Counterfeiting – the underworld threat to beating COVID-19
by ilene - June 18th, 2021 8:43 pm
Counterfeiting – the underworld threat to beating COVID-19
Counterfeit vaccines, testing kits, and vaccine passports are undermining the global fight against COVID-19. AnaLysiSStudiO/Shutterstock
Courtesy of Mark Stevenson, Lancaster University
While the word “counterfeit” may conjure up images of fake cash and knock-off handbags, the pharmaceutical industry – and with it, the fight against COVID-19 – has been significantly affected by illicit goods.
In a major operation, Interpol recently intercepted global counterfeit rings, closing more than 100,000 bogus online pharmacies, making nearly 300 arrests and seizing more than US$20 million (£14.2 million) worth of counterfeit items in the process. Mainly targeting counterfeit COVID-19 testing kits, this operation followed other examples. These have included the discovery of counterfeit networks in China and South Africa and the production of fake vaccines from simple, widely available ingredients such as saline solution and mineral water.
Despite these law enforcement breakthroughs, the world’s fight against COVID-19 is being undermined by a booming trade in counterfeit PPE, COVID-19 testing kits, vaccines, vaccine passports and other products that are contributing to the spread of the virus.
The appeal of fake vaccines
Pharmaceutical markets are worth more than US$1 trillion (£710.2 billion) annually, making them an attractive target for counterfeiters, who often trade anonymously via online auction sites or pharmacies.
There are many reasons why counterfeit COVID-19 vaccines in particular are emerging, including the high and instant demand – which has outstripped supply during the pandemic. This has not been helped by the expense of developing vaccines at a national level, affected by the high research and development cost behind producing a genuine product, which has made access difficult, especially for poorer countries. This has ultimately led to unequal global access to vaccines, with much of the world’s supply being controlled by the most powerful countries.
Meanwhile, the relative ease of producing a fake, which might potentially only be detectable as not genuine when it fails to protect someone from the virus, means the barrier to market entry can be relatively low.
The consequences of consuming fake products when they are safety critical, as in the case of an injected vaccine, can…
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A mix-and-match approach to COVID-19 vaccines could provide logistical and immunological benefits
by ilene - June 17th, 2021 5:22 pm
A mix-and-match approach to COVID-19 vaccines could provide logistical and immunological benefits
One of this and one of that might be a good strategy to coronavirus vaccination. SOPA Images/LightRocket via Getty Images
Courtesy of Maureen Ferran, Rochester Institute of Technology
While it’s now pretty easy to get a COVID-19 shot in most places in the U.S., the vaccine rollout in other parts of the world has been slow or inconsistent due to shortages, uneven access and concerns about safety.
Researchers hope that a mix-and-match approach to COVID-19 vaccines will help alleviate these issues and create more flexibility in the immunization regimens available to people.
Around the world, different pharmaceutical companies have taken different approaches to developing vaccines. Pfizer-BioNTech and Moderna created mRNA vaccines. Oxford-AstraZeneca and Johnson & Johnson went with what are called viral vectors. The Novavax COVID-19 vaccine is protein-based.
So mixing vaccines could mean more than just switching manufacturers – like from Pfizer for dose one to Moderna for dose two. You might be tapping into a different way to stimulate your immune response if you opt for a first dose of AstraZeneca and a second dose of Moderna.
The most obvious benefits of treating various brands and kinds of COVID-19 vaccine as interchangeable are logistical – people can get whatever shot is available without worry. By speeding up the global vaccination rollout, mixing and matching vaccines could help end this pandemic. Researchers also hope combining different vaccines will trigger a more robust, longer-lasting immune response compared to receiving both doses of a single vaccine. This approach may better protect people from emerging variants.
After vaccination, your body makes antibodies (blue in this illustration) that will hunt for coronavirus proteins (pink). Christoph Burgstedt/Science Photo Library via Getty Images
Biological effects of a mix-and-match approach
Scientists suspect there are a few ways that receiving two different COVID-19 vaccines may result in a stronger immune response.
