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Distribution Of Therapeutics, Vaccines and Mass Testing  — Giving Wings to Hopes and Dreams !!!

Distribution Of Therapeutics, Vaccines and Mass Testing — Giving Wings to Hopes and Dreams !!!

Journey Of Vaccine

Few weeks ago we had mentioned about “How Do We Plan to Help Re-open the Global Economy By Putting Trillions lying in Dry Powder at Work?” in this Note Of Hope. https://bit.ly/3ggde8d .

We have made a global alliance and we are ready to wage the final war against coronavirus has begun. About 70 percent of the world’s population — or 5.6 billion people — will probably need to be inoculated to begin to establish herd immunity and slow its spread.

Social distancing, contact tracing, and effective treatments can contain and minimize the impact of the COVID-19 pandemic, but only a vaccine can truly end it. Even these measures are failing as is seen from this IHME curve . The only way to overcome the COVID-19 pandemic is to ensure that everyone in the world has access to the eventual vaccine.

Global scramble to secure personal protective equipment as the coronavirus spread, showed the danger of the my-nation-first approach. Panic buying, hoarding and misuse have put people most at risk of infection exposed to the virus.

The global grab for protective equipment and ventilators that left poorer countries empty-handed suggests the competition over vaccines could be at least as fierce. As the vaccines near approvals we have created an allaince are to get manufacturing and supply chains lined up in a quest to ensure coronavirus vaccines are distributed equitably around the globe.

Multi Lateral Approach To Rapid / Fair / Equitable access to Development, Production , Distribution of COVID-19 tests, treatments, and vaccines — All is being built from scratch.

  1. Access to COVID-19 Tools (ACT) Accelerator — We have started working with the major health organizations — including the World Health Organization, CEPI, the Global Fund, and Gavi, the Vaccine Alliance and have formed the Access to COVID-19 Tools (ACT) Accelerator to oversee and facilitate this process to ensure universal and equitable access and to return the world to a sense of ‘normalcy. The ACT Accelerator is providing expertise, funding, and resources to labs working on a vaccine. But developing, scaling, manufacturing, storing, and distributing an effective vaccine will be difficult and many challenges, both known and unknown, remain in the way. You can join us in taking action on this issue here.
  2. COVAX — Together COVAX a truly global solution to the COVID-19 pandemic has been created. The COVAX Facility forms a key part of the COVAX pillar (COVAX) of the Access to COVID-19 Tools (ACT) Accelerator, a ground-breaking global collaboration to accelerate the development, production, and rapid/fair/equitable access to COVID-19 tests, treatments, and vaccines for every country in the world, rich and poor, to make rapid progress towards slowing the pandemic. More than 165 countries representing more than 60% of the world’s population have engaged in COVID-19 vaccine global access facility to protect their populations. The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be delivered equally to all participating countries, proportional to their populations, initially prioritising healthcare workers then expanding to cover 20% of the population of participating countries. Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.
  3. Funding — The success of these efforts will ultimately depend on securing enough funding from governments and commitments from vaccine manufacturers to participate at a scale large enough to deliver a global solution. The formal expressions of interest submitted are non-binding; the COVAX pillar will now begin a process of consultation with all 165 countries, with countries funding vaccines through their own domestic budgets being required to provide an upfront payment and a commitment to purchase doses by the end of August to secure involvement in the COVAX Facility. Significant progress has been achieved by the COVAX partners to date, with seven of the nine candidate vaccines supported by CEPI already in clinical trials. A memorandum of understanding with AstraZeneca also commits them to supply 300 million doses of COVID-19 vaccines to COVAX. In addition, in June Gavi launched the COVAX Advance Market Commitment (AMC), a financing instrument aimed at incentivising vaccine manufacturers to produce sufficient quantities of eventual COVID-19 vaccines to ensure access for developing countries. There are about 126 COVID-19 vaccine candidates currently registered with World Health Organization, research suggests that historically, vaccine programs that have not yet entered human trials have just a seven percent probability of succeeding, which rises to only 17 percent once they enter human trials. This poses high financial risks for pharmaceutical and life science companies to scale up production before they know the safety and efficacy of the vaccines, let alone most manufacturers are unlikely to have the production capacity to meet massive demands.
  4. Development — We start by asking what is the underlying technology we are using to develop the vaccine antigen. We’ve seen a few manufacturers that have said they are developing a vaccine, but they’re using different technologies. Some are using a recombinant protein approach and some are using an mRNA-based approach. A protein-based approach will take a while to get to a candidate that can be tested in clinical trials, while at least one manufacturer using the mRNA-based approach already has a candidate that has started clinical trials. Dozens of companies large and small are rushing to develop vaccines using different technologies and approaches. We are tracking atleast 140 vaccine projects and 400 therapeutic drug sponsored by governments, universities, nonprofit institutes and private companies.

