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COVID-19 Vaccine as a Global Common Good Campaign – Feasibility

GROUP PROJECT

Pınar Ertav (2026475)

Qais Atieh (2018203)

Harpreet Kaur Dhillon (2017299)

Rupesh Raj Giri( 2023802)

Natan Henrique Granetto (2023430)

University Canada West

BUSI 601 Ethics, CSR, and Business Environment

İbrahim Ujal

August 5, 2021

Background and current state of COVID-19 vaccine research and development

Vaccine Development Process

Under normal circumstances, the development of a new vaccine from pre-clinical trials until approval and licensing takes an average of 10 to 15 years. Vaccines are first tested for their ability to deliver protective immunity in suitable animal models, followed by the toxicity test of these vaccines on animals. After passing these two tests, the initial batches of this vaccine that are of current Good Manufacturing Practice (cGMP) quality are produced (1). However during emergency situations this process can be expediated via emergency use authorization. EUA is a mechanism to facilitate the availability and use of vaccines, during public health emergencies, such as the current COVID-19 pandemic (2).

Current Vaccine Development Status

Up to 2 August 2021, there are above 90 vaccine candidates in clinical development, with 32 of them undergoing Phase III clinical trials, 39 in Phase II trials, and 54 in Phase I Trials. Currently 8 vaccines are approved for full use (3). WHO has set its success benchmark for COVID-19 vaccines with the highest at 70% efficacy under a protected duration of one year and the lowest threshold at 50% efficacy for 6 months. (4) The vaccines will have to fulfill all regulatory requirements in terms of quality, efficacy, and safety before a marketing authorization is granted (3)

Challenges Encountered in Developing Vaccines and Current Progress

Efficacy and Safety, Emergence of Coronavirus Variants, Vaccine Distribution Challenges, Production capacity, Distribution requirements: temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution. Political influence and social equality (5) , Different vaccines(7)

Johnson & Johnson

Viability: Johnson and Johnson reported Jan. 29 that the immunization was 66% compelling generally speaking in ensuring against Coronavirus, and 85% viable in forestalling extreme sickness which incorporates ailments requiring hospitalization. In the US, the immunization gave a 72% degree of insurance against moderate to serious Coronavirus disease. In any case, in South Africa, where an exceptionally infectious transformation of the infection is the essential variation, the viability was just 57%. One single dose is required for it.

Availability: Johnson and Johnson got approval for crisis use from the Food and Medication Organization on Feb. 27. The organization hopes to have 20 million dosages conveyed before the finish of Spring, and 100 million during the main portion of 2021.

Novavax

Effectiveness: Novavax said Jan. 28 that its immunization was over 89% viable in ensuring against Coronavirus in its stage three clinical preliminary led in the Unified Realm, yet under half compelling against the alarming strain from South Africa. Two doses, one month apart. The vaccine only requires basic refrigeration. What amount of time it requires to construct invulnerability: Immunization viability in the U.K. preliminaries was 89% seven days after the subsequent portion.

Availability: Novavax was paid $1.6 billion as part of Operation Warp Speed this summer, with the goal of delivering 100 million doses by the beginning of 2021. A late-stage trial in the U.S. and Mexico started in late December, so it’s not clear at the moment when the vaccine will get authorized for use in the U.S.

Moderna

Effectiveness: The Moderna antibody has been displayed to have an adequacy of 94.1%. It additionally seems to give security against the new variations, yet is more viable on the U.K. variation than the one from South Africa. The organization declared Jan. 25 that it is chipping away at an antibody supporter to address new variations, which ought to be accessible by fall. (Adapting to new strains is a reasonable, generally speedy endeavor because of the way mRNA immunization innovation works.) A new report from the CDC tracked down that a solitary portion of Moderna or Pfizer-BioNTech’s antibodies was 80% viable in forestalling Covid contaminations in true conditions. Two doses are required second after 28 days.

Accessibility: Moderna’s antibody was supported by the FDA for crisis use on Dec. 18. The organization said it’s attempting to deliver up to 1 billion dosages of its Coronavirus immunization this year.

Pfizer-BioNTech

Number of doses required: Two doses given 21 days apart. The Pfizer vaccine also has to be stored in an ultra-cold freezer.

