“We’re going to lose anywhere from 75, 80 to 100,000 people. That’s a horrible thing. We shouldn’t lose one person over this.”
— President Trump
“I think if we are to reach a new normal, Sweden represents a model if we wish to get back to a society in which we don’t have lockdowns.” — Dr. Michael Ryan, WHO head of emergency management
“We have a public health crisis in this country, there’s no doubt about it. But we also have an economic crisis. And we’re doing everything in our power to get our state back open as soon as possible.” — Mississippi Governor Tate Reeves
- Recent Developments and Headlines
- Numbers and Trends
- Potential Treatments
- Antibody Testing – New Test may be “absolute game changer”
- New Scientific Findings
- Planning for the Unknown
- Lessons From Abroad
- The Road Back?
- Balancing Act
- Projections & Our (Possible) Future
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A. Recent Developments and Headlines
Note: All changes noted in this Update are since the 5/3 Update
Sources: New York Times Coronavirus Updates, New York Post Coronavirus Updates, Zero Hedge Coronavirus Updates, Drudge, Breitbart, Wall Street Journal, Coronavirus White House Task Force Briefing, NY Governor Daily Briefing, and Worldometers
- Texas starts reopening
- New York sees first rebound in deaths since April 25th
- 12.3% of New York state tested positive for COVID-19 antibodies
- Kroger Begins Limiting Purchases On Ground Beef And Pork In Some Stores
- Russia reports 4th straight record new cases
- Spain sees lowest deaths since March 18
- Moscow Mayor warns 2% of city likely already infected
- Niger reports polio outbreak as vaccinations halted
- France’s controversial ‘StopCovid’ app nearly ready
- Italy sees 76% surge in new COVID-19 deaths
- Spain allows outdoor exercise
- Russia adds record 10,000 coronavirus cases in dramatic turnaround as Putin’s problems stack up
- Video shows Mexican hospitals hiding bodies of COVID-19 patients as hallways packed with the sick
- France extends state of emergency order until July 24
- Singapore eases some lockdown measures as domestic cases decline
- Japan joins US in fast-tracking remdesivir
- Michigan Governor extends lockdown
- Japan sending Avigan to 43 countries for clinical trials
- CDC reports 4,913 cases among meat plant workers
- NY schools to remain closed for rest of academic year
- Italy sports teams can start training May 18
- NYC Mayor says city not yet ready to reopen
- 1 in 5 working-age Americans filed for unemployment benefits
- Dr. Fauci warns states against “leapfrogging”
- Left-wing demonstrators from Greece to Germany flout social distancing rules for “May Day” rallies
- UK warns that defective ventilators from China could kill patients
- NYPD Dispatches 1,000 Cops To Stop New Yorkers From Barbecuing On Saturday
- Austrian Cops May Intervene if They See People Kissing
- Don’t Expect Answers From Washington As The Fabric Of Society Unravels
- Massachusetts Walmart Ravaged By COVID, 21% Of Employees Infected, Store Closed
- Saudi Officials Say Whopping 70% Of Mecca’s Population Likely Infected With COVID-19
- Get Ready For Slaughterhouse Robots To Ease America’s Meat Processing Crisis
- Spain to Introduce Mandatory Mask Wearing on Public Transport
- Iran to Reopen ‘Low-Risk’ Mosques as Coronavirus Lockdown Eases
- Albanian Doctors Fighting Coronavirus in Italy Fined for Throwing Party
- Several Maine Restaurants Reopen Despite Democrat Guv Order
- California Cafe Defies Shelter-in-Place Orders
- More Chinese Dare to Speak Out Against Commie Cover Up
- Hassett: ‘Probably’ by End of Month, ‘Almost Every State Will Be Mostly Open’
- Spain Eases Lockdown
- France Extends Emergency to July 24
- Most Britons Still Too Scared to Leave Home
- Pink: Maybe We Should Protest Anti-Lockdown Protesters
- UK Border Officials Ordered Not to Routinely Wear Masks
- Buffett: ‘American Magic’ Will Spur Economic Recovery
- Alarm bells ring over blood testing results for C19 antibodies
- Most States fall short of coronavirus thresholds
- New York Gov. Cuomo warns against ‘blindly’ reopening states
- NYPD: ‘We Are Past The Point Of Warnings’ When It Comes To Social Distancing
- New Jersey on Alert for ‘Knucklehead’ Actions Slowing Reboot
- Boaters line up for hours at Miami marina
- Crowds gather to buy new Air Jordans in Atlanta after lockdown lifted
- Arizona sheriffs say they won’t enforce governor’s stay-at-home order
- Some U.S. Coronavirus Curbs Ease, as Cases Rise at Slower Rate
- Angry Undergrads Are Suing Colleges for Billions in Refunds
- Texas strip club says it can reopen as restaurant – with food, masks and no lap dances
- Teledildonics soar as lockdown lovers ‘have sex over the internet’
- As Nevada looks to reopen, the state’s sex industry is scrambling to figure out how to reduce risk during, um, “close-contact work”
- What happens if a coronavirus vaccine is never developed? It has happened before
- ‘Armageddon in Atlantic City’: casino town facing ruin again
- Phoning it in: Pandemic forces Supreme Court to hear cases in a new way
- Coronavirus Masks Are the New Concert T-shirts
- Bird-watching soars amid C19 as Americans head outdoors
- Telemedicine key to US health care even after pandemic ends
- Man arrested trying to quarantine on private Disney island
- Dozens of summonses issued over social-distancing violations in NYC parks
- Oklahoma city ends face mask rule for customers after threats of violence
- Ohio Gov. Mike DeWine says his face-mask order went ‘too far’
- Honeymooners arrested in Hawaii after violating mandatory quarantine
- Birx calls protesters without masks ‘devastatingly worrisome’
- Connecticut forced to close parks as crowds flock to enjoy spring weather
- Michigan has highest coronavirus fatality rate in US as protests continue
- Texas park ranger pushed into lake while trying to enforce social distance regulations
- FDNY orders ambulance workers to snitch on social-distancing scofflaws
- NYC mayor de Blasio is using coronavirus as excuse to empty NYC jails at public’s expense
- Funeral home ‘ripped off’ coronavirus victim’s prepaid lavish send-off, family says
- Texas strip club wins temporary court order allowing it to open with restaurants
- Coronavirus Tales: I left my family and home so I could walk to work in NYC
- Reality of the devastating mental health toll on coronavirus frontline workers
- Four NYC hotels meant for recovering coronavirus patients nearly empty
- Some Georgia restaurant owners refuse to reopen as coronavirus lockdown ends
- NY’s coronavirus death toll jumps as Gov. Cuomo warns it’s ‘obnoxiously high’
- Virtual sextortion surging as more men stay home during coronavirus lockdowns
- CDC official says US reacted too slowly to curb coronavirus
- Broadway star who lost leg to coronavirus taken off ventilator
- Denmark introduces ‘drive-in concerts’ during coronavirus pandemic
- Coronavirus surge in Brazil brings coffin shortage, hastily dug trenches
- Even ritzy Gramercy Park not immune from mask order, trustees say
- Coronavirus will cost sports at least $12 billion
- Protesters gather to demand the opening of California beaches
- American Airlines keeps NYC crews grounded amid coronavirus pandemic
- South Carolina governor says stay at home order will end next week
- Broadway theater producers working with Gov. Cuomo on re-opening process
- Nearly 5,000 meat plant workers have coronavirus, CDC says
- NYPD adding forces to target social distancing offenders this weekend
- These glasses let you ‘see’ people’s temperatures
- 42% of Americans in relationships have downloaded a dating app since the start of C19
- Robots ready to greet Japanese coronavirus patients in hotels
- NYC mayor De Blasio says coronavirus numbers trending down — but not enough to reopen
- UN chief laments lack of global leadership in fight against coronavirus
- More countries join Trump in call for probe of China, WHO over coronavirus
- French president tells country life won’t return to normal after lockdown lifted
- Seven miles of pedestrian, bicycle-only streets to open Monday, NYC mayor de Blasio says
- Javits Center hospital to close after treating nearly 1,100 patients
- Brazil’s president says he refuses to follow the WHO’s coronavirus guidelines because it promotes “masturbation” in kids under four.
- France paying for people to get their bikes fixed to boost cycling post-lockdown
- White House reportedly plans to punish China for coronavirus pandemic
- Dr. Birx: ‘We Underestimated Very Early On The Number Of Asymptomatic Cases’
- Apple Data Shows Shelter-In-Place Is Ending, Whether Governments Want It To Or Not
- New Mexico Governor Closes Roads to Coronavirus Hotspot
- NY Gov. Cuomo Had the Worst Response to the Crisis of Any Governor in America
- Precautions are still needed, even at protests against precautions, Dr. Birx says
- A Covid-19 vaccine may be something you get annually, an Oxford scientist says
- Mike Pompeo says there is ‘enormous evidence’ tying the virus outbreak to a lab in China.
- In this hospital, bedside concerts comfort coronavirus patients
- Anti-vaccination activists are a growing force at lockdown protests
- A few Texas movie theaters reopened, early experiments in back-to-normal living
- Los Angeles rolled out countywide testing. The website was quickly swamped
- Seven Eastern states will join together to buy vital virus-fighting supplies and equipment
- Thousands of Palestinian workers have crossed into Israel, and there’s fear they could bring the virus home with them
- Beirut’s nightlife survived a civil war. Can it withstand a pandemic?
B. Numbers & Trends
Note: The numbers in this update only include cases that have been (i) confirmed through testing, and (ii) reported. The actual number of cases may be materially higher than confirmed cases, which means that the number of actual deaths from COVID-19 and recoveries may both be materially higher than reported.
1. Confirmed Total Cases and New Cases
- Total Cases = 3,563,689 (+2.4%)
- New Cases = 82,340 (-0.7%) (-536)
- New Cases (5 day avg) = 85,436 (+2.0%) (+1,662)
- Total Cases = 1,447,503 (+1.6%)
- New Cases = 23,139 (-8.6%) (-2,162)
- New Cases (5 day avg) = 24,189 (+1.4%) (+341)
- Total Cases = 558,802 (+2.4%)
- New Cases = 12,992 (+1.3%) (+1,023)
- New Cases (5 day avg) = 12,806 (+2.3%) (+289)
- Total Cases = 1,188,122 (+2.4%)
- New Cases = 27,348 (-8.1%) (-2,396)
- New Cases (5 day avg) = 30,471 (+1.3%) (+388)
- US States & Territories (changes since 5/1):
- 45 States > 1,000 cases (+0)
- 41 States > 2,500 cases (+2), plus DC
- 35 States > 5,000 cases (+6)
- 20 States > 10,000 cases (+0): NY, NJ, MA, IL, CA, PA, MI, FL, LA, CT, TX, GA, MD, OH, IN, CO, WA, VA, TN & NC
- 13 States > 20,000 cases (+0): NY, NJ, MA, IL, CA, PA, MI, FL, LA, CT, TX, GA & MD
- 5 States With Largest Number of Total Cases:
Change in Total Cases (%)
Change in New Cases (#)
|Change in New Cases (%)|
- Top 5 States = 53.5% of Total US Cases (-0.8%)
- NY & NJ = 38.0% of Total US Cases (-1.2%)
- Trends: Top 5 States and NY/NJ percentages of total cases are declining as their average number of new cases continue to decline while new cases in other States are increasing
- For more information on US States and territories, see https://ncov2019.live/data & https://www.worldometers.info/coronavirus/country/us/
2. Serious or Critical Cases
- Worldwide serious or critical cases = 50,040 (-820)
- US serious or critical cases = 16,139 (-336)
- US serious or critical cases = 1.7% of Active Cases compared with worldwide percentage of 2.3%
- Worldwide deaths = 248,146 (+1.4%)
- Worldwide new deaths = 3,483 (-33.2%) (-1,732)
- Europe deaths = 140,603 (+0.9%) (+1,193)
- US deaths = 69,598 (+3.2%)
- US new deaths = 2,145 (+27.4%) (+463)
- NY deaths = 24,648 (+1.2%)
- NY new deaths = 280 (-6.4%) (-19)
- Deaths per 1M population of 5 Countries with Largest Number of Confirmed Cases:
- Spain: 540
- Italy: 478
- UK: 419
- France: 381
- US: 207
- US Total Confirmed Case Fatality Rate = 5.9% compared with a Worldwide Confirmed Case Fatality Rate of 7.0% [Note: The number of cases in which infected people recovered without being tested is believed to be a large number, which would substantially reduce the fatality rate. US health officials have estimated that the US actual fatality rate is 1% or less, but we do not have yet have sufficient data to calculate or estimate the actual fatality rate.]