RAPS COVID 19 Tracker

COVID-19 vaccine tracker

NYTIMES COVID 19 Tracker

Coronavirus Vaccine Tracker

5. Production — With an mRNA vaccine, we’ve not yet had any vaccine approved for any disease that uses that technology, so we don’t know how long that could take to manufacture. The good news about mRNA vaccines is that the investment required to manufacture the bulk product is less than with more traditional approaches like egg- and cell-based, which take three to five years to build up the facility and $500 million to $600 million to build it. What happens after bulk manufacturing? Then you need the facilities to fill and pack it. While the bulk product will have to come from the manufacturer that owns the intellectual property, you can use other companies to do the secondary manufacturing for formulation, fill and pack. Making sure there are enough vaccines for every country will require manufacturers to begin producing vaccine doses even before vaccines trials reach the clinical phase. It’s hard to know right now which vaccine candidate will be successful, so billions of doses of a number of failed vaccines may have to be thrown out once the trial results come back. This sunk cost might seem like a waste, but it’s necessary to ensure that the final vaccine is ready to go at a moment’s notice. The ACT Accelerator, meanwhile, is strengthening the links between every component in the vaccine chain. Because of this collaboration, no countries will receive priority treatment — vaccines will be fairly and equitably distributed to communities worldwide. Large-scale manufacturing capacity will be required to produce viable products out of those experiments and clinical trials. Some vaccines may require two doses, putting greater pressure on manufacturing capacity. Vaccine alliance finds manufacturing capacity for 4 bln doses of Covid-19 vaccines. The Coalition for Epidemic Preparedness Innovation (CEPI)plans to have two or three manufacturing plants for each vaccine, in its vast manufacturing push. Total available capacity is 4.9 Bn doses. With current estimates the world can do the two billion doses by the end of 2021. But that wont be sfficient and hence this effort. CEPI has taken initial steps toward securing manufacturing capacity with more than 200 biopharma or sterile vaccine production companies. Most people don’t believe that four billion is possible. we do without sidelining other critical vaccines. We are doing “matchmaking” based on manufacturers’ capabilities and the specific needs of the various vaccines. Manufacturing capacity has been easier to locate for vaccine candidates that employ traditional technology. But many of the COVID 19 candidates involve more complex mRNA- or DNA-based technology. Since there has never been a licensed vaccine using those approaches, no network of contract manufacturers exists to support high-volume production. The capacity just isn’t there and it all has to be built from scratch.

