As soon as the outbreak of the "Covid-19" virus, or the so-called new corona virus, spread during the month of March, until the alarm rang the doors of western industrialized countries, everyone began talking about a vaccine promised to deal with the virus, and some world leaders appeared in front of their people with the appearance of a dedicated knight. Who will defeat Ghoul Corona with the promised vaccine, news agencies have circulated clips and pictures of volunteers receiving experimental vaccines against the virus, but soon feared to talk about the vaccine, to emerge more rational views saying that the promised vaccine will not be ready a year at least.

Everyone is beginning to wonder: Is it possible that the major countries whose fleets roaming the world's seas are unable to stop a project to develop a vaccine for this virus? What are the obstacles to developing the vaccine? Are they scientific barriers associated with the biological structure of the virus? Or are the obstacles in the capabilities of the major countries and their technological and industrial capabilities? Is the decision to develop, manufacture and provide the vaccine in the hands of governments, in the hands of companies, or in the hands of international health organizations?

It is not easy to answer these questions without a deep understanding of the mechanism for developing vaccines and the necessary governmental policies, human and financial resources and manufacturing capabilities, in addition to cooperation between all governmental parties, companies, international organizations and universities. The issue of developing vaccines and providing them in a humane manner equitably for those who need them is a process characterized by With so much sophistication, national interests and commercial considerations are often the real driving forces of actors in this process. Below we will present in a simple way the stages that the development of vaccines goes through, after which we will discuss the questions raised and the position of different authorities. 

Stages of vaccine development

The first and most important step in the process of developing a vaccine for a disease is to study and understand the disease accurately to evaluate the feasibility behind developing a vaccine for it, and the most important factors that are studied in order to determine the feasibility of developing a vaccine are the severity of the disease, the size of geographical spread, the lack of treatment for the disease, and future expectation. With regard to the continued emergence of the disease to ensure continued demand for the vaccine, the size of the potential market for this vaccine and the level of health spending in this potential market. As for the development process itself, it is divided into four main phases, as follows:

1- Research and discovery phase: In this stage, a careful biological analysis of the microbe causing the disease and its genetic components is carried out to determine which of these components will be used in the vaccine in order to stimulate the immune system and build immunity in humans against the microbe (the components of the microbe used in the vaccine composition are called antigens). In this stage, the proposed vaccine from the selected antigens is prepared in addition to the immune-stimulating compounds, and this stage usually ends with checking the efficacy of the vaccine on laboratory animals before moving to the next stage, and this stage is usually done in academic, governmental or private research laboratories of companies Vaccine development.

 2- The stage of clinical trials on humans: This stage requires approvals from many health authorities, and must be carried out within a strict monitoring methodology. The first goal of these experiments on humans is to verify that there are no toxic effects of the vaccine, and the second goal is to verify the degree of effectiveness of the vaccine . At this stage, the role of companies and government regulatory bodies is highlighted.

3- The stage of developing the production process: at this stage the work is transferred to the manufacturers to study and develop the final production protocols, define quality standards, and obtain the necessary licenses for production.

4- Production and distribution stage: In this stage, the vaccine sale process is carried out to governmental agencies and international health organizations to start vaccination campaigns.

Given the process referred to in the graph (the stages of vaccine development), it is worth noting some important points. The first note: that despite the importance of the research and detection stage for developing a proposed vaccine, it does not constitute only 10% of the volume of achievement, and the second note: it may enter a track The race in the first stage is a large number of nominated experimental vaccines, but many of them fall into one of the stages before reaching the end line, and the third note: that the process needs huge budgets that may exceed a billion dollars, and in normal circumstances may take 10 years or more [1] . After this brief presentation on the stages of the development process, from the emergence of the disease to the production and distribution of the vaccine, we will return to discussing and analyzing questions about the obstacles to the development of vaccines in general, highlighting the vaccine expected to face "Covid-19".