- Worldwide recoveries = 1,153,847 (+2.9%) (+32,939)
- Worldwide recoveries = 32.4% of Total Worldwide Cases
- US recoveries = 178,263 (+2.9%) (+4,945)
- US recoveries = 15% of Total US Cases (+0.0%)
5. Countries/States Under Review
- Total Cases = 22,317 (+235)
- Deaths = 2,679 (+10)
- Deaths per 1 million population = 204
- Total Cases = 28,671 (+339)
- Deaths = 1,179 (+5)
- Deaths per 1 million population = 114
C. Potential Treatments
1. Researchers Explore Using Common Blood-Plasma Treatment to Fight Coronavirus
- Researchers are investigating whether a common blood-plasma product used in treating immune-system disorders could also be effective in coronavirus patients and potentially shape future trials of new treatments specific to C19.
- Already, some industry experts have raised concerns that new demand for the product, intravenous immunoglobulin, or IVIG, for experimental treatment of C19 patients could lead to shortages for patients with conditions for whom the benefit is proven.
- The immunoglobulin the researchers are focused on is made from antibodies taken from the blood plasma of donors in the general population. These antibodies aren’t expected to specifically target the coronavirus, because there isn’t yet widespread immunity to it.
- The antibodies are believed to help regulate the immune system overall, though, and researchers hope they can tamp down the out-of-control immune response that appears to be the cause of death in many coronavirus patients.
- Some physicians and researchers have given IVIG to C19 patients experimentally, but it doesn’t appear to be in widespread use for that purpose.
- Studies of how C19 patients respond to IVIG could eventually help inform drug companies’ efforts to develop a new product using the plasma of recently recovered patients, which would contain antibodies specific to the coronavirus.
- If proved effective, standard IVIG could offer an immediate new treatment option, because it is already in stock in many hospitals.
- “We want to help now and see what we could do with the product that is readily available,” said Flemming Nielsen, president of the U.S. subsidiary of Switzerland-based Octapharma AG, which is studying whether IVIG can help C19 patients. The company is also working with other manufacturers to make coronavirus-specific immunoglobulin.
- One theory is that antibodies regulate immune response by binding to immune cells and stopping them from releasing cytokines, proteins that help fight infection but that in excess can lead to organ failure and death.
- A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients.
- There is no guarantee off-the-shelf IVIG will be effective for treating C19. Experts caution that it isn’t always clear how the therapy works, even in some diseases for which it is routinely used.
- Immunoglobulin is a versatile medicine used for patients with certain autoimmune disorders as well as rare diseases such as primary immunodeficiency, for whom the antibodies help fight everyday infections.
- Last year, some hospitals and clinics had difficulties getting immunoglobulin due to increased demand and manufacturing issues. The supply of regular plasma is expected to fall because donors are staying at home to stop the spread of the coronavirus.
- “We are just starting to recover from the shortage and this hit,” said Michelle Vogel, vice president of patient advocacy for CSI Pharmacy, a specialty pharmacy.
1. US germ warfare research leads to new early C19 test
- Scientists working for the US military have designed a new C19 test that could potentially identify carriers before they become infectious and spread the disease.
- In what could be a significant breakthrough, project coordinators hope the blood-based test will be able to detect the virus’s presence as early as 24 hours after infection – before people show symptoms and several days before a carrier is considered capable of spreading it to other people. That is also around four days before current tests can detect the virus.
- The test has emerged from a project set up by the US military’s Defense Advanced Research Projects Agency (DARPA) aimed at rapid diagnosis of germ or chemical warfare poisoning. It was hurriedly repurposed when the pandemic broke out and the new test is expected to be put forward for emergency use approval (EUA) by the US Food and Drug Administration (FDA) within a week.
- “The concept fills a diagnostic gap worldwide,” the head of DARPA’s biological technologies office, Dr Brad Ringeisen, told the Guardian, since it should also fill in testing gaps at later stages of the infection. If given FDA approval, he said, it had the potential to be “absolutely a gamechanger”.
- While pre-infectious detection would improve the efficiency of test-and-trace programs as governments worldwide relax lockdowns, DARPA cautioned that it must wait until after FDA approval is given and the test can be put into practice for evidence of exactly how early it can pick up the virus.
- “The goal of research is to develop and validate an early host blood response diagnostic test for C19,” Prof Stuart Sealfon, who leads the research team at Mount Sinai hospital in New York, said in an email.
- He said the testing approach, which looks at the body’s response as it fights C19, should produce earlier results than current nose-swab tests that hunt for the virus itself. “Because the immune response to infection develops immediately after infection, a C19 signature is expected to provide more sensitive C19 infection diagnosis earlier.”
- The research behind the development of the tests will eventually be made public, with the collaborating teams from medical schools at Mount Sinai, Duke University and Princeton expected to publish online, allowing scientists around the world to trial similar methods.
- If EUA is granted, the test should start being rolled out in the US in the second half of May. Approval is not guaranteed, but DARPA scientists are enthusiastic about the potential impact as governments loosen lockdowns amid worries about controlling potential second-wave outbreaks.
- “We are all extremely excited. We want to roll this test out as quickly as we can, but at the same time share with others who might want to implement in their own countries,” said Dr Eric Van Gieson, who set up DARPA’s epigenetic characterization and observation (Echo) program last year to diagnose biological warfare victims, and has redirected it to focus on C19. Epigenetics looks at a set of controls on genes that can respond to the environment.
- Hope that the test might pick up carriers before they become infectious is based on previous research into other viruses, though Sealfon said this remained “unknown” for C19.
- “We have evidence that diagnosis happens in the first 24 hours for influenza and an adenovirus. We are still in the midst of proving that with C19. That said, we should know very soon after EUA.” He sees potential for the US to carry out up to a million tests a day, starting with 100,000 daily in May.
- The test would up the possibility of isolating pre-infectious cases and closing down transmission chains. It could also dramatically reduce quarantine periods for people exposed to C19 spreaders, allowing them to go back to work within days. “It could have exceptional demand,” said Chris Linthwaite, the chief executive of Fluidigm, a California life-sciences technology company that is part of the project, who believes frequent testing can help manage workforces as they return to offices, warehouses and factories.
- DARPA experts also see potential to improve protocols for protecting health care workers and others in high-risk jobs, as well as those in relatively self-contained or isolated communities such as care homes and prisons or onboard ships.
- The test uses the same polymerase chain reaction (PCR) machines used for checking nasal swabs from people suspected of having the virus. “It’s a simple tweak,” said Van Gieson. “The infrastructure is already there.”
- Limitations on use are similar to those already faced by countries such as Britain and depend on PCR capacity, stocks of chemical reagents and logistics. Results can take an hour, or longer if samples must be sent away to laboratories.
- Like the viral test, the new blood test hunts for a type of molecule called RNA. In this case it is messenger RNA (mRNA). “Target mRNA is part of the immune response to viral infection,” Sealfon said. “mRNA expression levels really do adjust due to the presence of C19. Understanding the immune response is key to fighting C19.”
- C19 is thought to incubate for about five days, at which stage people are assumed to become infectious. That is also when the virus can be detected by current nose swab tests. “They do the job, they just don’t tell you someone is sick until maybe four days after this [new test],” said Van Gieson.
- The research shows accuracy levels above 95%. “This is something that will need to be constantly monitored as it will inevitably change up or down,” Van Gieson said.
- Blood samples are harder to collect than nose swabs, but may be more reliable. Swab testing can be difficult because it requires taking a sample from deep inside the nose.
- “It can throw up a lot of false negatives,” said Prof Lawrence Young of Warwick University, adding that recent studies showing low reliability were probably due to poor swab sampling. “I’ve been very concerned by pictures on the television of drive-in testing. Something you could measure reliably in blood could be a good thing.”
- Like all researchers contacted by the Guardian, however, he was unwilling to comment further until the Mount Sinai-led team published its research. Most were concerned about potential problems with accuracy and practicality. Blood collection is a potential limitation, since drive-in centres are not usually equipped to do this. One millilitre of blood – a fifth of a teaspoon – is needed.
- The research team is expected to publish the mRNA sequence, allowing others to create the so-called “primer” required. A similar approach was taken when the genetic sequence of the virus itself was released by China in January, allowing tests to be developed rapidly in South Korea and elsewhere.
Source: The Guardian here.
2. FDA approves coronavirus antibody test with near-perfect accuracy
- The FDA gave emergency approval to a C19 antibody test that boasts near-perfect accuracy.
- Swiss drugmaker Roche said the new test, which determines whether someone had a past infection, has proven 100% accurate at detecting antibodies in the blood and 99.8% accurate at ruling out the presence of them.
- The company said the test requires intravenous blood draws, with higher accuracy than finger-prick tests.
- “If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein,” Thomas Schinecker, the company’s head of diagnostics, said.
- “You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”
- Schinecker said the tests are an important step in determining whether someone may have immunity, but acknowledged that more research is required to determine whether antibodies protect people from being reinfected.
- “Since this virus is not well known, one can hypothesize, but the proof will take longer,” Schinecker said. “Testing these people … is key to seeing whether or not people really have developed immunity.”
3. Is the coronavirus antibody test a magic bullet — or false hope?
- Most of the antibody tests currently on the market are a disaster. These tests are not worth anything, have very little use.
- Right now we continue to throw money at it with widespread testing, and we think we know what we’re doing. The truth is we’re just wasting billions of dollars.
- Most lab tests have a 5% false-positive rate.
- It’s also unknown whether those who test positive for C19 antibodies are contagious or not.
- While antibody tests are being hailed by some as an “immunity passport” — the first step out of the coronavirus pandemic — public-health officials warn that a positive test does not necessarily mean total immunity to the virus.
- “There’s an assumption — a reasonable assumption — that when you have an antibody that you are protected against reinfection,” said Dr. Anthony Fauci, an immunologist and member of the White House coronavirus task force, on an April 20 “Good Morning America” appearance. “That has not been proven for this particular virus.”
- But for elected officials eager to return to a sense of normalcy and reopen failing economies after weeks of coronavirus lockdown, antibody testing and tracing of C19 on a massive scale have now become de rigueur. Despite the uncertainty and scientists’ lack of knowledge of the virus, hundreds are lining up for the antibody tests in New York, where nearly 300,000 people have tested positive for C19.
