Vaccines, Treatments and Inequality

Will the Development of Treatments and Vaccines resolve our HealthCrisis?

STATS TRACKER FOR VACCINES AND TREATMENTS HERE

• Vaccines and Inequality
• Two functions of vaccines: they protect against infection, and reduce transmission
• Equitable vaccine distribution is essential to achieving herd immunity
• The development of candidates for Covid-19 vaccines is progressing faster than that for any other pathogen in history. According to the World Health Organization (WHO), there are already two clinical trials underway and more than 50 vaccine candidates in clinical evaluation. 
• Multilateral institutions funded by multiple governments, pharmaceutical companies, and philanthropists are all pouring hundreds of millions into the vaccine development effort, which has helped hasten discovery. 
• We also have vital international alliances such as the Coalition for Epidemic Preparedness Innovations (CEPI), which was set up in the aftermath of the Ebola crisis and is dedicated to financing and coordinating the development of vaccines and ensuring fair global access.
• Alongside the expedited discovery process, we need to plan for equally expedited distribution and delivery. 
• Those involved in investing and building delivery systems must work as quickly as those in the field of discovery to pave the way ahead and learn from prior vaccine delivery experiences.

One of the main concerns about a potential future vaccine is that it will only be available to the highest bidders – developed countries that have the financial resources to make bilateral deals with pharmaceutical companies to buy large amounts of doses once a vaccine is developed. This could prove problematic to achieve global herd immunity, since some populations will be more protected than others. 

• Historically, vaccines, once developed are distributed to wealthier nations first while the rest of the world's population waits DECADES (if ever) to get access. Will we repeat the mistakes of the past with the COVID-19 vaccine?
• Polio: Eradicated from the developed world in 1960s. It was not until August 2020, that the last case of polio was recorded on the African continent. Cases still exist in Afghanistan and Pakistan today.
• TB killed more than 1.4 million people last year, despite the fact that a vaccine was produced over a century ago
• Measles: in 2018, killed 140,000 children, 1 in 7 children worldwide do not receive the vaccine.
• Since COVID-19 is so highly infectious, the success of eradication will depend on the "weakest link" Unless the virus is eradicated in the poorest parts of the world, the virus will keep spreading and outbreaks will continue.
• xenophobia? Fear of immigrants with diseases, etc.
• Wealthier nations have currently "pre-purchased" massive quantities of promising vaccines to ensure they will be able to complete domestic vaccination. The US, UK, and EU have purchased FIVE TIMES the number of vaccines needed to immunized their entire populations.
• 50% of the vaccines expected in 2021 have already been bought up by the world’s wealthiest countries.
• Trump removed the US from the WHO who might ensure through funded programs the equitable distribution of the vaccine to poorer nations.
• Canada, UK, and others has joined a consortium, pledging to more equitably distribute the vaccine (COVAX), the US has not yet joined
•  the pandemic has pushed almost 37 million people into extreme poverty worldwide -limiting access to vaccines even more

• A vaccine for COVID-19 itself has become especially politicized

• Russia testing vaccines on scientists and China doing testing in the military-- Russia and China could use the distribution of a COVID-19 vaccine to poorer countries to try and sway political alignment. 
• Even in the extremely unlikely event that all five vaccines succeed, nearly two thirds (61 percent) of the world’s population will not have a vaccine until at least 2022. (OXFAM)
• “During a pandemic, vaccines and antivirals can’t simply be sold to the highest bidder. They should be available and affordable for people who are at the heart of the outbreak and in greatest need. Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics.”--Gates Foundation
• Gavi, the Vaccine Alliance, has been working since 2000 to address vaccine equity and helps vaccinate nearly half of the world’s children.While Gavi’s main focus is children, it has helped provide vaccines for people of all ages for epidemic-causing diseases such as yellow fever and meningitis. 
• Resolving these issues: (Harvard Business Review)
• Financing the purchase of vaccines
• One way to provide this financing is a bond structure backed by OECD countries that would allow the money to be raised in capital markets. 
• Supplemental donations by GAVI, OXFAM, BMGF and others
• Strengthening and protecting the health care workforce
• Some 1,700 health workers in Italy are known to have already been affected, decimating an overstretched health care workforce. 
• There are similar stories from Spain, and the same worrisome situation seems to be developing in New York City and other places in the United States. 
• Not only will this impede the treatment of patients inflicted with Covid-19, it will also affect the program to administer the eventual vaccine. 
• This could be an especially big problem in low- to middle-income countries, where the depletion of health care workers’ ranks could also weaken existing programs to vaccinate people against other diseases. 
•  Investment in personal protective equipment and testing capacity is needed to protect the global frontline workforce.
• Identifying residents of developing countries

• Around 1 billion people in the world — predominantly residents of developing countries — lack formal identities; many are mobile. 

