirus that infects cows. Because genetic mutations accumulate at a somewhat regular rate, the researchers were able to date the spillover from cows into humans to the late 1800s. Around this time, a highly infectious respiratory disease was killing cows, and even more curiously, in 1889, a human pandemic began killing people around the world. The older people were, the more susceptible they were. This illness, which produced “malaise, fever, and pronounced central nervous system symptoms,” was linked to influenza based on the antibodies found in survivors half a century later. But the cause was never definitively proved from tissue samples.
- Could it have been a coronavirus that jumped from cows to humans? This is all speculative, and the possible links between the other three cold coronaviruses and past pandemics are even less clear, says Burtram Fielding, a coronavirus researcher at the University of the Western Cape. “But,” he says, “I wouldn’t be surprised.” It would also be good news, in a way, because it would suggest that C19 could become less deadly over time, making that transition from pandemic to common cold.
- With a virus, there is a general trade-off between how contagious it is and how deadly it is. SARS and SARS-CoV-2 are illustrative points of comparison: The earlier virus killed a much higher proportion of patients, but it also did not spread as easily. And what a virus ultimately wants to do is keep spreading, which is much easier to do from a live, walking host than a dead one. “In the grand scheme of things, you know, a dead host doesn’t help the virus,” says Vineet Menachery, a coronavirus researcher at the University of Texas Medical Branch. The other four coronaviruses may also be less deadly because we have all encountered them as children, and even if our immunity does not prevent us from getting them again, it may still prevent severe disease. All of this, along with immunity from vaccines, means that C19 is likely to become far less disruptive down the line.
- Influenza might be another useful point of comparison. The “flu” is not one virus but actually several different strains that circulate seasonally. After pandemics like 2009’s H1N1 flu, also known as swine flu, the pandemic strain does not simply disappear. Instead, it turns into a seasonal flu strain that circulates all year but peaks during the winter. A descendent of the 2009 H1N1 pandemic strain is still the seasonal flu today. The seasonal peaks never quite reach pandemic heights because of building immunity in the population. Eventually, a new strain, against which people have no immunity, comes along and sparks a new pandemic, and then it becomes the new dominant seasonal strain.
- In this way, the long-term outlook for C19 might offer some hope for a return to normal. “I think this virus is with us to the future,” Ruth Karron, a vaccine researcher at Johns Hopkins, told me. “But so is influenza with us, and for the most part, flu doesn’t shut down our societies. We manage it.”
2. The Media Said Europe “Beat Back” COVID, But Lockdowns Loom Again
- In recent days governments in Australia, Europe, and the US have moved toward imposing a new wave of forced lockdowns in the name of fighting the spread of C19. Australia has imposed harsh new lockdown measures, including a curfew from 8 pm to 5 am. CNN reports:
- Those restrictions include a curfew in Melbourne for the next six weeks, a ban on wedding gatherings, and schools must go back to online classes. … Only one person per household is allowed to leave their homes once a day — outside of curfew hours — to pick up essential goods, and they must stay within a 5 kilometer (3.1 miles) radius of their home.
- Meanwhile in Europe, Belgium is threatening a “total lockdown” even as it tightens other measures, which now means “a family or those living together can meet only the same five people from outside their household over the next four weeks.” (Belgium has been in a state of lockdown in all but name for months, since even until the most recent restrictions, an individual was allowed to meet in person with only 15 different people per week.)
- Other regions of Europe are discussing similar measures. The Guardian reports:
- Europe is bracing for a second wave of coronavirus as continuing outbreaks raise the prospect of reimposed restrictions.
- [T]he Spanish region of Catalonia may also have to reintroduce lockdown measures if outbreaks are not brought under control within 10 days.
- In France, the health minister has called for greater vigilance after a sharp rise in C19 cases in young people, and Germany’s public health advisory body has said it is “deeply concerned” about the rise in cases over the past few weeks.
- Serbia and surrounding countries are announcing new restrictions and regional shutdowns as cases reach new all-time highs.
- With these new restrictions will come more economic devastation, more unemployment, more suicide, more drug overdoses, and more cancer death.
- This cycle is likely to repeat itself because lockdowns do not make diseases go away. They only— assuming the theory behind the lockdown is actually true— spread out infections into the future.