6. Distribution — But as we’ve seen with viral testing kits, manufacturing and distribution problems will almost immediately create shortages, at least in the short term. To quickly manufacture the nearly 8 billion doses required to protect everyone on the planet will be impossible.We are developing a tiered system for the distribution. Getting the vaccine to more than 8 billion people — could be the most challenging aspect of all. We have never attempted to roll out a vaccine at the scale and the speed that we are looking to do with COVID-19 vaccines. This is a vaccine that will be needed in every region of every country, for every age group. It will take an unprecedented manufacturing effort to produce the billions of doses we will need, careful work needs to be done on allocation to ensure the most vulnerable, such as health workers, are prioritized. And for global distribution, we are already planning out a multitude of scenarios to ensure the cold chain is ready to handle what will amount to one of the biggest logistical challenges in history. Take the “cold chain,” for instance. The cold chain presents one of the biggest logistical barriers to getting vaccines where they’re needed. Many vaccines need to be kept at a constant temperature of between 2 to 8 degrees Centigrade — just a few hours outside of a fridge can render a vaccine ineffective. As the COVID-19 vaccine reaches the market, on-the-ground distribution could depend on cold-chain technology, making it particularly difficult to reach remote, rural populations. In hot countries with unreliable power supplies this can present huge problems. We intend to provide support to health systems to ensure warehouses, vehicles, and health facilities have the right equipment to keep vaccines at the right temperature, including through our Cold Chain Equipment Optimization Platform, which is supporting the rollout of new solar-powered fridges. Other measures will have to be learned and developed as we go. Manufacturing billions of vaccines has never been attempted before on such a short time scale, according to our Future Councils report at the World Economic Forum (WEF). Alongwith GAVI we are working with distribution companies such as UPS to come up with solutions, and are also looking into drone technology to deliver equipment. Regional distribution sites have to be built so that we don’t have to make everything centrally and try and ship it around the world.

7. Integrity Of Healthcare Systems Worldwide — Successful vaccine delivery also depends on the integrity of health care systems around the world. The COVID-19 pandemic has already weakened health care globally. Health care workers have faced greater suspicion and discrimination, hospitals have run out of supplies, and economies have been unable to fund public health. Ensuring that everyone in the world gets access to a COVID-19 vaccine will require millions of community health workers worldwide to be trained to administer vaccines and perform community outreach. These workers will need the personal protective gear (PPE), tracking technology, medical gear, funds, and support networks to do their jobs effectively. During the current pandemic, vaccination campaigns for other diseases have been derailed, causing outbreaks of other infections, too. This development could potentially erode long-standing health care infrastructure and protocols. That’s why wealthy countries need to be investing in health systems in developing countries to ensure these networks recover. Past vaccination campaigns for diseases such as Polio, pneumococcus bacterium, and Ebola have helped to lay the groundwork for future vaccination campaigns and this infrastructure will help to streamline the COVID-19 campaign.

8. Running The Vaccination programs — We are also working to improve mapping, tracking, and delivery of vaccines through a variety of cutting-edge technologies. We are deploying drones to carry vaccines to remote areas, working with private contractors such as the United Parcel Services to leverage their expertise, and using artificial intelligence to plan the delivery strategy. In many countries delivering this vaccine to their populations at speed would have been near-impossible even 10 years ago. While work still needs to be done, much of the infrastructure we’ll need to roll out this vaccine is already in place and ready to meet this challenge. Alongside this, we are building/strengthening a system of tracking and contact tracing.

9. Packing Vials Glass — Access to medical glass is another known bottleneck. To overcome it, we are lining up the glass vials supply chian for the for billion of doses. We don’t want vials to be the reason we don’t have enough vaccine. The packaging products we choose are being kept uniform, so we can fill vials and finish packaging for any of the vaccines, rather than tailoring them to individual products. They have done the same with rubber stoppers that seal the vials and aluminum flip caps to cover them. Bigger firms are managing on their own while smaller biotechs and university labs we are supporting with sophisticated supply chains.

10. COVID-19 PPE — Our PPE have a triple shield technology and can be washed ten times and sterilised ten times for reuse.High-grade polypropylene is the raw material used to produce the equipment, lending it more opacity while keeping it lightweight. Our PPE suit consists of coveralls, gloves, shoe covers, three-ply or N95 face masks, headgear and face shield. All available at a cost of 10 USD.