• This presents a massive challenge for governments trying to reach a critical mass of dispersed people: Without reliable IDs, it’s difficult to know who has received vaccines. 

• The initial Covid-19 vaccine supply will be limited, so it will be essential to verify each dose reaches a real patient. 

• Corruption, leakage, and even accidental duplication waste precious supply and are deadly.

• biometric digital IDs can be a game changer. For example, Simprints has deployed biometric IDs on health and humanitarian projects across 12 countries, which have increased health care visits and quality while preventing fraud.
• Leveraging data to predict behavior
• need to understand risk of transmission at the hyperlocal level and the likelihood of adherence for specific geographies and sub-populations. 
• Establishing reliable supply chains

• need simple data-capture systems to understand the stock and flow of vaccines in the supply chain.

• Most vaccines need to be kept between two and eight degrees Celsius. 

• In many low- and middle-income countries, electricity sources are unreliable. New technologies can help. 
• Solar direct drive refrigerators, as well as efficient new ice-lined refrigerator technology, has revolutionized the cold chain in developing countries.  

To achieve all the things we have described, global coordination will be required. At least for the first eight to 12 months after the Covid-19 vaccine becomes available, it is likely that there will be only a limited supply to meet global demand. 

• There needs to be a global agreement on allocating stocks to countries around the world. If that doesn’t happen, the result will be political tensions like those we are currently experiencing over the allocation of personal protective equipment, ventilators, and test kits.
• Although the poorest countries have in place systems that have been well honed over 20 years through the Vaccine Alliance, middle-income countries ineligible for Gavi’s assistance do not.  We need to decide how to support them — whether to extend Gavi assistance to them or provide other mechanisms.

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Treatments, Drug Development and Inequality

• “Covid is all about privilege. The more privilege you have, the more you can ignore some of the rules of Covid. Where one person would need to be in the hospital, another person can have the hospital come to them. That’s privilege,” said Lakshman Swamy, an ICU physician at Cambridge Health Alliance in Massachusetts.
• The president’s privileged treatment is understandable given his prominence, (got treatment only 10 people have had access to).
• but the contrast is no less stark for millions of Americans who have faced down Covid-19 in their homes or local hospitals, where barriers to cutting-edge care do not simply melt at the mere mention of their names or job titles.
• “A portion of the people who are severely symptomatic don’t have access to health care … and they are the population that is just being decimated by this.”
• High-profile individuals — in particular, professional athletes — have had frequent access to testing with fast-turnaround results. For much of the rest of the population, however, confirming a case of Covid-19 has meant waiting in line for a test, and waiting even longer for results.
• Many patients are worried about losing their jobs because of a positive test, or afraid to go into the hospital because no one else will be available to care for their children if they’re admitted. So they stay home and try to ride it out.
• For ordinary patients, there is no such thing as a precautionary hospitalization. Unlike the president, they would not be admitted based on concerns about what could happen if they are not in close proximity to doctors and state-of-the art equipment. They are only hospitalized if signs of severe infection emerge.
• Data collected on Covid-19 cases have turned up significant disparities in who is infected — and who dies from an infection.
• Death rate is more than twice as high for Black patients, and nearly twice as high among patients identified as Native American or Alaska Natives. 
• The data also show that people with lower incomes are much more likely to become seriously ill. 
• About 35% of patients with household income under $15,000 became seriously ill, compared to just 16% of patients with income over $50,000.
• ordinary patients don’t necessarily get the everything-but the-kitchen sink care received by the president. 
• In addition to remdesivir and the antibody cocktail, the president’s physicians have also said he was given the steroid dexamethasone after a temporary drop in his oxygen levels. 
• getting access to Regeneron’s experimental drug, a cocktail of two monoclonal antibodies which has not yet been authorized by the FDA, is harder still. 
• Bateman-House said the bigger problem is that the process itself is not based on need. “We know who gets access to investigational medicine is not a random cross section of the American population,” she said, adding that many patients do not even know there is a way to apply. “This particular case of Trump just makes it real for people.”