Each company used slightly different regions of the SARS-CoV-2 spike protein in their…
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The FDA’s big gamble on the new Alzheimer’s drug
by ilene - June 10th, 2021 2:19 pm
The FDA's big gamble on the new Alzheimer's drug
Do the benefits of approving a drug before confirming it works outweigh the potential costs? monkeybusinessimages/iStock via Getty Images Plus
Courtesy of C. Michael White, University of Connecticut
The Food and Drug Administration set off a firestorm of debate when it approved a new drug, aducanumab, for Alzheimer’s disease via an accelerated approval pathway. This decision ignored the recommendation of the FDA’s external advisory panel to reject the drug.
The FDA grants accelerated approvals for drugs to treat serious illnesses for which there are no known, or at least very few, treatments. The type of data used to support accelerated approvals is very different from the typical benchmark safety and efficacy data required for approval. As a pharmacist and researcher, I have documented several reasons drug research conducted in a laboratory environment differs substantially from what is ultimately seen in people. The challenge lies in striking a balance between taking the time to ensure a treatment works and meeting urgent patient need.
Using a different standard
The FDA created an accelerated approval pathway for drugs treating serious diseases for which many patients feel a desperate need for more options. This has included treatment for advanced-stage cancer, multiple sclerosis and HIV, among others.
When considering accelerated approval, the agency examines a drug’s efficacy using what’s called a “surrogate endpoint.” While most drug trials measure success based on clinical endpoints that determine whether a drug helps people feel better or live longer, like reducing heart attacks or strokes, surrogate endpoints measure biomarkers that suggest potential clinical benefit. These surrogate endpoints are viable substitutes for hard clinical endpoints because they’re proven to be directly linked to the desired clinical outcomes. For example, the clinical endpoints of reducing heart attacks and strokes could use reduced blood pressure and low-density lipoprotein (LDL) cholesterol as surrogate endpoints.
While many hypotheses on the correct surrogate endpoints to treat certain diseases have panned out, several others have been shown to be off-base or only partially correct. A great example is homocysteine, an amino acid once thought to be a driver of cardiovascular diseases…
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How virus detectives trace the origins of an outbreak – and why it’s so tricky
by ilene - June 7th, 2021 5:11 pm
How virus detectives trace the origins of an outbreak – and why it's so tricky
The prevention of future pandemics requires examining viral family trees. Stockcrafter/iStock via Getty Images Plus
Courtesy of Marilyn J. Roossinck, Penn State
Every time there is a major disease outbreak, one of the first questions scientists and the public ask is: “Where did this come from?”
In order to predict and prevent future pandemics like COVID-19, researchers need to find the origin of the viruses that cause them. This is not a trivial task. The origin of HIV was not clear until 20 years after it spread around the world. Scientists still don’t know the origin of Ebola, even though it has caused periodic epidemics since the 1970s.
As an expert in viral ecology, I am often asked how scientists trace the origins of a virus. In my work, I have found many new viruses and some well-known pathogens that infect wild plants without causing any disease. Plant, animal or human, the methods are largely the same. Tracking down the origins of a virus involves a combination of extensive fieldwork, thorough lab testing and quite a bit of luck.
Viruses jump from wild animal hosts to humans
Many viruses and other disease agents that infect people originate in animals. These diseases are zoonotic, meaning they are caused by animal viruses that jumped to people and adapted to spread through the human population.
It might be tempting to start the viral origin search by testing sick animals at the site of the first known human infection, but wild hosts often don’t show any symptoms. Viruses and their hosts adapt to each other over time, so viruses often don’t cause obvious disease symptoms until they’ve jumped to a new host species. Researchers can’t just look for sick animals.
Another problem is that people and their food animals aren’t stationary. The place where researchers find the first infected person is not necessarily close to the place where the virus first emerged.
