A Vaccine The world is a small village that could be traveled across in a matter of hours. It is so small that no one is immune, especially during pandemics that cease to exist only by the Almighty's Power. History still repeats itself in everything, even in those lethal pandemics that have left their survivors with bitter memories. Crises recur, and so do their solutions. I recall memories that go back to more than 70 years ago. I’m an old man now.
Smallpox spread all over Sudayr Region. Uncle Abdullah Al-Fakhry brought a nurse carrying a bag; I still remember it. He called upon all his family members and relatives to come and get vaccinated against smallpox.
Of course, we were his relatives. My brother, sisters and I came and got vaccinated. Unfortunately, some of his own family members refused. O brother, this might save you from getting sick, and you won’t get infected. Some even said it is unlawful and not permissible.
Vaccination took place at his house. May Allah have mercy upon them all. Thankfully... I remember, more than 30 children were vaccinated.
Surely, more. Thanks to Allah, they have been the only survivors of smallpox among many others who passed away, especially children. People around the world led a healthy life in the last 50 years.
No major pandemics that disturb life’s peace were recorded, except for a few epidemics that were contained by effective treatments and due to their low chance of spread among humans, reinforcing the conspiracy theory believed by some people, that most of the pathogenic viruses are created in laboratories for political and economic gains. The genetic sequence of any germ that affects humans usually leads to the source of that specific germ. Viruses or bacterias mix... ... mix with living organisms called intermediary host species, which are either domestic or wild animals. Obviously, Corona or SARS-CoV-2 is not a laboratory-made virus. Instead, it has originated from intermediary host species, which carry and transmit the virus from animals to humans.
Is novel coronavirus the only type that transmits from animals to humans? With respect to germs that infect humans, there are nearly 1400 different microorganisms, such as bacterias, viruses, fungi, and monocytes. Around 70% of these types are animal-derived. The emergence of these viruses and the interest of WHO in them are not related only to food consumption. There are also several other reasons behind human exposure to these emerging germs, such as human breaking into the world of forests, or what is called deforestation; their interest in hunting exotic and bizarre animals. As you have mentioned, there are no strict laws regarding public hygiene in meat, poultry, and vegetable markets, and so on. ... Every country should take into consideration developing leadership foundations to restrain animal-human interaction, and if interaction is necessary, then have it on clear hygienic and sterilizing bases.
Early last year, worldwide media started airing unusual news that was never heard before about a rapid pandemic outbreak of an unknown strain. A breath infection which virus aggressively attacks the respiratory system, admitting the infected person into ICU, or even taking his life. It is noteworthy that in some countries affected by the virus, the health care system collapsed and did not withstand for long. First, you hear news… you hear information...
concerns gradually escalate as the news spreads starting with the first affected cases to worldwide spread… global concern... announcements… observations… caution... growing interaction... The solution to a pandemic or epidemic spreading with such speed and threat, and as witnessed in developed countries worldwide has been lockdowns, with more cases, deaths, crowded emergency rooms everywhere, health systems collapsing... This is very scary and terrifying. The whole world is stunned, confused, and truly horrified. The optimal solution lies in taking the utmost precautionary and preventive measures.
The world has realized very early that this situation cannot be controlled or escaped except by developing vaccines. Saudi Arabia has moved quickly and formed a committee of gov. leaders that took charge of the crisis management to follow up and monitor the latest developments, and provide higher authorities with recommendations on how to optimally manage the pandemic file. It has also realized that it is not immune against the pandemic, which prompted it to proactively secure chains of food, drugs, and medical supplies, and take the most effective precautionary measures, such as closing borders, cutting face-to-face teaching, suspending Umrah, and enforcing curfews to ensure control over health conditions. The Custodian of the Two Holy Mosques gives a fatherly speech, in which the spirit of reassurance radiates, and the language of determination prevails, that the Kingdom would be the best example in crisis management.
We assure you that we are very keen to provide all our citizens and residents with the necessary medicine, food, and basic living needs. Your Majesties and Excellencies... The Kingdom of Saudi Arabia realizes the importance of intensifying international efforts to fight the novel coronavirus pandemic. And... In the same day, the Custodian of the Two Holy Mosques, Leader of the G20 Summit, invites the Group Members to hold an emergency meeting in which visions are unified and efforts are joined to combat the pandemic. … aiming to discuss ways to unify efforts to face the spread of coronavirus epidemic.
On the 26th, the emergency meeting was held. and the pandemic issues dominated the discussions. Committees' works were certainly affected, including that of the Future of Health Committee.
This committee is responsible for foreseeing the future of health through science. It determines how science serves and views the future of health. There is no way at all that coronavirus is taking over the world and the Future of Health Committee deals with other matters or is not directly connected to this issue. Committees' works were held, and the dominant topic, of course, was COVID-19.