Effectiveness: The Pfizer immunization was 95% powerful at forestalling lab affirmed Coronavirus disease in individuals without proof of past contamination. Pfizer disclosed to CNBC Thursday that their immunization was as yet powerful against lab-designed changes that are found in the new variations found in the U.K. what’s more, South Africa. Pfizer said Wednesday that its Coronavirus immunization was 100% powerful in young people between the ages of 12 and 15, and the drug maker will demand a revision to its crisis use approval.

Accessibility: Pfizer’s antibody was endorsed for crisis use on Dec. 11. The organization hopes to convey 200 million dosages by July. President Joe Biden said Jan. 26 that the public authority intends to buy 100 million additional dosages from both Pfizer and Moderna.

Oxford-AstraZeneca

Effectiveness: Information from enormous preliminaries delivered in November tracked down that the antibody was 62% successful, however there were issues with that review. Another investigation distributed Sunday tracked down that the immunization just offers “negligible security” against gentle to direct infection brought about by the South African Covid variation. Two doses second after 3 months.

Accessibility: AstraZeneca hasn’t applied for crisis use approval in the U.S. however. England gave the Oxford-AstraZeneca antibody crisis use approval on Dec. 30, and India additionally conceded crisis use on Jan. 3. South Africa suspended the utilization of the Oxford-AstraZeneca antibody Feb. 7, after information recommends it doesn’t deal with the nation’s variation.

COVID-19 Vaccines Global Access (COVAX) initiative and its effectiveness in reality

            By mentioning “COVAX,” Covid-19 vaccine global access facility, it’s notable that many factors and aspects all have a strong connection with each other. Such as Coalition for Epidemic Preparedness Innovations “CEPI,” The access tools to COVID-19 Accelerator “ACT,” The Vaccine Alliance “Gavi,” World Health Organization “WHO,” UNICEF, and many others. All of them are sharing the same concepts of making an equity delivery process of the vaccine worldwide. Including developing poor and wealthy participated countries making priorities for the people who need to be vaccinated the most as a fast response by making an effective collaboration between them, public, and private sectors to make a healthy planet, free-Covid citizens (ReliefWeb, 2021).

COVAX and The Pandemic ratio

            The Covid-19 virus made and still has enormous effects on our world day after day; hundreds of economic and health losses are hitting almost all countries worldwide. The peak was direct during the process of several lockdowns, quarantines, and travel delays and bans. According to the World Bank Blogs (2020), Covid-19 has a massive role in making rapid downturns and maybe lead to several global recessions. In addition, 500 billion USD is the estimated global economy’s value of losses per month.

In addition, with the help of many influential people and organizations concerned, everyone needs to be vaccinated the soonest; it’s the only approach to get back as before. After that, quick actions were taken to achieve the lofty goals. A collaboration between GAVI, CEPI, WHO, and UNICEF was launched (CEPI, 2021). 

COVAX initiative, roles, and offers.

On the one hand, COVID-19 vaccines global access “COVAX” is co-leaded by CEPI, GAVI, and WHO (CEPI, 2021). COVAX is considered one of the three major pillars in accessing the Corona Virus tools accelerator to give it the opportunity to make significant actions in response to the current situation of the pandemic. COVAX has a role in making a strong base bringing together all people and organizations. Public and private, to positively impact the situation, collaborating with health organizations, societies, governments, pharmacists, manufacturers, and scientists to find an effective way to produce the vaccine and proceed with deliveries (GAVIAlliance, 2020). It acted as an insurance policy, with the largest vaccine candidate’s portfolio in the world.

Furthermore, COVAX started to focus on the coordination process by making a solid platform in which the concerns are in research and development, supporting the existed researches, supporting the under process manufacturers who are developing their own vaccine with making a feasible study on proposed prices (The Vaccine Alliance, 2020). Some first initial goals were set to give equal vaccination access for all kinds of people once doses are ready, starting with people who have major health issues and workers in health sectors. Taking into consideration funded and unfunded developing countries with low income and wealthy countries as well. The process of the vaccine distribution and deliveries will be protected and well-organized. In this case, COVAX is a strong and effective way for countries’ citizens to be vaccinated and protected (The Vaccine Alliance, 2020). It worked to collect and develop financial resources to be a part of the vaccines development plan, make a wide range of purchases, and enter the investment field to achieve its humanitarian goals (EPI, 2021).