A challenge in viral origin tracing is
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Book calls for a rethink of capitalism amid the ravages of COVID-19
by ilene - June 3rd, 2021 5:13 pm
Book calls for a rethink of capitalism amid the ravages of COVID-19
A woman sweeps outside her shack in Khayelitsha, Cape Town. South Africa is among the most unequal societies in the world. Getty Images
Courtesy of Edward Webster, University of the Witwatersrand
Instead of being the great leveller, as pandemics have been throughout history, the coronavirus pandemic has revealed and compounded pre-existing inequalities in wealth, race, gender, age, education and geographical location.
This is the paradox with which Ian Goldin – the former CEO of the Development Bank of Southern Africa and now a professor at the University of Oxford – begins his recently published book, “Rescue: from global crisis to a better world”.
Past studies of the forces driving the reduction of inequality have foregrounded ‘malign forces’ – such as wars, natural catastrophes and epidemics – and ‘benign forces’ – more widely accessible education, increased social transfers and progressive taxation.
Social scientist Goran Therborn, in his classic 2013 study of inequality, brings these two forces together. He acknowledged the significance of the ‘malign’ forces of violent revolution and war. But he also emphasises the ‘benign’ forces of peaceful reform that led to the ‘egalitarian moment’ after World War Two. This is when welfare states were built around the notion of full employment, universal health care, education and social security.
Under certain circumstances, far-reaching peaceful reform has been possible.
Why then has the coronavirus pandemic deepened inequality rather than reduced it?
Goldin attributes this paradoxical outcome to four decades of neoliberal thinking.
I agree with his critique of neoliberalism. But he doesn’t give sufficient attention to power, particularly the concentration of economic power. This book, nevertheless, offers important opportunities for the elites of the world and ordinary citizens to explore ways of reducing inequality.
The case for a rethink
Inequality, Goldin suggests had been rising in both Europe and the US since the 1980s. He argues that this is:
mainly due to the tide of liberalisation that was ushered in when Margaret Thatcher in Britain and Ronald Reagan in the US initiated a
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Israel Spots Probable Link Between Pfizer Vaccine, Myocarditis
by Zero Hedge - June 2nd, 2021 9:23 am
Note: It may be premature to call the link between Pfizer's vaccine and myocarditis "probable".
Courtesy of ZeroHedge
According to Reuters, Israel's Health Ministry released a statement Tuesday describing how Pfizer Inc. and BioNTech SE's COVID-19 vaccine could be linked to dozens of heart inflammation cases, mainly observed in younger men.
So far, the vaccine has been administered to 5 million people in the country and could soon be expanded to teens as young as 12-15 years old.
The ministry's findings found 275 cases of myocarditis between December 2020 and May 2021, including 148 cases within a month after the first vaccination. Of these, 27 cases after the first dose and 121 after the second. Half of the people had previous medical conditions.
According to the findings, most patients who experienced heart inflammation spent less than four days in the hospital, and 95% of the cases were classified as mild.
The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30."
Pfizer said in a statement that it had reviewed the Israeli observations of myocarditis, noting that no link to its vaccine has been confirmed.
"A careful assessment of the reports is ongoing and it has not been concluded," Pfizer said. "Adverse events, including myocarditis and pericarditis, are being regularly and thoroughly reviewed by the companies as well as by regulatory authorities."
Meanwhile, Nachman Ash, Israel's pandemic-response coordinator, told local radio station Radio 103 FM, "the health committee gave the green light for vaccinating 12- to 15-year-olds, and this will be possible as of next week."
An advisory group with the U.S. Centers for Disease Control and Prevention recommended last month further examination into the possible link between myocarditis and mRNA vaccines.
The handful of myocarditis cases seem to outweigh the positives as more than 55% of Israel's population has already been vaccinated.
