End Vaccine Apartheid Before Millions More Die

By Anis Chowdhury and Jomo Kwame Sundaram

SYDNEY and KUALA LUMPUR, Mar 23 2021 (IPS) – At least 85 poor countries will not have significant access to coronavirus vaccines before 2023. Unfortunately, a year’s delay will cause an estimated 2.5 million avoidable deaths in low and lower-middle income countries. As the World Health Organization (WHO) Director-General has put it, the world is at the brink of a catastrophic moral failure.

Vaccine apartheid
The EU, US, UK, Switzerland, Canada and their allies continue to block the developing country proposal to temporarily suspend the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to enable greatly increased, affordable supplies of COVID-19 vaccines, drugs, tests and equipment.

Meanwhile, 6.4 billion of the 12.5 billion vaccine doses the main producers plan to produce in 2021 have already been pre-ordered, mostly by these countries, with 13% of the global population.

Thirty two European and other rich countries also have options to order more, while Australia and Canada have already secured supplies enough for five times their populations. Poor countries, often charged higher prices, simply cannot compete.

Big Pharma has also refused to join the voluntary knowledge sharing and patent pooling COVID-19 Technology Access Pool (C-TAP) initiative under WHO auspices. Thomas Cueni, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General, snubbed the launch, claiming he was “too busy”.

Pfizer’s CEO dismissed C-TAP as “nonsense” and “dangerous”, while the AstraZeneca CEO insisted, “IP is a fundamental part of our industry”. Such attitudes help explain some problems of alternative vaccine distribution arrangements such as COVAX. According to its own board, there is a high chance that COVAX could fail.

Suppressing vaccine access
Despite knowing that many developing countries have much idle capacityCueni falsely claims the waiver “would do nothing to expand access to vaccines or to boost global manufacturing capacity”, and would jeopardise innovation and vaccine research.

Big Pharma claims manufacturing vaccines via compulsory licensing or a TRIPS waiver “would undermine innovation and raise the risk of unsafe viruses”. US Big Pharma representatives wrote to President Biden earlier this month claiming likewise.

Both Salk and Sabin made their polio vaccine discoveries patent-free, while many contemporary vaccine researchers are against Big Pharma’s greedy conduct only rewarding IP holders regardless of the varied, but crucial contributions of others.

Big Pharma’s price gouging
Vaccine companies require contract prices be kept secret. In return for discounts, the EU agreed to keep prices confidential. Nonetheless, some negotiated prices were inadvertently revealed, with a UNICEF chart listing prices from various sources.

Reputedly the cheapest vaccine available, Oxford-Astra Zeneca’s is sold to EU members for around US$2 each. Although trials were done in South Africa, it still pays more than twice as much, while Uganda, even poorer, pays over four times as much!

US negotiated bulk prices, for Moderna and Pfizer-BioNTech vaccines, are much higher, at US$15.25–19.50 per dose in several contracts, yielding 60–80% profit margins! Moderna will charge the rest of the world US$25–37 per dose.

Hypocrisy
Quite understandably, most developed countries opposing temporary TRIPS suspension have provisions in their own IP laws to suspend patent protection in the national interest and for public health emergencies.

Canada, Germany, France and others have recently strengthened their patent laws to issue compulsory licences for COVID-19 vaccines and drugs. European Council President Charles Michel announced that the EU could adopt “urgent measures” by invoking emergency provisions in its treaties.

Similarly, in the US, 28 US Code sec. 1498 (a) allows the government to make or use any invention without the patentee’s permission. To handle emergencies, the 1977 UK Patents Act (section 55) allows the government to sell a patented product, including specific drugs, medicines or medical devices, without the patentee’s consent.

When avian flu threatened early this century, the US was the only country in the world to issue compulsory licences to US manufacturers to produce Tamiflu to protect its entire population of over 300 million. The drugs were not used as the virus was not brought over either Pacific or Atlantic Oceans.

Biden must act
By helping developing countries expand vaccine manufacturing capacity and access existing capacity, US President Biden can earn much world appreciation overnight. US law and precedence enables such a unilateral initiative.

The Bayh-Dole Act allows the US government to require the owner or exclusive licensee of a patent, created with federal funding, to grant a third party a licence to an invention. Moderna received about US$2.5 billion from Operation Warp Speed, which dispensed over US$10 billion.

Moderna was founded in 2010 by university researchers with support from a venture capitalist. It has focused on mRNA technology, building on earlier work by University of Pennsylvania scientists with National Institutes for Health (NIH) funding.