Is the biology of the Covid-19 virus the barrier to vaccine development?

According to available preliminary scientific evidence, the answer is no, that is, there is a good opportunity to develop an effective vaccine against this virus. The first and most important of these evidence is the self-recovery of a group of those who contracted the disease, which indicates the ability of the immune system to develop self-immunity that resists the disease, and creates an immunological memory that prevents the disease from recurring again to the body, but more research is required to know the extent of this immunity. There is a second evidence that indicates the formation of immune immunity after the first infection with the virus. In a preliminary experiment conducted on a group of monkeys, monkeys exposed to the "Covid-19" virus appeared symptoms similar to those that appear in humans, and it was noticed that the monkeys became resistant to the virus after recovering From the first injury [2].

This promising evidence is consistent with a golden rule in infectious pathology and immunity, which confirms that the occurrence of self-recovery indicates the possibility of developing an effective vaccine for the disease, and this enabled the development of many vaccines that are used to this day with great success. On the other hand, there is a group of microbes that defies the immune system due to its genetic modification, and it constantly changes the form of its antigens, such as HIV, which makes AIDS a scientific challenge.

Who decides to develop vaccines, governments or companies?

During the past five decades, the vaccine industry has undergone significant changes that have affected the volume of interest and investment in this sector, as well as the distribution of roles and the way in which decisions are taken, as well as the requirements for obtaining licenses, so that after governments in the Western countries were the main player in developing and making vaccines, The role of these governments has diminished, especially after the basic vaccines were developed to control diseases that posed the greatest health threat to children in Western countries, such as tetanus, diphtheria, whooping cough, polio, measles, mumps, and rubella. The 1980s saw a setback for the vaccine industry after many companies exited the market due to what is known as “market failure”, as there were no longer financial incentives and profit guarantees, and the company crisis doubled after it was obliged to bear responsibility and compensation in the event of any side effects as a result Receiving vaccines [3].

As for the countries with emerging economies at the time, some of them, such as China, Brazil, India, Mexico and Indonesia, sought to acquire the compositions for basic childhood vaccines and manufacture them locally, and those countries witnessed few attempts to develop new vaccines. The role of the World Health Organization emerged in the 1970s as a coordinator of international initiatives to distribute vaccines to poor countries, which vaccines usually reach after decades of production in Western countries. Today the rules of the game have changed, and a great variation has emerged in the motives of different parties to enter the process of developing new vaccines. To realize the current reality, we will review the motives of the main parties, with a focus on governments and companies as the most important parties in financing and managing the development process.

Governments and vaccine development

Although the role of governments in the major industrialized countries is considered a pivotal role in controlling infectious diseases and in monitoring the budgets needed to combat them, these governments currently do not have the infrastructure to make vaccines, as was confirmed by Dr. Anthony Fushi, director of the American National Institute of Allergy and Infectious Diseases, when he said The US government may, through its research institutes, have access to an initial test vaccine for the "Covid-19" virus within a few months, but it will definitely need the pharmaceutical companies that have the infrastructure for the development and manufacture process, which is expected to take more than a year under high pressure. And the reduction of its stages, and it came in response to questions by Senator "Mitt Romney" about the US government's capacity during the hearing held by Congress on the third of March / March last [4]. It is clear that the US government seeks all its capabilities, and provides facilities for some companies to reach the vaccine in the shortest time, but the important question will the US government and the governments of Western countries will change their future strategies to address the epidemics and enhance their role and responsibilities?

Working to find a vaccine for the "Covid-19" virus may relieve internal pressure on Western governments, but this does not mean that these countries have played their humanitarian role and assumed their responsibilities as part of the human family. The fundamental problem with the role of Western governments lies in excessive selfishness and thinking on a capitalist basis. It is purely in dealing with human epidemics. Western governments treat the epidemics in poor countries as if they were problems on another planet, but they soon move if these epidemics threaten their national security at home or their economic interests.