Importance of COVAX

            Likewise, COVAX has a mission to make as many chances as possible to vaccinate people in participating countries. The importance of it comes from the safety, fair, and fast actions provided and monitoring its process and categorizing candidates based on their needs (The Vaccine Alliance, 2020).

Otherwise, COVAX offers vaccine doses for at least 20% of every country’s citizens to cover almost 50% of the world’s population. Organize and manage vaccination portfolios, fast delivery process for the doses, and contribute to making economies stable again by ending the effects of this pandemic (The Vaccine Alliance, 2020).

Real-life effectiveness and results

            COVAX physical results started to appear to the public in many countries once the first delivery was accomplished. In February 2021, Ghana was the first country to receive the first COVAX shipment of vaccines which took less than a year of processing and planning when the initiative was started. Achievements kept going and requests multiplied (GAVIAlliance, 2021). It’s a privilege that more than 170 countries engaged and signed up. Six regions have received their doses; Africa, America, Eastern Mediterranean, Europe, South-East Asia, and Western Pacific. There were more than 2 Billion vaccines secured and around 7 Billion Dollars assured. Nowadays, COVAX is reaching the broadest rollout, which is rapidly increasing in the world (GAVIAlliance, 2021). COVAX is shipping vaccine doses to less fortunate countries as well.

Views of the WHO, WTO, USA, Canada, and the EU on COVID-19 vaccine as a common good.

            After the rapid spread of the Covid-19 and the massive adverse effects on almost every economy, it was necessary to take an international series of actions to face this damage and protect human beings at the first line. There was a genuine need to declare that the vaccination process must be considered as a common good. One of the striking claims held was the one by Yunus Centre. It concentrated on making the Covid-19 vaccine a global common good out of the colloquium 51. This one and many others claimed to make vaccines available to everybody at a free cost, and all world’s expertise in concerned fields should collaborate. They believed that it’s the only way to end the pandemic (Yunus, 2020).

Moreover, It worth knowing that up to date, a total of more than 3000 people from all around the world have collaborated in making a joint appeal to global leaders, concerned people, and organizations to consider the vaccines to be a global common good. It includes more than 115 international personalities and more than 19 Noble Laureates (Yunus, M., Donaldson, C., & Perron, J.,2020). In addition, there are views from the WHO, WTO, USA, Canada, and EU on the issue of considering the vaccine as a common good as follows:

WHO, World Health Organization

WHO provided free access to studies and publications and has adopted many global common goods, guidance, contributing, assessment, and many kinds of support. WHO was and still one of the biggest supporters in the issue of vaccines as a common good, such as the implementation of GAVI and COVAX (GAVI, 2021).

WTO, World Trade Organization

World Trade Organization deals with rules of the trading concept between all international nations and economies; it plays a significant role in exporting, importing, and producing goods and services. As a response to the Covid-19 pandemic and vaccines as a global common good, WTO urged all vaccine factories to increase production and facilitate its delivery to all countries. Especially developing countries cannot purchase or provide the vaccine to their citizens by establishing commercial links to facilitate the process (Weala, 2021).

The USA, United States of America and Canada

On the one hand, the USA has a positive view on the vaccine issue as a common good. It is motivating and supporting all related organizations, and it’s trying to deliver the vaccines to other nations as well. It is giving rewards to people who will be vaccinated, no complicated procedures in manufacturing, supporting and collaborating to make faster production, and it took a role in donating for developing countries. On the other hand, Canada has urged people to take the vaccine, it’s a moral incentive, and it’s an act of social solidarity. It is believed that it is a global common good (Speer, S., & Dijkma, B., 2021).

EU, European Union

            EU was one of the main supporters of the issue of making the vaccine as a common good. It adopted many procedures to provide facilities such as making all vaccines common, transparency, fast testing and free of charge for all, equity in access, no discrimination, and data protection (Fyeg, 2021).

Views/potential views of the effective vaccine manufacturing companies surrounding the COVID-19 vaccine as a common good appeal.