- Consequently, it increasingly looks like the global public should expect regimes to keep locking down their citizens again and again. The only possible end to this cycle will be if (a) populations revolt against lockdowns, or (b) herd immunity is reached either through widespread transmission or through a vaccine.
- The preferred course of action on the part of the experts and politicians is clear: lockdown forever, or until there’s a vaccine.
The “Successful” First Round of Lockdowns
- Yet just a few weeks ago, though, we were hearing about what success stories lockdowns were in Europe and Australia. A commonly used phrase in the media has been that European regimes have “beat back” the virus.
- The actual outcomes were apparently immaterial, so long as lockdowns are imposed. It seemed that by definition, a country that employed a lockdown strategy is successful. This is perhaps the only possible explanation for why some experts have ridiculously asserted Italy—among the worst countries in the world in terms of deaths attributed to COVID— “beat” the disease with lockdowns.
- The implication of all these declarations of “victory” was that if sufficiently harsh lockdowns were adopted, then C19 would be under control.
- Some even insisted that lockdowns could make the disease disappear. Australian health bureaucrats, for example, suggested that lockdowns could cause the disease to be eliminated entirely. This Australian report claims “it is expected that the virus would die out within Australia” if extreme social distancing mandates are maintained for “months.” Another “expert” proclaimed in June: ““Having brought the case numbers right down [in Australia], we may not need lockdowns again.”
- But if we employ the logic of the advocates of lockdowns themselves, there has never been any reason to presume that lockdowns can “beat back” a disease or eliminate it.
The Logic of Lockdowns, As Stated by Advocates
- The claim that forced lockdowns lead to fewer deaths has always been debatable. Some countries with harsh lockdowns, like Spain and the UK, have worse per capita death totals than countries and jurisdictions with no mandatory lockdowns, such as Sweden in Europe, and Utah and Iowa in the US.
- But for the sake of argument, let’s accept that lockdowns do help to slow—i.e., not prevent—the transmission of disease. (We’ll ignore, for now, the deaths caused by lockdowns themselves.)
- The logic therefore is this: a slowing of transmission prevents hospital resources from being overwhelmed. This, it is assumed a certain minimum level of quality can be maintained at medical institutions with the help of lockdowns. Thus, the best that can be hoped for is that some lives will be saved by ensuring hospital beds will continue to be available. But, over time, the total number of infections is the same because lockdowns do nothing to actually eliminate the disease.
- Consequently, the number of lives saved is only the number of lives that would have been lost due to a lack of adequate hospital resources.
- In the United States, this has, so far, been accomplished. No health system has yet been overwhelmed, and no hospital system has run out of ventilators. Any lives that might have been lost due to a lack of hospital beds have been preserved, whether through luck, lockdowns, or unknown circumstances.
- But how many lives exactly have been saved, and exactly how many hospital systems would have been overwhelmed without mandated lockdowns? This is unknown and cannot be known because any number proffered for total “lives saved” requires counterfactuals.
- The idea that “millions of lives” have been saved by lockdowns in the US and Europe is pure theater.
- Moreover, any benefit that can be gained from lockdowns must be compared against increases of “deaths of despair,” increased child abuse, and deaths due to neglected medical conditions as a result of lockdown policies. And then, of course, there is the fact lockdowns constitute human rights violations against the basic right to seek employment and income.
From “Flatten the Curve” to “Lockdowns Until Vaccine”
- That lockdowns bring economic, social, and psychological devastation has long been obvious to more astute observers. This is why the lockdown strategy was at first sold to the public as a strictly temporary and limited option.
- During the early days of the C19 panic, politicians and technocrats justified the lockdowns on the rationale “15 days to slow the spread.” But then the rationale changed. We saw this shift begin to take shape in early April when, for example, US health bureaucrat Anthony Fauci claimed it would be impossible to even “relax” mandatory social distancing until there were “essentially no new cases, no deaths for a period of time.” Former presidential advisor Ezekiel Emanuel insisted “The truth is we have no choice.” but to remain locked down for “for the next 18 months or more.”
- Since then, it has become increasingly clear the preferred policy of the health technocracy is one of permanent lockdown. Both inside the US and outside, we have repeatedly heard that, worldwide, “normalcy may not be possible before a vaccine is widely available.“
What If There’s No Vaccine Coming?
- But what if there’s no vaccine right around the corner?