- “The entire operation has never been done before,” said New York Gov. Cuomo on April 25, pledging to test as many as 40,000 New Yorkers for both the coronavirus and its antibodies on a daily basis.
- The military-style operation in the state, which is the epicenter of the virus in the United States, will be conducted with Johns Hopkins University and with funding from former New York City Mayor Michael Bloomberg and the federal government, which has already pledged $1.5 billion to the effort, Cuomo said.
- As of April 27, of those tested in a random sample of 7,500 people, nearly 15% were positive, suggesting that statewide more than two million people may have had the virus and shown no symptoms and might now have antibodies to fight against it, Cuomo said. In New York City, early results showed that nearly 25% of those tested may have been infected at some point but showed no symptoms.
- While the CDC has confirmed that asymptomatic carriers can transmit the disease, it’s still unclear how many of them are contagious and for exactly how long. It’s also unknown whether those who test positive for C19 antibodies are contagious or not.
- What the antibody tests do reveal is “what we already know — that the disease is all over the place,” said Marvin Lerner, a retired Manhattan physician and expert on infectious diseases. “Right now we continue to throw money at it with widespread testing, and we think we know what we’re doing. The truth is we’re just wasting billions of dollars.”
- Worldwide, there are more than 3 million confirmed cases of C19 and more than 212,000 deaths, according to statistics compiled by Johns Hopkins University. And in the US, which is now the world leader with more than 1 million confirmed cases, there is still much confusion about the antibody tests themselves, most of which have not been properly vetted by the FDA.
- “Doctors should be aware most serology tests haven’t been reviewed by FDA,” tweeted Scott Gottlieb, a physician and former FDA commissioner, on April 21. “Quality is highly variable, with some or perhaps many giving uncertain results. False-positive rates may be inappropriately high. Patients and doctors shouldn’t rely on unproven tests for clinical decisions.”
- The head of the world’s largest biotech company took it one step further when he told an April 22 news conference that most of the antibody tests currently on the market are “a disaster.”
- “These tests are not worth anything, have very little use,” said Severin Schwan, the CEO for Roche Holding AG, according to Reuters. “Every kind of amateur could produce an antibody test. The two of us could do it overnight in the garage. That’s not the problem. The question is, does it really work?”
- Even in the face of these warnings, the FDA is responding to an urgent demand for testing and is now allowing developers to “self-validate” their own antibody tests, clearly labeling their products to indicate they have gone through the vetting on their own and submitted their findings to the FDA.
- “It’s kind of like the honor system: The FDA gives you a guideline and you say you followed the guideline and you give them your data,” said Lerner. “But not everyone in business can be trusted and a lot of guys are out there just to make a buck.”
- As of April 27, the FDA said it was still reviewing nearly 150 tests and had authorized only 7.
- At Northwell Health, which runs 23 hospitals in New York, including Lenox Hill Hospital, staff plan to conduct 10,000 antibody tests per day once their antibody-testing program for the general public gets underway in early May, according to Christopher Zavala, director of business development for Northwell Health Labs. Northwell Health has already started testing hospital workers, a spokesman for the health-care network told The Post.
- “Northwell is putting a plan in place for all frontline workers — health-care workers and first responders,” Zavala told The Post. “But because the virus is so new we don’t have any understanding of what will trigger immunity.”
- Meanwhile, an increasing number of private clinics in Manhattan are offering serology tests for those who don’t want to wait for public-sector testing.
- Cardiologist Robert Segal has been conducting antibody tests at his Manhattan Cardiology clinics on the Upper East Side and Midtown since April 16 “for anyone who has felt that they had exposure to the coronavirus,” he told The Post. He said he’s already tested more than 200 people and is fielding 400 requests a day for the antibody test.
- The test itself costs $95, but the price goes up to $299 with pre-screening and administration, Segal said. He is opening up another clinic in Columbus Circle to handle the overflow, he noted. The tests, which are covered by insurance, are set up through LabFinder.com, a platform he co-founded that prescreens candidates before they show up for the blood draw.
- “We are not testing the acutely ill,” Segal said. “We are looking for people who feel they may have been exposed to the virus and give them back the trust and confidence that their immune system has developed some kind of level of attack against the virus.”
- Segal’s tests have been self-validated and the manufacturer, Diazyme Laboratories, has been authorized by the FDA to produce and market the tests under emergency protocols in place during the coronavirus pandemic, his spokeswoman told The Post.
- Unlike some serology test kits that rely on a “pin-prick” sample of blood and feature almost instant results, Segal’s clinics use a vial of blood that is analyzed by a lab. Results take up to 72 hours and are 95% accurate, he claimed. “There is a 5% false-positive rate which in my world is not dangerous,” Segal said. “Most lab tests have a 5% false-positive rate.”
- Segal stressed that the tests are not showing full immunity to C19, but the indication of antibodies in the blood that might possibly guard against re-infection and infecting others.
- Segal and others also hope that those with C19 antibodies will be in a position to donate “convalescent plasma” to help those stricken with the coronavirus fight the disease. The US has already treated 500 people with convalescent plasma, conducting clinical trials at 1,500 hospitals across the country. Clinical trials are also underway at hospitals around the world to determine whether plasma transfusions could improve a patient’s recovery and help them survive.
- Jake Deutsch, a physician and founder of Cure Urgent Care in Manhattan, was also among the first to offer the tests. On April 24, his two clinics on the Upper East and West sides of the city conducted 250 tests and he has 600 others registered on his Web site, he said, adding that he has already started offering walk-in testing at both of his facilities.
- “We’ve been very proactive about getting testing because when you are sick and vulnerable you want reassurance,” he said. “I’m a physician in the business of helping people. When the pandemic started we very quickly pivoted when we saw people who wanted to know if they were contagious.”
- Less than two days after his antibody test on April 17, Danny got the results that said he had the C19 antibodies in his blood. The test, he claimed, shows he has a 97% chance of immunity and is not contagious.
- But while the results made Danny feel better, experts are continuing to ask some hard questions not just about their validity, but also about the way they’re carried out.
- “Are these tests true?” asked Lerner, who has a Ph.D. in biochemistry from McGill University in Montreal. When he worked as a physician, Lerner often sent back results of even the most mundane kind of medical tests because he didn’t trust the way labs were handling his requests.
- “Are the tests being carried out in the right way when you have a system that is basically in chaos and when most of the good lab technicians have been furloughed?” he wondered. “Technology is only dependent on your level of knowledge as a doctor.”
- No matter what the experts say, Danny said he feels like his antibody test has given him his life back.
- “I feel amazing knowing that I have almost a 100% chance of not catching it again,” he said. “I am still very cautious and wearing my mask when I go to the supermarket and the bank, but now I can touch things again. It sounds crazy, but it’s a great feeling.” [Note: The belief that he has an almost 100% chance of not catching the coronavirus again is pure speculation and not based on any scientific evidence. Whether or not he is clinging to a false hope is yet to be determined.]
E. Scientific Findings & Other Advances
1. People with low vitamin D levels more likely to die from coronavirus
- People with low levels of vitamin D may be more likely to die from the coronavirus, according to a preliminary study.
- Researchers at Queen Elizabeth Hospital Foundation Trust and the University of East Anglia in England compared the average vitamin D levels of 20 European countries with C19 mortality rates — and found “significant relationships” between vitamin D levels and the number of deaths caused by this infection.
- The study, which has not been peer-reviewed, notes sun-starved “Nordic” countries are among the most at risk.
- “We believe that we can advise vitamin D supplementation to protect against coronavirus infection,” the researchers wrote.
- The finding falls in line with previous research that suggests healthy vitamin D levels can reduce the risk of respiratory infections.
- And a study from Trinity College Dublin earlier this month, in response to the coronavirus pandemic, found that the vitamin plays a critical role in preventing respiratory infections and boosting the immune system response to infections. The researchers wrote that vitamin D reduced the risk of chest infections by half in people who took supplements.
- The latest study found older people in Switzerland, Italy and Spain were the most at risk of being deficient.
- “The most vulnerable group of the population for C19 is also the one that has the most deficit in Vitamin D,” it wrote.
- Vitamin D is a fat-soluble vitamin that promotes healthy bones and supports immune system function. Your body produces vitamin D naturally when it’s directly exposed to sunlight, but it can also be obtained from eating foods such as fatty fish, egg yolks, mushrooms and cheese.
2. Cough syrups may boost replications of coronavirus
- Coughing is one of the hallmark symptoms of being infected with the novel coronavirus. So it’s no surprise that many are swigging dextromethorphan, a workhorse cough suppressant, to calm those bone-rattling expulsions of germs and air.
- It may be doing them more harm than good, new research suggests.
- As part of an ambitious project to identify drugs that could be repurposed to treat C19, an international team of scientists reported Thursday they had happened upon a surprising finding: A common active ingredient in dozens of over-the-counter cough syrups, capsules and lozenges appeared to boost replication of the coronavirus when tested under laboratory conditions.
- That’s a long way from concluding that cough medicines containing dextromethorphan will worsen the condition of people infected with the new coronavirus, or that it will make frightening outcomes more likely. But the researchers said the findings are concerning enough for them to advise cough sufferers who might be infected with coronavirus to avoid these medications.
- Given that cough suppressants are likely to be widely used by people with coronavirus infections — whether they’ve got an official diagnosis or not — the researchers called for more research on dextromethorphan’s safety.
- Dextromethorphan stifles signals in the brain that set off the reflex to cough. It is a key ingredient of virtually all over-the-counter cough and cold formulations, including those sold as Robitussin, Benylyn, DayQuil/NyQuil, Delsym, Triaminic, and Theraflu.
- In tests conducted at the Pasteur Institute in Paris, researchers found that when dextromethorphan was introduced into the cells of African green monkeys growing in petri dishes, the subsequent addition of coronavirus resulted in more prolific viral growth.
- UC San Francisco pharmacologist Nevan J. Krogan, one of the team’s leaders, said that the group had alerted officials overseeing the government’s C19 response to its concerns.
- The findings were reported Thursday in the journal Nature.
- But the group’s discoveries raise hopes as well.
- The research team, led by scientists at the Pasteur Institute and UC San Francisco, had set out to find promising potential treatments for C19 among compounds that were already known to scientists, physicians and consumers. The idea was to identify drug candidates that could be deployed quickly, either separately or in combinations, to short-circuit the coronavirus’s ability to infect and sicken humans.
1. Blood pressure medicines don’t raise C19 risk
- Commonly used blood pressure medicines do not heighten susceptibility to C19 infection, or increase the risk of becoming seriously ill with the disease, three major new studies said Friday, positive news for the millions of people who take them (all 3 studies were published in the New England Journal of Medicine (NEJM)).
- The research primarily concerned angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs), which are also given to diabetes patients to help protect their kidneys.
- ACE inhibitors include the likes of ramipril, lisinopril and other drugs ending in -pril; while ARBs include valsartan and losartan, and generally end in -sartan.
- There had been concerns arising from animal studies that these medicines might increase the body’s levels of a protein called ACE2, which the coronavirus latches on to when it invades human cells, thus increasing people’s vulnerability to the disease.
- Confusing matters further, there were also contradictory animal studies that showed having more ACE2 proteins might lessen an inflammatory reaction in lungs to C19, a beneficial effect.
- “We saw no difference in the likelihood of a positive test with ACE inhibitors and with angiotensin receptor blockers,” Harmony Reynolds of the NYU Grossman School of Medicine, who led one of the studies that involved about 12,600 people, told AFP.
- The studies were “observational,” meaning the researchers observed the effect of a risk factor.