COVID-19’s international expansion has immediately generated an immediate need for an effective and safe vaccination, which is currently being developed. And even in the United States, the politicization of the vaccine authorization, including whether prominent personalities endorse it, might erode views about its benefits and risks, as well as the desire to take it (Bokemper, Huber, Gerber, James, & Omer, 2021). Moreover, In the United States, Americans need to be more usually able to get vaccinated when provided with US-made vaccinations that provide a low chance of minimal side effects and seem remarkably efficient. The potential views of primary vaccines and its manufacturer can be listed bellows:

A.    BioNTech

It was approved for immediate use, but several individuals are still waiting for it to be thoroughly reviewed. Because of the threat posed by the highly transmissible delta form, the Biden government is attempting to vaccinate as many people as possible (FDA Puts All Hands on Deck to Review Pfizer-BioNTech Covid Shot, 2021). Furthermore, Clinical studies and real-world settings suggest that the Pfizer SARS-CoV-2 vaccination is efficacious. Most people, according to current research, are safe from its effects. Moreover, Six-month effectiveness dropped from 96 percent to 84 percent, according to data presented by Pfizer and BioNTech. Pfizer may need a third dosage of the Covid-19 vaccination in the future.

B.     Moderna Inc

According to the FDA’s comprehensive evaluation of clinical trial data, Moderna’s Covid-19 treatment is available and 94 percent efficient in infection control. Moreover, Pfizer carries the same effect, but most people who got Moderna as their vaccine causes high fever than Pfizer. As of now, it’s unclear to what extent the Moderna vaccination will protect COVID-19 patients.

C.    Janssen Vaccines

Despite the vaccination’s high level of protection, health authorities were concerned that certain Americans would consider it inferior to its predecessors, which Moderna and Pfizer-BioNTech created. Moreover, on the other hand, some people are anxious to obtain it due to its ease. It’s a win-win situation for public health professionals, especially in underprivileged areas who may not otherwise have access to vaccination. However, Most of the public change their mindset of having the J&J vaccine when they get known of its 66% of effectiveness.

D.    AstraZeneca

Any COVID-19 vaccine’s success depends on the public’s trust and faith in it. Despite the positive results of the safety evaluation and the recommencement of the study, significant attention was given to the proper pause in the experiment to examine for safety problems. Moreover, “About three out of every 1,000 dosages provided were suspected of having adverse effects, according to the Medicines and Healthcare Products Regulatory Agency (MHPRA). However, there is no evidence that the vaccinations were responsible for any of the 143 recorded deaths. Initial reports of deaths following injections in Norway have sparked an increased examination of vaccine safety due to the worldwide rush to protect susceptible people against the coronavirus. There is no direct relationship, according to the country’s health experts” (Pfanner & Paton, 2021).

Considering history, the pros and cons of relaxing intellectual property rights for vaccines. You may consider historical events such as: (i) declaration by the inventor that polio vaccine would be a common good and  (ii) the HIV AIDS drugs patent controversies

For nearly 30 years, intellectual property rights (IPRs) have been a subject of heated debate as to whether and to what extent these rights contribute to increased innovation and life-saving medical technologies or whether they unfairly restrict access to those technologies. Similarly, Given the public health issue of equitable access to affordable COVID-19 vaccines, South Africa and India have asked the WTO to waive their intellectual property rights to facilitate access to vaccines and any technologies related to COVID-19. There was considerable support for the proposal co-sponsored by Kenya, Eswatini, Mozambique, Bolivia, and Pakistan, even though a limited number of veto parties, including the United States, United Kingdom, Canada, and the European Union, which blocked consensus. Since a consensus could not be reached within the 90-day period set by the Agreement Establishing the WTO, Members have agreed to keep the proposal for a waiver of COVID-19 on the agenda for the TRIPS Council in 2021,  fortunately, midway through the second quarter of 2021, the United States, Russia, and China announced their support for the IP waiver for vaccines, in a surprising and welcome move.

We cannot understate the significance of the US decision in particular, as it is the largest pharmaceutical market in the world. Since the 1990s, US governments have worked together with companies, universities, and other nations with highly diversified industries to establish and enforce laws regarding intellectual property. Recently, these efforts have been conducted through discussions at the World Trade Organization (WTO), where it is currently being considered whether to grant waivers of intellectual property. There was no way anyone could have imagined that a few months ago, the United States would have taken a position like this. In light of this decision, many countries that are still in limbo should follow suit, especially Japan, South Korea, the United Kingdom, and members of the European Union.