11. COVID-19 Testing : We are also gearing up to partner with the government and local municipalities to rampup coronavirus testing for rapid mega-scale Covid testing across the world using RT-LAMP (Reverse Transcriptase-Loop Mediated Isothermal Amplification) COVID-19 diagnostic kit, which is cheap and gives a quick result. COVID-19 RT-LAMP (Reverse Transcriptase-Loop Mediated Isothermal Amplification) test is a nucleic acid-based test carried out from nasal or throat swab samples from the patients. The test has been developed and successfully demonstrated using synthetic templates. RT-LAMP test is cheap because you don’t need to have instrument cost. It’s also quite quick. You can actually take it into different areas. You can very quickly take it into the rural area. The new testing kit “could cost between USD 1–2 . It will take less than an hour for a test to do. Within one hour, we can get the result. Technological basis of Feluda kit and RT-LAMP kit is different. Faluda is based on technique call crisper cash, while RT-LAMP is based on RT-PCR. There is isothermal PCR. So, the technology of both kits is different. RT PCR requires a specialised machine. The first step is a reverse transcription that is common to both RT-PCR as well as RT-LAMP. The second step is once DNA is made from RNA, the PCR quantitative to PCR machine does three cycles of temperature. In this condition, you do something at 92 degrees; you do something at 55 degrees; you do something at 73 degrees, and you keep cycling between these three temperatures about 25 and 30 times, and in each cycle the number of DNA molecules doubles and you measure. That is in the fluorescent level. So that is a base of RT-PCR. But RT-PCR required this machine the fluorescent level is costly and it takes time. On the other hand, the RT-LAMP test is using only four to six primers for the amplification of DNA. It uses four and six primers and you do the amplification of DNA. First of all, it is common for converting RNA into DNA. When in the second step, you use only a single temperature something like 60-degree Celsius. We have scaled up the production of the test kit.

12. Our Family Business / Foundations / Private Equity — The Foundation’s within the family businesses we represent globally are committed in their aim to respond to all disaster situations wherein human lives and livelihoods are jeopardized. Our Foundations strives to assist speedily in the immediate aftermath of disasters, directly engaging with affected communities and leveraging its strengths — human resources and information technology — to efficiently and effectively provide relief and alleviate human suffering. In the event of severe and long-lasting impact, our Foundations work with the communities to revive livelihoods, improve health and education, and ensure sustainable development. The Oslo, Norway-based group is backed by 14 governments, the Bill and Melinda Gates Foundation, and Britain’s Wellcome Trust. Our foundations will ensure that vaccine, PPE, testing reaches every nook & corner of the world.

13. Rapid / Fair / Equitable Access : A multivalue ethical framework for vaccine stewardship — When a vaccine comes on the market, the U.S. Centers for Disease Control and Prevention and other advisory groups will issue guidelines on who should get first dibs. The top tier will include health care and other workers whose jobs are considered essential in the pandemic. People most likely to die if stricken may also get priority. But these are just guidelines. The ultimate decisions on who gets vaccinated will be made by state and local health departments and community hospitals interpreting the federal guidelines. If doctors are prioritized for getting the vaccine, will the delivery persons, grocery store clerks, and home health aides who often live in underserved communities also be given preference? Not giving due priority to these communities will only deepen their mistrust in the health care system that is already present and was worsened by debacles like the bungled rescue efforts after Hurricane Katrina. But in the midst of the global pandemic, a geopolitical race to prioritize immunization of each country’s own nationals is on the rise. High-income countries are scrambling to secure pre-production contracts with vaccine manufacturers to reserve supplies. Some fear that export control would be in place once COVID-19 vaccines become available. Given the inevitable demand for the COVID-19 vaccine and the high burden of disease already placed on many countries, there is a need for an equitable global framework for vaccine distribution. Without advanced planning and thoughtful execution, pre-existing health and socioeconomic disparities will only be exacerbated by this pandemic. It seems inevitable that high-income countries will obtain and use the bulk of vaccines, while lower income countries are in far greater need. Planning for distribution must begin as the vaccine is being developed so that a paradigm is ready when distribution begins. Otherwise, the framework loses efficacy as national interests for developed states favour perpetuation of existing international disparities as seen in the influenza pandemic.