- This type of investigation is always considered weaker than “experimental” where an intervention is introduced along with a control, which leaves less to chance.
- The authors of an accompanying editorial in the New England Journal of Medicine acknowledged this inherent limitation, but added: “We find it reassuring that three studies in different populations and with different designs arrive at the consistent message.”
- Reynolds said the findings were relieving, because she had been getting questions from worried patients who had read press reports and were asking if they should stop their medicines.
- “I’m very happy to be able to tell patients that they should continue their blood pressure medications,” she said.
Source: GeoTV here.
G. Planning For the Unknown
1. Assumption of Risk
- Below are some of the coronavirus unknowns that we are currently facing:
- What are the primary means by which the virus is transmitted
- How long can a person shed the virus after becoming infected
- How lethal is the virus
- What are the long-term effects of the disease on our health
- Will the virus dissipate in the summer
- Will the virus recur each year
- Will being infected result in any immunity against further infection or, if it does, how long will the immunity last
- When will treatments be available and how effective will they be
- When will vaccines be available and how effective will they be
- It is hard enough to plan for known risks, but how do we plan for unknown risks, conditions and timetables? Do we adopt the most conservative position or start making assumptions about some or all of the potential risks? While many assumptions may be derived or inferred from other infectious diseases, we must acknowledge that any assumption we make about C19 may be incorrect. For example, it is widely assumed that infected persons will be immune or protected against further infection, at least for some period of time, but there is currently no scientific evidence that is true (and studies of other coronaviruses indicate that such an assumption may be incorrect).
- In a lockdown, we don’t have to take risk because the government has mitigated much of the risk by forcing isolation on us. But, States are starting to open their economies and it seems likely that process will continue if not rapidly accelerate. And most people do not have the option of staying home much longer without suffering financial ruin. And, of course, many people are essential workers and we need them to continue working regardless of the risk.
- As restrictions on our activities are lifted, we must all choose how much risk we are willing to assume. In deciding which activities to engage in, there are two primary risks to consider: (i) the risk to ourselves, and (ii) the risk we create for others.
- Let’s start with the easier factor: the risk to ourselves. We know people over 65 and those with underlying health conditions are the most at risk. Every person can evaluate their risk and make a decision about how much risk they are willing to take. If they are concerned about the risk, they can elect to distance or isolate as much as they can. Those that are not concerned can return to normal like to the extent permitted by law. A third choice would be to take a middle position and distance or isolate in some circumstances but not others by avoiding risker activities. For example, you could go to a restaurant but not a sporting event or large wedding. But, all activities that put us in close proximity to other people necessarily subject us to some level of risk and we can get infected at a restaurant, sporting event or wedding. So, we can try to shave the odds against infection by avoiding some events while doing others based our assessment of the risk, but it is just a form of Russian roulette. Maybe you win, maybe you don’t. But, even so, it seems both appropriate and necessary to me for people to be given the right to make decisions and assume the risk arising from those decisions.
- The risk we pose to others is a far more difficult issue. Regardless of the risk to ourselves, every one of us is a potential transmitter of the virus to others. So, while we may be willing to assume the risk for ourselves, do we have any duty to protect others? Or is it everyone for themselves? As transmission is indiscriminate, our decisions apply to everyone we come into contact with, whether a stranger or family member. And, as a potential transmitter, our assumption of risk has the potential to affect the people we care most about.
- Based on recent scientific findings and public health warnings (and, equally important, what we don’t know about the virus and disease), it seems clear that no matter what precautions we take (other than absolute isolation, which is impractical), there is some level of risk that we will become infected and be an asymptomatic transmitter of the virus, even if we were previously infected.
- What are the implications of that conclusion? First and foremost, the only way to protect people in a high risk group is to continue distance ourselves from them as much as possible. Any other decision puts those people at risk and the consequences can be severe or lethal as we have seen.
- But, what if people in a high risk group are prepared to assume the risk? While they (as we) should be permitted to assume risk if they want to, we should at least consider how we would feel if they assume risk and then become seriously ill or die (possibly alone on a ventilator). Although it may happen whether or not we come into contact with them, that would be unprovable and it would only be natural to wonder what if…. Regret can be a very heavy weight to carry for the rest of our lives.
- Of course, as new treatments are developed and our understanding of the disease improves, we may be able to meaningfully reduce the risk to people in the high risk groups, which could alter risk/benefit analysis.
- In the meantime, while not a replacement for in-person contact, there are ways to interact with people in high risk groups that are far better than nothing – including face-to-face conversation, cocktails or dinner on Facetime or Zoom as well as keeping up on social media. Unfortunately, many of the most vulnerable are older people that uncomfortable or unfamiliar with technology, which can make it challenging to communicate with them through technology.
- The burden of bringing older generations into the technology age falls on the rest of us, which can undoubtedly push our patience to the limits, especially if we are not technologically savvy.
- My wife and I are currently dealing with this situation as her mother is technology challenged but really wants to connect with her kids and friends on Facetime or Zoom. Trying to explain how to make that happen over the phone has not worked. So, for Mother’s Day, we are buying her an iPad, having it shipped to us so that we can upload apps and prepare written step-by-step instructions, and then ship it to her. It is a group project and we’ll draft my nephew (a millennial) to assist with technology as needed (and it will be needed).
- Another idea is to have backyard get dinners, drinks or talks at which an appropriate distance is maintained from vulnerable individuals. There are virtually no known cases of transmission of the coronavirus outside and seems low risk. We may not be about to hug or touch them, but it can be a big step in the right direction.
- There are many other ways to be together while apart. It just takes some creative effort and commitment.
- In an odd twist, social distancing may increase our connection to family members. Silver linings are out there, but we have make them happen.
H. Lessons From Abroad
1. Sweden Has Already Won the Debate on COVID ‘Lockdown’ Policy
- As Europe and North America continue suffering their steady economic and social decline as a direct result of imposing ‘lockdown’ on their populations, other countries have taken a different approach to dealing with the coronavirus threat. You wouldn’t know it by listening to western politicians or mainstream media stenographers, there are also nonlockdown countries. They are led by Sweden, Iceland, Belarus, Japan, South Korea and Taiwan.
- Surprisingly to some, their results have been as good or better than the lockdown countries, but without having to endure the socio-economic chaos we are now witnessing across the world. For this reason alone, Sweden and others like them, have already won the policy debate, as well as the scientific one too.
- Unlike much of the rest of the world who saw fit to unquestioningly follow China’s lead on everything from quarantining, to economic shutdowns, to contact tracing, and PCR mass testing, nonlockdown countries have instead opted for a somewhat lighter touch – preserving their economies and societies, and in doing so avoiding an endless daisy chain of new problems and obstacles deriving directly from the imposition of brutal lockdown policy.
- On the European front, the Scandinavian country of Sweden is now garnering more attention than before, and has become an object of both criticism and fascination for those against or in favor of lockdown policy. While countries like the United States and Great Britain continue to top the global tables in terms of C19 death tolls, Sweden has only suffered marginal casualties in comparison, while avoiding the intense strain on society and loss in public confidence which lockdown governments are now grappling with as they continue to push their populations to the limits of social stress and economic tolerance. You could say those governments are already careening over the edge by looking at the latest jobless figures coming out the US with 30 million new people filing for unemployment in the last few weeks.
- Unlike many others, Sweden has not enforced any strict mass quarantine measures to contain C19, nor has it closed any of its borders. Rather, Swedish health authorities have issued a series of guidelines for social distancing and other common sense measures covering areas like hygiene, travel, public gatherings, and protecting the elderly and immune compromised. They have kept all preschools, primary and secondary schools open, while closing college and universities who are now doing their work and lectures online. Likewise, many bars and restaurants have remained open, and shoppers do not have to perform the bizarre ritual of queuing around the block standing 2 meters apart in order to buy groceries.
- According to the country’s top scientists, they are now well underway to achieving natural herd immunity. It seems this particular Nordic model has already won the debate.
- Because Sweden decided to follow real epidemiological science and pursue a common sense strategy of herd immunity, it doesn’t need to “flatten the curve” because its strategic approach has the added benefit of achieving a much more gradual and wider spread.
- Anders Tegnell, Sweden’s government advisor for epidemiology explains,
- “We are all trying to keep the spread of this disease as low as possible, mainly to prevent our healthcare system from being overstretched, but we have not gone for the complete lockdown. We have managed to keep the number of cases low enough so the intensive care units have kept working and there has always been 20 per cent beds empty and enough protective equipment, even in Stockholm, where there has been a huge stress on healthcare. So in that way the strategy has worked.”
- Similarly, it doesn’t have the deal with the newest ‘crisis’ obstacle which lockdown states seem to be using as an excuse not to reopen society and the economy, which the fear of a ‘second peak‘ which governments are telling the public will wreak havoc on the nation by “infecting the vulnerable” and will “overwhelm the health services” if everything is suddenly reopened and social isolation and distancing is relaxed.
- This catch 22 which countries like the US and UK are caught in is predicated on the belief that the coronavirus might suddenly unleash itself again on the populace. Certainly, there could be a second surge, but it should be noted that this is also a direct result of the decision to impose lockdown in the first place. According to top epidemiologist Dr Knut Wikkowski, the decision to lockdown only delayed the inevitable for countries like the US and UK, and quite possibly made the C19 problem even worse than it would have previously been in the short to midterm, but in the long-term the results would be relatively the same proportionally in term of human casualties.
- The penny should have really dropped after it was revealed two weeks ago by Oxford Professor Carl Heneghan, Director for Centre for Evidence-Based Medicine, that the peak of the UK’s coronavirus ‘crisis’ actually came a full week before Boris Johnson initiated lockdown on March 23rd.
- In fact, if you plug in Sweden’s actual data into Neil Ferguson’s own infamous computer model which sent the UK government into mass-panic mode, here’s what you would get:
- The numbers don’t lie, but statistics can be made to tell any story the narrator wants, especially when the storyteller is government. Just look at the last 50 years of announcements regarding unemployment and inflation levels. One thing we should have learned by now is that government will never let things like facts and real science get in the way of a slow motion train wreck in progress, hence you can see some UK officials still clinging to Ferguson’s initial prediction as some sort of ‘proof’ that the lockdown was necessary to avoid ‘mass death.’
- Outside of popular supposition and media talking points, there is no scientific study which shows that lockdown saved any significant number of lives. Instead, new data strongly suggests quite the opposite (see next story for details).
The Ribbing of Sweden
- As western lockdown countries drift further and further into an economic and social purgatory, nonlockdown countries like Sweden seem to be the target of bad-natured criticism by western media punditry. This seems to be out spite more than anything, as some journalists are sensing defeat after they had thrown their lot in with draconian lockdown policy early on, unquestioningly backing their governments’ one-size-fits-all approach to emergency management, once again invoking the TINA (There Is No Alternative) principle which history shows often precedes most man-made calamities from World War I, the Iraq War in 2003, to the 2008 Wall Street Bail Out.
- Nonetheless, the media and political pressure has been almost relentless on Sweden for not complying with the west’s ‘lockdown consensus.’
- The country has also been roundly criticized by some 2,300 academics who piled on scorn upon it in a letter posted in March demanding the government change course and immediately head for lockdown.
- However, the country has held off, and has since won endorsements from a number of eminent academics and professionals, like Professor Heneghan who hailed Sweden for “holding its nerve,” in the face of such public condemnation. That steadfastness seems to finally be paying dividends now, as some western mainstream media outlets, and even the UN itself, are acknowledging their comparable success. The New York Post begrudgingly acknowledged that Sweden received praise from the high chair of global public health at the World Health Organization (WHO), now lauded it as a “model” for overcoming the coronavirus crisis.