- Earlier this week, WHO Director-General Tedros Adhanom Ghebreyesus said during a press conference from the agency’s Geneva headquarters. “However, there is no silver bullet at the moment and there might never be.” British PM Boris Johnson has admitted a vaccine is “by no means guaranteed.” Given the history of failed attempts at creating vaccines for coronaviruses, there’s no reason to assume this coronavirus will have a vaccine in 2020, or 2021, or even beyond.
- Many politicians and health bureaucrats are acting as if there are only two options available: world-ending plague and endless lockdown.
- Unfortunately for the experts, we’ve already seen the likely scenario that results from a policy of no mandatory lockdown: The case of Sweden.
- Sweden’s total per capita death toll is by no means presently among the lowest. But Sweden has always maintained that over the long term, the total per capital death toll of C19 will be similar across countries regardless of their lockdown policies. Even now, Sweden’s death toll is better than that of the UK, Belgium, Spain, and Italy, all of which have enacted draconian lockdowns.
- In fact, the Swedish model looks increasingly prescient as time goes on. While the rest of Europe is talking about surges in cases and new lockdowns, the number of Swedish case continues to decline, while total ICU hospitalizations have plummeted.
- Meanwhile, Sweden was the only “the only major economy to grow in the first quarter of the year” while most of Europe was in economic disarray.
1. Can C19 apps and wearables benefit patients?
- With C19 cases again climbing, health tech companies and researchers are renewing their pitch for wearables and apps as a cutting-edge way to catch new cases and detect when patients are growing sicker.
- The flood of tech tools — and the marketing machinery playing up their potential — promises to give users more timely information and fill key gaps in testing and tracing cases. But it is not altogether certain that these devices will benefit patients. It’s not just a basic question of whether a device or algorithm is accurate, health technology experts say, but whether the information provided is actually helpful in delivering better care or stemming the spread of the virus.
- It is easy to take an off-the-shelf monitoring device, slap a C19 label on it, and tell the world the device can be used to help lift us out of a public health crisis. It is far more difficult to ensure the product can home in on the unique signature of this virus and improve outcomes for patients, especially when it affects people so differently.
- “I can tell you for a given system, it may be 80% accurate. But for me to show you it made someone’s care better is actually much harder to accomplish,” said Karandeep Singh, a physician and professor at the University of Michigan who studies the use of technology in health care.
- But in certain clinical settings and populations, apps and wearables might be able to provide significant assistance during the pandemic, experts said. Here are a few questions to ask when trying to differentiate between empty promises and valuable tools.
Is it providing information specific to C19?
- Plenty of apps designed to monitor vital signs can accurately detect a fever and changes in respiration, but that’s not the same thing as correctly diagnosing C19.
- “That kind of app is not going to be nearly specific enough,” said Singh. “We’re heading into flu season. You can’t tell apart flu from cold from anything else.”
- John A. Rogers, a biomedical engineer at Northwestern University, has spent months trying to tackle this problem with a wearable he developed for the university’s health system in Chicago. It is a Band-Aid-sized patch that attaches to the user’s throat to help monitor coughing and respiratory symptoms, such as shortness of breath.
- One of the planned uses was to monitor signs of possible infection of frontline health care workers. So far, however, none of the health workers who have tested the device with Northwestern’s health system has become sick. It’s not clear whether none has contracted the virus, or whether some did but were asymptomatic, which points to a challenge facing any tech tool designed to track C19 symptoms.
- “You have to have some type of symptoms in order for us to pick anything up,” Rogers said. “If you’re completely asymptomatic we’re not going to be able to see it. This is not a molecular scale test.”
- That’s not to say it can’t be helpful for other purposes. The wearable, which is experimental and has not been approved by regulators, is also being used to monitor symptoms in hospitalized patients. In one case, Rogers said, it flagged periods where a patient was experiencing a dangerous heart arrhythmia. It also picked up respiratory interruptions at night, helping providers spot signs of sleep apnea.
- “It turned out to be pretty severe and we could see it pretty clearly,” Rogers said.
- He said the impact of the wearable is still being evaluated and that his partners at the Shirley Ryan Ability Lab are seeking to develop an AI model that would use the data to help predict infections from symptom data.
Is the product targeted toward a particular population?
