Audio digest of this article:
See updates (at the end of this article) about the WHO resuming its hydroxychloroquine trial and three of the authors of the controversial article about hydroxychloroquine published in The Lancet on May 22 retracting their study. Updated statistics can be found here.
It’s more than four months since the city of Wuhan in China’s Hubei province was locked down – at 10 a.m. local time on January 23 – and the world began to realise that a novel coronavirus had been identified and was spreading.
Many countries are still in lockdown. Only a few are emerging relatively unscathed by the pandemic.
More than 5.8 million cases of Covid-19 have been reported worldwide and the death toll is now put at 358,100. More than 2.5 million people are reported to have recovered and there are reported to be more than 2.9 million active cases globally.
The highest number of recorded cases and deaths is in the United States, with more than 1.7 million total recorded cases, more than 102,000 recorded deaths, and more than 1.15 million reported active cases.
Doctors are grappling with symptoms that are unlike those they dealt with in the previous SARS and MERS epidemics and are struggling to find the best treatments in a situation that is evolving all the time. They are seeing patients in a condition that is more like high-altitude sickness than pneumonia and people suffering from blood clots that appear to be an effect of infection with SARS-CoV-2, the virus that causes Covid-19.
Doctors in the US, Britain, and Italy are reporting increases in cases of the rare inflammatory disorder, Kawasaki disease, in young children and a link is being made with SARS-CoV-2.
According to a new study by Chinese scientists Yiwen Zhang et al., SARS-CoV-2 uses the same strategy to evade attack from the human immune system as the human immunodeficiency virus (HIV) does.
According to the Chinese researchers, whose report was published as a preprint on bioRxiv.org and has not been peer-reviewed, both viruses remove marker molecules on the surface of an infected cell that are used by the immune system to identify invaders.
The researchers warned that this commonality could mean that Sars-CoV-2 could be around for some time, like HIV.
The Chinese scientists collected T-cells from five patients who had recently recovered from Covid-19. These cells are generated by people after they are infected with Sars-CoV-2 and their job is to find and destroy the virus.
The T-cells used in the study were not effective at eliminating Sars-CoV-2 in infected cells. When the scientists took a closer look they found that a molecule known as major histocompatibility complex (MHC) was missing.
As researchers work to understand more about how Sars-CoV-2 operates, pharmaceutical companies in the US , China, the UK, India, and Australia are announcing their progress – or lack of progress – in the race to find a vaccine and a pharmaceutical company in San Diego in the United States says it has identified a specific antibody that it says inhibits SARS-CoV-2 infection of healthy cells.
Scientists are also examining how SARS-CoV-2 has made its way around the world. The results of a study by a group of researchers from the US, Canada, Scotland, and Belgium challenge previous findings about how the earliest sustained SARS-CoV-2 transmission networks became established in Europe and the US.
Michael Worobey et al. say their results refute findings that erroneously linked cases in Europe and the US in January 2020 with outbreaks that occurred weeks later.
“Rapid interventions successfully prevented onward transmission of those early cases in Germany and Washington State,” the researchers say in a preprint article published on bioRxiv on May 23.
“Other, later introductions of the virus from China to both Italy and Washington State founded the earliest sustained European and US transmission networks.”
Worobey et al. say their analyses reveal “an extended period of missed opportunity when intensive testing and contact tracing could have prevented SARS-CoV-2 from becoming established in the US and Europe”.
The researchers say that, despite the early successes in containment, SARS-CoV-2 eventually took hold in both Europe and North America during February 2020: evidently first in Italy in early February, then in Washington State mid-February, and then in New York City later that month.
“Our finding that the virus associated with the first known transmission network in the US did not enter the country until mid-February is sobering, since it demonstrates that the window of opportunity to block sustained transmission of the virus stretched all the way until that point,” Worobey et al. said.
In spite of the continued deaths, and the debilitation suffered by those infected by SARS-CoV-2, there is growing restlessness in the United States, and in some European countries, among those who are demanding an end to lockdowns and a return to “normal life”. In the US, many of the anti-lockdown demonstrators are heavily armed.
The number of new coronavirus cases continues to rise in 17 US states. These include Georgia, Arkansas, California, and Alabama. Over the recent Memorial Day weekend, however, people thronged the beaches in Florida, Maryland, Georgia, Virginia, and Indiana and hundreds of Americans threw caution and social distancing to the wind at crowded pool parties.
The world has essentially divided into two main groups: those who consider Covid-19 to be dangerous enough to warrant forgoing certain liberties for now so as to protect their own health and that of other people and those who say Covid-19 is a “plandemic”, a hoax created to bring about a New World Order, keep people under what they refer to as “house arrest”, and force everyone to submit to mandatory vaccination.
Some people find themselves stuck in the middle, worried about the pandemic, but also concerned about the way the authorities in some countries appear to be using Covid-19 as a reason to restrict civil liberties.
There is talk of the “new normal”: life after Covid-19, which, it is said, will never be the same as it was pre-pandemic. Air travel, for example, will be transformed into an ordeal that even seasoned travellers will now dread. There is much resistance against the “new normal” among those who say it will be a totalitarian, AI-ruled dystopia.
For environmentalists, a different kind of “normal” would be no bad thing. The Earth is getting time to breathe during the lockdowns, they say, and animals are reclaiming spaces that humans had overwhelmed.
Billions of people around the world are too poor and neglected to care about the New World Order or the plans of the self-appointed vaccine czar, Bill Gates, but those who do have the time to think about where the world is heading are frequently at loggerheads.
Those who prefer to comply with lockdowns and stay at home are mocked by those who claim to be “woke”. Those complying with the Covid-19 restrictions are accused of being “sheeple”. Those protesting against confinement say their freedom to go out, work, not wear a mask, and basically do what they wish is primordial. This pits them against those whose loved-ones have died from Covid-19 or who are in the essential services and are working on the front line. Those who see Covid-19 as a real and ever-present danger consider the protesters to be selfish and short-sighted.
There appears to be a distinct east–west divide, with the anti-lockdown protests mostly occurring in the West. European anti-lockdown protesters cite countries like Taiwan as examples of success against Covid-19 without lockdown, but they neglect to mention that Taiwan has employed widespread tracking (a “digital fence”) that most Europeans would never accept.
At last week’s AutismOne conference, which took place online this year, the American lawyer and environmentalist Robert F. Kennedy Jr said it was a tragedy that the issue of Covid-19 was turning into a partisan issue.
“This should not be a partisan issue,” Kennedy said. “It should be an issue that we can all talk about, and that we can debate civilly. This is going to affect our nation for generations. We ought to not be taking sides and moving into tribalism.”
Ironically, the anti-lockdown protests are in countries where the restrictions have not been extreme and people have, for example, still been able to go out and take exercise.
In Texas, the owner of a hairdressing salon was briefly jailed after keeping her business open in defiance of public health orders and then refusing to apologise in court for what she had done. The Republican senator of Texas, Ted Cruz, flew from Houston to visit Shelley Luther’s salon for a haircut.
‘Why are people allowed to shop in Walmart when Christians are not allowed to gather in church?” the anti-lockdown protesters argue. “I’m healthy, I don’t have Covid; why should my rights be infringed upon?”
The US president, Donald Trump, has said he will override governors if they choose not to allow places of worship to open as “essential places that provide essential services”.
He does not have the power to do this, but he could potentially withhold federal aid to states if they do not allow religious services to resume.
In the US, and in other countries, there have been numerous Covid-19 outbreaks that started in religious meetings.
Early on in the pandemic, infection clusters occurred in Malaysia and India after large gatherings organised by members of the Islamic missionary movement Tablighi Jamaat.
The German Press Agency Deutsche Presse-Agentur reported that more than forty people tested positive for SARS-CoV-2 after a Baptist church service in Frankfurt on May 10.
The agency reported that most of those infected were not seriously ill and only one person was recorded as having been admitted to hospital.
Several commentators have pointed out that employees may not feel safe going back to work if they risk being exposed to SARS-CoV-2, but they then risk being fired and could lose unemployment benefits.
Co-host on the Signal Boost radio show, CNN commentator, and political strategist Jess McIntosh says in a video put out on Twitter that it is not a question of US states “reopening” the economy. The economy, she says, is already open.
“What we’re talking about is forcing some people to go back to work in unsafe conditions,” McIntosh said. “That’s not reopening the economy … The people who are protesting are not protesting for the right to be waitresses and hairdressers. They’re protesting for the right to have waitresses and hairdressers … what they want is a haircut. They want service.
“What I want to make sure we know we’re watching is white people, armed white people, screaming for the right to be served. It’s a really small minority … No one is fighting for the right to work.”
White House advisor Kevin Hassett said in an interview on CNN: “Our human capital stock is ready to get back to work.”
Epidemiologist, health economist, and public health scientist Eric Feigl-Ding tweeted in response: “When human lives are merely ‘Capital stock’, that explains everything about the WH reopening strategy.”
A tale of two drugs
The debate over the effectiveness of hydroxychloroquine as a treatment for, and the prevention of, Covid-19 infection continues, with Trump saying he has been taking it as a prophylactic.
The Food and Drug Administration (FDA) in the US has given hydroxychloroquine and chloroquine, from which it is derived, emergency-use authorisation for treating Covid-19. Hydroxychloroquine was already being used off-label for Covid-19 patients by some GPs and in some hospitals.
Hydroxychloroquine is being used to treat Covid-19 patients in several countries in Asia, including India and Malaysia. In India, it has been given as a prophylactic to healthcare workers and police, but plans to give it to people in slums in Mumbai have been shelved.
On May 25, the World Health Organisation (WHO) announced that it had suspended a trial of the use of hydroxychloroquine for patients with Covid-19, saying it wanted to “err on the side of caution”.
This came after the publication, on May 22, of the results of a controversial study that covered six continents and contained an analysis of data from more than 96,000 patients.
The researchers in the US who conducted the study say treatment with chloroquine or hydroxychloroquine (taken with or without the antibiotics azithromycin or clarithromycin) offers no benefit for patients with Covid-19.
Mandeep R. Mehra et al., who published their findings in The Lancet medical journal, also said that, after they accounted for factors including age, race, body mass index, and underlying health conditions including heart disease, lung disease and diabetes, they found that the chloroquine and hydroxychloroquine drug regimens were associated with an increased risk of death.
The study by Mehra et al. has been criticised by 120 scientists from around the world who wrote an open letter to its authors, and the editor of The Lancet, in which they questioned the researchers’ methodology. The scientists listed ten main concerns about the statistical models and the data used by Mehra et al. They demanded more transparency about the provenance of the data and independent validation of Mehra et al.’s analysis.
The WHO said that the executive group of the Solidarity Trial, representing ten of the participating countries, met on May 23 and agreed to review all the evidence about hydroxychloroquine that was globally available.
The trial is testing remdesivir, lopinavir-ritonavir, lopinavir-ritonavir with interferon beta-1a, and hydroxychloroquine as potential treatments for Covid-19.
The executive group decided to implement a “temporary pause” of the hydroxychloroquine arm of the Solidarity Trial while the safety data was reviewed by the data safety and monitoring board, the WHO said.
Enrolment for the hydroxychloroquine trial was temporarily suspended on May 24.
The director of the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection in Marseille, Didier Raoult, casts aside claims that hydroxychloroquine is too dangerous to be used as a treatment for Covid-19. There are patients, Raoult says, who have been taking it as a treatment for rheumatoid arthritis for thirty years.
Ocular side effects never occur over a period of about ten days, which is the length of time such treatment would be needed in the case of Covid-19, Raoult says. They occur, he says, in the case of one percent of patients after five years’ treatment.
Raoult argues that using hydroxychloroquine, which is already well known, is safer than using new drugs whose toxicity has not yet been established.
The anti-viral drug remdesivir, which is much more expensive than hydroxychloroquine and was invented by the pharmaceutical company Gilead Sciences, originally to treat Ebola, has been much vaunted by the director of the National Institute of Allergy and Infectious Diseases (NIAID), Anthony Fauci. In the case of Ebola, remdesivir was found to be adequately tolerated, but less effective than several monoclonal antibody therapeutics.
Fauci said data shows that remdesivir “has a clear-cut and significant positive effect in diminishing the time to recovery” in cases of Covid-19.
Elizabeth Lee Vliet, writing for The Association of American Physicians and Surgeons website, talks of the rapid and unusual FDA authorisation for remdesivir.
In an article entitled ‘A Tale of Two Drugs: Money vs. Medical Wisdom’, Lee Vliet writes about how, at a presidential briefing on April 30, Fauci announced early results, prior to peer review, of one clinical trial of remdesivir.
“At the ‘warp speed’ currently in vogue for the Fauci-led push to a new vaccine, the very next day the FDA issued an Emergency Use Authorisation (EAU) for remdesivir to be used in seriously ill hospitalised patients,” she wrote.
“To announce the emergency approval, President Trump met with the CEO of the drug’s manufacturer, Gilead Sciences, in the Oval Office.”