For example, the Ebola virus has killed more than one African country throughout the past century, but its attacks were in the form of limited outbreaks, but it did not receive much attention in that era, but once the problem of biological attacks emerged through the messages loaded with anthrax, After the events of September atheist, until the US government accelerated in 2004 the launch of the BioShield project, which approved a budget to develop vaccines against a group of microbes, including the Ebola virus, and it is strange that work began to develop the vaccine and continued for several years, then Support and interest decreased, and meeting was stored Experimental cases in research institutes refrigerators, but as soon as the most serious outbreak of the virus appeared in 2014, which began in Guinea and then spread to several African countries, leaving behind 26,800 infections, 11,325 of whom died, actual fears of the outbreak emerging from the control and the possibility It moved out of African geography, until international efforts started to develop the vaccine and extract frozen vaccines from the refrigerators of the research institutes.

In an unprecedented vaccine sector, the Ebola vaccine called rVSV-ZEBOV, which was approved by the World Health Organization last year, was accomplished in a record time of five years, and at the forefront of these efforts was the "vaccine alliance" organization known as "GAVI", It is an organization founded in 2000 during the World Economic Forum in Davos, and brought together partners and supporters from several international organizations, including the Bill and Melinda Gates Foundation, the World Health Organization, the UNICEF, the World Bank and some Western governments [5]. 

Western governments, led by the government of the United States of America, have come under harsh criticism for the very modest spending of fighting global epidemics, in a report prepared by a working group for sustainable defense issued by the Center for International Policy in Washington in June 2019, The team, most of whose members are former military experts and military personnel who held sensitive positions in the US government, confirmed that the most pressing threats to US security are not primarily military, but other, more worrying threats include climate change, economic inequality, and epidemics. Universality, which confirmed the report that these global pandemics do not know geographic boundaries, constitute an economic and societal risks to all countries, reinforcing insecurity and conflicts [6].

We must not forget the role of governments in developing countries, or even poor countries, because the governments of these countries are not exempt from responsibility, whether with regard to building systems to monitor and monitor infectious and emerging diseases, or with regard to preparing cadres and infrastructure to confront these diseases, so it is not reasonable to spend on Armament is the budgets of these countries, while their governments turn to international health organizations and the World Bank to provide vaccines for their societies. 

Pharmaceutical companies and vaccine development

As reported by one of Nature's periodicals for drug exploration, as of April 8, there are 78 active projects to produce a vaccine against the "Covid-19" virus [7]. Most of these candidate vaccines are still in the research and discovery phase, and only four of them She moved to the stage of initial clinical trials in humans to check for toxicological complications, which include two vaccines for two companies in the United States of America, "Moderna" and "Inovio", and two vaccines from China, one from "CanSino" and another from "Shenzhen Geno-Immune Medical Institute" "Institute, which is affiliated with the Shenzhen County government, is in rare condition and under pressure from the race against time And, in the absence of a typical laboratory animal, the step of animal testing has been jumped, or conducted in parallel with clinical trials in some of these projects.

What is striking about the list of 78 projects is the absence of the names of major companies known for their great capabilities in developing and producing vaccines such as "GlaxoSmithKline", "Merck & Co", "Sanofi" and "Pfizer", with the exception of the well-known company "Johnson & Johnson" which signed a partnership contract. With more than a billion dollars with the US Department of Health to develop and provide a vaccine against the "Covid-19" virus, most of the companies that entered the race are emerging vaccine development companies. The question is why do major companies are reluctant to enter the race to develop a vaccine?

Most major companies have taken the observer's position with caution, and the waiting for the battle dust to clear and the huge investment opportunities revealed.