- Dr. Micheal Ryan, WHO head of emergency management said, “What it has done differently is it has very much relied on its relationship with its citizenry and the ability and willingness of its citizens to implement self-distancing and self-regulate.”
- He added, “In that sense, Sweden has implemented public policy through that partnership with the population …. I think if we are to reach a new normal, Sweden represents a model if we wish to get back to a society in which we don’t have lockdowns.”
- So according to WHO, it is Sweden which could be the new normal – and not the reactionary medieval quarantine policies favored by other states. Is WHO really making an argument against obsessive social isolation, and collective economic suicide? Such words from WHO should, in theory, be reassuring to those stuck in their lockdown death spirals. But many in the west are still convinced of the TINA principle, even if their next door neighbor has chosen a short and more practical route through the eye of the storm.
- More than anything, this conundrum speaks to the relationship between people and their governments. Indeed, it is the social contract between government and its citizens which forms the core of the country’s policy formation. The idea that the choice of lockdown policy is a straight trade-off between lives and economy is a false dichotomy which ignores many concomitant variables and factors which are at play.
- “I don’t think it was in terms of economy versus a health of people. I think it was a broader concern about the social fabric in general,” said Lars Trägårdh, professor of history and civil society studies at Ersta Sköndal University College.
- “It is wonderful that we have retained the amount of freedoms that we have here ….Who would have thought, you know, that Swedish social democracy would be in bed with American right-wing libertarians? Not me,” remarked Trägårdh.
- Professor Cecilia Soderberg-Naucler from Sweden’s Karolinska Institute explained why the state was duty-bound to take the direction it did.
- “We must establish control over the situation, we cannot head into a situation where we get complete chaos. No one has tried this route, so why should we test it first in Sweden, without informed consent?” said Soderberg-Naucler.
- This concept of people talking responsibility for their actions and for public well-being is actually enshrined in Sweden’s constitution. This means that the state does not have to threaten and abuse its citizens for things like not observing social distancing and buying ‘non essential items’ when out shopping, or meeting in small groups – as some governments are doing. Swedes know the risks and observe government guidelines accordingly. Swedes also acknowledge that humans are not perfect and won’t use police and courts to punish citizens if they are not following guidelines to the letter – as is the case in many lockdown countries. In lockdown countries, the bad blood between the public and government will not evaporate after the ‘crisis’ is over, which is a real problem which lockdown governments will continue facing in the future.
- Still, New York Post had to include the caveat that Sweden was something of a pariah state for “controversially refused restrictions“. The propaganda war could be seen in the paper’s subtle wordsmithing, where editors even went so far as to change their headline from “WHO lauds Sweden as ‘model’ in coronavirus fight for resisting lockdown,” to a slightly more incendiary “WHO lauds lockdown-ignoring Sweden as a ‘model’ for countries going forward”
- Swedish critics are quick to point out how poorly it’s doing compared to its Scandinavian neighbors, Denmark, Norway and Finland. They do this by pointing to the new global bible of public policy – the World-o-Meter coronavirus running totals – which for some people is now the end all and be all which it comes to declaring how really, really bad things are, and will continue to be (because that meter just keeps on running).
- As of today, Sweden, which has a population of roughly 10.5 million, has recorded 21,092 cases and 2,586 fatalities from C19, that’s roughly 256 deaths per million people.
- By contrast, its southern neighbor Denmark which has a population of 5.8 million has recorded 9,105 cases and 452 fatalities, roughly 78 deaths per million persons. Norway is similar population at 5.4 million, and has recorded 7,738 cases and 210 deaths, that’s 39 deaths per million. Finland has a population of 5.5 million confirmed just 4,995 cases and 211 deaths, with 38 deaths per million.
- Critics of Sweden have all seized upon these differences in order to condemn their government for being ‘irresponsible’ and “playing Russian roulette” with their citizens’ lives. If one didn’t know better from all the hysterical rhetoric, you’d think there was an impending genocide happening in Sweden. While these sort of polemic arguments seem to work in the narrow band of reality that are social media threads, the reality is that after scaling up its neighbors’ results to be in line with Sweden’s larger population which is roughly twice their size, the difference is statistically insignificant for a country of 10.5 million. The critics are basically arguing that when comparing Sweden to its neighbor Denmark, that a proportional difference of approximately 1,500 fatalities warrants Sweden closing all its schools and shutting down its entire economy and suffer all the chaos ill effects that goes with that course of action.
- To put things in even more perspective, while Sweden has already suffered 2,586 COVID deaths in 2020, back in 2018 there were approximately 6,997 total respiratory disease deaths in Sweden – and the country’s healthcare capacity was not overrun, nor were any of their public systems stretched to breaking point.
- It’s a ridiculous argument on its face, and yet, this is the line of thinking which seems to permeate through lockdown countries desperate to justify their own fatal policy decision.
- It’s not a discussion for faint hearts, but this has been a reality for nations since time immemorial who have faced war, plagues and pandemics. There is no perfect answer, but there are practical answers that take utilitarianism into account.
Fear of the ‘Second Wave’
- In what can only be described as a macabre display of bad faith, exasperated naysayers from lockdown countries seem to almost eager to see Sweden fall victim to the dreaded “second wave” which many Britons and Americans insist is a fait accompli, as their political leaders and science ‘experts’ keep telling them.
- The threat of a ‘second wave’ is certainly being used by some governments to justify an increasingly unpopular lockdown policy, but also lends itself to the preferences of Bill Gates who has been publicly advocating an open-ended lockdown arrangement until such a time that salvation will arrive in the form of a vaccine for the coronavirus. But even the most optimistic scenario would be somewhere between 18 months and two years, which begs the question of whether democracies and their economies can survive such an extended period of tumult. That’s a scenario which no one can realistically endorse, and yet it’s given prime time by mainstream media outlets who have been keen of offer-up the Gates plan as another TINA solution to the ‘pandemic’. Besides the obvious civilizational problems with the Gates global lock-up plan, it chronically ignores the fact that there are nonlockdown countries like Sweden who never opted into the west’s collective self-destruction pact.
- Not everyone is on board with the inevitability of a “second wave” which the American and British government keeps insisting is coming if lockdown is lifted too early. Renowned Scottish microbiologist Professor Hugh Pennington is not convinced, saying that such a second peak is unlikely. “No, I’m not sure where this ‘second peak’ idea comes from,” says Pennington.
- Still, Prof. Pennington seemed miffed as to where Boris Johnson’s government is getting its science from. “I know where it comes from, it comes from flu. Because when we have a flu pandemic we always get a second peak, and sometimes we get a third peak …. Now, why we should get one with this virus, I don’t quite understand …. It just seems to be a phenomenon with flu, and I don’t see any reason myself, and I haven’t seen any evidence to support the idea that there would be a second peak of the virus.”
- According to other experts, one of the fundamental problem with lockdown policy favored by the US, UK other European countries, is that it was never evidence-based, or “guided by the science.” Quite the opposite in fact. Rather, it was a political decision, undertaken by politicians. Never in history has a country enacted such a universal measure which quarantines the healthy as well as the sick and infirmed. This also flies in the face of hundreds of years of epidemiological science and epidemic policy, and eschews the entire concept of natural herd immunity.
- Again, the pragmatic approach would have been to protect those most directly effected by C19 which is overwhelmingly the elderly and those in palliative care – a policy which would eventually bring a population herd immunity as a natural by-product of that policy. That’s been the approach taken by Sweden and other states, and according to numerous experts in the field, it makes sense on both an epidemiological level and well as a social and economic level.
- In a recent interview with Radio 5, leading Swedish epidemiologist, Dr. Johan Gieseck, remarked how the UK had initially proposed the same plan as Sweden, but then Boris Johnson came under intense pressure from the media and opposition after the arrival of Imperial College’s notorious “500,000 dead” paper presented to the government by Prof. Neil Ferguson. As a result, UK officials quickly changed course in a “180 degree U-turn,” said Gieseck, who was shocked how an unpublished paper relying on computer models and with no peer review – could have played such a crucial role in altering such an important policy decision. How did that happen? One only has to look at the obvious nexus of funding between the UK government, Imperial College and the Gates Foundation to get a possible answer to that question.
- The real question in all of this should be: who and what is driving western governments’ disastrous lockdown policy? After reviewing the evidence, we can rule out one possibility: it’s certainly not the science.
2. Delaying herd immunity is costing lives [By Martin Kulldorff, Harvard Medical School]
- Because of its virulence, wide spread and the many asymptomatic cases it causes, C19 cannot be contained in the long run, and so all countries will eventually reach herd immunity. To think otherwise is naive and dangerous. General lockdown strategies can reduce transmission and death counts in the short term. But this strategy cannot be considered successful until lockdowns are removed without the disease resurging.
- The choice we face is stark. One option is to maintain a general lockdown for an unknown amount of time until herd immunity is reached through a future vaccine or until there is a safe and effective treatment. This must be weighed against the detrimental effects that lockdowns have on other health outcomes. The second option is to minimize the number of deaths until herd immunity is achieved through natural infection. Most places are neither preparing for the former nor considering the latter.
- The question is not whether to aim for herd immunity as a strategy, because we will all eventually get there. The question is how to minimize casualties until we get there. Since C19 mortality varies greatly by age, this can only be accomplished through age-specific countermeasures. We need to shield older people and other high-risk groups until they are protected by herd immunity.
- Among the individuals exposed to C19, people aged in their 70s have roughly twice the mortality of those in their 60s, 10 times the mortality of those in their 50s, 40 times that of those in their 40s, 100 times that of those in their 30s, and 300 times that of those in their 20s. The over-70s have a mortality that is more than 3,000 times higher than children have. For young people, the risk of death is so low that any reduced levels of mortality during the lockdown might not be due to fewer C19 deaths, but due to fewer traffic accidents.
- Considering these numbers, people above 60 must be better protected, while restrictions should be loosened on those below 50. Older people who are vulnerable should stay at home. Food should be delivered and they should receive no visitors. Nursing homes should be isolated together with some of the staff until other staff who have acquired immunity can take over. Younger people should go back to work and school without older coworkers and teachers at their sides.
- While the appropriate magnitude of countermeasures depends on time and place as it is necessary to avoid hospital overload, the measures should still be age-dependent. This is how we can minimize the number of deaths by the time this terrible pandemic is over.
- Among anti-herders, it is popular to compare the current number of C19 deaths by country and as a proportion of the population. Such comparisons are misleading, as they ignore the existence of herd immunity. A country much closer to herd immunity will ultimately do better even if their current death count is somewhat higher.
- The key statistic is instead the number of deaths per infected. Those data are still elusive, but comparisons and strategies should not be based on misleading data just because the relevant data are unavailable.
- While it is not perfect, Sweden has come closest to an age-based strategy by keeping elementary schools, stores and restaurants open, while older people are encouraged to stay at home. Stockholm may become the first place to reach herd immunity, which will protect high-risk groups better than anything else until there is a cure or vaccine.
- Herd immunity arrives after a certain still unknown percentage of the population has acquired immunity. Through long-term sustainable social distancing and better hygiene, like not shaking hands, this percentage can be lowered, saving lives. Such practices should be adopted by everyone.
- Social distancing that cannot be permanently sustained is a different story. Some people will eventually be infected, and for every young low-risk person avoiding infection, there will ultimately be roughly one additional high-risk older person that is infected, increasing the death count.