In the case of hydroxychloroquine, Lee Vliet writes, it took two months from the publication of reports of successful use in China and South Korea to get the March 28 FDA EUA for use in hospitalised COVID-19 patients.
“HCQ was approved in 1955 for malaria, and later for lupus and rheumatoid arthritis. Over the last 65 years, hundreds of millions of prescriptions have been written for HCQ worldwide,” Lee Vliet writes.
“The EUA for HCQ did not, however, expand its availability but imposed restrictions to prevent non-hospitalised patients from accessing the government’s stockpile of the drug.”
The dark side of lockdowns
Lockdowns have had a massively negative effect on economies, not least in countries that depend heavily on tourism, and innumerable businesses have gone under.
The darker side of confinement also includes patients with health problems outside of Covid-19 being unable to get treatment, or being too afraid to go to hospitals or clinics for a medical checkup, and the plight of migrant workers in India who had to leave the big cities because they could not afford to pay for accommodation and basic necessities. Thousands of seafarers are stranded on cargo and cruise vessels in foreign ports around the world.
Millions of Indian migrant workers have walked hundreds of kilometres to reach their villages. Mainstream and social media have carried harrowing images of whole families, many barefoot, trudging along roads night and day, carrying all they own, and chasing after trucks to try and get a ride at least some of the way home.
Sixteen migrant workers died when they were run over by a freight train in the state of Maharashtra. They had fallen asleep on the railway tracks.
The Wire reported that as many as six migrants, including a four-year-old and a one-month-old, died in the course of, and after, travelling on the Shramik Special trains that have been designated to take migrants to their home villages.
According to The Wire, on May 23 a 46-year-old migrant worker died on a Shramik special train while travelling to Jaunpur after not getting water or food for sixty hours and a one-month-old baby died of heat and dehydration on May 25 on a train to Gorakhpur.
The Telegraph reported about the death of a four-year-old who became desperately hungry when, on May 24, the Shramik Special train took 39 hours to go from Delhi to Patna – more than double the usual time.
The train crawled along throughout the day, stopping intermittently as the temperature reached more than 40 degrees, and no food was distributed during the day, the Telegraph reported.
The railway ministry has blamed route congestion for the lengthy Shramik Special delays.
On April 15, the Stranded Workers Action Network (SWAN) in India published a report that included the following findings.
- Fifty percent of workers had rations left for less than one day.
- Ninety-six percent had not received rations from the government and 70 percent had not received any cooked food.
- Seventy-four percent had less than half their daily wages remaining to survive for the rest of the lockdown period.
- Eighty-nine percent had not been paid by their employers at all during the lockdown.
- Forty-four percent of the calls received were “SOS” calls from people with no money or rations left or who had previously skipped a meal.
- The rate of hunger is exceeding the rate of relief. The percentage of people who said they had less than one day of rations increased from 36 percent to 50 percent in the third week of lockdown while the percentage of people who received government rations increased from one percent to only four percent in the third week of lockdown.
- The percentage of people who did not get cooked food from the government or any local organisation decreased from 80 percent to about 70 percent from the end of the second week post lockdown to the end of the third week post lockdown.
The Malaysian authorities have been criticised for their treatment of undocumented workers during the pandemic. Several major raids were conducted in and just outside the capital, Kuala Lumpur, and more than two thousand undocumented workers were taken to crowded detention centres, where there are now large clusters of Covid-19 cases.
More than one hundred Covid-19 cases have been detected at three detention centres since May 21. While most Malaysians remained indifferent to, or supported, the crackdown against undocumented workers, human rights activists condemned the raids.
Phil Robertson from Human Rights Watch tweeted that the detentions risked worsening the pandemic in Malaysia, both in terms of potential outbreaks inside the detention camps and also by making undocumented people less likely to cooperate.
The Asia Pacific Refugee Rights Network said many of those arrested were asylum seekers not formally registered by the United Nations’ refugee agency the UNHCR.
There has been a dramatic upsurge in domestic violence during the Covid-19 lockdowns.
The United Nations secretary-general, António Guterres, tweeted about the urgent need to combat domestic violence, saying: “I urge all governments to put women’s safety first as they respond to the pandemic.”
Guterres has described the global surge in domestic violence as horrifying. “Local support groups are paralysed or short of funds,” he said. “Some domestic violence shelters are closed; others are full.”
In Beijing, China, the NGO Equality, which works to combat violence against women, has seen a surge in calls to its helpline since early February. Local media reported that, in Hubei province, domestic violence reports to police more than tripled in one county alone in February, rising from 47 in 2019 to 162 this year.
There have been similar reports in numerous countries, from Brazil, Russia, Cyprus, Singapore, and Belgium to Ireland, Italy, Australia, Poland, and Britain.
The National Commission for Women in India has recorded a 100 percent increase in domestic violence during the lockdowns and this just relates to reports sent to the commission by email, so the real increase is certain to be higher.
In Spain, the domestic abuse helpline received 18 percent more calls in the first two weeks of lockdown compared with the first two weeks of the previous month.
In France, police have reported a nationwide spike of about thirty percent in violence against women, including sexual violence.
The China Global Television Network (CGTN), which is an international English-language news channel based in Beijing, reported that some countries had taken new steps to support victims of domestic abuse. Italy, Spain, and France were turning vacant hotel rooms into temporary shelters for women escaping domestic violence, CGTN reported.
In Spain, the report continued, the government launched the initiative Mascarilla 19. Victims of domestic violence are urged to discreetly ask for help at a pharmacy by ordering a “mask 19”, a code that initiates a call to the police. France and Italy quickly adopted the code in their pharmacies as well, CGTN reported.
The Fondation Jean-Jaurès in France has reported on the Covid-19 pandemic’s negative effect on women’s rights and lives all around the world.
In an article published on April 27, and written under the foundation’s banner, the French minister for equality, Marlène Schiappa, says confinement not only increases domestic violence but also decreases women’s opportunities to find help or to end the cohabitation.
“Confinement with a predator or an abusive man is obviously the first cause, but we can also note a greater difficulty for women to go out and find help from colleagues, friends or their families,” Schiappa wrote.
“In addition to that, confinement can escalate tensions and create conflicts: without confusing conflicts and violence, one can lead to the other and the escalation can accelerate without any way of unwinding, external intervention by a third party, or easy access to an alternate shelter.”
Citing a report in the newspaper El Pais, Schiappa said that, over a two-week period during the lockdown in Mexico, the number of arrests for domestic violence increased by 7.2 percent, and 1,608 domestic violence cases were being investigated. Some women’s associations reported increases of up to sixty percent in the number of calls they received about domestic violence.
Britain’s largest domestic abuse charity, Refuge, reported a 25 percent increase in calls to its helpline over a five-day period during the week beginning March 30, a week after the UK government imposed a nationwide lockdown.
On April 6, after significant media reports about its national domestic abuse helpline, the charity reported that calls and other appeals were up by 120 percent as compared with the previous day.
“The true number of women experiencing domestic abuse is likely to be much higher and is why Refuge has also developed an online webform which women can use to access support if they are unable to call,” the charity said. The webform allows women to specify a safe time when they can be contacted.
Authorities in Britain reported that nearly three times as many women had been killed by their spouse during a three-week period during the Covid-19 lockdown than the average for the same period over the past decade, Schiappa said. This statistic is based on data compiled by monitoring and advocacy groups.
Karen Ingala Smith, who runs Counting Dead Women and is the CEO of Nia, a nonprofit dedicated to ending sexual violence and domestic abuse, said that, in the three weeks from March 23, 14 women were killed by men in the UK. That’s the highest number recorded in more than ten years.
Smith said that the lockdown had not created more violent men, but escalated long-lasting abuse and, because lockdown significantly reduced social contact, support services became less accessible.
Schiappa says that cyber harassment also increases during lockdowns.
“The idleness of confinement, lack of supervision and the feeling of impunity of cyber-attackers behind their screens tend to favour online harassment,” she wrote.
“Sexist digital raids targeted against influencers or young women, targeted cyber-harassment of public, scientific or political women who speak in the media, as well as revenge porn skyrocket during confinement.”
The World Health Organisation’s regional director for Europe, Hans Kluge, said member states had reported up to a sixty percent increase in emergency calls from women subjected to domestic violence in April this year, as compared to 2019. Online inquiries to domestic violence hotlines had increased up to five times, Kluge said.
There is also concern that lockdowns are increasing the suicide rate.
António Guterres wrote in an article for Time magazine: “Unless we act now to address the mental health needs associated with the pandemic, there will be enormous long-term consequences for families, communities and societies.”
Far-right activists challenge lockdowns
A legal action against the lockdown in Ireland was brought by the far-right wannabe politician Gemma O’Doherty and former journalist John Waters.
The pair said that Covid-19 legislation introduced in Ireland amounted to an effective suspension of citizens’ constitutional rights. In proceedings against Ireland’s minister for health and the attorney-general, O’Doherty and Waters sought the leave of the High Court to bring judicial review proceedings challenging the constitutionality of legislation and regulations enacted to arrest the spread of the novel coronavirus in the country.
They also challenged the steps taken and the procedures followed by the Oireachtas (legislature) in enacting the legislation.
The preliminary application to determine if permission to bring their legal challenge should be granted was heard by Justice Charles Meenan.
Justice Meenan refused the application. In his ruling, he said that the applicants, in their Statement of Grounds and submissions to the court, questioned the accuracy of the figures given for the numbers of people infected with the virus that causes Covid-19 and the number of deaths reported.
“They went a good deal further and maintained that the science involved was ‘fraudulent’,” Justice Meehan said. “Other than their views, the applicants identified no supportive expert opinion either in the Statement of Grounds or grounding affidavit.”
The judge added in his ruling: “Unfortunately, in making their case for leave the applicants, who have no medical or scientific qualifications or expertise, relied upon their own unsubstantiated views, gave speeches, engaged in empty rhetoric and sought to draw an historic parallel with Nazi Germany – a parallel which is both absurd and offensive.
“Unsubstantiated opinions, speeches, empty rhetoric and a bogus historical parallel are not a substitute for facts.”
The EURACTIV independent pan-European media network has reported that anti-lockdown protests in Germany have been infiltrated by far-right extremists.
EURACTIV quoted Matthias Quent, who researches right-wing extremism and is the director of the Institute for Democracy and Civil Society in Jena and describes the anti-lockdown demonstrations in Germany as “classically populist, anti-intellectual and anti-institutional”.
The media network also quoted Gideon Bosch from the Moses Mendelssohn Centre for European Jewish Studies in Potsdam as saying: “In the corona-crisis, we are already seeing a further normalisation of anti-Semitism and racism, which threaten social cohesion and the participation of those attacked.”
Quent says the importance of the anti-lockdown protests in Germany should not be overestimated.
“According to current surveys, around 81 percent of the German population is satisfied with the government’s management of the pandemic,” EURACTIV reported.
In an interview with Science magazine, Marc Lipsitch, an epidemiologist and professor at Harvard University’s TH Chan School of Public Health, compared lockdowns as a pandemic response to getting to a “life raft” without solving the bigger problem: how to get to the shore?
‘Too little too late’
While Gemma O’Doherty and John Waters have little support for their extreme position, there is widespread criticism of the Irish government’s handling of the Covid-19 crisis, with accusations that it has been taking too little action too late.
Ireland is not yet in phase two of easing Covid-19 restrictions, but one local said on Twitter on Thursday: ” … was at the beach today and it was packed along with many other beaches, and social distancing in shops is nearly out the window”.
Writing an opinion piece in the Irish Times, Mark Paul reacted with shock and horror to a new proposal that travellers coming in to Ireland should be quarantined for two weeks at a “designated facility”. Paul described this as a plan for “the future involuntary detention for two weeks of any returning Irish travellers from abroad”.
Paul said the recommendation came in a letter that the country’s chief medical officer, Tony Holohan, wrote to the government on May 8.
New regulations that have already been decided upon in Ireland, and will initially be in effect from May 28 to June 18, require incoming travellers to provide the address at which they will self-isolate for 14 days.
This measure is already being put into place in Britain and is already in effect in France. From June 8, all international arrivals in Britain, including returning Britons, will be required to self-isolate for 14 days and provide the authorities with details of where they will be staying.
The measure will be enforced in England through random spot checks and £1,000 fines for noncompliance. Lorry drivers, seasonal farm workers, and coronavirus medics will be exempt. The requirement will also not apply to those travelling from the Republic of Ireland, the Channel Islands, and the Isle of Man.
France’s Foreign Minister, Jean-Yves Le Drian, said that, as of May 20, French citizens and residents returning from abroad will be asked to place themselves in voluntary quarantine.
‘Stay alert’ strategy comes under fire
Britain’s prime minister, Boris Johnson, has come under fire for his shift of strategy from “Stay at Home” to “Stay Alert” and a large proportion of the British public are scandalised by the behaviour of Johnson’s advisor Dominic Cummings, who drove 260 miles out of London, to Durham, with his wife and child during lockdown. Cummings was already ill with Covid-19.