In pursuit of the G20's support to these efforts, we all have to assume the responsibility of furthering our cooperation to finance research and development works in quest for coronavirus vaccine. The Kingdom of Saudi Arabia, President of the 2020 G20, announced its $500m contribution to support the international efforts in confronting the emerging COVID-19 pandemic. The Kingdom’s generous support, actually, is a source of pride to all of us. Besides, it has been a wonderful initiative and an important step followed by the Members States in providing similar supports that focus on several issues. Yet, one of the most important issues dealt by the Future of Health Committee is not only how to achieve a solution, but also, how to develop a full-scale system that predicts future pandemics.
The Custodian of the Two Holy Mosques, with this generous support, lays the foundations to advance scientific research and urges developing an effective vaccine that saves the world from this pandemic. In the beginning, we heard of some drugs trials, interaction trials, approaches of worldwide scientific research centers, even of contributions of scientists, experts, and partnerships with scientists and experts in Saudi Arabia, and with prominent national centers here in this field. But all we had was information! What we know is that hundreds or even thousands of tests have started, but are gradually falling apart, and hope lies in only dozens of researches that move on from one stage to another. Constantly, during the times of awareness-raising and communication or at media conferences, we used to pass heart-breaking news, which was, “So far, no treatment or vaccine has proven effective in fighting this virus.”
It is painful to convey such news, but one must be clear and honest with the community. When signs of hope and success began to show, and some [vaccines] have reached advanced testing phases followed by approvals, that was quite a lovely feeling because you are approaching the breakthrough and escaping this pandemic. Saudi Food and Drug Authority has been fully prepared to engage in international vaccine discussions, monitor research and development phases conducted by scientific centers and drug companies, and carefully assess them. Actually, after the virus spread and the events accelerated all over the world, SFDA was on full alert in the Kingdom, being responsible for regulating and approving vaccines and drugs. There have been discussions at that time about the possibility of finding effective treatments of any available antivirals that have therapeutic effects against this virus. That was the hope at the very beginning, to have an available therapeutic option.
However, it has become clear with the accumulated data at research centers that most of the available therapeutic options in the early days of the crisis have failed in curbing the virus. Thus, attention began to turn to an option capable of preventing the disease, i.e., vaccination; as, historically, vaccines have proven to be one of the most important factors in curbing pandemics or epidemics, whether viral or bacterial. Scientific research circles were tightly closed, and only very limited information was leaked.
Yet, the Kingdom, with its well-known diplomacy represented by the Food and Drug Authority, has penetrated these circles and joined ICMRA, the largest international coalition of medicines and vaccine regulatory authorities. Thankfully, today, the Kingdom of Saudi Arabia, represented by the Food and Drug Authority, has joined the International Coalition of Medicines Regulatory Authorities. This will facilitate communication with regulatory authorities around the world, which, in turn, enhances the regulatory role of SFDA and that of the other worldwide regulatory authorities as well. ICMRA is the largest worldwide gathering in terms of major drug regulatory authorities. Joining this coalition entails that the requesting party is able to participate effectively with scientific capabilities and expertise.
Thankfully, the Kingdom is the only Middle Eastern country participating in this coalition. It was unanimously agreed to let SFDA join this coalition. In fact, Saudi Arabia’s participation has helped a lot in discussing many topics; it has helped the Kingdom at the same time, because any findings by pharmaceutical companies are incorporated into the regulatory authorities in their countries. Thus, discussions held by major regulatory authorities together allow the members to consider the scientific data and promising vaccines against novel coronavirus which has been, and still is, the focus of the coalition.
It has been a successful step; the Kingdom has actively participated, and is still participating, in the coalition. Medical research centers have become the focus of man's concern. They have occupied everybody's attention, and their news widely spreads in international media in hope that these efforts would help restore normal life and stop the loss of lives that have strained the world.
A frenzied race in which only successful tests would deservedly win... Thus, SFDA has actively started inspection visits to international companies’ facilities striving to produce this vaccine. All SFDA policies, procedures, regulations, and legislation, stipulate that exporters must pass pharmaceutical factory inspections, i.e., SFDA regulations do not allow the registration of any product submitted for this purpose unless it passes inspection which is a specialized and complex process through which SFDA ensures that all documents submitted for registration are verified on the ground in drug factories. With regard to corona vaccines, we have conducted a number of inspection visits. Inspection is a challenging and meticulous process, as most factories are located in remote areas and need traveling During the corona virus pandemic, however, it was even harder, due to travel bans and precautionary measures taken by some countries.
Some countries that we’ve been to imposed a 14-day quarantine. They also imposed many health checks on us upon entry. At the end of each inspection visit, a detailed technical report of all the observations taken during that visit is prepared.