While the country continues a vaccination spree, what's not being widely spoken about is a new study that suggests natural immunity to the virus could last a lifetime.*
***
* ZeroHedge's last sentence
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The next pandemic is already happening – targeted disease surveillance can help prevent it
by ilene - June 2nd, 2021 3:14 am
The next pandemic is already happening – targeted disease surveillance can help prevent it
Sustained surveillance for disease outbreaks at global hot spots may be the key to preventing the next pandemic. MR.Cole_Photographer/Getty Images
Courtesy of Maureen Miller, Columbia University
As more and more people around the world are getting vaccinated, one can almost hear the collective sigh of relief. But the next pandemic threat is likely already making its way through the population right now.
My research as an infectious disease epidemiologist has found that there is a simple strategy to mitigate emerging outbreaks: proactive, real-time surveillance in settings where animal-to-human disease spillover is most likely to occur.
In other words, don’t wait for sick people to show up at a hospital. Instead, monitor populations where disease spillover actually happens.
The current pandemic prevention strategy
Global health professionals have long known that pandemics fueled by zoonotic disease spillover, or animal-to-human disease transmission, were a problem. In 1947, the World Health Organization established a global network of hospitals to detect pandemic threats through a process called syndromic surveillance. The process relies on standardized symptom checklists to look for signals of emerging or reemerging diseases of pandemic potential among patient populations with symptoms that can’t be easily diagnosed.
This clinical strategy relies both on infected individuals coming to sentinel hospitals and medical authorities who are influential and persistent enough to raise the alarm.
Sentinel surveillance recruits select health institutions and groups to monitor potential disease outbreaks.
There’s only one hitch: By the time someone sick shows up at a hospital, an outbreak has already occurred. In the case of SARS-CoV-2, the virus that causes COVID-19, it was likely widespread long before it was detected. This time, the clinical strategy alone failed us.
Zoonotic disease spillover is not one and done
A more proactive approach is currently gaining prominence in the world of pandemic prevention: viral evolutionary theory. This theory suggests that animal viruses become dangerous human viruses incrementally over time…
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World’s worst pandemic leaders: 5 presidents and prime ministers who badly mishandled COVID-19
by ilene - May 18th, 2021 6:43 pm
World's worst pandemic leaders: 5 presidents and prime ministers who badly mishandled COVID-19
Belarus President Alexander Lukashenko visits a hospital for COVID-19 patients, unmasked, in Minsk on Nov. 27, 2020. Andrei Stasevich\TASS via Getty Images
By Sumit Ganguly, Indiana University; Dorothy Chin, University of California, Los Angeles; Elizabeth J King, University of Michigan; Elize Massard da Fonseca, Fundação Getulio Vargas; Salvador Vázquez del Mercado, Centro de Investigación y Docencia Económicas, and Scott L. Greer, University of Michigan
COVID-19 is notoriously hard to control, and political leaders are only part of the calculus when it comes to pandemic management. But some current and former world leaders have made little effort to combat outbreaks in their country, whether by downplaying the pandemic’s severity, disregarding science or ignoring critical health interventions like social distancing and masks. All of the men on this list committed at least one of those mistakes, and some committed all of them – with deadly consequences.
Narendra Modi of India
Sumit Ganguly, Indiana University
India is the new epicenter of the global pandemic, recording some 400,000 new cases per day by May 2021. However grim, this statistic fails to capture the sheer horror unfolding there. COVID-19 patients are dying in hospitals because doctors have no oxygen to give and no lifesaving drugs like remdesivir. The sick are turned away from clinics that have no free beds.
Many Indians blame one man for the country’s tragedy: Prime Minister Narendra Modi.
In January 2021, Modi declared at a global forum that India had “saved humanity … by containing corona effectively.” In March, his health minister proclaimed that the pandemic was reaching an “endgame.” COVID-19 was actually gaining strength in India and worldwide – but his government made no preparations for possible contingencies, such as the emergence of a deadlier and more contagious COVID-19 variant.