Johnson has defended Cummings, saying he acted responsibly, and, in a press conference on May 25, Cummings offered no apology and said he believed he was acting “reasonably” and within the law. He said he made the right decision as he had Covid-19, his wife was ill, and Durham was the place he knew there were people who could take care of their son if the boy’s parents were both incapacitated.
Cummings even admitted that, on April 12, 15 days after he started to have Covid-19 symptoms, he drove to Barnard Castle, southwest of Durham, to “test” whether he was in fit condition to drive back to London the next day. He said he and his wife were worried because Cummings’ eyesight seemed to have been affected by Covid-19.
The recorded death toll for Covid-related deaths in Britain is more than 37,000 and the recorded number of active cases stands at nearly 60,000.
The co-founder of Scientists for EU, Mike Galsworth, who is a visiting researcher at the London School of Hygiene and Tropical Medicine, put out a message on social media about the British government’s current strategy for combatting Covid-19. He says the government wants to start moving the country out of lockdown, but to not itself take responsibility for the actions of the public. It is, he says, a move from “red to green”, “home to alert” and “if things do go wrong there can be more shift of blame onto the public and how the public has responded rather than the government”.
The government, Galsworth says, has not given any single irresponsible instruction to the public, “but increasingly would be able to blame the public for doing conga in the streets, for having their street parties, or for not listening to the wisdom of Boris Johnson”.
The statistics for Covid-19 cases and deaths are widely disputed. Some say they are hugely overestimated and others say the number of cases and deaths must be much higher than the media reports.
The Centers for Disease Control and Prevention (CDC) in the US caused consternation earlier this month when it acknowledged that it was mixing the results of two different kinds of tests for SARS-CoV-2 infection: the RT-qPCR test, which is designed to identify people who are actively infected, and a more rapid serology test, which looks for antibodies to identify people who have previously been infected.
There are serious concerns that this mixing of test results could be creating an inaccurate picture of the state of the pandemic in the US.
The CDC’s practice was first reported by the Miami public radio station WLRN and was confirmed by the CDC in a subsequent email to National Public Radio (NPR).
Several states, including Pennsylvania, Georgia, and Texas are reported to also be conflating the results of RT-qPCR and antibody tests.
Even if traces of SARS-CoV-2 are found in an antibody test, those results are not logged by states or by the CDC as “positive” results for an acute infection. Combining the results of the two types of test could reduce the number of tests that appear to be producing positive results, lowering the overall positivity rate.
Jennifer Nuzzo, who is an epidemiologist at the Johns Hopkins Center for Health Security, told NPR that putting the results of RT-qPCR and antibody testing together could give the impression that more testing of active cases had been conducted than was actually the case. Combining the tests was problematic, she said, because it could give governments and businesses a false picture of the scope of the pandemic.
There is also controversy over the CDC’s newly published Infection Fatality Rate (IFR) for Covid-19.
The CDC is now saying that its best estimate of the overall Covid-19 death rate is 0.26 percent. Officials estimate a 0.4 percent fatality rate among those who are symptomatic (the case fatality rate or CFR) and project a 35 percent rate of asymptomatic cases among those infected, which would bring the overall infection fatality rate (IFR) to just 0.26 percent.
Eric Feigl-Ding tweeted that the CDC’s IFR was “implausibly low”.
Biology professor Carl T. Bergstrom tweeted: “Their best estimate of the CFR for people over 65 is 1.3%, and the worst case scenario is 3.2%. I’d love to know how these estimates were obtained, given that they are being used for government planning and recommended to modelers everywhere.”
He added: “The more I think about it, the more this bothers me. These numbers are so far outside of the scientific consensus that this strikes me as a devious and cynical effort to manipulate not only federal modeling but the broader scientific discourse.”
Both RT-qPCR and antibody tests can give inaccurate results. The antibody tests are particularly unreliable.
On March 22, pathologist Sin Hang Lee, who is the director of Milford Molecular Diagnostics in Connecticut in the US, wrote to the WHO and White House Coronavirus Task Force representatives offering to retest borderline or questionable positive samples.
The letter was sent to Margaret Harris and Eduardo Guerrero from the WHO and Anthony Fauci.
“It has been widely reported in the social media that the RT-qPCR test kits used to detect SARS-CoV-2 RNA in human specimens are generating many false positive results and are not sensitive enough to detect some real positive cases, especially during convalescence,” Sin Hang Lee wrote.
“The major technical flaw of RT-qPCR for molecular diagnosis is the limitation of the length of its DNA probe which is about 25 bases long or shorter. And hybridisation is not an accurate method to determine nucleotide sequences, the foundation of all nucleic acid-based diagnostics.”
More cases and new clusters as restrictions are eased
As several countries have eased their lockdown restrictions, new cases of Covid-19 have been reported. In France, seventy new cases of Covid-19 were recorded in schools just one week after they reopened. The affected schools were closed again immediately.
Beaches have been reopened in France to runners, swimmers and anglers, but sunbathing is still banned on most beaches.
The beach at La Grande-Motte in the south of France introduced a system whereby people could book a three-and-a-half-hour slot to sunbathe in one of 66 spaces allocated for up to six people and cordoned off by ropes and wooden stakes. Places have to be booked two days in advance. Picnics are still forbidden.
Mayors in Brittany closed down a string of beaches just days after re-opening them for strollers or swimmers, citing dangerous behaviour and lack of social distancing.
Public parks and gardens remain shut in France’s four high-infection red zones, including the Paris region and an area of eastern France.
South Korea had successfully controlled the spread of Covid-19, but this month a new outbreak hit the capital, Seoul.
The new cluster of cases increased to 255 people as of noon on May 26. The cluster has been identified as being linked to the infection of a 29-year-old man who visited several establishments in the nightclub district of Itaewon on May 2.
South Korea’s public health authorities announced that the man, who later tested positive for SARS-CoV-2, may have come into contact with about 5,500 people.
The man was identified as a member of the city’s LGBTQ community and that led to a backlash against members of that community, who already face discrimination.
On May 9, the authorities in Seoul ordered the indefinite closure of all bars and clubs.
Local media reported that, in just two weeks, Seoul tracked down 46,000 people who had been in contact with nightclub goers who were infected with SARS-CoV-2, and tested them. By May 18 the tally of new daily domestic Covid-19 cases had fallen to nine.
On May 26, the government reported that cases in Seoul totalled 792 as of 10 a.m., an increase of 16 cases on the 776 reported at the same time the previous day.
South Korea has made rapid and effective use of information and communications technology; contact tracing and testing. The police worked with telecommunications companies to use mobile phone data to confirm who was in Itaewon on the weekend of May 2.
According to the Washington Post, the authorities used GPS tracking, credit card records, and video surveillance to trace people’s travel history.
South Korea has not locked down the country in its battle against Covid-19. It has closely monitored Covid-19 patients via a phone app. Inbound and outbound traffic to the country has also been closely vetted.
The South Korean Foreign Minister, Kang Kyung-wha, said in an interview on March 18 with the BBC’s Andrew Marr that nearly a quarter of a million people in South Korea had been tested to that date.
Kang Kyung-wha told Marr that the basic principle of the strategy in South Korea was openness and transparency, “fully keeping the public informed”. There was a very good health care system that was “highly wired”, she said.
There have been problems with South Korea’s cautious reopening of schools. Students at 66 schools in the port city of Incheon were sent home just three hours after they arrived after two students tested positive for SARS-CoV-2.
Hundreds of schools in the country were obliged to close yesterday (Friday) just days after they reopened. Thousands of students had returned to school on Wednesday, but, on Thursday, 79 new Covid-19 cases were recorded, the highest daily figure in nearly two months.
Hundreds of kindergartens and schools have postponed reopening.
In another development in South Korea, researchers found that patients who tested positive for SARS-CoV-2 weeks after recovering from Covid-19 probably aren’t capable of transmitting the infection.
Scientists from the Korean Centres for Disease Control and Prevention studied 285 people who had been diagnosed with Covid-19 who had tested positive for SARS-CoV-2 after their illness had apparently resolved and they had previously tested negative.
Virus samples collected from these patients couldn’t be grown in culture, which indicates that the patients were shedding non-infectious or dead virus particles.
For the first time since the pandemic began, China, on May 23, reported no new cases of Covid-19. Fears of a second wave means that many restrictions are still in place.
The small city of Shulan in northeastern China was locked down when a growing cluster of infections was identified there. All villages and residential compounds in the city were sealed off at noon on May 18.
The city’s coronavirus prevention and control group said that only one person per household was allowed out every two days for two hours to buy essentials. No one is allowed to enter or leave villages or compounds where there are suspected or confirmed cases and, in these cases, all supplies are to be delivered by local stores.
Elsewhere in the Asia-Pacific region, Vietnam has been very successful in its battle against Covid-19 and Thailand was this month able to ease its restrictions.
On May 22, Thailand reported no new SARS-CoV-2 infections or deaths. The total number of cases now stands at 3,065, sixty-three of which are active, and the death toll is 57.
On May 17, the country opened shopping malls and department stores after a closure lasting more than two months. Shoppers are expected to use the ‘Thai Chana’ mobile phone app to enter malls and stores.
Vietnam, where there has been very strict contact tracing, has not reported a single death from Covid-19.
In Taiwan, the Central Epidemic Command Centre announced on May 18 that there had been no new cases of Covid-19 for 11 straight days. Taiwan’s total number of cases stands at 441, with only 14 of them active. The death toll stands at seven.
Taiwan’s vice-president, Chen Chien-jen, has been praised for his handling of the Covid-19 pandemic.
Chen Chien-jen was a top health official during the SARS crisis in 2003. The New York Times reports that the reforms he introduced to prepare Taiwan for any further epidemics including building isolation wards and virus research laboratories, establishing a disaster management centre, increasing the production of protective gear, and revising the infectious disease law.
New Zealand is another success story. The country has had no new cases for seven days, and now has only eight active cases. The total number of confirmed cases since the start of the pandemic is 1,504, and 1,474 of those people recovered. The death toll is 22. The country’s prime minster, Jacinda Ardern, has also been praised for her handling of the Covid-19 crisis.
Slovakia, which has a population of five million people, has had just 1,500 reported cases of Covid-19, and a death toll of thirty. The country went into lockdown, closing all major airports, before any Covid-19 deaths were reported. A state of emergency was declared in the country on March 15 and the government ordered the closure of all shops except food stores, pharmacies, banks, petrol stations, and post offices from 6 a.m. on March 16.
On March 12, Slovakia announced that it was closing its borders to all foreigners except Polish citizens. Only Slovakian citizens or those with a residence permit were then allowed to enter the country and all Slovaks returning from abroad had to remain in quarantine for two weeks.
Greece, where an early and strict lockdown was imposed, has reported fewer than 200 Covid-19 deaths and just under 3,000 total cases.
On May 15, Slovenia became the first European country to officially state that its Covid-19 epidemic was over. There had been fewer than seven new cases each day for the previous two weeks.
The country’s National Institute of Public Health said that “all indicators point to a slowdown in the spread of the virus in the population”.
Slovenia started easing its lockdown on April 20 and there have been no signs of an increase in infections.
People coming from European Union states who have not left the EU in the previous 14 days no longer need to go into quarantine for seven days on arrival in Slovenia, but a 14-day quarantine is still mandatory for those arriving from non-EU states, except for diplomats and those involved in transporting cargo. Any foreign citizen with signs of Covid-19 infection will not be allowed to enter the country.
Social distancing requirements remain, however, masks must be worn in public indoor spaces, and only very small public gatherings are allowed.
Sweden has been held up as an example of how to tackle Covid-19 without going into lockdown, but the picture is not as rosy as some would make out.
The number of deaths of people diagnosed with Covid-19 has declined in the country, but Sweden recorded an average of 6.25 deaths per million inhabitants per day between May 12 and 19, according to Ourworldinsata.org. This number was the highest in Europe at that time.
Over the course of the pandemic, Sweden has had fewer deaths per capita than the United Kingdom, Spain, Italy, Belgium and France, which have all opted for lockdowns, but the death toll is much higher than in neighbouring Denmark, Norway, and Finland. Recently, Sweden had the largest daily increase in active cases.
Most schools, restaurants, and other businesses have been kept open in Sweden during the pandemic and the government has placed the onus on the public to implement social distancing. The elderly were advised to stay at home, there has been no school for those aged over 16, and gatherings of more than fifty people were banned.
Sweden and the UK have the most Covid-19 deaths per capita in the world, followed by Brazil.
New analysis by the Financial Times indicates that, looking at “total excess deaths per million people”, the UK has suffered the second-highest death toll from the Covid-19 pandemic after Spain.
According to the Financial Times, the UK has registered 59,537 more deaths than usual since the week ending March 20, which, the FT says, indicates that SARS-CoV-2 has directly or indirectly killed 891 people per million.