Table 1

A multivalue ethical framework for the global allocation of a severe acute respiratory syndrome coronavirus 2 vaccine

It suggests a multi-parameter model based on age, co-morbidity, income and profession to justify one’s claim for vaccine. The imperative is to develop a rules-based regime for the distribution of vaccine and the allocation of scarce healthcare resources in this time of public health crisis.

Table 1. Multi-parameter framework for Vaccine Distribution

Why a multilateral framework is key

To secure immunization access for developing countries, a few global initiatives have been proposed.

  1. An Opportunity for Equitable Distribution
  2. Framework for Distribution
  3. Flexible, Trusted Governance
  4. Adequate, Predictable Financing
  5. Open Collaboration and Evidence-Based, Health-Driven Allocation

Principle 1: Ability to develop or to purchase

Vaccine distribution is currently determined by two primary considerations: (1) ability to develop and test and (2) ability to purchase. Five multinational companies produce most of the world’s vaccines and negotiate with the private and public sector for purchasing. Nationalistic approach will result in unethical and inequitable allocation based on citizenship and a country’s ability to pay.

Principle 2: Reciprocity

Historical events establish the need for a system of reciprocity, which improves equitable vaccine distribution to countries involved in drug development. Reciprocity is well established in research ethics and some clinical trial participants may have post-trial access to medications. Therefore, countries that share viral samples or have participants in clinical trials should receive priority for vaccine supplies.

Principle 3: Ability to implement

Although no single ethical principle can guide vaccine allocation, some consideration must be made for utilitarian considerations, which prioritise saving the most lives or life years. Vaccine deployment is inherently a resource-intensive endeavour that requires specialised transportation, trained personnel for administration and an intact public health infrastructure for identifying need and surveillance. Thus, to maximise vaccine benefits and reduce waste due to improper utilisation, allocation frameworks should consider a country’s ability to vaccinate.

However, this approach will bias against countries that do not have the resources and infrastructure for successful vaccine deployment. Therefore, before allocating based on this principle, all reasonable efforts should be taken to redistribute human and supply chain resources to alleviate these inherent inequalities. Otherwise, disparities are perpetuated (and amplified) by a utilitarian approach to allocation, as low-income countries with poor health outcomes have less access to preventative treatment. After the acute pandemic response, interpandemic years should focus on building up resources in low-income countries.

Principle 4: Distributive justice for developing countries

Distributive justice is the fundamental consideration for equitable vaccine deployment. This principle requires fair allocation of scarce resources, which can be applied to communities both locally and globally. However, limited supply and mass demand during a catastrophic situation, such as the current pandemic, make equitable distribution suboptimal or even impossible.

Since a primary goal of vaccination is reducing infectious disease burden and spread by herd immunity, people with a higher risk of infection or poor outcomes should be prioritised in allocation.

This framework provides an algorithmic scoring system that can be used to balance utilitarian and egalitarian values in country-by-country vaccine allocation. Further considerations will be necessary on the national level regarding distribution within smaller geographical areas. Additionally, specific criteria for scoring are omitted because there are no standardised measurement systems for each variable. Although we provide guidelines on point allocation, we recognise that this omits specifics on the quantity of countries per grouping and point cut-offs per group. We leave the framework up for interpretation based on the status quo of the pandemic. Guidelines should respond to emerging scientific, supply chain and public health updates. A framework is paramount to prevent inevitable global inequity during this time of crisis and our allocation framework offers a starting point for discussion. Success is dependent on global collaboration, and if ever there was an opportunity for cooperation, that time is now.

14. Regulators — One other massive challenge is the need to work with dozens, if not scores, of regulators globally. Each regulatory agency could ask for something different, so our job is a bit more complex. A CEPI regulatory working group has been looking into ways to try to standardize requirements to the extent possible. But then each of the countries that receive the vaccine also need to license it.

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