- Anti-vaxxers do not suffer the consequences of their beliefs, as they are protected by the herd immunity generated by the rest of us. Neither will the anti-herders, many of whom can afford to isolate themselves from C19 until natural herd immunity is achieved by others. It is older and working-class people that disproportionately suffer from the current approach, becoming infected and thereby indirectly protecting much lower-risk college students and young professionals who are working from home.
- The current one-size-fits-all lockdown approach is leading to unnecessary deaths. Protecting older people and other high-risk groups will be logistically and politically more difficult than isolating the young by closing schools and universities. But we must change course if we want to reduce suffering and save lives.
3. Some countries take tiptoe steps in easing restrictions
- At least 12 countries began easing restrictions on public life on Monday, as the world tries to figure out how to placate restless populations tired of being inside and reboot stalled economies without creating opportunities for the coronavirus to spread.
- The measures, which included reopening schools and allowing airports to begin domestic service, offer a preview of how areas that have managed to blunt the toll of the coronavirus might work toward resuming pre-pandemic life. They also serve as test cases for whether the countries can maintain positive momentum through the reopenings, or whether a desire for normalcy could put more people at risk.
- Most of the countries easing their restrictions are in Europe — including Italy, one of the places where the virus hit earliest and hardest, leaving more than 28,000 dead as of Monday. The country plans to reopen some airports to passengers.
- In Germany, where widespread testing has helped keep the pandemic under control, children will return to schools. Neighboring Austria also plans to restart its school system.
- In Lebanon, bars and restaurants will reopen, while Poland plans to allow patrons to return to hotels, museums and shops.
- India allowed businesses, local transportation and activities like weddings to resume in areas with few or no known infections. Wedding ceremonies with fewer than 50 guests will be permitted, and self-employed workers like maids and plumbers can return to work.
- Japan is set to announce an extension of its state of emergency through the end of this month while allowing public facilities like museums and libraries to reopen if they maintain social distancing controls.
- China and South Korea, both of which appear to have emerged from brutal early encounters with the virus, have begun limited reopenings. Restaurants and art galleries are returning to a semblance of normal operation, although the introduction of hand sanitizer and other preventive measures remains a constant reminder of how Covid-19 has changed much of the world.
- Other countries planning to lift some restrictions beginning on Monday include Belgium, Greece, Iceland, Hungary, Monaco, Nigeria, Poland and Portugal.
Source: NY Times here.
I. The Road Back?
1. One-size-fits-all doesn’t work for reopening America
- Time for reopening? Let’s reframe the question. Time for what to reopen? With what precautions? In which states and counties?
- And who really decides? Governors, mayors, the president? Business owners or consumers?
- Any effort to address questions yields the lesson that one-size-fits-all answers are ill-suited for a nation of 329 million people, half in million-plus metropolitan areas and the other half thinly spread out over a continent-sized landmass.
- Nonetheless, much of the public debate assumes, Twitter-style, that there is just one decision to be made, presumably by President Trump. And partisan affiliation shapes many Americans’ responses.
- Democrats, usually boastful of respecting alternative lifestyles, tend to insist that lockdowns stay in place. Republicans, sometimes depicted as deferential to traditional authority, tend to favor reopening.
- Both sides operate from a position of massive and unavoidable ignorance. So do even the most respected experts. Epidemiologists’ projections of mass deaths have been far off; speculation about modes of virus transmission has been largely discredited; ventilators, initially considered vital, now seem ill-suited to the virus.
- Lockdowns ordered by state governors and encouraged by Trump were premised on a need to avoid overwhelming hospitals and caregivers. But outside New York City, hospitals are half-empty and caregivers are being laid off.
- They’ve joined the 22 million who had filed for unemployment by mid-April — Great Depression levels. Low-skill workers, whose wages have finally been rising more than average in the Trump years, have been hit hardest.
- Polling shows majorities favor continued restrictions on reopening, especially if the question mentions the possibility of a second wave of infection. But there is also increasing evidence of people going out in public and chafing at restrictions.
- The partisan tilt of responses reflects the incidence of the virus. It has struck hardest in New York and, though much less, in other large metro areas, and those able to continue working for pay tend to be white college graduates: mostly Democratic voters. Outside million-plus metros, it has caused few deaths, and those losing paychecks tend to be non-college grads: mostly Republican voters.
- One-half of US coronavirus deaths have been in New York and New Jersey. Nearly a third have been in New York City, which, perhaps not coincidentally, has more than half of the nation’s rail-transit riders. In contrast, only 2% of US deaths have been in Florida, whose lockdown was less stringent and imposed later but whose concentration was put on isolating the elderly.
- C19 has primarily killed the elderly, mostly those with aggravating medical conditions. For children, it’s been no more deadly than the seasonal flu. This points toward reopening schools and colleges and universities. As Purdue University President Mitch Daniels points out, C19 “poses close to zero lethal threat” to young people.
- It points toward Florida Gov. Ron DeSantis’ policy of isolating and providing masks for senior citizens, and away from New York Gov. Andrew Cuomo’s policy of sending C19-infected patients back to nursing homes.
- And C19 isn’t the only threat to American lives. As Heather Mac Donald points out in The Spectator, “Lives are being lost to the overreaction,” including those of cardiac and cancer patients who have been avoiding hospitals, needed tests, chemotherapy and organ transplants. Job losses have probably led to suicides and opioid abuse.
- No one knows, or can know, how high these losses are. Weighing the risks of the virus and the lockdown is a job for private-sector leaders and elected officials.
- Officials — plural. Trump detractors have suddenly come to appreciate that the Constitution leaves the police power to impose quarantines and lockdowns in the hands of state governors, not the federal government.
- Cuomo, facing a grim situation in New York, seems unready to reopen. DeSantis in Florida and Gov. Greg Abbott in Texas, both with more people and far fewer C19 deaths than New York, are moving ahead to launch a reopening.
- The final say, however, goes to the American people. They may avoid restaurants but throng to churches and gyms, weighing risks against rewards. Sensible people will presumably factor in experts’ recommendations. But in a self-governing republic, they’re likely to come to their own conclusions.
2. The virus continues to spread. What’s needed now: rapid antigen tests like the one for flu or strep. [By Scott Gottlieb, former FDA Commissioner]
- The C19 epidemic continues to expand in some 20 states. The number of new cases in New York City is slowing, but the picture is different elsewhere in the nation. America has hovered around 30,000 new daily infections and 2,000 deaths for almost a month. Yet the number of days it takes for infections to double has improved, from less than a week in hot spots to almost a month nationally. This represents progress.
- But everyone thought we’d be in a better place after weeks of sheltering in place and bringing the economy to a near standstill. Mitigation hasn’t failed; social distancing and other measures have slowed the spread. But the halt hasn’t brought the number of new cases and deaths down as much as expected or stopped the epidemic from expanding.
- Officials face intense pressure to reopen, and the reality is stark: Continuing spread at something near current levels may become the cruel “new normal.” Hospitals and public-health systems will have to contend with persistent disease and death.
- Higher rates of spread may be limited to some areas; a majority of states have more than 250 new cases of C19 every day. But as states begin to open up their economies and Americans return to traveling, the disease will continue to expand. We need to prepare to deal with such a grim future, which will require a persistent posture of prevention and treatment.
- That means doubling down on screening and isolating sick people to slow the spread as much as possible, which will save lives and prevent health-care systems from being overwhelmed. That means channeling resources into places where outbreaks are prone to happen: nursing homes and shop floors, and among disadvantaged communities that lack access to testing and can’t practice social distancing easily.
- Technology and a well-equipped and competent medical and public-health workforce will be essential. This includes better drugs. On Friday the FDA authorized the use of remdesivir by Gilead Sciences. This drug is the first antiviral medicine that blocks SARS-CoV-2 replication. It isn’t a cure, but it will help patients at highest risk of bad outcomes, especially when deployed early in the course of the disease. More treatments are likely to follow, including antibody drugs that bind and block the virus. These should be available this fall if progress continues apace.
- A number of vaccines, meanwhile, are on track to clear early FDA safety trials by fall, and tens of millions of doses could be ready to use in studies that test for efficacy. These doses can be used in large trials that will establish whether the vaccine is safe and effective for mass inoculation, trials that can be conducted in cities suffering from outbreaks.
- But the public also needs better diagnostic tests to make screening for C19 inexpensive and routine. This is where medical progress has been slow. Testing so far has relied on detecting the nucleic acids of the virus’s genetic material. These platforms are reliable and were initially easy to expand. The U.S. medical system is now screening more than 1.5 million people a week. But these platforms can only run so many tests each day, and issues like transporting samples are precluding quick turnarounds.
- What’s needed now is the equivalent of the rapid flu and strep tests available in a doctor’s office. These tests look for antigens that the pathogen produces, which betray its presence in blood and saliva. Antigen tests are less precise than polymerase chain reaction (PCR) tests, but they enable fast and widespread testing. The government needs to rush development of these technologies and work with manufacturers to increase capacity.
- More-precise platforms like PCR will still have an important role. They’ll be used by big commercial labs that can run them at the scale needed to improve cost and efficiency. They’ll also serve as a reference standard and be used for mass screening by pooling many patients’ samples—say, in a workplace—and testing them all at once to see if anyone in the group is infected.
- If the virus continues to spread, the economy won’t snap back. Many Americans will be scared to go out, and with good reason. Summer may provide some reprieve, but the virus could return aggressively in the fall. Activity can resume in parts of the country where risk is low, but there is still much disease and death in the days to come.
- Dealing with this new reality will require screening to identify new cases and isolate infections. That will depend on better testing technologies that aren’t yet available—but can be achieved. The sooner the better for the health of Americans and the economy.
Source: The Cruel Covid ‘New Normal’
3. Four keys to safely reopening NYC during coronavirus crisis By Corey Johnson & Stephen Levin, members of NY City Council]
- New York City has been through hell. Now we need a clear strategy for what we do next.
- There is growing consensus that the way forward is through “containment”: confronting a pandemic using four key tactics: widespread testing, contact tracing, social distancing and isolation/quarantine of confirmed cases and their contacts. It will take a massive effort and unprecedented coordination among the city, state the region. Containment must be our new mantra.
- We need sufficient supplies of both PCR tests, which diagnose active infections, and antibody tests, which screen for prior infections.
- Mayor Bill de Blasio has announced that we should have 100,000 PCR tests per week soon. This is good news; we need to be able to PCR-test everyone who wants a test, regardless of symptoms. That means dozens of temporary testing sites throughout the city available to everyone, regardless of immigration status or insurance. New Yorkers also need clear guidance on how, when and where to get tested.
- Meanwhile, Gov. Cuomo and the state Department of Health’s work on antibody testing has been extraordinary. We need to build on this by running clinical trials on antibody tests to determine their sensitivity, what percentage of cases are asymptomatic, whether people develop immunity from infection and, if so, for how long.
- Once someone tests positive for C19, we have to be able to trace all of that person’s recent close contacts. This is labor-intensive and specialized work. Before C19, the city had only 50 contact tracers for all five boroughs. We need to immediately bring on thousands if we’re serious about containment.
- Technology can help. Apple and Google are teaming up to create a system to let iPhones and Androids ping one another within six feet for a period of time. Using anonymized coding to protect privacy, these phones will remember one another, and if the owner of one tests positive for C19, the owner of the other will be notified.
- This can’t replace the essential shoe-leather work of contact tracers, but it may complement it. Of course, we must set checks on any encroachment on our civil liberties, and Apple and Google have committed to strict limits.