Until Thursday, the UK had a higher rate of death than in any country for which high-quality data exist. However, Spain revised its mortality estimates, adding 12,000 to its toll of excess deaths from Covid-19. This increased its death rate to 921 per million.
The absolute number of excess deaths in the UK is the highest in Europe, and is second only to the US, according to data collected by the Financial Times.
In France, Germany, and Italy the number of active cases is in decline. Until recently, the number of cases had declined in Spain, but there is now an increase. Nevertheless, the country is about to reopen to tourism and there will be no quarantine or self-isolation imposed for incoming visitors.
Brazil has been hard hit by Covid-19. On May 18, the health ministry said there had been 674 new coronavirus deaths and there were 254,220 confirmed cases in the country.
This made Brazil the country with the third-highest number of Covid-19 infections, behind the US and Russia.
The Covid-19 death toll in Brazil is now put at 25,697 and there are reported to be 222,317 active cases.
The country’s daily tally does not indicate that infections and deaths necessarily occurred in the previous 24 hours, but rather that the records were entered into the system during that time period.
In Brazil, 15 percent of the fatalities attributed to Covid-19 have been deaths of people aged under 50. This is ten times more than the number of deaths in this age group in Italy and Spain.
In Mexico, nearly 25 percent of deaths attributed to Covid-19 have been of people aged between 25 and 49.
In India, officials reported this month that nearly half of those who have died from Covid-19 were aged under sixty.
In the US, more than 20,000 African Americans have died from Covid-19. This is nearly one in 2,000 of the country’s entire black population.
In Indonesia, at least 55 medical workers – 38 doctors and 17 nurses – have died from Covid-19 complications.
An official with the government’s coronavirus task force, Wiku Adisasmito, said that limited supplies of personal protective equipment (PPE), combined with fatigue and risky emergency procedures, contributed to the high rate of fatalities among medical personnel.
Wiku Adisasmito said the situation had been exacerbated by patients not being honest about their infection, recent travel history, and contacts.
Indonesia has recorded 24,538 Covid-19 cases, including 16,802 that are still active. The death toll is put at 1,496.
The vaccine race
As the race to produce a vaccine gains pace, concerns about the dangers of such a vaccine, or such vaccines if several are brought to market, are growing. There is already fast tracking and there is bound to be inadequate testing.
There is much evidence that there is a plan to introduce global, mandatory vaccination, and this would merge with Bill Gates’ desire for “digital certificates”, contained in quantum-dot tattoos, to be introduced to identify who has been tested for Covid-19, who has recovered, and who has been vaccinated against it.
Gates describes himself as a health expert, but has no scientific qualifications whatsoever.
There are currently no DNA or RNA vaccines approved for human use, but Gates says that the time for trying these out on the world’s population has arrived.
On May 18, the American biotech company Moderna issued a press release entitled “Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus”.
The company is putting a shiny gloss on results from the trials of their vaccine that are not at all promising.
Robert F. Kennedy, Jr has been scathing about Moderna’s vaccine claims.
“This morning, Moderna was up 39 percent and rising on the news of its ‘successful’ COVID vaccine trials,” he wrote on Instagram on May 19. “All five networks were parroting Moderna’s claim that its fast track clinical trial was a triumph.
“Then our Instagram exposed the entire canard as smoke and mirrors; the shocking 20 percent ‘serious’ injury rate (medical intervention or hospitalisation required) among the extremely healthy volunteers in the high dose group means the vaccine is DOA [dead on arrival].”
There are concerns that there will, with vaccines against SARS-CoV-2, be pathogenic priming, also known as disease enhancement. This happened with vaccines against SARS.
Research scientist James Lyons-Weiler wrote in an article published in March: “In SARS, a type of ‘pathogenic priming’ of the immune system was observed during animal studies of SARS spike protein-based vaccines.
“The exposure of vaccinated animals to the SARS virus led to increased morbidity and mortality. The problem, highlighted in two studies, only became obvious following post-vaccination challenge with the SARS virus.”
He added: “SARS-CoV-2 is the sister taxon of SARS-CoV. If pathogenic priming is to occur in humans given spike-protein based SARS-CoV-2 vaccine, as is expected given the SARS spike protein animal studies, the 20 percent mortality rate expected in the elderly could raise to 40 percent – and the rest of the population could be sensitised and we could see mortality rates worldwide of the next coronavirus higher than 20 percent.”
Damian Garde, writing for the Stat news website, reported that Moderna’s chief medical officer, Tal Zaks, began this year with nearly 100,000 shares in the company.
“In late February, days before Moderna announced that its coronavirus vaccine was ready for human testing, he began dumping 10,000 shares a week, Garde reported.
“Over the next 11 weeks, as the pandemic pushed Moderna’s share price from $18 to $50, Zaks liquidated his entire position, making $3.4 million in the process.”
Once Zaks ran out of stock, he began exercising options priced at $12.21 per share, Garde reports.
“Over the next two weeks, he sold more than 250,000 more Moderna shares at an average price of $67. Zaks profited more than $18 million from his 2020 trades. He currently holds zero shares of Moderna stock.”
Garde reports that the top five executives at Moderna have sold more than $89 million of stock so far this year – initiating nearly three times as many stock transactions than in all of 2019.
“The trades, which led to about $80 million in profits, were prescheduled through a legal programme that allows company insiders to buy and sell shares at a later date,” Garde wrote.
Kennedy wrote on Instagram on the day that Moderna issued its press release (May 18): “Despite Moderna’s cheery press release this morning, the clinical trial results for its groundbreaking Covid vaccine could not be much worse.
He says the vaccine, developed and championed by Anthony Fauci and financed by Bill Gates, used an experimental MRNA technology that the two men hoped would allow rapid deployment to meet President Trump’s ambitious ‘warp speed’ time line.
“Dr Fauci was so confident of his shot’s safety that he waved ferret and primate studies (Moderna suspiciously reported no health data from its mouse studies).”
Kennedy (pictured left) says that three of the 15 people in the high dose (250 microgrammes) cohort suffered a “serious adverse event” within 43 days of receiving Moderna’s vaccination.
Moderna did not release its clinical trial study or raw data, Kennedy says, and its press release was freighted with inconsistencies.
Moderna allowed only exceptionally healthy volunteers to participate in the study.
The company did not explain why it reported positive antibody tests for only eight trial participants, Kennedy says.
“These outcomes are particularly disappointing because the most hazardous hurdle for the inoculation is still ahead; challenging participants with wild Covid infection.”
Moderna describes the effects on the three people receiving 250 microgrammes of mRNA-1273 as “grade 3 systemic symptoms, only following the second dose”.
The company stated: “All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.”
It added that the levels of neutralising antibodies at day 43 were at or above levels generally seen in convalescent sera.
Moderna said its findings were based on results from the first eight people who each received two doses of the mRNA-1273 vaccine, starting in March.
The company said it was now proceeding on an accelerated timetable, with the next phase involving six hundred people to begin soon.
Moderna says that additional tests in mice that were vaccinated and then infected showed that its vaccine could prevent SARS-CoV-2 from replicating in their lungs. The company says the animals had levels of neutralising antibodies comparable to those in the people who had received the vaccine.
Moderna says the high 250-microgramme dose is being eliminated from future studies, “not so much because of the side effects, but because the lower doses appeared to work so well that the high dose is not needed”.
The company says that its trial showed that mRNA-1273 “was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies”.
It says the sole incidence of a grade 3 adverse event in the cohorts given a 25-microgramme and a 100-microgramme dose was a single participant, given the 100-microgramme dose, who experienced grade 3 redness around the injection site.
The chairman and president of the non-profit organisation ACCESS Health International, William Haseltine, has criticised Moderna for putting out a press release without adequate data, and affecting its share prices. Moderna’s announcement, he says, was premature as only eight people had been studied. “It was not impressive and it was opaque,” Haseltine told CNBC television.
The Oxford Vaccine Group
William Haseltine also points out that, in the trials of a vaccine being tested at Oxford University, none of the monkeys who were vaccinated were protected against SARS-CoV-2. He told CNBC: “Yes, they didn’t have as much virus in their lungs, but they still had a nasal infection. A hundred percent of the vaccinated monkeys got infected.”
Despite the Oxford University’s vaccine failing to prevent infection in macaques, and not stopping them from spreading the infection to others, there will still be trials on humans, and no saline placebo will be used.
Adult participants in both the Phase II and Phase III trials will receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or the MenACWY meningitis vaccine, Nimenrix, which will be used as a “control”.
The Oxford University researchers, who are working in collaboration with the pharmaceutical company AstraZeneca, argue that it is better to use another vaccine rather than a saline solution as a control.
It’s stated on the university website: “The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever.
“Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine.
“It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study.”
There has been widespread criticism of the Oxford group’s decision to use a meningitis vaccine as a control. One American doctor, Michael Master, tweeted: “It should be saline placebo and, most definitely, not another vaccine! What’s the concern, afraid of too many vaccine side effects so attempting to camouflage w/ similar vaccine? That’s NOT science; that’s deceptive and unethical!”
Australia, China, and India
Testing of a vaccine against SARS-CoV-2 is set to start in Australia, where more than one hundred people in Melbourne and Brisbane have volunteered to take part in the clinical trials.
The Nucleus Network Clinical Research Organisation is working with the US-based biotechnology company Novavax and is set to begin phase one testing of the NVX-CoV2373 vaccine.
Globally, there are dozens of companies and institutions involved in the race to produce a vaccine against SARS-CoV-2. These include 14 projects in India. In China, five of the vaccine projects are at the stage of human trials.
Beijing-based Sinovac Biotech, which developed one of the vaccines being tested, told the Agence France Presse news agency that it was looking to carry out the final stage of its trial abroad because China does not now have a large enough Covid-19 cluster.
In a pre-proof article published in Clinical Immunology on May 21, Aristo Vojdani and Datis Kharrazianb from the Department of Preventive Medicine, Loma Linda University, California, stated: “We live in critical times when the world may be veering towards the very real possibility of requiring immunity certification ‘passports’ earned by prior infection with SARS-CoV-2 or vaccination before being allowed to travel, or perhaps even to work.”
They added: “At the moment, scientists are frantically trying to develop either a definitive cure, neutralising antibodies, or a vaccine to protect us from contracting the disease in the first place, and they want it right now.
“We must consider that finding a vaccine for a disease may normally take years. There are reasons for all the cautions involved in developing a vaccine, not the least of which are unwanted side-effects.”
Vojdani and Kharrazianb said that, in light of the information presented in their report about the crossreactivity of the SARS-CoV-2 proteins with human tissues “and the possibility of either inducing autoimmunity, exacerbating already unhealthy conditions, or otherwise resulting in unforeseen consequences”, it would only be prudent to do more extensive research regarding the autoimmune-inducing capacity of the SARS-CoV-2 antigens.
“The promotion and implementation of such an aggressive ‘immune passport’ programme worldwide in the absence of thorough and meticulous safety studies may exact a monumental cost on humanity in the form of another epidemic, this time a rising tide of increased autoimmune diseases and the years of suffering that come with them,” Vojdani and Kharrazianb said.
Andre Watson, who is the founder and CEO of Ligandal, which he describes as a “regenerative medicine and pandemic defence biotechnology company” tweeted that DNA vaccines and recombinant spike protein vaccine technologies “are likely to generate many of the wrong antibodies, which can lead to antibody-dependent enhancement and worsening of viral symptoms”.
Missing MHC molecules
Andre Watson has also commented about the new discovery by Chinese scientists that MHC molecules are absent from molecules when there is a Sars-CoV-2 infection.
“This is really not good,” Watson tweeted. “SARS-infected cells are becoming MHC-negative. This means that chewed up pieces of the virus are not appearing on the cell surface for T cells to be able to recognise.”
He added: “While innate immune cells (NK cells) actively clear cells that are MHC-, this is a big blow to adaptive immunity, especially when coupled with antibody avoidance techniques the virus has.”
Eric Feigl-Ding explained: “The molecule is an identification tag usually present in the membrane of a healthy cell, or in sick cells infected by other coronaviruses such as SARS. It changes with infections, alerting the immune system whether a cell is healthy or infected by a virus.”
He added: “HIV uses the same strategy – MHC molecules are also absent in cells infected with that virus. In contrast, Sars-1 does not make use of this function. The SARS-2 coronavirus removes these markers by producing a protein that pulls MHC inside the infected cell and destroys them”
Feigl-Ding says suppression of MHC molecules has also happened in other viruses such as some herpes viruses. The new coronavirus was not hijacking T-cells and turning them into a means to reproduce, as HIV did, he said. The new virus, he says, has been mutating at a much slower pace.
He tweeted: “By destroying/suppressing MHC molecules used by T-cells to identify which cells are foreign-invaded (virus infected), #SARSCoV2 effectively cloaks itself inside cells it infects, thereby hiding from T-cells & allowing time to reproduce! This cloak is very bad.”