Drugs (all gotten by Trump)

• Monoclonal Antibodies: 
• The treatment, called bamlanivimab, has been approved to treat non-hospitalized adults and children over age 12 with mild to moderate symptoms who have recently tested positive for COVID-19, and who are at risk for developing severe COVID-19 or being hospitalized for it.
• This includes people over 65, people with obesity, and those with certain chronic medical conditions. 
• The single-dose treatment must be given intravenously and within 10 days of developing symptoms.
• Monoclonal antibodies are manmade versions of the antibodies that our bodies naturally make to fight invaders, such as the SARS-CoV-2 virus. Bamlanivimab attacks the coronavirus's spike protein, making it more difficult for the virus to attach to and enter human cells.
• This treatment is not authorized for hospitalized COVID-19 patients or those receiving oxygen therapy. (could make them worse)
• Convalescent Plasma:
• Convalescent plasma — literally plasma from recovered patients — has been used for more than 100 years to treat a variety of illnesses from measles to polio, chickenpox, and SARS.
• antibody-containing plasma from a recovered patient is given by transfusion to a patient who is suffering from COVID-19. 
• The donor antibodies may help the patient fight the illness, possibly shortening the length or reducing the severity of the disease.
• patients with (or at risk of) severe COVID-19 who received convalescent plasma within three days of diagnosis were less likely to die than patients who received convalescent plasma later in their illness.
• In order to donate plasma, a person must meet several criteria. 
• They have to have tested positive for COVID-19, recovered, have no symptoms for 14 days, currently test negative for COVID-19, and have high enough antibody levels in their plasma. A donor and patient must also have compatible blood types. 
• Once plasma is donated, it is screened for other infectious diseases, such as HIV.
• Each donor produces enough plasma to treat one to three patients. 
• Anti-Viral Treatments
• remdesivir --The drug may be used to treat adults and children ages 12 and older and weighing at least 88 pounds, who have been hospitalized for COVID-19. 
• Clinical trials suggest that in these patients, remdesivir may modestly speed up recovery time.
• HIV protease inhibitors lopinavir and ritonavir, and lopinavir and ritonavir in combination with the immunomodulatory agent interferon beta-1a. (still experimental and not utilized)
• Steroid Treatments:
• dexamethazone -- the corticosteroid drug decreased the risk of dying in very ill hospitalized COVID-19 patients. 
• patients who have developed a hyper-immune response (a cytokine storm) to the viral infection--it is the immune system's overreaction that is damaging the lungs and other organs, and too often leading to death.
• when should it be started? 
• If you start too soon you blunt the body's natural defense system, and that could allow the virus to thrive. 
• Ibuprofen--Is it safe?
• Some French doctors advise against using ibuprofen (Motrin, Advil, many generic versions) for COVID-19 symptoms based on reports of otherwise healthy people with confirmed COVID-19 who were taking an NSAID for symptom relief and developed a severe illness, especially pneumonia. 
• These are only observations and not based on scientific studies. (anecdotal)
• Chloroquine, hydrochloraquine, and azithromycin
• patients with severe symptoms of COVID-19 improved more quickly when given chloroquine or hydroxychloroquine. 
• The jury is still out regarding whether these drugs, alone or in combination, can treat COVID-19 viral infection. 
• While recent human studies suggest no benefit and possibly a higher risk of death due to lethal heart rhythm abnormalities, two studies supporting these conclusions have been retracted by the authors because of irregularities in how results were collected and analyzed.
• Vitamin D

• There is some evidence to suggest that vitamin D might help protect against becoming infected with, and developing serious symptoms of, COVID-19.

• it may help boost our bodies' natural defense against viruses and bacteria. Second, it may help prevent an exaggerated inflammatory response, which has been shown to contribute to severe illness in some people with COVID-19. 
• people with low vitamin D levels may be more susceptible to upper respiratory tract infections. 
• Vitamin C
• No evidence it prevents COVID infection
• IV infusion may decrease death rate, but studies have not been conducted
• Zinc
• Helps the immune system fight off bacterial and viral infections
• Fatotidine
• The generic name for Pepcid, famotidine is commonly used to treat ulcers, heartburn, indigestion and reduces the amount of acid in the stomach. A clinical trial testing the drug in hospitalized COVID-19 patients in New York wasn't able to recruit enough patients to properly evaluate its impact
• Melatonin
• Commonly used to treat insomnia, some studies have suggested that melatonin could also help COVID-19 patients with diabetes and obesity
• Aspirin
• Commonly given to older patients to prevent heart disease, aspirin is also a popular painkiller. It can reduce the risk of blood-clotting, and evidence has shown COVID-19 can trigger blood clots in some patients. 