- While our heroic essential workers — health care, grocery and food workers, pharmacists, police, firefighters, sanitation workers, MTA workers, delivery workers, nonprofit staff — have been showing up on the front lines every day, millions of us have spent the past five to six weeks largely indoors. This has been key to flattening the curve.
- We adapted, because we know the stakes. We must keep it up, even as we reopen our city. Protecting fellow New Yorkers means doing your part by maintaining social distancing.
- That will be easier for some than for others. The pandemic has exposed the inequity that runs deep in our city, and it has had deadly consequences. Black and brown communities have been hit hardest, by far. We need targeted policies that factor in race and socioeconomic status to make social distancing possible for everyone.
- We need to ensure that someone who’s C19-positive doesn’t spread the infection further. Because much of the community spread occurs within households, Drs. Harvey Fineberg, Jim Yong Kim and Jordan Shlain recently wrote in The New York Times of one approach, “smart quarantine”: creating a tiered framework where people who test positive are isolated (at no expense to themselves) and those in their household are quarantined and quickly tested themselves.
- If they test positive, they will also be isolated. In addition to slowing the spread of C19, this would help relieve the massive pressure on our health-care heroes.
- Of course, this entails sacrifice. Families might be disrupted and endure separation for weeks. But we know New Yorkers are willing to sacrifice to protect one another; we’ve done it time and time again. [Note: While unclear, it appears that the authors of this article are suggesting forced isolation or internment. I could be wrong, but I think that the authors are clueless if they believe most New Yorkers will be accept forced isolation from their families.]
- None of these tactics alone will work. But if we do them all together, with a sense of purpose and shared sacrifice, we’ll be able to safely reopen the city, slowly and responsibly.
- The next outbreak will come. Transmission of C19 will resume, and we know how fierce it will be. But with a clear strategy and preparation now, we can contain the next outbreak. We have to: The future of our city depends on it.
J. Balancing Act
1. Warmer weather and protests put pressure on states
- Warmer weather and fatigue over weeks of confinement lured millions of Americans outside this weekend, adding to pressure on city and state officials to enforce, or loosen, restrictions imposed to limit the spread of the coronavirus.
- In New York City, Mayor Bill de Blasio pleaded with residents to resist the impulse to gather outdoors. In New Jersey, golf courses reopened and Gov. Philip D. Murphy said early anecdotal reports indicated that people were maintaining social distance.
- “If we hear minimal reports of knucklehead behavior at our parks, then we know you all have taken to heart your responsibility to help us mitigate this pandemic,” Mr. Murphy wrote on Twitter.
- Many states have started easing stay-at-home orders and allowing businesses to reopen, as unemployment has soared and economic fears have intensified. But there has been an increasingly diverse patchwork of orders.
- In Texas, three movie theaters in the San Antonio area became some of the first in the country to reopen, a move that worried infectious disease experts but was applauded by those who went to the screening.
- Elsewhere, protesters pressing for the loosening of restrictions gathered in the capitals of Kentucky; Florida, where the governor has already announced a relaxing of restrictions; Oregon, where Gov. Kate Brown has extended a state of emergency through July 6; and Michigan, where protesters pressed Gov. Gretchen Whitmer to reopen the state completely. She has not relented, however, saying in an interview on “State of the Union” on CNN that she would continue to steer her policy based on the advice of public health experts.
- In Stillwater, Okla., officials abandoned a requirement that people wear masks in shops and restaurants after workers were faced with violent threats.
- Gov. Larry Hogan of Maryland, a Republican, said on CNN that the resistance to restrictions in his state did not overshadow the gravity of the pandemic. “We had far more people die yesterday in Maryland than we had protesters,” he said.
- In Mississippi, Gov. Tate Reeves had already relaxed his stay-at-home order in favor of a less stringent “safer-at-home” order, and had planned to ease restrictions even further on Friday. But he held off after nearly 400 new cases were reported that morning.
- Mr. Reeves, a Republican, noted on “Fox News Sunday” how the balance has shifted between trying to act aggressively to curb the virus and attempting to stanch the severe economic fallout those measures have created. “We have a public health crisis in this country, there’s no doubt about it,” Mr. Reeves said. “But we also have an economic crisis.”
- He noted the surge in unemployment, and the protesters that had gathered outside the governor’s mansion in Jackson. “I know they were protesting for the 200,000 Mississippians who have lost their jobs in the last six weeks,” he said. “I understand and I feel their pain. And we’re doing everything in our power to get our state back open as soon as possible.”
K. Projections & Our (Possible) Future
1. Coronavirus may spread in a ‘slow burn’ in the US
- The virus is still spreading in the United States, because efforts to contain it have been incomplete at best, public health experts warned on Sunday, saying that there were signs that the country may face a steady flow of new cases and deaths for many months to come.
- “While mitigation didn’t fail, I think it’s fair to say that it didn’t work as well as we expected,” said Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration, referring to stay-at-home orders and social distancing guidelines.
- Coronavirus case counts continue to rise in 20 states, including Illinois, Texas and Maryland, even as some states are beginning to relax restrictions, Dr. Gottlieb said on the CBS program “Face the Nation.”
- “We’re looking at the prospect that this may be a persistent spread,” he said, with a steady stream of 20,000 to 30,000 new cases daily that result in 1,000 deaths a day across the country.
- “You can see this slow simmer explode into a new epidemic or large outbreaks,” Dr. Gottlieb said. “That’s the concern — that if we don’t snuff this out more, and you have this slow burn of infection, it can ignite at any time.”
- The White House coronavirus response coordinator, Dr. Deborah Birx, said she found it “devastatingly worrisome” that hundreds of protesters amassed at Michigan’s state Capitol last week to object to Gov. Gretchen Whitmer’s plan to extend many business closures through the end of May.
- “If they go home and infect their grandmother or grandfather who has a co-morbid condition, and they have a serious or unfortunate outcome, they will feel guilty for the rest of their lives,” Dr. Birx said on Fox News.
- Pressed by the host of the program, Chris Wallace, about whether some states were reopening too soon, Dr. Birx said it was important for individuals to keep track of coronavirus cases in their communities and keep following their own precautions through each phase of the gradual process that the task force recommends.
- “You need to continue to social distance, you need to continue to practice scrupulous hand-washing,” Dr. Birx said. “If you have any pre-existing condition, through Phase 1 and Phase 2 of any reopening, we have asked you to continue to shelter in place.”
- Researchers are racing to develop a vaccine, but a scientist in one of the leading teams said its protection may not last long, and it may have to be readministered every year the way flu shots are.
- Sir John Bell, the Regius Professor of Medicine at Oxford, said on the NBC program “Meet the Press” that while the coronavirus “doesn’t mutate at the pace of flu as far as we can see, it’s also quite a tricky virus in terms of generating longstanding immune responses to it.”
- Dr. Bell is involved in the development at Oxford of a potential vaccine that could begin to be available by September — several months ahead of other announced efforts. “We are pretty sure we’ll get a signal by June about whether this works or not,” he said.
1. A Primer on C19 Vaccines: 100-plus in the works, 8 in clinical trials
- The clearest way out of the C19 crisis is to develop a safe, effective vaccine—and scientists have wasted no time in getting started.
- They have at least 102 vaccine candidates in development worldwide. Eight of those have already entered early clinical trials in people. At least two have protected a small number of monkeys from infection with the novel coronavirus, SARS-CoV-2, that causes C19.
- Some optimistic vaccine developers say that, if all goes perfectly, we could see large-scale production and limited deployment of vaccines as early as this fall. If true, it would be an extraordinary achievement. Less than four months ago, SARS-CoV-2 was an unnamed, never-before-seen virus that abruptly emerged in the central Chinese city of Wuhan. Researchers there quickly identified it and, by late January, had deciphered and shared its genetic code, allowing researchers around the world to get to work on defeating it. By late February, researchers on multiple continents were working up clinical trials for vaccine candidates. By mid-March, two of them began, and volunteers began receiving the first jabs of candidate vaccines against C19.
- It’s a record-setting feat. But, it’s unclear if researchers will be able to maintain this break-neck pace.
- Generally, vaccines must go through three progressively more stringent human trial phases before they are considered safe and effective. The phases assess the candidates’ safety profile, the strength of the immune responses they trigger, and how good they are at actually protecting people from infection and disease.
- Most vaccine candidates don’t make it. By some estimates, more than 90% fail. And, though a pandemic-propelled timeline could conceivably deliver a vaccine in as little as 18 months, most vaccines take years—often more than 10 years, in fact—to go from preclinical vetting to a syringe in a doctor’s office.
- Abridging that timeline can up the risk of failure. For instance, vaccine candidates usually enter the three phases of clinical trials only after being well tested in lab animals that can model the human disease. But, with such a new virus, there is no established animal model for C19. And amid a devastating pandemic, there’s not enough time to thoroughly develop one. Some researchers are now doing that ground-level animal work in parallel with human trials—such as the small monkey trials mentioned above.
- Researchers already have reason to be a little anxious about the safety of any C19 vaccine. When they tried in the past to make vaccines against some of SARS-CoV-2’s coronavirus relatives, they found a small number of instances when candidate vaccines seemed to make infections worse. That is, these candidate vaccines seemed to prompt berserk immune responses that caused lung damage in monkeys and liver damage in ferrets. Researchers still don’t fully understand the problem and don’t know if it could happen in humans, let alone if it will show up with the new candidate vaccines against SARS-CoV-2.
- But we may soon know the answers. As the pandemic tops the grim milestone of three million cases worldwide and well over 200,000 deaths, researchers are relentlessly moving forward with vaccine development. Here’s where the scientific community currently stands in its frenetic effort.
First, the basics
- Researchers are using a wide variety of tools and techniques to develop a vaccine—some are tried and tested, others are fresh and unproven. Regardless of the strategy, they all aim to do the same thing: train the immune system to identify SARS-CoV-2 (or some element of it) and destroy it before it establishes an infection and causes C19.
- The way a vaccine can pull this off, typically, is by feeding immune cells a signature element of a disease-causing germ, such as a unique protein that coats the outside of a dangerous virus. From there, a type of white blood cell called B cells can generate antibodies that specifically recognize and glom onto those signature germ elements. Antibodies are Y-shaped proteins, which have their germ-specific detecting regions on their outstretched arms. The base of their “Y” shape is a generic region that can signal certain immune responses if they detect an invading germ.
- A strong, effective vaccine can generate so-called neutralizing antibodies. These antibodies circulate in the blood, surveilling the whole body after a vaccine is given. If the germ they’re trained to detect actually shows up, the antibodies can swarm and paralyze it. The base of the antibodies—now dangling off their smothered target germ—can then signal immune cells to help finish the job.
- In the case of C19, the goal of candidate vaccines is to train our immune systems to make antibodies that specifically detect and destroy SARS-CoV-2 (which is, again, the novel coronavirus that causes C19). Though there’s a lot we don’t know about SARS-CoV-2, we know enough of the basics to direct early vaccine development.
- We know that SARS-CoV-2 is a betacoronavirus related to two other notorious betacoronaviruses: SARS-CoV-1, which causes SARS (severe acute respiratory syndrome), and the Middle East respiratory syndrome coronavirus (MERS-CoV), which causes MERS.
- Coronaviruses, generally, keep their genetic blueprints in the form of a large, single-stranded, positive-sense RNA genome, which is bundled into a round viral particle. That genetic code provides the molecular instructions to make all of the components of the virus, including enzymes required to make copies of the virus’s genome, and the virus’s famous spike protein.