In a Viewpoint entitled ‘The Ethics of COVID-19 Immunity-Based Licences (“Immunity Passports”)’, published on May 6 in the Journal of the American Medical Association, Govind Persad and Ezekiel J. Emanuel say that immunity-based licences “have the potential to help realise important values, including enhancing the liberty of individuals who have been infected with Covid-19 without worsening the situation of those who have not been infected, maximising benefits to individuals and society by allowing immune people to engage in economic activity, and protecting the least advantaged by allowing safer care for vulnerable populations”.
Commenting on the article by Persad and Emanuel, Michael Hoffer from the Miller School of Medicine at the University of Miami, said, however: “In a society where leaders are often too desperate to reach for and then publicise ‘solutions’ it is critical that science unequivocally states that this type of licensing while not unethical is potentially the most disastrous and divisive option and that implementation requires overcoming a host of very significant obstacles the list or which exceeds what this article presents.”
Hoffer said he had “grave concerns” that the authors of the paper did not reach a more firm conclusion “that this licensing would be a grave mistake”.
Persad and Emanuel say immunity-based licences do not violate equal treatment “because the factors used to grant a licence are not discriminatory, like race or religion, but instead grounded in relevant evidence”.
While immunity-based licences require careful implementation and scientific support to be ethical in practice, “nothing makes them unethical in principle”, the researchers say.
Persad and Emanuel prefer the term “immunity-based licences” rather than “immunity passports”.
“Passports suggest an all-or-nothing permission and endorse categorical denial of access to an entire country,” they wrote.
“In the setting of Covid-19, immunity-based licences could apply to specific, high-risk activities, such as working in a nursing home, and could permit exceptions and gradations.
“The ethical case for immunity-based licences can be buttressed by working to ensure that licences do not exacerbate inequality.”
Ethically sound immunity licensing policies would reject licence fees and would ensure that unlicensed people are not subject to social or economic exclusion, are not banned from entering grocery stores, using public services, or travelling, and are not confined to their homes for an indefinite period of time, Persad and Emanuel say.
“Activities currently permitted under public health orders, like walking outdoors, driving, interacting with household members, and shopping or working remotely or at businesses like grocery stores, should not require immunity licences.
“The list of activities that require licences should change in response to public health needs, as the least restrictive alternative principle requires.”
Persad and Emanuel say. argue that preferentially hiring immune individuals in nursing homes or as home health workers could reduce the spread of the novel coronavirus in those facilities and better protect the people most vulnerable to Covid-19.
“Friends, relatives, and clergy who are immune could visit patients in hospitals and nursing homes,” they said.
Persad and Emanuel point out that serology tests used to determine whether someone has had Covid-19 for licensing purposes must be valid and reliable, with high specificity and sensitivity.
“This requires a governmental body, such as the FDA, to establish and impose valid, evidence-based certification procedures. Immunity-based licences can only be introduced if serology testing is accurate.
“In addition, depending on rigorous evidence regarding the duration of immunity, periodic testing and renewal of immunity licences at designated intervals based on specific criteria may be necessary, similar to the renewal process for driver’s licences.”
Persad and Emanuel point out that immunity-based licensing requires evidence that a positive serology test result indicates immunity.
“Otherwise, licences could cause more harm than good by creating a false sense of immunity and facilitating spread.
“As research into immunity progresses, a guiding principle will be that no certification or test is perfect.”
The benefits of immunity licences could encourage forgery, illegal markets, or fraud by unethical physicians or testing facilities, Persad and Emanuel point out.
“These problems underscore the need for careful implementation through strategies like anticounterfeiting designs, cryptographic or biometric features, and reliable chains of verification for tests. But they do not vitiate the advantages of licensing.”
Hoffer said: “The authors acknowledge that there needs to be more science to determine if antibody testing provides immunity but don’t give full weight to the volume of science that would need to be done.”
It would have to be established what amount of antibody confers immunity, Hoffer says.
“The world would need to switch entirely to costly antibody titer testing rather than simple point of care ELISAs [Enzyme-linked immunosorbent assays], and the permanency of immunity would need to be established, likely requiring re-issue of the licence every three months.
“We appreciate that the article was examining ethics but feel it is important for this journal and the AMA to state that firmly that even if ethically sound – this policy is scientifically, medically, and socially disastrously flawed.”
In his commentary on the article by Persad and Emanuel,New School for Leadership in Healthcare in Taipei City, Taiwan, said the authors offered an interesting ethical perspective on immunity-based licences but numerous dilemmas resulted from their proposed initiative:
“Even if governments were to waive licence fees, would they waive the cost of testing as well since test results are needed to determine licence eligibility? If not, it would be socially and economically restrictive to disadvantaged populations,” Ng wrote.
“Licensing requires re-certification after a predetermined length of time. Since COVID-19 is new, immunity might be found to be short-lived. Would the cost associated with issuing a licence be better spent elsewhere?”
Ng points out that determining immunity requires drawing blood and testing for antibodies. “Privacy guarantees would need to limit its analysis. What are the ethical considerations if governments were the ones analysing and storing the samples … ?”
Hydroxychloroquine has been used to treat Covid-19 patients in Malaysia since the outbreak began.
The country’s health director-general, Noor Hisham Abdullah, said patients who were in categories one and two, in terms of the severity of their illness, did not deteriorate into categories four and five when treated with hydroxychloroquine.
Only five percent of Covid-19 patients in Malaysia needed to be admitted to an intensive care unit as compared with ten percent of patients in other countries, he added.
As a result of using hydroxychloroquine, 88 percent of Covid-19 cases in Malaysia were stage one and two, just seven percent were stage three, and five percent were stage four or five, Noor Hisham said.
Stage one is when a patient tests positive for Covid-19, but has no symptoms. At stage two, a patient has only mild symptoms. At stage three, patients have lung infections, but don’t need assistance to breathe and, at stage four, patients, do require help to breath. At stage five, patients need to be put on a ventilator.
In Malaysia, there have been four Covid-19 deaths per million population compared to a world average of 9.7 per million.
The country imposed strict lockdowns, including movement controls during the Raya festivities at the end of Ramadan, and Covid-19 has been well contained. The country’s borders have been closed to foreigner travellers since March 18. Since April 3, a two-week quarantine has been imposed on all people returning to the country from abroad.
The report published in the Lancet on May 22 by Mehra et al. presents a very different picture to that portrayed by Noor Hisham and those scientists who say hydroxychloroquine is a generally safe and effective option for Covid-19 patients.
However, there are serious concerns about Mehra et al.’s statistical analysis and the integrity of the data used in their study.
Mehra et al. say their study suggests that treatment with chloroquine or hydroxychloroquine (taken with or without the antibiotics azithromycin or clarithromycin) offers no benefit for patients with Covid-19.
The researchers go further and say their study shows that treatment of Covid-19 patients with chloroquine or hydroxychloroquine, either alone or in combination with macrolide antibiotics, was linked to an increased risk of serious heart rhythm complications in these patients.
“We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for Covid-19,” Mehra et al. said.
“Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of Covid-19.”
Mehra et al. analysed data from 96,032 patients hospitalised between December 20 last year and April 14 this year. The data came from 671 hospitals on six continents. All the patients had tested positive for SARS-CoV-2 infection.
Nearly 15,000 of the patients were receiving a combination of any of the four drug regimens and just over 81,000 were controls.
Mehra et al. compared outcomes from patients treated with chloroquine alone (1,868), hydroxychloroquine alone (3,016), chloroquine in combination with a macrolide (3,783), or hydroxychloroquine with a macrolide (6,221). Patients from these four groups were compared with the remaining control group of 81,144 patients.
At the end of the study period, about one in 11 patients in the control group had died in hospital. All four of the treatments were associated with a higher risk of dying in hospital, Mehra et al. said.
Of the patients treated with chloroquine or hydroxychloroquine alone, about one in six patients had died (16.4 percent in the case of chloroquine and 18 percent in the case of hydroxychloroquine).
When the drugs were used in combination with a macrolide, the death rate rose to more than one in five in the case of chloroquine and almost one in four in the case of hydroxychloroquine, Mehra et al. said.
The researchers said some of the difference in the mortality rates was due to underlying differences between patients who received the treatments and those who didn’t.
“Researchers suggest these treatment regimens should not be used to treat Covid-19 outside of clinical trials until results from randomised clinical trials are available to confirm the safety and efficacy of these medications for COVID-19 patients,” the report stated.
The clinicians, medical researchers, statisticians, and ethicists who wrote an open letter to the study’s authors and the editor of The Lancet say that the results of the study by Mehra et al. have had a considerable impact on public health practice and research.
“The WHO has paused recruitment to the hydroxychloroquine arm in their Solidarity Trial. The UK
regulatory body, MHRA, requested the temporary pausing of recruitment into all hydroxychloroquine trials in the UK (treatment and prevention), and France has changed its national recommendation for the use of hydroxychloroquine in Covid-19 treatment and also halted trials,” the signatories to the letter wrote.
“The subsequent media headlines have caused considerable concern to participants and patients
enrolled in randomised controlled trials seeking to characterise the potential benefits and risks
of these drugs in the treatment and prevention of Covid-19 infections.”
The criticisms of Mehra et al.’s study listed in the open letter include the following:
- there was inadequate adjustment for known and measured confounders (disease severity,
temporal effects, site effects, and dose used),
- there is no data/code sharing and availability statement in the paper,
- there was no ethics review,
- there was no mention of the countries or hospitals that contributed to the data source, and
- data from Australia were not compatible with government reports (too many cases for just
five hospitals, and more in-hospital deaths than had occurred in the entire country during the
The letter’s signatories also question the data from Africa and say there were “unusually small reported variances in baseline variables, interventions, and outcomes between continents”.
They further question the mean daily doses of hydroxychloroquine cited in the study and say there are “implausible ratios of chloroquine to hydroxychloroquine use in some continents”.
The patient data in the study was obtained through electronic patient records and are held by the US company Surgisphere, the letter’s authors point out.
They say that, “given the enormous importance and influence of these results”, they consider it imperative that Surgisphere provides details about data provenance.
The letter’s authors have called for independent validation of Mehra et al.’s analysis by a group convened by the WHO, “or at least one other independent and respected institution”.
They asked The Lancet, “in the interests of transparency”, to make openly available the peer review comments that led to Mehra et al.’s manuscript being accepted for publication.
French orthopaedic surgeon, oncologist, and statistician Gérard Delépine wrote an article for Agora Vox in which he also challenged the study’s findings, saying they are based on data that is neither verified nor verifiable.
Delépine says there has been an “organised lynching” of chloroquine and hydroxychloroquine by the media.
The media are lauding the study as “the largest international study” about chloroquine and hydroxychloroquine, but it is not even a macroanalysis, he says.
“In reality, we are dealing only with a large collection of unsupported data, based on non-verifiable elements, recovered by a private for-profit site,” Delépine said.
None of the authors of the study is an infectious disease specialist, Delépine says, and none has treated a patient with Covid-19; and there is conflict of interest.
The hospital registers cited in the study are mainly American, Delépine adds, are not published in international literature, and are not accessible on the Internet.
“Their medical values and data have never been verified by independent doctors. The article in question therefore constitutes only a sum of data of uncertain values, coming from sites whose selection is possibly biased.”
It is no coincidence, Delépine says, that, while hydroxychloroquine is being lynched, the drug remdesivir, which, he says, “will in reality only do good to the shareholders of Gilead” is being vaunted.
Delépine points out that the study in question refers only to hospitalised patients. “The aim of treatment with hydroxychloroquine is to avoid hospitalisation by treating patients early in the course of the disease.
“This study of registers is retrospective and non-randomised, without a control group drawn by lot.”
It’s unscientific and biased, Delépine says, to select only the failures of a treatment to supposedly assess its global interest. “The conclusion that chloroquine and hydroxychloroquine are ineffective is invalidated by their own figures.”
The researchers’ conclusions about excess mortality after treatment with chloroquine or hydroxychloroquine are biased by their sampling and/or their a priori, Delépine says.
“Only a prospective study could assess the risk of mortality and the cardiac risk,” he said.
“The risk of heart rhythm disturbances after treatment with hydroxychloroquine alone has been known for seventy years and is well below one percent. The possibility that the risk could be increased if azithromycin is also given cannot be excluded in the elderly with heavy comorbidity, but has not been observed in pregnant women in malaria-endemic countries where these drugs are frequently used together.”
In a report published in the New England Journal of Medicine on May 7, Joshua Geleris et al. said that the administration of hydroxychloroquine was not associated with either a greatly lowered or an increased risk of intubation or death.
The report gave the results of a study of hospitalised patients diagnosed with Covid-19. The researchers said randomised, controlled trials of hydroxychloroquine in patients diagnosed with Covid-19 were needed.
Didier Raoult says hydroxychloroquine can be contraindicated if a patient is taking the heart medication Cordarone, but this, he says, is derisory given the positive effects the drug can have.