Testing:

• Seriologic Antibody Testing
• A serologic test is a blood test that looks for antibodies created by your immune system. There are many reasons you might make antibodies, the most important of which is to help fight infections. The serologic test for COVID-19 specifically looks for antibodies against the COVID-19 virus.
• Your body takes at least five to 10 days after you have acquired the infection to develop antibodies to this virus. For this reason, serologic tests are not sensitive enough to accurately diagnose an active COVID-19 infection, even in people with symptoms.
• good to find those who have been infected in the past and recovered
• Your body takes at least five to 10 days after you have acquired the infection to develop antibodies to this virus. For this reason, serologic tests are not sensitive enough to accurately diagnose an active COVID-19 infection, even in people with symptoms.

Drug Development and the Economics of Inequality

• “During a crisis, some people will go out of their way to sacrifice their lives, and others will hoard medicines and be complete jerks. On institutional levels, we have the same span of good actors and bad actors”
• in the absence of comprehensive trial coordination mechanisms, signs of disarray are emerging. 
• “The scale of these trials is too small, and the variation in terms of how they are being run is too large”, says John-Arne Røttingen, chief executive of the Research Council of Norway and proponent of a more collaborative approach. 
• “These trials aren't really designed to answer the questions that need to be answered.” 
• Clinical trial literature, moreover, is riddled with drugs that looked promising in small trials only to prove ineffective in bigger, more rigorous studies.
• Nine repurposed drugs, should they demonstrate efficacy against the coronavirus, could be manufactured profitably at very low costs, for much less than the current list prices.
• But: A course of sofosbuvir, a medication by pharmaceutical company Gilead Sciences that is currently used to treat hepatitis C, costs around US$5 to make, but the current list price in the US is US$18,610, as cited by The Guardian.
• “That’s been extremely common with infectious disease medications in the past, like hepatitis and HIV, and we can’t let it happen with medications for Covid-19. 
• Otherwise, hundreds of thousands of preventable deaths would occur and health care inequality amongst the poor will worsen,” said Dr Jacob Levi, one of the study’s authors
• Intellectual property policies in the U.S., Canada and other research powerhouse nations have prompted concerns over price gouging, geographic discrimination and other strategies that can lead to profit at the expense of affordable medicines. 
• While manufacturing a drug is generally cheap, the process of research and development costs much more. Various estimates place the cost anywhere between $300 million and $2.6 billion (though the higher figures are often disputed) per drug brought to market, and companies expect sufficient intellectual property protection on their marketed drugs to recoup these development costs. 
• This isn’t unreasonable to ask, and governments are happy to restrict competition for these companies as long as development and production of novel medicines continues. 
• Pharmaceutical companies are part of an industry that enjoys the largest profit margin compared to any other private industry, even surpassing oil and gas. 
• The ratio of revenue spent on promotion and marketing – upwards of 25 percent – compared to the 1.3 percent devoted to discovering new molecules is striking. 
• The pharmaceutical industry, in both domestic policies and under potential trade agreements like the TPP, is granted exclusive power over the market; companies rationally use this power to make as much profit as possible before their exclusive rights expire. 
•  Ten million people die each year due to a lack of access to essential medicines, and nearly three billion worldwide are at risk from diseases that lack market incentives for drug development. 
• The Commission on Health Research for Development found that less than 10 percent of worldwide resources devoted to health research were put towards health in low and middle income countries, where over 90 percent of all preventable deaths worldwide occurred.
• Although high drug prices as a result of the intellectual property system have long been identified primarily as a problem for developing countries, they are becoming a growing concern even for industrialized nations. 
• Pharmaceutical patents and exclusivity reduce access to lifesaving drugs, and allow technologies developed with public funding to be purchased and monetized by private entities in developed nations. 
• Taxpayer-sourced research funding from governmental organizations like the Canadian Institutes of Health Research or the National Institutes of Health is a major component of the R&D landscape. 
• Between one fourth and one third of new drugs originate on public university campuses, but are then bought out by the industry to be monetized. Though development costs are borne by the taxpayer, the benefits of the research are mostly enjoyed by private parties.