The vaccine developer also used technology for previous coronavirus vaccines developed by the NIH. The NIH also provided extensive logistical support, overseeing clinical trials for tens of thousands. Moderna has already announced it will not enforce its patents during the pandemic.

Thus, POTUS has the needed leverage. The Bayh-Dole Act applies to Moderna’s vaccine, enabling the Biden administration to act independently and decisively against vaccine apartheid.

Sharing knowledge crucial
Developing countries not only need to have the right to produce vaccines, but also the requisite technical knowledge and information. Hence, the Biden administration should also support C-TAP, as recommended by Dr Anthony Fauci.

When the Medicines Patent Pool (MPP) was in similar trouble, the Obama administration came forward to put US-owned patents into the pool while encouraging drug companies to help improve developing countries’ access to medicines.

President Biden knows that early US support was critical for the MPP’s eventual success. It dramatically increased production and lowered prices of medicines for HIV, tuberculosis, hepatitis C and other infectious diseases in developing countries.

Peter Breggin MD, raises questions on US-China ‘gain-of-function’ Coronovirus research.

THIS WEEK saw a special report by Peter Breggin, MD, raising serious questions about US-sponsored ‘Gain-of-Function’ Coronovirus research at China’s Wuhan laboratory facility.

This type of research was temporarily halted over ethical concerns under the Obama administration. Gain-of-function (GOF) research ‘typically involves mutations that confer altered functionality of a protein or other molecule.’

He says a ‘2015 Scientific Paper Proves US & Chinese Scientists Collaborated to Create Coronavirus that Can Infect Humans‘.

In 2015, American researchers and Chinese Wuhan Institute of Virology researchers collaborated to transform an animal coronavirus into one that can attack humans. Scientists from prestigious American universities and the US Food and Drug Administration (FDA) worked directly with the two coauthor researchers from Wuhan Institute of Virology, Xing-Yi Ge and Zhengli-Li Shi. Funding was provided by the Chinese and US governments. The team succeeded in modifying a bat coronavirus to make it capable of infecting humans.

The research was published in December 2015 in the prestigious British journal, Nature Medicine (volume 21, pages 1508–1513). The paper by Vineet D. Menachery et al., “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence” is available here as a PDF as well as on-line.i

The research demonstrates how a modified Bat coronovirus capable of attacking ACE2 was created by Chinese researchers and also their failure to develop a vaccine, and was followed by warnings of the danger involved published by The Scientist, 16 November 2015.

We built a chimeric virus encoding a novel, zoonotic CoV spike protein—from the RsSHC014-CoV sequence that was isolated from Chinese horseshoe bats1,” claim the researchers.

“The results demonstrate the ability of the SHC014 surface protein to bind and infect human cells, validating concerns that this virus—or other coronaviruses found in bat species—may be capable of making the leap to people without first evolving in an intermediate host, Nature reported. They also reignite a debate about whether that information justifies the risk of such work, known as gain-of-function research. “If the [new] virus escaped, nobody could predict the trajectory,” Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris, told Nature.”

Breggin’s astonishing report comes the same week that an investigation into the same Wuhan facility has been reopened by the USA.

Breggin is well known within the medical and scientific community and has authored dozens of scientific articles and over twenty books, ‘promoting more caring and effective therapies’. He is also highly critical of the drug establishment and pharmaceutical industry.

His report follows initial articles, questioning whether Sars-Cov-2 is a chimera of two different viruses?

And apparently conclusive evidence that the virus is not man-made.

Breggin is at pains to point out that the man-made coronovirus referred to in the 2015 scientific literature is not SARS-CoV-2, the virus responsible for Covid-19. He instead presents various questions, necessitating further inquiry:

Concluding Questions:

  • Who in the US government enabled this research? Why was it allowed when it was enabling the Chinese to develop a military weapon or to accidentally cause an epidemic?
  • Why was an FDA official involved as an author and why was NIH funding the project?
  • The virus created in collaboration with the Chinese and the current epidemic virus are both SARS-CoV with many shared characteristics. This writer has found no scientific research that specifically compares the two viruses, a subject that needs to be investigated.
  • How many more lab-created or manipulated viruses are in the world’s laboratories and under the control of governments and the military?
  • Are potentially dangerous research projects continuing to go on involving American and Chinese collaboration with or without funding from both countries?
  • Why and how has this research project wholly escaped notice amid the growing concern about China’s role in causing the ongoing novel coronavirus pandemic?
  • Why have none of the American researchers come forward to draw attention to this project which, at the least, enabled and promoted Chinese efforts to weaponize viruses?