- A major shortcoming of most wearables is that they are deployed in populations with very low risk of developing the problem they are designed to detect. The Apple Watch, for example, is often used by young, healthy people unlikely to benefit from its ability to detect the heart arrhythmia known as atrial fibrillation.
- In C19, that means many symptom tracking apps meant to flag the onset of illness in broad populations are likely to flag perceived problems that don’t amount to much. This results in a low positive predictive value, or the probability that a subject who tests positive truly has the illness.
- “It’s going to be crying wolf a lot,” Singh said. He said that’s a significant drawback in a health care system trying to contend with a pandemic.
- “With any of these apps, if you identify a problem, usually that problem results in a connection to the health care system, which has a time and a cost value to it. We don’t have unlimited resources,” he added.
- However, the problem of false positives is mitigated in higher-risk populations, such as people who live in nursing homes or whose immune systems are compromised. In those defined user groups, it is helpful to provide caregivers with alerts about sudden changes in vital signs or a fever, because those are more likely to be associated with medical emergencies.
Will having the information support better care?
- Apps and wearables can collect massive amounts of biological data from patients. But that doesn’t mean the information is going to be helpful to doctors who are trying to treat them.
- A C19 symptom tracker developed earlier this year by researchers at King’s College London, Harvard University and Stanford compiled symptoms reported by more than 2.6 million people, such as fever, cough, shortness of breath, and loss of taste and smell.
- While the researchers are hopeful that the smartphone app can help inform individuals of their risks, and potentially flag infection hot spots, they are not arguing that it would significantly improve the care of infected patients.
- That’s because it’s not clear that providing that information, through this app or another, will help doctors triage patients or change the way they are treating them.
- “That’s something that remains to be seen,” said Andrew Chan, a Harvard professor who helped develop the app. “There’s a lot of hope this approach could be used in the setting of Covid because it is so highly infectious and there is a need to keep distance between patients and providers.”
- But so far, there is no evidence that apps or wearables used to collect biological information on C19 patients is improving their care. Singh said proving a positive effect on care is likely to take years, even in the case of products that have demonstrated an ability to accurately measure changes in symptoms and predict a patient’s deterioration.
- “This is all experimental,” he said. “Studying the impact of a technology like this takes a ton more time than studying the validity of a technology.”
J. Practical & Other Useful Information
1. A CEO has flown 33 times and spent 160 nights away this year. Here’s his safety routine
- Mika Manninen has been on the road for approximately 75% of 2020.
- As the CEO and co-founder of dairy-free yogurt brand Hälsa Foods, the Finnish native who now resides in Palm Beach, Florida, has taken 33 flights (including four abroad) and spent 160 nights in hotels in cities such as Los Angeles, Chicago, New York, Seattle, London and Helsinki. Since the beginning of March — while much of the rest of the world has been sheltering at home — Manninen has spent nine days in his own house.
- Manninen is an essential worker — one of 11.3 million people who are employed in the U.S. food and agriculture industry. As the only person in his company who travels (so that other employees don’t have to), he maintains he has followed quarantine rules “to the hilt” and has quarantined in hotel rooms for 14 days when required.
- “There are several trips I did not do, some I deemed too risky, and with others, we could not figure out the rules,” he said.
- For the business trips he did take, Manninen relies on a strict safety routine when on the road.
At the hotel
- “When I check into my room, I clean every surface with wipes — all door handles, light switches, the remote control and the phone. In the bathroom, I also wipe down the showerhead. I’m 6 feet 2 inches, and I always end up adjusting it.”
- “If I stay for multiple nights, I only let the cleaning service into the room every fourth day. Once I have cleaned the room for myself, letting someone else come in only forces me to clean the whole place again. I leave trash and dirty towels outside the door and get fresh towels in return.”
- “Now that various states have gone back into lockdown mode, some hotels may require a letter stating that you’re an essential worker before they allow you to check-in, so keep one ready.”
At the airport
- Manninen says he worries less about being infected on airplanes but that the airport “is a different story.”
- “When I enter the airport, I wear multiple layers of disposable gloves, and I peel them off as I go through it. Trams, escalators — peel a layer, check-in, use a kiosk with a touch screen — peel a layer, TSA security check — peel a layer. I did not realize how many surfaces I actually touch until I started paying attention to it.”