Reuters

Part of the answer to this question is what was mentioned by one of the most important vaccine development scientists in the current period, Dr. Reno Rapoly, head of the research and development department at "GlaxoSmithKline", during a global seminar held last week through video conferences, where he said that vaccine development companies She fears placing too much investment to develop vaccines to respond to emerging epidemics, which usually appear as outbreaks and then often disappear or be controlled by methods other than vaccination, such as the SARS virus, the MERS virus or the Zika virus, and Dr. Rapoly adds. His company's previous experiences in this type of disease are disappointing, As soon as the outbreak becomes under the media’s microscope, public attention increases, then pressure begins on governments, which start launching projects to finance vaccine development, and everyone starts to rush to collect the gains that governments promise, and once the epidemic recedes and is controlled in some way until the voices subside and begin Government agencies give up support and follow-up to vaccine projects, and this is what happened in some emerging epidemics [8].

The process of developing vaccines has significant investment risks, and the project may fall in the "Valley of Death" as indicated in the stages of vaccine development, or health authorities may refuse to adopt the vaccine, in addition to the absence of feasible profit guarantees, for this we note that most major companies I have taken the observer's position with caution, and the prospect is for the battle dust to clear and the bloody investment opportunities unfolded, and this situation may change if the crisis course changes, and a tempting market for the vaccine changes, such as if the virus takes a seasonal pattern - such as the flu - in western societies, or perhaps some major companies enter The race is at a late stage for adoption One promising candidate vaccines after they have crossed the "Valley of Death".

In the field of medical industries, projects are evaluated according to two criteria; the criterion of health and social value, and the criterion of economic value for companies. The economic value is the most important factor in decision-making. When comparing the vaccine market to the pharmaceutical market, the vaccine market - according to the capitalist concept - is considered an investment that is not feasible As shown in the graph (vaccine-making versus drug treatments), paradoxically, the profit generated by an expensive drug to maintain a patient with terminal illness on the brink of death is many times greater than the profit that a low-cost vaccine may generate for a child with Threshold of life!

Covid-19: The Challenges of the Vaccine System ... What Next?

There is no doubt that one or more of the candidates, "Covid-19" vaccine candidates, will see the light in one to two years, and we may witness a relief soon before that in the face of the crisis after a group of laboratory experiments appeared on promising drugs in treating patients, perhaps the most important of which are the bodies. Monoclonal antagonist, or drug inhibiting enzymes for reproductive viruses. In spite of the catastrophic effects that the current crisis of the Corona virus will have on the human and economic levels, there are positive aspects in which we may draw lessons and lessons from them. Perhaps the most important of which was revealed by the crisis that human health problems and deadly epidemics in particular are a global responsibility and should not be dealt with as Regional problems, as the crisis revealed the existence of real problems in the mechanism of developing and manufacturing vaccines, which are considered one of the most important health pillars, the most prominent of these problems are weak government interest, pure capital motives for pharmaceutical companies, development management mechanisms and Manufacturing that needs creative ideas to increase process efficiency while maintaining safety standards.

In conclusion, this crisis assures us that the world is in urgent need of rational systems, in which budgets are planned on humanitarian standards, the most important of which are lives that will be saved in exchange for the money that will be spent, in 2020 we still use vaccine-making technologies that were designed in the middle of the last century, and the health staff suffers in Poor countries transfer and store these vaccines under appropriate cooling conditions and deliver them to those who need them, while an aircraft carrier can direct a missile and deliver it to a specific building thousands of kilometers away, and military bases can distribute death and terror through drones that are controlled across the continent at.

We need a more humane, global health system characterized by justice, seeking to provide care to all who need it and working to fight diseases wherever they are. Our invisible enemies of microscopic organisms have proven more just than us, because they do not know the boundaries between races yellow, white and black, or between countries Its south and north, nor among the rich and poor. These invisible creatures have proven that we are the most unjust creatures for ourselves when we believed that infectious diseases that kill the poor in the dark corners of the world will not reach us, and will not reach the rich countries that possess the largest arsenals of weapons. When will we wake up to realize that the vaccine will protect us more than weapons ?!