Two years before the Covid-19 coronavirus pandemic upended the world, U.S. Embassy officials visited a Chinese research facility in the city of Wuhan several times and sent two official warnings back to Washington about inadequate safety at the lab, which was conducting risky studies on coronaviruses from bats, according to Washington Post.

A new investigation, titled “Coronavirus 2019-nCoV contains a furin-like cleavage site absent in CoV of the same clade,” suggests it is unlike anything seen before. Which might require furin inhibitors.

Coronavirus study identifies ‘gain of function for efficient spread in humans’

Another paper raises Ethical and Philosophical Considerations for Gain-of-Function Policy: The Importance of Alternate Experiments

Inside the Chinese lab poised to study world’s most dangerous pathogens

Hunger must be seen as a determinant of health

YESTERDAYS looting of supermarkets in several South African townships, is unfortunately driven by hunger. These food riots are indicative of an alarming situation unfolding two and a half weeks into the hard lockdown. Gatesville, Manenburg, Tafelsig, Alexandra, are where low-income families have been forced into the lockdown without any tangible relief from government. Hunger must be seen as a determinant of health alongside the burden of disease.

Instead our government appears hellbent on implementing prescriptions driven by the WHO in Geneva. Solutions which may turnout to be wholly unsuited to conditions in emerging economies such as our own. The lockdown may be wrong for Africa.

It is doubtful whether or not the hard lockdown will accomplish any of the supposed objectives laid out by our Health Minister, and should rather be replaced by a smart lockdown, or soft lockdown as soon as possible. Despite experiencing a surge, Japan has implemented a soft lock-down, as have many countries fully aware that completely suppressing the virus risks the situation where one merely postpones and lengthens the epidemic.

According to chief scientist Prof Salim Karim, ‘South Africa will know on 18 April’ if the methodology utilised against the coronovirus is inaccurate or factually correct. The measures may have bought time for our health system to prepare for a coming surge, known as the ‘delayed exponential curve of infection’.

If mitigation measures  to curtail the spread of hunger, are not implemented immediately, the problem of mass starvation could dwarf the current epidemic and grow to haunt South Africans as we move forward during an unprecedented period of economic turmoil. Most households are only able to maintain a two-week supply of food. Without income or food parcels, the situation could quickly deteriorate to conditions seen during wartime, famine and natural disasters.

“Our problem is not that we don’t have enough food in South Africa. Our problem is that the food is only available to those who have cash” writes business strategist Marius Oosthuizen.

The closure of restaurants and hotels has perversely resulted in literal food mountains. Tonnes of produce is being destroyed around the world because of the global pandemic, while ordinary consumers are ironically forced to pay more for fresh produce.

Since 2011, three million more South Africans have been pushed below the poverty line, according to a study by the national data agency, Statistics South Africa. More than 30.4 million South Africans—55.5% of the population—live on less than 992 rand (about $75) per person per month. Yesterdays interest rate cut will assist middle-class households, but the problem remains that most households were already below the poverty line at the beginning of the lock-down.

Ekurhuleni mayor Mzwandile Masina on Tuesday launched a food bank to provide relief to the poor during the Covid-19 outbreak. The same plan alongside further disaster relief is required in every Metro, town and city. School feeding schemes urgently need to be restored. Other relief measures that should be contemplated include once off emergency cash payments to each and every household.

Current relief packages rolled out by national government include  assistance to SMMEs, tax relief, Agricultural Aid, UIF, Health and other support services. More needs to be done if the lockdown continues. As an anonymous author from Iran writes, ‘the difference between barbarism and civilisation is a plate of food’.

It is imperative that food security be seen alongside the burden of disease, as a determinant of people’s health.

 

South Africa’s controversial Chloroquine Phosphate adoption

WHY ANYONE would prescribe a substance such as Chloroquine Phosphate for the treatment of Covid-19 is a mystery. For starters the anti-malaria drug is an amebicide, ‘an agent used in the treatment of amoebozoa infections, called amoebiasis’ and is not an anti-viral as such.

It has a low LD50, the lethal dose at which rats and patients die (low is more toxic). It has been touted by both the Trump administration and the World Health Organisation as a treatment for the disease but has been lambasted by critics. Chloroquine: Trump’s misleading claims spark hoarding and overdoses reads one headline.

On the March 19, South Africa adopted Chloroquine Phosphate in its guidelines for the clinical management of Covid-19, published by the Department of Health and the National Institute for Communicable Diseases. A local pharmaceutical company has received permission from the medical regulator to import half a million chloroquine phosphate tablets.