Raoult says there are no major risks in the use of azithromycin, but, as a precaution, certain patients would need to undergo an electrocardiogram before they are given it.
The WHO says that those patients “previously randomised to hydroxychloroquine treatment” should continue to receive hydroxychloroquine until they finish their course of treatment.
“The use of hydroxychloroquine and chloroquine are accepted as generally safe for use in patients with autoimmune diseases or malaria,” the organisation said.
The WHO’s director-general, Tedros Adhanom GhebreyesusTedros, told patients taking the medication for its well-established uses beyond Covid-19 that they shouldn’t worry.
“This concern relates to the use of hydroxychloroquine and chloroquine in Covid-19,” he said. “I wish to reiterate that this drug is accepted as generally safe for use in patients with autoimmune diseases and malaria.”
The WHO said a final decision about the harm, benefit, or lack of benefit of hydroxychloroquine for the treatment of Covid-19 would be made once the evidence had been reviewed by the data safety and monitoring board. This review would include data from the Solidarity Trial and other ongoing trials as well as any evidence published so far.
Valerie Richardson, reporting for The Washington Times, said that an international poll of more than 6,000 doctors released on April 2 found that the hydroxychloroquine was the most highly rated treatment for Covid-19.
Richardson said the survey, conducted by Sermo, of 6,227 physicians in thirty countries found that 37 percent of those treating Covid-19 patients rated hydroxychloroquine as the “most effective therapy” in a list of 15 options.
Sermo found that hydroxychloroquine usage for Covid-19 treatment was most widespread in Spain, where 72 percent of physicians surveyed said they had prescribed it, followed by Italy (49 percent). The drug was least popular among those surveyed in Japan, where just seven percent said they had used it to treat Covid-19.
One critic of the Sermo study said it was a non-random survey of physicians, a survey of doctors’ gut instincts. Randomised, double-blind experiments were the only way to truly measure effectiveness, the netizen said.
Gilead Sciences said on April 29 that positive data had emerged from the NIAID study of remdesivir for the treatment of Covid-19.
“We understand that the trial has met its primary endpoint,” the company said.
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of Covid-19. Its safety and efficacy for the treatment of Covid-19 patients are being evaluated in multiple ongoing phase 3 clinical trials.
Fauci told reporters that the data presented by an independent data and safety monitoring board showed that patients on remdesivir recovered in 11 days, compared with 15 days for patients receiving a placebo.
Fauci said that, although a 31 percent improvement didn’t seem like “a knockout 100 percent”, it was a very important proof of concept. It had been proven that a drug can block this virus, he said. Fauci also said the mortality rate among patients receiving remdesivir trended toward being lower than in patients who received a placebo (8 percent versus 11 percent), but that the difference was not yet statistically significant and the data needed to be further analysed.
The results of a different clinical trial published on April 29 in The Lancet indicated that remdesivir was not associated with statistically significant clinical benefits in Chinese patients with severe Covid-19 when compared with placebo.
Yeming Wang et al. said that in their study of patients admitted to ten hospitals in Hubei with severe Covid-19, remdesivir “was not associated with statistically significant clinical benefits”.
The numerical reduction in time to clinical improvement in those treated earlier required confirmation in larger studies, the researchers said.
After one month, it appeared 13.9 percent of the remdesivir patients had died compared to 12.8 percent of patients in the control arm. The difference was not statistically significant, Yeming Wang et al. said.
“In this study of hospitalised adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary states.
The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing.
In her article for The Association of American Physicians and Surgeons website Elizabeth Lee Vliet wrote of remdesivir: “Initially for treating Ebola, it failed to show benefit and was shelved. If remdesivir is used to treat COVID-19, Gilead shareholders, not the taxpayers, will profit.”
The pharmaceutical company Sorrento Therapeutics in San Diego in the United States says it has identified a specific antibody that it says inhibits SARS-CoV-2 virus infection of healthy cells.
Sorrento Therapeutics says that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100 percent inhibition of SARS-CoV-2 infection in an in vitro experiment at a very low antibody concentration and after a four-day incubation.
The company says the antibody specifically binds to the S1 subunit of the SARS-CoV-2 spike protein and completely blocks its interaction with the ACE2 receptor.
Sorrento Therapeutics aims to generate an antibody cocktail that would act as a “protective shield” against SARS-CoV-2 infection and remain effective even if virus mutations render a single antibody therapy less effective over time.
The company has determined that STI-1499 will likely be the first antibody in the cocktail it is developing and is also expected to be developed as a stand-alone therapy.
Triple antiviral therapy
The results of a prospective, randomised, phase 2 trial of triple anti-viral therapy were published in The Lancet on May 8. The trial involved Covid-19 patients who were admitted to six hospitals in Hong Kong.
Ivan Fan-Ngai Hung et al. said there was evidence that early treatment with the interferon beta-1b, lopinavir-ritonavir, and ribavirin – alongside standard care – was safe and shortened the duration of viral shedding as compared to treatment with lopinavir-ritonavir alone (on average seven days versus 12 days), in patients with mild to moderate Covid-19.
“Early triple antiviral therapy was safe and superior to lopinavir–ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19,” Ivan Fan-Ngai Hung et al. said. “Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.”
The authors said that larger phase three studies of critically ill patients were needed to confirm whether the triple regimen could provide clinically meaningful benefit.
Ivan Fan-Ngai Hung et al. said: “Previous research found that a combination of oral lopinavir-ritonavir (normally used to treat HIV) and ribavirin (an oral hepatitis C virus drug) significantly reduced respiratory failure and death in patients hospitalised with severe acute respiratory syndrome (SARS) during the 2003 outbreak.
“Interferon beta-1b, which was developed to treat multiple sclerosis (MS), has been shown to reduce viral load and improve lung problems in animal studies of Middle East respiratory syndrome (MERS) coronavirus infection.”
(See earlier article for information about convalescent plasma therapy and treatment with vitamin C and with homeopathy.)
Scientists stress that, overall, children remain minimally affected by Covid-19, but there is concern about a reported increase in cases of Kawasaki disease in young children in the US, Britain, and Italy and researchers say there is a link with SARS-CoV-2.
The recorded cases being linked with SARS-CoV-2 include one of a boy who died in Marseille, France. The French news agency Agence France Presse (AFP) reported on May 15 that a nine-year-old boy had died from a Kawasaki-like disease.
The head of the paediatric intensive care unit at the La Timone hospital in Marseille, Fabrice Michel, was quoted by AFP as saying the child died after a “neurological injury related to a cardiac arrest”.
The boy, who tested positive for the novel coronavirus, received treatment at the hospital for seven days and died on the previous Saturday, the doctor told AFP.
According to AFP, France’s public health agency said there were 125 reported cases of a Kawasaki-like disease in the country between March 1 and May 12. The patients’ ages ranged from one to 14.
In a case in England, a 14-year-old boy with no underlying health conditions was reported to have died from Kawasaki disease at a London hospital on May 13. He had tested positive for SARS-CoV-2.
The governor of New York, Andrew Cuomo, said that three children diagnosed with Kawasaki disease in the state had died and more than 100 cases were being investigated.
Also in the US, a Los Angeles-based children’s hospital has reported three coronavirus patients who have shown Kawasaki disease symptoms.
Kawasaki disease typically affects children under the age of five. It causes blood vessels to become inflamed and swollen. The typical symptoms include fever and rash, red eyes, dry or cracked lips or mouth, redness on the palms of the hands and soles of the feet, and swollen glands. Typically, around a quarter of children affected experience cardiac complications, but the condition is rarely fatal if treated appropriately in hospital. It is not known what triggers the condition, but it is thought to be an abnormal immune overreaction to an infection.
In a paper published in The Lancet on May 13, researchers from the Papa Giovanni XXIII hospital in Bergamo, Italy, stated that there may be a link between SARS-CoV-2 and Kawasaki disease.
Bergamo has the highest rate of infections and deaths from Covid-19 in Italy and is one of the worst affected areas in the world.
Lucio Verdoni et al. reported on ten cases of young children brought to hospital in the Lombardy region of northern Italy and diagnosed as being SARS-CoV-2 positive. The children’s average age was 7.5. Seven were boys and three were girls.
Before the Covid-19 outbreak, doctors at the Bergamo hospital treated about one case of Kawasaki disease every three months. Between February 18 and April 20, 2020, ten children were treated for symptoms of the disease.
The increase could not be explained by a general increase in hospital admissions, the researchers say, as the number of patients admitted during that time period was six-fold lower than before the novel coronavirus was first reported in the area.
The researchers said only 19 children were diagnosed with Kawasaki disease in the Lombardy region in the five years up to the middle of February 2020.
They say the latest reports could represent a thirty-fold increase in the number of cases of Kawasaki disease, but add that it is difficult to draw firm conclusions with such small numbers.
Eight of the ten children brought to hospital after February 18, 2020, tested positive for SARS-CoV-2 in a serological antibody test. Two of them tested positive for SARS-CoV-2 in an RT-qPCR test.
All of the ten children in the study survived, but those who became ill during the pandemic displayed more serious symptoms than those diagnosed with Kawasaki disease in the previous five years, Lucio Verdoni et al. said.
Children diagnosed after the SARS-CoV-2 epidemic began showed evidence of immune response to the virus, were older, had a higher rate of cardiac involvement, and had features of macrophage activation syndrome (MAS), the researchers wrote.
“The SARS-CoV-2 epidemic was associated with high incidence of a severe form of Kawasaki disease. A similar outbreak of Kawasaki-like disease is expected in countries involved in the SARS-CoV-2 epidemic,” they said.
Verdoni told Changing Times that he was very confident, for several reasons, that the trigger for Kawasaki disease in the ten children was SARS-CoV-2.
“The first is that the outbreak of Kawasaki disease occurred just after the appearance of the epidemic in Bergamo. The second is that, in 15 days, we saw a number of patients equal to that seen in the previous three years.”
The cases in the previous three years were also scattered over time, Verdoni said.
“The third, and probably definitive proof, is that almost all these patients had antibodies against SARS-CoV-2, demonstrating that they got infected recently.
“We should consider that only five to ten percent of the healthy population has antibodies against SARS-CoV-2 at this stage.”
Furthermore, Verdoni said, health professionals in other areas of the world have started seeing an outbreak of Kawasaki disease since the Covid-19 pandemic began. “I have no doubt Kawasaki disease in these patients is caused by SARS-CoV-2,” he said.
How might SARS-CoV-2 be involved in causing Kawasaki disease? Verdoni says that coronaviruses trigger a very powerful inflammatory response in the host immune system, causing a cascade of inflammatory molecules. This is called a cytokine storm. The onset of Kawasaki disease is delayed after the SARS-CoV-2 infection, Verdoni says.
Six of the ten children admitted to hospital after February 18 (60 percent) had heart complications, compared with just 10 percent of those treated before the pandemic. Half of the children had signs of toxic shock syndrome, whereas none of the children treated before February 2020 had this complication.
All the patients with Kawasaki disease who were admitted before and after the pandemic received immunoglobulin treatment, but 80 percent of those admitted during the outbreak required additional treatment with steroids, compared with 16 percent of those in those treated before February 2020.
Two of the patients treated after February 18, 2020 tested negative for SARS-CoV-2 on an antibody test. Verdoni et al. say the test used is not 100 percent accurate (95 percent sensitivity and 85–90 percent specificity), suggesting these could be false negative results.
In addition, one of the patients had recently been treated with a high dose of immunoglobulin, a standard treatment for Kawasaki disease, which could have masked any antibodies to the virus.
Annalisa Gervasoni, another author of the study and a paediatric specialist at the Papa Giovanni XXIII hospital, said: “In our experience, only a very small proportion of children infected with SARS-CoV-2 develop symptoms of Kawasaki disease.
“However, it is important to understand the consequences of the virus in children, particularly as countries around the world grapple with plans to start relaxing social distancing policies.”
Writing in a linked comment, Professor Russell Viner, who is president of the Royal College of Paediatrics and Child Health and professor of adolescent health at the Great Ormond Street Institute of Child Health in Britain, who was not involved in the study, said: “Although the article suggests a possible emerging inflammatory syndrome associated with Covid-19, it is crucial to reiterate – for parents and healthcare workers alike – that children remain minimally affected by SARS-CoV-2 infection overall.
“Understanding this inflammatory phenomenon in children might provide vital information about immune responses to SARS-CoV-2 and possible correlates of immune protection that might have relevance both for adults and children.”
Viner points out that children younger than 18 years of age have made up only 1.7 percent of national Covid-19 cases in the US, 1 percent of cases in the Netherlands, and 2 percent of a large observational cohort in the UK.
“Whether these proportions reflect lower susceptibility among children versus adults, or similar infection rates, but much higher proportions with asymptomatic disease, is unclear,” he said.
“Studies from several countries have confirmed that severe illness and death due to Covid-19 among children are rare, with accurate estimates unavailable because of an absence of true population denominators.”