Even as significant pockets of the country had not fully suppressed the virus, Modi and other members of his party held jampacked outdoor campaign rallies before April elections. Few attendees wore masks. Modi also allowed a religious festival that draws millions to proceed…
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Herd immunity appears unlikely for COVID-19, but CDC says vaccinated people can ditch masks in most settings
by ilene - May 15th, 2021 1:08 am
Herd immunity appears unlikely for COVID-19, but CDC says vaccinated people can ditch masks in most settings
A woman walks by a sign in New York City amid the coronavirus pandemic on March 30, 2021. Noam Galai/Getty Images
Courtesy of William Petri, University of Virginia
When COVID-19 first began spreading, public health and medical experts began talking about the need for the U.S. to reach herd immunity to stop the coronavirus from spreading. Experts have estimated that between 60% and 90% of people in the U.S. would need to be vaccinated for that to happen. Only about 35% of the population has been fully vaccinated, and yet the CDC said on May 14, 2021 that fully vaccinated people can lose their masks in most indoor and outdoor settings.
An important question now arises: What happens if we don’t reach herd immunity? Dr. William Petri is a professor of infectious diseases at the University of Virginia who helps lead the global program to achieve herd immunity for polio as the chair of the World Health Organization’s Polio Research Committee. He answers questions here about herd immunity and COVID-19.
What is herd immunity?
Herd immunity occurs when there are enough immune people in a population that new infections stop. It means that enough people have achieved immunity to disrupt person-to-person transmission in the community, thereby protecting nonimmune people.
Immunity can result from either vaccination or prior infection. Herd immunity may exist globally, as it does with smallpox, or in a country or region. For example, the U.S. and many other countries have achieved herd immunity for polio and measles, even though global herd immunity does not yet exist.
Has herd immunity been achieved globally for other infections?
This has happened only once on a global scale, with the eradication of smallpox in 1980. This was after a decadelong worldwide intensive vaccination campaign.
We also are also approaching global herd immunity for polio. When the Global Polio Eradication Initiative was formed in 1988 there were 125 countries with endemic polio and over 300,000 children paralyzed annually. Today, after 33 years of immunization campaigns, Afghanistan and Pakistan are…
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How America’s partisan divide over pandemic responses played out in the states
by ilene - May 13th, 2021 2:57 am
How America’s partisan divide over pandemic responses played out in the states
The COVID-19 pandemic seems to have widened the partisan divide between Democrats and Republicans on health care. John M. Lund Photography/Getty Images
Courtesy of Julie VanDusky-Allen, Boise State University and Olga Shvetsova, Binghamton University, State University of New York
Throughout the COVID-19 pandemic, a partisan divide has existed over the appropriate government response to the public health crisis. Democrats have been more likely to favor stricter policies such as prolonged economic shutdowns, limits on gathering in groups and mask mandates. Republicans overall have favored less stringent policies.
As political scientists and public health scholars, we’ve been studying political responses to the pandemic and their impacts. In research published in the summer of 2020, we found that “sub-governments,” which in the U.S. means state governments, tended to have a bigger impact on the direction of pandemic policies than the federal government. Now, as data on last year’s case and death rates emerge, we’re looking at whether the political party in the governor’s office became a good predictor of public health outcomes as COVID-19 moved across the country.
Looking at states’ COVID-19 case and death rates, researchers are finding the more stringent policies typical of Democratic governors led to lower rates of infections and deaths, compared to the the pandemic responses of the average Republican governor. In preparation for future pandemics, it may be worth considering how to address the impact that a state government’s partisan leanings can have on the scope and severity of a public health crises.
Comparing responses by Democratic and Republican governors
To compare and chart our state-by-state COVID-19 policy stringency data, we’ve developed our “Protective Policy Index.” To calculate this index, we took into account the types of policies state governments adopted over the course of the pandemic, such as school closings, lockdowns and mandatory mask mandates. We combined the adopted measures for each state over time to calculate the index. Higher values of the index indicate states adopted more stringent measures.
When we charted the policy responses of Democratic and Republican governors between May 1 and July 31, 2020, they revealed…
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Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...
Ilene is editor and affiliate program
coordinator for PSW.