- “Keep the distance. Sit in the corner alone. Do not buy anything: no food and no drinks. If you buy water, wipe the bottle with antiseptic wipes.”
- “Don’t use your phone app as a ticket; use a paper ticket instead. Hundreds of passengers scan their phones, and many lay them flat on the glass.”
- “Find a non-crowded bathroom in the airport (avoid the bathroom in the plane). I swap my mask every time I use a bathroom.”
On the plane
- Aircraft cabins undergo a “total change” of air between 20 to 30 times per hour and modern aircraft recycle up to 50% of cabin air through high efficiency particulate air (HEPA) filters which trap bacteria, fungi and viruses, according to WHO’s website.
- For this reason, Manninen is more concerned about surface contact in airplanes.
- “Wipe all surfaces at your seat, including the seat belt, belt buckle, headrest, window shades and the air and light adjusters above your head.”
- “I expose the least amount of skin as possible. Funny, the only time I wear collared shirts is on the airplane, just to cover my neck. I don’t let my skin touch any surfaces.”
- “Change your mask every four hours; it’s safer and oddly gives you a feeling of freshening up.”
- “Bring extra masks; last week I tried to drink water with my mask on. Needless to say, I had to change it.”
In a rental car
- Manninen has rented a car 22 times this year.
- “Spend 10 minutes cleaning it up before driving off. I use sanitizing wipes to clean every surface I might touch, including the steering wheel, seat belt, key fob, seat adjusters, rearview mirror and steering column adjuster. I assume the rental car is my own little domain after that.”
- “When I exit the car, I put gloves on and when I come back, I dispose of them. I try to keep all germs outside.”
The kicker: This routine isn’t new
- Manninen said he developed this routine over a decade ago to avoid the common flu, which sickened him around five times a year due to his travel schedule.
- Wearing a mask and gloves is new though, as is others’ reactions to his cleaning routine.
- “The only difference now is that I don’t get ‘the dude is paranoid’ dirty looks nearly as much,” he said. “But I figured that if by following this regime I can keep myself healthy, I will help keep us all healthy, so it’s worth the extra effort.”
Is a strict cleaning routine a cure-all?
- To date, Manninen has been tested twice and remains virus-free. Still, he has encountered ridicule and fear from others.
- “When flying to Europe in late February… I was going through my routine cleaning of my seat and two guys across the aisle were staring at me,” he said. “One said ‘We should probably do the same. Might be smart right now.’ The other one looked at me and said “Dumhuvud” which is Swedish for dumbass.”
- His father in Scandinavia, who Manninen described as a “super smart healthy guy,” refused to meet with him, even through a glass window, because “I was coming from the U.S. where the virus is not taken seriously.” As a dual citizen of Finland and the U.S., Manninen is not subject to the EU’s current travel ban on American travelers.
- Manninen has been nicknamed “El Diablo Covid” by several coworkers. He has been repeatedly told to stand outside or back away from others and feels “poisonous” at times.
- “When I come home, I can’t hug my wife, and I have to stay on the other side of the house,” he said.
- A low point came in New York while he was driving late at night in the rain beside a long line of ambulances with sirens blaring and lights flashing “like a scene from an end-of-the-world movie.”
- While his travel rituals have protected him to date, Manninen admits he too is scared at times.
- “It would be insane not to be afraid,” he said.
K. Johns Hopkins COVID-19 Update
August 5, 2020
1. Cases & Trends
- The WHO C19 Situation Report for August 4 reports 18.1 million cases (219,862 new) and 691,013 deaths (4,278 new). The WHO data indicates that the global daily incidence could potentially be approaching a peak or plateau.
- Brazil reported only 16,641 new cases on August 3, its lowest daily incidence since June 8, but yesterday, it reported more than 51,000 new cases. This is nowhere near its record high (69,074 new cases), but it is much more consistent with its recent trend. Brazil remains #3 globally in terms of daily incidence and continues to fall further behind India.