In Britain, the South Thames Retrieval Service in London, which provides paediatric intensive care support and retrieval in southeast England reports that, over a period of ten days in mid-April, 2020, there was “an unprecedented cluster” of eight children with hyperinflammatory shock, showing features similar to atypical Kawasaki disease, Kawasaki disease shock syndrome, or toxic shock syndrome.
Information about the cases is provided in an article by Shelley Riphagen et al., published in The Lancet on May 7.
“This case cluster formed the basis of a national alert,” Riphagen et al. stated. “All children were previously fit and well. Six of the children were of Afro-Caribbean descent, and five of the children were boys. All children except one were well above the 75th centile for weight. Four children had known family exposure to coronavirus disease 2019 (Covid-19).”
The researchers say that the children’s clinical presentations were similar, with unrelenting fever (38–40°C), variable rash, conjunctivitis, peripheral oedema, and generalised extremity pain with significant gastrointestinal symptoms.
“All progressed to warm, vasoplegic shock, refractory to volume resuscitation and eventually requiring noradrenaline and milrinone for haemodynamic support,” Riphagen et al. reported.
“Most of the children had no significant respiratory involvement, although seven of the children required mechanical ventilation for cardiovascular stabilisation. Other notable features (besides persistent fever and rash) included development of small pleural, pericardial, and ascitic effusions, suggestive of a diffuse inflammatory process.”
All the children tested negative for SARS-CoV-2 on broncho-alveolar lavage or nasopharyngeal aspirates.
One child developed arrhythmia with refractory shock, requiring extracorporeal life support, and died from a large cerebrovascular infarct.
“Since discharge, two of the children have tested positive for SARS-CoV-2 (including the child who died, in whom SARS-CoV-2 was detected post mortem),” Riphagen et al. reported. “All children are receiving ongoing surveillance for coronary abnormalities.”
The researchers stated: “We suggest that this clinical picture represents a new phenomenon affecting previously asymptomatic children with SARS-CoV-2 infection manifesting as a hyperinflammatory syndrome with multiorgan involvement similar to Kawasaki disease shock syndrome.”
Riphagen et al. say that one week after the initial submission of their article to The Lancet, the Evelina London Children’s Hospital’s paediatric intensive care unit had managed more than twenty children with a similar clinical presentation, the first ten of whom tested positive for SARS-CoV-2 antibodies. This included the eight children in the cohort described in The Lancet article.
The World Health Organisation (WHO) said in a briefing document on May 15 that those children who did contract Covid-19 generally had milder symptoms than adults, but some children did require hospitalisation and intensive care.
Relatively few cases of infants confirmed to have Covid-19 had been reported, the WHO said, and those who were infected had experienced mild illness.
“Robust evidence associating underlying conditions with severe illness in children is still lacking,” the WHO said.
“Among 345 children with laboratory-confirmed Covid-19 and complete information about underlying conditions, 23 percent had an underlying condition, with chronic lung disease (including asthma), cardiovascular disease, and immunosuppression most commonly reported.”
Commenting about the reports from Europe and North America about clusters of children and adolescents having a condition similar to Kawasaki disease and toxic shock syndrome, the WHO said: “It is essential to characterise this syndrome and its risk factors, to understand causality, and describe treatment interventions.
“It is not yet clear the full spectrum of disease, and whether the geographical distribution in Europe and North America reflects a true pattern, or if the condition has simply not been recognised elsewhere.”
The WHO called for an urgent collection of standardised data describing clinical presentations, severity, outcomes, and epidemiology.
The Japanese Kawasaki disease society states on its website that it has not yet found information in Japan or neighbouring countries that shows a connection between SARS-CoV-2 and Kawasaki disease.
The academic group asked its members to inform them if, in the three months up to April, they had seen any rise in the number of patients with Kawasaki disease. No rise had been reported.
The ‘plandemic’ theory
The “plandemic” theory, which has various strands that range from claims that SARS-CoV-2 doesn’t exist at all to the argument that it does exist, but is no more dangerous than the flu, and that global measures taken against the spread of Covid-19 are part of a planned assault on people’s human rights, has been bolstered by a stream of videos on social media, including those featuring the controversial American research scientist Judy Mikovits, which went viral, garnering millions of views.
Facebook, YouTube, Vimeo, and Twitter removed the 26-minute ‘Plandemic’ video featuring Mikovits from their platforms, but the video is still on the far-right website BitChute and Mikovits has been interviewed on other outlets such as London Real.
Videos featuring Irish scientist Dolores Cahill, who chairs the far-right Irish Freedom Party, are also popular among those who say lockdowns have been a big mistake and Covid-19 is no big deal.
Cahill is a strong advocate of the use of hydroxychloroquine both as a prophylactic and a treatment.
The videos featuring Mikovits, Cahill, and other anti-lockdown – and anti-mask – advocates such as American osteopath Rashid Buttar, who says panic over Covid-19 has been created by falsified statistics, are usually echo-chamber presentations.
The video “interviewers” are usually solid believers in the views of the “interviewee”, who is never challenged, even on controversial points. Other YouTubers then come on board to debunk what has been said and it is difficult for the general public to sift fact from fiction.
Mikovits (pictured left) doesn’t believe that Covid-19 is caused by SARS-CoV-2 alone but, rather, that the virus may serve to activate latent XMRV retroviral infection.
Her theory that XMRV (xenotropic murine leukemia virus-related virus) causes chronic fatigue syndrome has been heavily disputed and her clash with the Whittemore Peterson Institute, a private research centre in Reno, Nevada, where she was research director, turned into a furore that still reverberates today.
Mikovits says that retroviruses, not coronaviruses, are what cause the cytokine storms observed in patients infected with Covid-19.
She suspects that, in people who do not have retroviral infections, SARS-CoV-2 causes no or only mild symptoms.
Mikovits, who co-authored the recently published book Plague of Corruption: Restoring Faith in the Promise of Science, also says that anyone who has received a flu vaccine is likely to register as positive for SARS-Co-V-2 in a RT-qPCR test. Buttar says the same.
Covid-19: the depths of the disease
One ER nurse in the US videoed her heartbreaking descent into the depths of Covid-19 illness. Pamela Orlando, from New Jersey, documented her harrowing fight with the disease until she died, aged 56, on April 16, 24 days after she fell ill.
One of her sons, Reid, told CBS television that he had begged his mother not to go to work, but she continued to battle on the front line.
In an opinion piece for the British Medical Journal, Paul Garner, a professor of infectious diseases at the Liverpool School of Tropical Medicine, talks about having Covid-19. It was, he says, a seven-week roller coaster of ill health, extreme emotions, and utter exhaustion.
One afternoon in mid-March he started to feel strange.
“In the first days at home I wasn’t sure I had Covid-19,” he said. “Then I damaged my hands with bleach. It had no smell, I assumed it was old and inactive – but it was just I could not smell the chlorine.
“The heaviness and malaise became worse, I had a tightness in the chest, and realised it could be nothing else. I was mortified that I might have infected the staff I had worked with for over twenty years. I imagined their vulnerable relatives dying and never forgiving myself. My mind was a mess. “
Garner’s condition deteriorated. “One afternoon I suddenly developed a tachycardia, tightness in the chest, and felt so unwell I thought I was dying. My mind became foggy. I tried to google fulminating myocarditis, but couldn’t navigate the screen properly.”
The tightness in Garner’s chest was replaced by extreme fatigue. Sometimes he felt better, but then the next day he felt as though someone had hit him around the head with a cricket bat.
The illness went on and on, Garner says. “The symptoms changed, it was like an advent calendar, every day there was a surprise, something new. A muggy head; acutely painful calf; upset stomach; tinnitus; pins and needles; aching all over; breathlessness; dizziness; arthritis in my hands; weird sensation in the skin with synthetic materials. Gentle exercise or walking made me worse – I would feel absolutely dreadful the next day.”
Garner says he wrote the opinion piece to get this message out: “for some people the illness goes on for a few weeks. Symptoms come and go, are strange and frightening. The exhaustion is severe, real, and part of the illness. And we all need support and love from the community around us”.
Mara Gay, who is a member of the New York Times editorial board, wrote an article about her experience of contracting Covid-19, which was published on May 14.
“The day before I got sick, I ran three miles, walked ten more, then raced up the stairs to my fifth-floor apartment as always, slinging laundry with me as I went,” Gay wrote.
Gay points out that, in just under two months, an estimated 24,000 people died in New York city after contracting Covid-19. “That’s more than twice the number of people we lost to homicide over the past twenty years,” she wrote.
“When I see photographs of crowds packing into a newly reopened big-box store in Arkansas or scores of people jammed into a Colorado restaurant without masks, it’s clear too many Americans still don’t grasp the power of this disease.”
Gay says that, on the second day of illness, she woke up to what felt like hot tar buried deep in her chest. “I could not get a deep breath unless I was on all fours. I’m healthy. I’m a runner. I’m 33 years old,” she wrote.
“In the emergency room an hour later, I sat on a hospital bed, alone and terrified, my finger hooked to a pulse-oxygen machine. To my right lay a man who could barely speak but coughed constantly. To my left was an older man who said that he had been sick for a month and had a pacemaker.”
Gay says she is one of the lucky ones. “I never needed a ventilator. I survived. But 27 days later, I still have lingering pneumonia. I use two inhalers, twice a day. I can’t walk more than a few blocks without stopping.
“I want Americans to understand that this virus is making otherwise young, healthy people very, very sick. I want them to know, this is no flu.”
The debate about whether wearing a face mask helps to prevent SARS-Co-V-2 infection has not abated. Anti-lockdown protesters demand the freedom not to wear a mask and argue that their health will be negatively affected by mask wearing. Judy Mikovits is one of many who say that mask wearing makes people sick. Anti-mask netizens argue long and hard about their right not to wear what some of them describe as a “muzzle” and one described mask wearing as “demeaning”.
The argument in favour of mask wearing is “My mask protects you, and your mask protects me”. Discussions about which masks are better than others, and whether cloth masks help to combat Covid-19, continue.
In an extremely comprehensive e-print paper, posted on arXiv on April 22, De Kai et al. say the results of their research into the effect of mask wearing during the Covid-19 pandemic “show a near perfect correlation between early universal masking and successful suppression of daily case growth rates and/or reduction from peak daily case growth rates, as predicted by our theoretical simulations”.
In their paper, which has not been peer reviewed, De Kai et al. say their theoretical and empirical results argue for urgent implementation of universal masking.
“As governments plan how to exit societal lockdowns … a ‘mouth-and-nose lockdown’ is far more sustainable than a ‘full body lockdown’, on economic, social, and mental health axes,” they wrote.
De Kai et al say that some studies do indicate negative effects of improper cloth mass use, for instance higher risks of infection as a result of moisture retention, reuse of poorly washed cloth masks, and poor filtration compared with medical masks.
They added, however: “To address concerns that lay individuals may use both medical and/or cloth and paper masks incorrectly, masking techniques and norms need to be taught with targeted information to different demographics, just as proper handwashing and social distancing techniques have been taught.”
The researchers say that masking should be mandatory or strongly recommended for the general public when in public transport and public spaces for the duration of the Covid-19 pandemic.
They also say that masking should be mandatory for individuals in essential functions (health care workers, social and family workers, the police and the military, the service sector, construction workers, etc.) and medical masks and gloves or equally safe protection should be provided by employers. Cloth masks should be used if medical masks are unavailable, De Kai et al. say.
“Until supplies are sufficient, members of the general public should wear nonmedical fabric face masks when going out in public and medical masks should be reserved for essential functions,” they added.
On Tuesday President Trump asked the Reuters White House correspondent Jeff Mason (pictured below, on the left) to take off his mask during a White House news conference.
Trump said he couldn’t hear Mason and, when the reporter said he would just speak louder, Trump mocked him, saying “because you want to be politically correct”. Mason replied: “No sir, I just want to wear the mask.”
Trump’s own task force has recommended face coverings while in public to help stop the spread of SARS-CoV-2.
Trump mocked former vice-president Joe Biden for wearing a mask at a Memorial Day ceremony and mostly avoids donning one himself.
Natural or engineered?
There is still no clarity about where SARS-CoV-2 originated, and there are numerous theories. These range from the theory that the virus originated in wildlife to suggestions that it was released, either accidentally or on purpose, from the National Biosafety Laboratory in Wuhan, or that it came from the American biowarfare laboratory in Fort Detrick, Maryland. (See earlier article for statements and articles that support the view that SARS-CoV-2 originated in wildlife.)
French scientist Luc Montagnier, who was a joint winner of the 2008 Nobel Prize for discovery of the human immunodeficiency virus (HIV), has caused controversy with his assertion that some nucleotide sequences of HIV-1 have been found in the SARS-CoV-2 genome. Other scientists have challenged Montagnier’s assertion, saying that each of these sequences also appears in other viruses.
Montagnier says that the sequences in question must have been added to SARS-CoV-2 and that this could not have happened naturally. It is meticulous, professional work, Montagnier says.