  When it comes to the benefits of easing intellectual property rights, in the first place, each country gains the ability to manufacture the vaccines that it needs in the event of a pandemic. ​That is the basis for the campaign to temporarily waive intellectual property rights (IP) protection on coronavirus vaccines in the short term. This raises the question of how quickly vaccine production can be increased if manufacturers in emerging economies commit to it now, this could potentially result in immediate relief with respect to production and distribution. Industry data indicate that about ten billion vaccine doses are expected to be manufactured by the end of 2021. Researchers at the IMF point out that current trends mean this won’t happen. They say the industry will probably have produced six billion doses by the end of 2021, and that delays for people in low-income countries will likely be even longer

There are a number of opposing factors that can be discussed when discussing the cons of relaxing intellectual property rights. These reasons can be seen as making the proposed waiver unnecessary and potentially harmful. It is important to point out that pharmaceutical companies are offering the vaccine at very reasonable prices, and many of them have announced plans to conduct large-scale not-for-profit sales. A repeal of patent protection poses health risks from less-than-expertly produced vaccines, as well as political risks from uncertainty, both of which could negatively impact the pharmaceutical industry’s ability to innovate.  Given the particular challenges related to making COVID-19 vaccines, it cannot be assumed that a simple patent release will result in previously untrained vaccine manufacturers being able to manufacture safe, effective vaccines. One should also consider another risk that a government-initiated limitation of patent protection would carry if one takes into account how complex and costly the development of drugs is. The government’s ability to waive or limit patent protection could discourage pharmaceutical companies from undertaking the costly research and development that is necessary to develop lifesaving medicines in the future because they fear they will not be able to recoup the investments made. 

            A significant impact on human health ensued a large field trial involving millions of Americans used the world’s first successful polio vaccine at the turn of the 20th century to prove its safety and effectiveness. developed by Jonas Salk, a physician, and scientist who owned the patent. On April 12, 1955, Edward Murrow interviewed and asked Salk Who owned the patents for the polio vaccine? “Well, the people,” Salk responded. “There is no patent Could you patent the sun? To begin with, Salk claimed that the polio vaccine belonged to the people. Then, he quoted the famous quote comparing a vaccine to the sun. These three statements have been the core of the protests against big pharma’s control over vaccines for decades.  The following provides a brief background to polio so that the reader can get a sense of the magnitude of this disease. At the beginning of the twentieth century, approximately 13,000 to 20,000 children were paralyzed by polio each year, and it was Salk became the face of the vaccination movement.

Pros and cons of making COVID-19 vaccine as a generic drug. Generic vs brand vaccines.

Any patent registered by an agency that regulates intellectual property will have a maximum period of existence. In Brazil, for example, this period is 20 years after the patent filing date or 10 years after the grant date, the option that provides the most benefits to the owner will be chosen. During this period of validity of the patent, its owner may economically exploit the asset, either through its own production or through technology transfer.

In the case of drugs, for example, the holder of the formula may choose the laboratories that will produce that drug and stipulate an amount to be received from these laboratories, that is, royalties. When the patent expiration date for this drug arrives, its formula will go into the public domain. This means that everyone will have access to the technical details of that invention, therefore, all laboratories will be able to produce that drug without having to pay the owner anything.

It is then that the so-called generic drugs appear, they are drugs whose formulas are in the public domain. The fact that any laboratory can produce drugs in the public domain justifies the fact that generic drugs are cheaper. The drug itself that was exclusively sold has its price reduced to be closer to the price of generic drugs. Generics are drugs that have the same active ingredient as a reference drug. It is nothing more than a copy of the drug, whose patent is no longer in force, thus losing its exclusivity and making it possible to manufacture the generic version. These drugs can replace the reference drugs, when prescribed by the doctor.

To reach the population, the generic is subjected to strict quality control standards, such as bioequivalence tests carried out on human beings (verifies that it is absorbed at the same concentration and speed as the reference drugs) and pharmaceutical equivalence (accredits that the composition of the product is identical to that of the drug that originated it). Thanks to these tests, generic drugs are interchangeable. In other words, by law they can substitute the reference drugs indicated in medical prescriptions. The exchange, when the doctor does not directly prescribe the generic, can be recommended by the responsible pharmacist, in retail establishments, with absolute safety for the consumer.