Central & South America
- Broadly, the Central and South American region remains a major C19 hotspot. Colombia reported 7,129 new cases, its lowest daily incidence since July 22. Columbia remains #4 globally in terms of daily incidence. Mexico is reporting an average daily incidence of 6,752 new cases per day, and it remains #6 globally in terms of daily incidence. Including Brazil, Colombia, and Mexico, the Central and South American region represents 5 of the top 10 countries globally in terms of daily incidence, along with Peru (#7) and Argentina (#8), and multiple other countries in the region are reporting more than 1,000 new cases per day. Additionally, the region includes 6 of the top 10 countries in terms of per capita daily incidence—Panama (#2), Brazil (#3), Peru (#4), Colombia (#5), the US (#7), and Bolivia (#10)—and numerous other countries are reporting more than 100 new daily cases per million population.
India & Bangladesh
- India continues to report daily incidence in excess of 50,000 new cases per day, but the daily totals have remained relatively consistent over the past week. India remains #2 globally in terms of daily incidence. With the US daily incidence continuing to decrease and India’s leveling off, India could potentially surpass the US for #1 globally in the next week or so. Following several days of low daily incidence, Bangladesh reported 2,654 new cases, consistent with its expected trend. Bangladesh’s test positivity fell from a spike of 32% on August 2 to 24% today.
- The Philippines’ daily incidence continues to surge rapidly, climbing to more than 4,000 new cases per day—more than doubling since July 30. The Philippines remains #10 in terms of daily incidence, but it is on a trajectory to climb higher in the coming days.
- South Africa reported 4,456 new cases and remains among the top countries globally in terms of both per capita (#9) and total daily incidence (#5). Additionally, South Africa remains #5 globally in terms of cumulative incidence.
- Bahrain (#6) is the only country in the Eastern Mediterranean region remaining in the global top 10 in terms of per capita daily incidence, and Kuwait is the only other country in the region reporting more than 100 new daily cases per million population. Nearby Israel (#8), in the WHO’s European region, remains among the top countries globally as well.
Maldives & Montenegro
- The Maldives climbed to #1 globally in terms of per capita daily incidence, with nearly 250 new cases per day per million population. Montenegro fell out of the #10 in terms of per capita daily incidence.
- The US CDC reported 4.70 million total cases (49,715 new) and 155,204 deaths (733 new). This is the second consecutive day that the CDC reported fewer than 1,000 deaths, but this is due, in part, to delays in weekend reporting. We expect the daily mortality to increase as the week progresses. According to the CDC data, 13 states are reporting more than 100,000 cases, including California with more than 500,000; Florida with more than 475,000; and New York and Texas with more than 400,000. The Florida Department of Health is currently reporting more than 500,000 cumulative cases, so we expect this to be reflected in the CDC data in the next day or two. The US remains #7 in terms of per capita daily incidence and #1 in terms of total daily incidence.
- The Johns Hopkins CSSE dashboard reported 4.79 million US cases and 157,186 deaths as of 12:30pm on August 5.
2. Long-Term Health Effects
- Clinicians and researchers continue to investigate potential lingering health effects after C19 patients recover from the acute stage of the disease. Science published an overview of several recent studies and anecdotes from C19 survivors that address long-term health effects associated with C19. Much of the early research on C19 focused on addressing treatment for acute C19 symptoms, particularly severe and life-threatening disease, but as the pandemic continues and more patients recover, longitudinal studies are tracking patients after their recovery to identify conditions and symptoms that could last for months or longer.
- C19 patients often experience respiratory symptoms, so it is not surprising that some of these longer-term conditions are linked to respiratory function; however, SARS-CoV-2 appears to be capable of infecting a broad range of tissues. Some of the documented conditions include “brain fog,” which impairs individuals’ cognitive function; respiratory symptoms, including shortness of breath; and cardiological symptoms, such as heart arrhythmia and hypertension. Long-term symptoms vary both in terms of severity and the tissues or systems affected. The symptoms are mild or non-existent in some patients, but they can be severe in others, making it difficult or impossible for them to return to normal activity. Long-term health effects have been documented for many diseases, including those associated with viral infections, but it will take time to better characterize the full scope of effects from SARS-CoV-2.
- In some studies, more than 70 or 80% of patients—including the full spectrum of acute disease severity, from mild to severe cases—experience lingering health effects after their initial recovery. At this time, there does not appear to be a direct correlation between the severity of the acute and chronic symptoms. Beyond the direct health impact for individuals, long-term conditions could hinder the ability of some C19 patients to resume normal levels of activity, which could have long-term effects on societal and economic recovery as well.