Detractors say that a tiny bit of the SARS-CoV-2 genome is about 85 percent similar to part of the HIV-1 genome, but that the sequence can be found in other viruses.
A paper by Indian scientists who said there were four unique inserts in the 2019-nCoV (SARS-CoV-2) spike glycoprotein that were not present in any other coronavirus reported to date was retracted by the authors.
The paper had been published as a preprint on bioRxiv on January 31. It was stated on bioRxiv that the authors intended to revise the paper “in response to comments received from the research community on their technical approach and their interpretation of the results”.
Prashant Pradhan et al. had said the inserts were either identical or similar to the motifs in the highly variable (V) regions (V1, V4 and V5) in the envelope glycoprotein or in the Gag protein of some unique HIV-1 strains from three different countries (Thailand, Kenya and India).
They speculated that these motif insertions sharing similarity with HIV-1 proteins could provide an enhanced affinity towards host cell receptors and increase the range of host cells of 2019-nCoV. The study implied that 2019-nCoV might be generated by gaining gene fragments from the HIV-1 genome.
In a paper published on February 14 on PubMed Central (PMC), Chuan Xiao et al. discuss the Indian scientists’ assertions and their own examination of the sequences of 2019-nCoV, other CoV viruses and HIV-1 as well as the GenBank database.
Chuan Xiao et al. say their results demonstrate no evidence that the sequences of the four inserts are HIV-1 specific or that 2019-nCoV obtained these insertions from HIV-1.
“First, the results of blast search of these motifs against GenBank shows that the top 100 identical or highly homologous hits are all from host genes of mammalian, insects, bacterial and others,” Chuan Xiao et al. said.
“There are only a few hits on coronaviruses, but none of them are HIV-1 related.”
Chuan Xiao et al. say the insertion sequences in question exist widely in all kinds of viruses.
“While the 100 percent match between the insertion 1 and 2 sequences and the HIV sequences were found in 19 entries, the matches between the insertion 3 and 4 sequences and HIV-1 sequences were rather poor (from 42 percent to 88 percent).
“Sequences that completely match the insertion 3 and 4 sequences were not found in any HIV-1 sequences. This clearly shows that these insertion sequences are widely present in living organisms including viruses, but not HIV-1 specific.”
Montagnier also puts forward the theory that the novel coronavirus came from the Wuhan laboratory, escaping in an “industrial accident” when Chinese scientists were attempting to develop a vaccine against HIV.
Whatever the origin of SARS-CoV-2, there is widespread evidence that the virus has been mutating.
Researchers in China have detected 33 mutations of SARS-CoV-2, including 19 that were previously undiscovered.
Lanjuan Li et al. found that some of these mutations could lead to functional changes in the virus’s spike protein, which SARS-CoV-2 uses to attach itself to human cells.
“We provide direct evidence that the SARS-CoV-2 has acquired mutations capable of substantially changing its pathogenicity,” Li and her collaborators wrote in a paper that has not been peer reviewed and was published on the preprint server medRxiv on April 19.
The researchers found that the most aggressive strains of Sars-CoV-2 could generate 270 times as much viral load as the least potent type.
The mutations that had the highest viral loads had also been found in most patients across Europe, according to Li and her colleagues. Those strains with lower viral loads were the predominant ones found in parts of the United States.
Li et al. analysed the SARS-CoV-2 strains isolated from 11 randomly chosen Covid-19 patients from Hangzhou in the eastern province of Zhejiang. They examined how the virus acted on cells. Li and her team used a sophisticated method known as ultra-deep sequencing.
“A diverse collection of mutations was identified in the 11 viral isolates, including two sets of founding mutations for two major clusters of viruses currently infecting the world population,” Li et al. wrote.
The researchers found that 19 of the identified mutations were novel. This was despite the relatively early sampling dates and indicated that “the true diversity of the viral strains is still largely underappreciated”, they said.
All of the 11 viral isolates had at least one mutation.
Scientists at deCODE genetics and their colleagues from Iceland’s Directorate of Health and the National University Hospital say 291 mutations of SARS-Cov-2 have been found in the country that have not been identified elsewhere.
In an article in the New England Journal of Medicine the researchers said that analysis of sequence data revealed that the haplotypes of the virus detected in the early targeted testing were almost entirely of the A2 clade originating in Austria and Italy and entering Iceland with people returning from skiing holidays. (Haplotypes are a set of genetic determinants located on a single chromosome.)
“By contrast, the cases identified in the more recent targeted testing and in deCODE’s population screening show that various haplotypes of the A1 clade prevalent in countries such as the UK had become more common, and that there is now a wide and growing variety of haplotypes present in the population,” the researchers said.
“This suggests that the virus entered Iceland from many countries, including those that were then deemed low-risk.”
Researchers from Germany and England have meanwhile identified three main variants of the virus, distinguished by amino acid changes, which they have named A, B, and C.
In an article published in the Proceedings of the National Academy of Sciences of the United States of America, Peter Forster et al. say that type A is the “ancestral type according to the bat outgroup coronavirus”.
They added: “The A and C types are found in significant proportions outside East Asia, that is, in Europeans and Americans. In contrast, the B type is the most common type in East Asia, and its ancestral genome appears not to have spread outside East Asia without first mutating into derived B types, pointing to founder effects or immunological or environmental resistance against this type outside Asia.”
Forster says that the Wuhan B-type virus could be immunologically or environmentally adapted to a large section of the East Asian population.
“It may need to mutate to overcome resistance outside East Asia. We seem to see a slower mutation rate in East Asia than elsewhere, in this initial phase,” he said.
He added: “The viral network we have detailed is a snapshot of the early stages of an epidemic, before the evolutionary paths of Covid-19 become obscured by vast numbers of mutations. It’s like catching an incipient supernova in the act.”
The research team has extended its analysis to 1,001 viral genomes. Forster says the latest work, which has yet to be peer reviewed, suggests that the first infection and spread among humans of Covid-19 occurred between mid-September and early December last year.
Forster et al. say that, outside of East Asia, 10 B-types were found in viral genomes from the United States and Canada, one in Mexico, four in France, two in Germany, and one each in Italy and Australia.
While the ancestral B type is monopolised (26/26 genomes) by East Asians, they say, every single (19/19) B-type genome outside of Asia has evolved mutations.
Type C is the major European type, the researchers say, and is represented in France, Italy, Sweden, and England, and in California and Brazil. It is absent in the mainland Chinese sample, but evident in Singapore and also found in Hong Kong, Taiwan, and South Korea.
Sin Hang Lee says four mutations of the virus have been identified in the US: two that were reported in California, one that was identified in Texas, and one that was found in Massachusetts.
“These four mutations were not reported from China at the time when I searched the GenBank databases,” Sin Hang Lee told Changing Times.
Watching the divisions play out in our city ‘has been very painful’
Nicole Tucker lives in Spokane, Washington State, in the US, with her husband Chris and their four children: Grace, aged 18; Andrew, 16; William, 13; and Mary, aged 11.
Half of the Tucker family are in the high-risk category, including Mary, who has Down Syndrome.
Chris runs the family’s food distribution business and goes to numerous grocery stores daily.
“From the beginning he has worn a mask and gloves to protect us and others and we have also implemented measures at home to minimise our exposure, including having Chris stay in a separate part of the house from us,” Nicole said.
“Chris was, and still is, mocked by some people in our community for wearing a mask.”
Current daily pressures are exacerbated for Nicole because so many people in Spokane, including the local mayor, are pushing for a rapid reopening of the local economy and also because her 16-year-old has friends whose parents view the risk caused by the pandemic, and the way it needs to be managed, very differently to the way she and Chris see it.
“We have a population of 522,000 in our city and are next to the Idaho state border. It is a four-hour drive from here to Seattle, where the first case of Covid-19 was reported in the US on January 20,” Nicole said. “The first death in our state was on February 29.
“Since this pandemic started not only am I faced with the very stressful job of trying to keep my family safe from the virus, I am also faced with dealing with the awful political divide that has happened in this country over how to manage the pandemic.
“The divide between our two political parties has been more distressing to deal with than all we have to do to try to prevent us from getting Covid-19. Watching these divisions play out in our city, in our federal government, and within my own family, has been very painful.”
Nicole praises the rapid actions taken by the Washington State governor, Jay Inslee.
“He took quick action to put in place stay-at-home orders and closed all the schools in our state for the remainder of the academic year. His actions have saved many lives. I was so relieved that I could keep my family more safe. All of my family except for Chris stayed at home even before those orders were put in place.”
When Inslee imposed the stay-at-home requirement in mid-March, Washington State had the highest number of confirmed cases of Covid-19 in the country, and more cases per capita than any other US state. Since restrictions were imposed, the state has dropped to 21st in the national cases-per-capita list.
Nicole and Chris have already dealt with several very difficult health challenges over the past 11 years with three of their children.
“We have already lived through times during which we needed to quarantine our family, and have already experienced intense feelings of isolation,” Nicole said.
“When this pandemic began, I felt tremendous heartbreak that our now stable lives were being uprooted and torn apart yet again, but I took some comfort in the fact that we would have other families around us going through the same thing and I thought we could all be a support to each other.
“I quickly discovered that this was not going to be the case.”
Nicole realised that not all local parents were going to approach the pandemic in the same cautious way she and Chris feel is best.
“That set in motion a terrible pull between what we want for our family and what our 16-year-old wants to be able to do with his friends, who are allowed to do more.
“He has been influenced a lot by the opinions of these families and what our mayor wants.”
The mayor of Spokane, Nadine Woodward, and other local officials pushed for, and succeeded in obtaining, an early move into phase 2 of the easing of Covid-19 restrictions.
“This transitional time between the first two phases has been the most stressful time for us,” Nicole said. “The pressure from my son to be able to see some of his friends has been exhausting and nerve wracking.
“It has caused arguments and some tears. It caused us to compromise and allow him one outing so far with a friend outside, with social distancing. This is despite the fact that half of our family will need to continue to stay at home throughout all the phases as we are high risk.”
Nicole says the number of Covid-19 cases in Spokane is now the highest it has ever been.
“Some people in our city have, from the start, not followed the guidelines, including those about social distancing and wearing masks. I believe this is why we are not containing the virus as well as we could be.
“There are even people in the state who are going to court to sue Inslee about the stay-at-home orders and the way he is phasing out restrictions.”
The plaintiffs, who include Republican lawmakers, allege that there is no longer an emergency in Washington State, and that Inslee’s “coronavirus-related proclamations” have unduly infringed upon constitutionally protected rights.
The plaintiffs are asking for the governor’s proclamations to be declared unconstitutional and want Inslee and his administration banned from enforcing them.
The editors of The Lancet have published an “Expression of Concern” about the paper by Mandeep Mehra et al. about hydroxychloroquine and chloroquine.
They said that “important scientific questions” had been raised about data reported in the paper.
“Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information,” they wrote.
The WHO is resuming its hydroxychloroquine trial.
The organisation’s director-general, Tedros Adhanom Ghebreyesus, said that the Solidarity Trial’s data safety and monitoring committee had reviewed the available mortality data and recommended that there were no reasons to modify the trial protocol.
“The executive group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including hydroxychloroquine,” Ghebreyesus said.
The group would communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm of the trial, he added.
Three of the four authors of the controversial paper about hydroxychloroquine and chloroquine that was published in The Lancet on May 22 have retracted their study.
The Lancet said the authors were unable to complete an independent audit of the data underpinning their analysis and, as a result, had concluded that they could no longer vouch for the veracity of the primary data sources.
“The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study,” The Lancet said.
“Following guidelines from the Committee on Publication Ethics (COPE) and International Committee of Medical Journal Editors (ICMJE), institutional reviews of Surgisphere’s research collaborations are urgently needed.”
The three authors – Mandeep R. Mehra, Frank Ruschitzka, and Amit N. Patel – said: “After publication of our Lancet Article, several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication.
“We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.”
The authors said that their independent peer reviewers informed them that Surgisphere would not transfer the full data set, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements.
“As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process,” they added.
“We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards.
“Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.”
The three authors said that they all entered the collaboration “to contribute in good faith and at a time of great need during the Covid-19 pandemic”.
They added: “We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”
Two of the leading scientists involved in the Recovery Trial in Britain, in which possible treatments for patients admitted to hospital with Covid-19 are being assessed, say their research has shown no clinical benefit from the use of hydroxychloroquine.
Peter Horby and Martin Landray said: “We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with Covid-19.
“We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the Recovery Trial with immediate effect.”
Landray said the preliminary results from the Recovery Trial showed that hydroxychloroquine did not reduce the risk of death among hospitalised patients with Covid-19.
The scientists said that 1,542 patients were treated with hydroxychloroquine and were compared with 3,132 patients who received “usual care alone”.
They said there was no significant difference in the “primary endpoint of 28-day mortality” and added that “there was also no evidence of beneficial effects on hospital stay duration or other outcomes”.
Horby said: “The Recovery Trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with Covid-19. Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.”
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