Covid-19 vaccines have emerged as a great hope to combat the global pandemic. However, the distribution of coronavirus vaccines in the world is uneven, “privileging” the strongest economies such as the United States and the United Kingdom. In the fight against the virus, while 44% of the US population and 51% of the British population were already vaccinated against COVID-19, in Brazil only 16.4% of Brazilians received at least one dose of the drug. This great inequality is reinforced by the difference between the economies. There are some initiatives for the distribution of vaccines in a more equitable way, but they have not yet reached expressive results. This is the case of the COVAX Facility, led by the World Health Organization (WHO).

However, pharmaceutical companies believe that breaking patents should not contribute to greater access to immunizations produced by US and European companies. For example, mRNA (messenger RNA) vaccines are a new, complex, and expensive technology, which would hamper the ability of other researchers and groups to learn and produce.

To counter this barrier, emerging countries would need to invest large amounts in research, which would take time. On the other hand, breaking patents can facilitate the replication of vaccines that use traditional technologies against COVID-19, such as Covishield (Oxford / AstraZeneca) or even CoronaVac. In fact, in some countries the two formulas are already expected to be produced in the country but based on a commercial technology transfer agreement.

Finally, one of the main arguments against breaking patents is that the maneuver would discourage investments in ​​innovation in health. In the case of the COVID-19 pandemic, laboratories and pharmaceutical companies invested billions of dollars in research, studies and tests and achieved strong results in the fight against the infection. For the first time in the history of science, so many safe and effective vaccines have been developed in such a short time (less than a year and a half). These immunization agents are even the main bets of governments around the world for humanity to overcome the virus.

Now, it is only fair that these companies benefit from the commercial profitability of these billions of dollars invested and that they did not have a 100% guaranteed profit, as the formulas could fail. Some, it is true, were even discontinued, after verifying their inability to protect themselves against the coronavirus. Furthermore, experts point out that breaking patents could create a dangerous precedent.

For now, countries, international entities, and laboratories themselves must think of effective ways to expand the distribution of vaccines against COVID-19, allowing these doses to reach the poorest countries as well. After all, if there is something indisputable in the matter, it is the public interest in the subject being debated in the WTO.

Challenges of making the COVID-19 vaccine as a global common good campaign a reality

Vaccines will play a key role in returning the world to normal after the pandemic, but there are many obstacles that will make the journey much longer for some than for others. For example, some governments and political blocs began to compete for supplies as soon as they were available, and this “vaccine nationalism” is pushing the populations of the poorest countries to the bottom of the line. Other problems, such as vacillation in the acceptance of the vaccine among many people, bottlenecks in production and supply problems also impede global herd immunity, which is the main objective of the fight against covid-19.

The term “vaccine nationalism” refers to the actions of governments that seek to secure supplies for their own populations, at the expense of others, whether greedy or unjust. Many rich nations are buying supplies in bilateral agreements with countries that have pharmaceutical industries, and they buy much more than they really need. For example, Canada has ordered enough doses for five times its population and is also expected to receive a surplus of AstraZeneca vaccines from the U.S. After President Joe Biden announced that he would donate part of the supply pending approval of the vaccine for use in the country.

All of this means that valuable vaccine supplies are being held up in a handful of rich economies and not shared equally with the poorest nations. These economic differences between countries will directly influence the possibility of making the covid vaccine a global reality. No predictions can be made about when all countries will have access to medication. Therefore, the challenge of making the vaccine a global common good will depend on the common effort of entities and countries. Many middle-income countries and most low-income countries depend on the Covax Vaccine Coalition to ensure vaccines for their populations.

The WHO-led initiative aims to deliver six billion doses to the poorest countries, with two billion to be administered in 2021. Covax has sent 32 million doses to 70 participants, with Tonga and Trinidad and Tobago receiving the latest deliveries, according to Gavi. , the alliance that coordinates the Covax program. These solutions emerge as a source of hope for the equitable distribution of vaccines and a possible alternative to combat the global pandemic.

Your view toward the campaign/appeal and your recommendations

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