- The spike protein is what the coronaviruses use to grab a hold of host cells—that is, human cells they infect or the cells of any other animal victim. Once the virus latches on with its spike protein, it gets into the cell and hijacks the cell’s activities, forcing it to help manufacture viral clones, which then burst forth to infect more cells.
- There are many copies of the spike protein on the outer surface of coronaviruses, creating a spikey exterior—think a cartoon sea mine. The pointy adornments are actually what give coronaviruses their name. Under an electron microscope, the spikes give the viral particle a crown-like appearance, hence corona viruses. But more importantly, the spike proteins are a prime target for antibodies. And, because we have the whole genome sequence for SARS-CoV-2, researchers have a good start at figuring out effective ways to engineer vaccines to attack the spike proteins and other critical components of the virus.
- There are many ways to try to train the immune system to fight off a specific germ or specific elements of germs, such as SARS-CoV-2 or the SARS-CoV-2 spike proteins. Here are the general categories currently in play:
- Live-attenuated vaccine: These vaccines use whole viruses that are weakened so they can no longer cause disease. This is a well-established method for creating vaccines. In the past, researchers weakened viruses by growing them in lab conditions for long periods of time—which is a bit like domesticating germs. The cushy, all-inclusive petri-dish lifestyle can essentially allow viruses and bacteria to adapt to their tranquil surroundings and lose virulence over time. But, it can take a while. Scientists grew the measles virus in lab conditions for nearly 10 years before using it for a live-attenuated vaccine in the early 1960s.
- Nowadays, there are faster, more controlled approaches to engineer weakened viruses, such as targeted mutations and other manipulations of a virus’s genetic code.
- Live-attenuated virus vaccines have the advantage of generating the same variety of protective antibodies as a real infection—without causing a pesky, life-threatening disease, for the most part. But there are risks. Because the virus can still replicate, certain people (particularly those with immunodeficiencies) may have severe reactions. Though the newer strategies for weakening viruses may reduce these risks, they still require extensive safety testing before reaching the market.
- That said, this is a vaccine platform that has already proven successful. Several vaccines in use are live-attenuated vaccines, including vaccines for chickenpox and typhoid. If such a vaccine proved effective at preventing C19, we already have the know-how and infrastructure to quickly scale up production to make these vaccines.
- Inactivated vaccine: This is another straightforward, old-school method that uses whole viruses. In this case, the viruses are effectively dead, though, usually inactivated by heat or chemicals. These corpse viruses can still prime the immune system to make neutralizing antibodies; they just do it less efficiently.
- The advantage of this strategy is that it is relatively simple to make these types of vaccines and, because the viruses don’t replicate, there is no risk of infection and less risk of severe reactions. Disadvantages include that inactivated, non-replicating viruses don’t elicit as strong of an immune response as a disease-causing or weakened virus. Inactivated vaccines always require multiple doses and may need periodic booster shots as well.
- Like weakened virus vaccines, using a whole viral particle gives the immune system many potential viral targets for antibodies. Some may be good targets to neutralize a real infection, and some may not. But, using an inactivated virus is a proven method. For instance, some existing vaccines against polio, hepatitis A, and rabies use this method.
- Viral vector-based vaccine: For these vaccines, researchers take a weakened or harmless virus and engineer it to contain an element of a dangerous virus they want to protect against.
- In the context of C19, this might mean engineering a harmless virus to produce, say, the spike protein from SARS-CoV-2. This way you get the immune response to a live but benign virus, coupled with the likelihood of having antibodies that target a specific critical protein from the dangerous SARS-CoV-2.
- This, too, is a proven strategy for effective vaccines. The newly approved Ebola vaccine, for instance, uses this method.
- Subunit vaccines: These are bare-bones vaccines that include only a component of a dangerous virus to elicit immune responses. For C19 vaccines, the spike protein is—no surprise—a popular candidate.
- Subunits can be delivered in formulations with adjuvants—accessory ingredients that can enhance immune responses. One common adjuvant is alum, an aluminum salt, long known to be useful for vaccines. Some newer subunit vaccines come in snappier packages, however. These include artificial “virus-like particles” (VLPs) and nanoparticles.
- Subunit vaccines are already an established vaccine platform. The HPV vaccine in use involves a VLP that feeds the immune system proteins from the HPV’s outer shell—which can then be targeted by antibodies.
- RNA and DNA vaccines: These are among the newest types of vaccines—and among the shakiest. There are currently no licensed vaccines that use this method. But researchers are optimistic about their potential.
- The basic idea is to deliver genetic material of a virus—either in the form of DNA or RNA—directly to human cells, which are then somehow compelled to translate that genetic code into viral proteins and then able to make antibodies against those.
- Some of the details of how these candidate vaccines work are proprietary and unproven, so it’s difficult to assess how likely they are to succeed or how easy it will be to scale up vaccine production if they are successful.
- As mentioned earlier, in some previous work on developing a vaccine against SARS-CoV-1—the virus behind SARS—researchers came across a few instances where candidate vaccines seemed to make disease worse in animal models. This led to some instances of organ damage in a few animal models, namely monkeys, ferrets, and also mice.
- So far, it’s unclear what was going on there. Some researchers have speculated that it may be a form of Antibody-Dependent Enhancement (ADE). Very generally, this is a scenario in which the immune system makes antibodies against an invading germ, but those antibodies are not able to neutralize the germ completely. This can make the situation worse if the shoddy antibodies signal for immune cells to respond while the germ is still infectious. Basically, the antibodies are just recruiting immune cells to be the germ’s next victims. And this, in turn, can lead to additional—excessive—immune responses that end up damaging the body.
- One of the best understood examples of this occurs with dengue viruses. There are four types of dengue viruses that circulate (in people and mosquitoes), and research suggests that some antibodies to one type of dengue may sometimes generate ADE in subsequent infections or exposures with other types of dengue. This is why researchers think that some patients with dengue fever, which can be a mild disease, go on to develop dengue hemorrhagic fever. This is a rare but severe form of the disease in which immune cells release chemicals called inflammatory cytokines that end up damaging the circulatory system, leading to blood plasma leaking out of capillaries. From there, the patient can go into shock and die.
- But, many researchers are not convinced that ADE is behind some of the problems seen with early SARS vaccines—nor that ADE will necessarily be an issue with a C19 vaccine. For one thing, the berserk immune responses seen in the animal models don’t seem to involve some of the same immune system components seen in well-understood cases of ADE, like dengue.
- “There’s no clear evidence that ADE is an issue,” microbiologist Maria Elena Bottazzi tells Ars. Bottazzi is the associate dean of the National School of Tropical Medicine at Baylor College of Medicine.
- Instead, Bottazzi and colleagues hypothesize that something about the coronaviruses and whole-virus vaccine candidates may induce an excessive, aberrant inflammatory response, potentially through the activity of specialized, pro-inflammatory immune cells called T helper 17 cells, which are linked to inflammatory autoimmune diseases. This may help explain why some patients with the most severe forms of C19 seem to experience so-called “cytokine storms,” which are like a disastrous deluge of pro-inflammatory signals unleashed by the immune system that end up causing damage to the body—just like in the animal models.
- Much of this is still speculative, but Bottazzi says what we know so far may be helpful for directing vaccine development strategies. She notes that the excessive immune responses may mainly occur when the immune system is presented with a whole, intact coronavirus particle. Something about interacting with that whole particle may send our immune systems into a tailspin, the thinking goes. A safer strategy may be to use a subunit vaccine or another more targeted approach to train our immune systems—an approach that only shows the immune system what it needs to see to defeat the virus.
- Many vaccine developers are already on board with this thinking, it seems. Bottazzi notes that most of the candidates in development now do not involve the whole virus, but subunits, genetic material, or other targeted strategies. “Having the whole virus, of course it has higher risks, so the new platforms are actually selecting for better candidates,” she says.
- Bottazzi and her colleagues are themselves now working up such a subunit vaccine candidate for SARS-CoV-2, which follows up on their vaccine work for SARS-CoV-1. The vaccine includes just a portion of the SARS-CoV-2 spike protein—the precise segment that actually binds to human cells.
- She notes that further questions about potential ADE or excessive immune responses to any candidate vaccine might be more closely looked at further along in vaccine development, perhaps in phase II trials. But, right now, “it’s not a high-ranking concern,” she says.
- Another potential problem vaccine developers should keep in mind is how long the antibody responses may last in the body. Past research has suggested that coronaviruses that cause just common colds—there are four strains of these that circulate in humans—don’t prompt long-lasting antibodies. A person may only be protected for a few years.
- Ideally, vaccines should be optimized to generate the strongest immune response possible that will, hopefully, offer long-lasting if not life-long protection. But, if immune responses to an otherwise effective vaccine wane over time, and SARS-CoV-2 becomes an endemic disease or comes in seasonal waves, we may have to look at periodic boosters until a more effective vaccine is developed.
- We already have annual vaccines for influenza, but this is because the influenza virus mutates so quickly that our immune system may not recognize strains from one year to the next. Also, there are different mixes of strains circulating from season to season. Both of these issues lead to the need for season-specific vaccine formulations. So far, SARS-CoV-2 does not seem to be mutating in a particularly fast or problematic fashion, suggesting that we may not need seasonal shots—at least not for these reasons.
- With all of this in mind, vaccine developers have charged ahead. There are currently at least 102 candidates, and eight of them are in clinical trials.
- One of the earliest was an RNA vaccine, called mRNA-1273, from biotechnology company Moderna. As we mentioned earlier, vaccines based on genetic material are unproven so far. Moreover, because the technology is so new, much of it is still proprietary, so outside researchers don’t know a lot about how these vaccines work. As such, they’re difficult to assess from the outside—and it’s difficult to know how easy it will be to scale up production for worldwide vaccination campaigns (if they work), Bottazzi says.
- Based on what we know about Moderna’s work, their vaccine contains the genetic blueprints for the SARS-CoV-2 spike proteins. The genetic code is modified to have artificial components—such as pseudouridine instead of RNA’s usual uridine—so that the immune system doesn’t automatically recognize the vaccine as foreign genetic material and try to destroy it. The genetic material is also packaged for cell delivery in a lipid nanoparticle.
- Moderna, working with the National Institutes of Health, got a clinical trial set up in February and gave its first doses to humans on March 16. If all goes to plan, the company has suggested that it could have a vaccine ready for frontline healthcare workers by this fall.
- Meanwhile, in China, biotechnology company CanSino Biologics began a trial March 17 for its viral vector-based vaccine candidate. The strategy packages genetic material from SARS-CoV-2 into a weakened adenovirus strain. The company has already gotten to work on a Phase II trial.
- Beijing-based Sinovac Biotech made headlines this month after its whole-virus inactivated SARS-CoV-2 vaccine candidate was shown to protect a small number of monkeys from C19 in early lab tests. Its Phase I clinical trials in humans began on April 16. The results are positive, but some researchers are anxious to see more testing and safety data.
- Researchers at Oxford University are also off to a good start with their viral vector-based vaccine candidate. They have packaged the SARS-CoV-2 spike protein in a weakened adenovirus, similar to CanSino’s approach. And like Sinovac, their vaccine has protected a small number of monkeys in early lab experiments. Oxford researchers began dosing trial participants last week. The researchers told The New York Times that if the trials go to plan, they could produce millions of doses by September.
- The latest, ever-expanding and updating list of candidate vaccines assembled by the World Health Organization can be found here.
Source: Ars Technica here