3. Italy Seroprevalence Survey
- Italy published preliminary results from a national seroprevalence survey. The survey initially aimed to include more than 1 million participants, but the preliminary report includes 64,600 individuals whose results were available by July 27. The serological tests used for this study were CLIA or ELISA kits designed to detect IgG neutralizing antibodies for SARS-CoV-2 (sensitivity of 90% and specificity of 95%). This study estimates that Italy’s overall C19 seroprevalence is 2.5%, with the highest seroprevalence in the Lombardy region at 7.5%. The Lombardy region represents more than 50% of Italy’s C19 incidence. Additionally, the study estimates seroprevalence stratified by age group. The lowest estimated seroprevalence was among individuals aged 18-34 years (2.1%), and the highest was among those aged 50-59 years (3.1%). The analysis identified high levels of transmission among family units. Among seropositive individuals, 41.7% lived with someone else who was also infected. Notably, 27.3% of individuals with detectable antibodies reported never experiencing any symptoms, which indicates a relatively high level of asymptomatic infection.
4. Israeli Schools
- As schools in the US and elsewhere plan and implement protocols for reopening schools, Israel’s experience could provide insight into some of the operational challenges and risks associated with in-person classes in the midst of a C19 epidemic. Israel was one of the first countries to reopen schools on a large scale for in-person classes. As Israel began to bring its C19 epidemic under control the government permitted schools to resume in-person classes in May. At that time, Israel was reporting fewer than 50 new cases per day. Almost immediately, SARS-CoV-2 transmission was reported in schools, including one of the largest outbreaks at a single school anywhere in the world. The virus quickly spread in the community as well, sparking a “second wave” of transmission that was 3 times as bad as its first. With the exception of the first weeks of students resuming in-person classes, it does not appear that Israel implemented any consistent physical distancing or other risk mitigation protocols as students nationwide returned to school, which provided ideal conditions for rapid transmission. Furthermore, a heat wave drove some schools to exempt students from wearing masks and close classroom windows in order to use air conditioning. Ultimately, Israel’s Ministry of Education “closed more than 240 schools and quarantined more than 22,520 teachers and students.”
- The Philippines has reported one of the world’s most severe C19 surges over the past week. The national average daily incidence increased from 1,888 new cases per day on July 30 to 4,131 today, including a daily record of 6,263 new cases reported yesterday. Reportedly, some hospitals have been forced to turn away patients due to a lack of available capacity, and “80 medical associations…called on President Rodrigo Duterte to toughen restrictions” in order to contain the surge in transmission. The organization represents more than 1 million healthcare workers nationwide. The Philippines has reported more than 115,000 cases and 2,100 deaths nationwide, and there are currently more than 47,000 active cases.
- As a result of ongoing surge, President Duterte re-instituted “modified enhanced community quarantine” (MECQ; the Philippines’ version of “lockdown”) in severely affected parts of the country, including the National Capital Region. The MECQ began yesterday and is scheduled to continue through August 18. In conjunction with the MECQ, the Philippines government is also implementing enhanced contact tracing and testing, including a pilot program for pooled testing (ie, combining multiple specimens and testing the pooled sample with a single test), as well as expanding hospital and isolation capacity, with the aim of increasing the number of hospital beds by 40-50%.
- Some critics of President Duterte have drawn parallels between his militaristic response to the drug trade and the pandemic response. As part of the national government’s response to the current surge, President Duterte announced that he will mobilize “military reservists” and the Philippines National Police to combat the C19 epidemic. While the use of military and law enforcement resources is aimed at supporting response activities, including clinical patient care, analysis published by The Washington Post identified approximately 76,000 arrests associated with lockdown violations between March and July. Additionally, the report indicates that government officials forcefully removed suspected C19 cases from their homes and placed them in government-operated quarantine facilities, sometimes based on tips provided by neighbors. Some of these tactics echo those utilized in President Duterte’s “drug war.”
- The Philippines government is also coordinating with the UN and international non-governmental organizations (NGOs) to implement humanitarian response operations. The effort will involve approximately 50 UN and NGO partners, which will work to implement a variety of response activities, including ensuring access to healthcare services, food and water, and proper sanitation. The program is projected to cost US$122 million and scheduled to continue throughout 2020, the “largest response” since the Typhoon Haiyan/Yolanda in the Philippines in 2013.