New research published on Wednesday however, ‘suggested that “off label” re-purposing of drugs such as hydroxychloroquine could lead to “drug-induced sudden cardiac death”. The paper by the Mayo Clinic, a nonprofit medical organisation, found that ‘chloroquine and Kaletra, a HIV drug also being used against coronavirus, can cause the heart muscle to take longer than normal to recharge between beats.’

Most RNA viruses develop solely in cytoplasm (a thick solution that fills each cell and is enclosed by the cell membrane.) Unlike plasmodium malaria (amoebozoa ) viral populations do not grow through cell division, because they are acellular.

Coronaviruses are enveloped positive-stranded RNA viruses that replicate in the cytoplasm.

‘To deliver their nucleocapsid into the host cell, they rely on the fusion of their envelope with the host cell membrane. The spike glycoprotein (S) mediates virus entry and is a primary determinant of cell tropism and pathogenesis.’

There are over 100 known drug compounds capable of disrupting the viral replication of Sars-CoV-2, the coronovirus responsible for COVID-19. These substances have been located via an unprecedented bioinformatics search by two groups of scientists working round-the-clock on the equivalent of the Manhattan Project.

Their findings were published less than three weeks apart and must be considered required reading by anyone working in the field of coronovirus medicine. Unfortunately due to politics surrounding branded drugs and the Trump administration, and the machinations of the World Health Organisation, and our own government, these findings are being ignored.

Local use of the drug appears to pre-empt a WHO trial already underway in Norway and Spain.

Although Chloroquine Phosphate, ‘the phosphate salt of chloroquine, a quinoline a compound with antimalarial and anti-inflammatory properties’ appears on one of the lists provided by the researchers, the substance is not recommended by doctors as anything more than a last resort.

The chief executive of Novartis cautioned on Friday that it is “too soon” to be sure whether the anti-malaria drugs could be a definitive treatment for the coronavirus.

“Researchers have tried this drug on virus after virus, and it never works out in humans. The dose needed is just too high,” says Susanne Herold, an expert on pulmonary infections at the University of Giessen,

The latest list of potential coronovirus drugs discovered via an unprecedented bioinformatics search, include many compounds already approved for administering by doctors, some are already in preclinical trials. Among them is a 1971 antiviral drug, Ribavirin capable of disrupting the RNA synthesis of the coronovirus itself, the bug responsible for the biggest health crisis event of the 21st Century.

The drug is described in a paper aptly entitled ‘Broad-spectrum coronavirus antiviral drug discovery‘. It escaped media attention, perhaps due to its patent rights lapsing, while Lopinavir–Ritonavir, a relatively new HIV drug has received a lot of press, alongside Favivlavr a drug from China approved by the National Medical Products Administration of China .  Clinical trials of a promising COVID-19 antiviral, Remdesivir, which gets incorporated into viral RNA and prevents it being synthesised, halting viral replication, are currently underway.

Ribavirin, also known as tribavirin, is an antiviral medication used to treat RSV infection, hepatitis C and some viral hemorrhagic fevers.

A team lead by Nevan Krogan of the Gladstone Institute, working around the clock have identified more than 300 human proteins that interact with SARS-CoV-2 during infection.

Since the Trump announcement there has been attempts to classify coronovirus medicine research and restrict any adverse criticism of Chloroquine, with EPA announcing broad restrictions.

Efforts to raise awareness amongst local organisers of a Peninsula community coronovirus response team were instead met with ridicule, and the writer threatened with prosecution. The lack of debate amongst local authorities is reminiscent of the HIV-denial era, since anyone publishing coronovirus information ‘not authorised by the DOH ‘ may run foul of recently gazetted regulations governing the spread of information.

It is safe to say when this epidemic broke, we were dealing with denialists who refused to believe there was an epidemic. Overnight, these same folk have turned into gatekeepers of what can and cannot be said. Now even government officials are denying there are any antiviral treatments capable of bringing down the epidemic to manageable proportions and urging us all to use Chloroquine  the most widely used drug against malaria.

The safety issues here are also reminiscent of the thalidomide disaster,  one of the darkest episodes in pharmaceutical research history

Although the mechanism of action is not fully understood, chloroquine has been shown to inhibit the parasitic enzyme heme polymerase that converts the toxic heme into non-toxic hemazoin, thereby resulting in the accumulation of toxic heme within the parasite.

Chloroquine may also interfere with the biosynthesis of nucleic acids. However the coronovirus is not a microbial parasite and more research on the use of the substance in symptomatic treatment of a condition associated with an RNA virus would be required.

The most important lesson of the 1918 influenza pandemic: Tell the damn truth