These reports are sent to the company which factories have to redress the remarks before getting the approval. In the event of having many or serious remarks on a factory, such factory is rejected and its vaccines are not approved. SFDA has opened direct lines of communication with the companies who passed the clinical tests and designated points of contact to manage the process. SFDA has received thousands of scientific papers which are carefully examined before registration in order to verify the safety and efficacy of these vaccines before taking any decision.
Companies test these vaccines on animals. The test consists of three basic parts: studying the vaccine’s ability to produce immune responses, conducting harm or toxicity testing in animals, and assessing its safety in terms of reproduction and its effect on animals’ ability to conceive, and so on, in order to verify its safety. Upon completing these steps, companies conduct clinical studies on humans.
Phase one of these studies on humans deals with a small sample of not more than 100 people. It aims to verify the vaccine’s ability to produce immune responses and makes sure that it has no harm, toxicity, or side effects that prevent its use; and that the company, thus, is positive that such vaccine is suitable for humans. The company then moves on to phase two where it conducts the studies on a bigger number or a group of recipients with diverse characteristics, different ages, and various health conditions to verify that the vaccine is capable of producing the adequate immune response in all these groups. Clinical studies of phase three are the largest and most important studies to the supervisory authorities, as to assessing the vaccine’s efficiency and safety.
Our main goal here lies in knowing the efficiency of the vaccine, its safety, and the protection it provides. SFDA identifies the expected risks of vaccines by monitoring them, analyzing their raisers, and participating in developing plans to mitigate their potential impacts in the world. During the clinical studies phase, all side effects are listed. Accordingly, the company provides us with a risk management profile which consists of risk mitigation actions and covers known risks, potential risks and unknown risks.
These actions provided by the company are educational materials that target health practitioners or individuals. They include guidebooks, safety messages for health practitioners, or alert cards given to vaccine recipients, and much more. Quality assurance is of utmost significance in all the phases of developing and manufacturing vaccines. Its accurate indicators play a pivotal role in safety and efficacy, and SFDA's experts closely monitor these processes.
In fact, ensuring the quality of vaccines depends on the commitment of manufacturers to scientific and regulatory standards and specifications that comply with vaccine pharmacopoeias. Thus, the quality profile consists of all vaccine development phases, from laboratory tests to the final commercial product. So, the quality assurance team is divided internally into three teams: a manufacturing assessment team, an analysis assessment team, and a factory-distinctions assessment team who [collectively] verify the product quality. Eventually, we work integrally through these teams to make scientific decisions. In general, when assessing manufacturing data, my colleagues and I in the manufacturing assessment team consider three points: firstly, raw materials used in manufacturing, secondly, manufacturing procedures and controls, and thirdly, manufacturing outputs reflected in the vaccine and in its conformity with pre-set quality specifications.
Usually, dozens of chemical and biological raw materials are used in such manufacturing processes. For example, in one of the vaccines that have been reviewed, 80 raw materials were used. So, it is imperative and important to verify the quality and safety of such materials by reviewing certificates of analysis and verifying their conformity with pharmacopoeias and international benchmarks. The analysis team assesses a set of tests that enable verifying the identity of the active substance and that it is free of any impurities, and studies the biological, physical, and chemical properties of the vaccine. Research teams focus on everything in the vaccine profile, including technical specifications for packaging, in order to avoid possible errors. We’ve received some products, but with missing or unclear information.
For instance, the recipient dose was not written at all; therefore, [the product] was rejected. Other products were not labeled in English, but in other unknown language; so, they were rejected, too. We asked some companies to focus on [information] accuracy, and they did the amendments. Thus, when the health practitioner gives the package to a recipient, all basic information is clear to him/her: the name of the drug, dosage, storage info, and administration.
There has been a great dispute when the vaccine first appeared. Some people ascribe that tremendous acceleration to the very so-called conspiracy that produced the virus, while others think it has been delayed, looking at the worldwide scientific research development. The vaccine is not delayed; on the contrary, it has surprised us. It has been promising and dazzling, the acceleration, flow, and focus on researches conducted on vaccines which are usually subject to long years of tests. However, we consider two things… or actually three.
The virus has caused an unprecedented global epidemic with such massive impacts. Two, the great desire, determination and persistence of the whole world to find solutions. Three, today’s technologies are not the same as those of 20, 30, 40 and 50 years ago. It is unfair to compare old technologies with those of today’s. Therefore, thanks to Allah, by His Will, the world has taken big strides in developing vaccines in a record time in human history in general.
Those who have doubts keep wondering: What do these vaccines do? and how do they relate to changing human genes? What is said, that it changes human genes, is inaccurate and has no scientific bases. On the contrary, changing the human genome is extremely difficult and is not easy at all. Therefore, changing it is quite impossible. In similar vaccines against other viruses, no changes have occurred in the genome; rather, they have protected us.
In addition, the body gets rid of the vaccine and the substance found within in the same way it does with the regular influenza virus. What happens is that our bodies produce immunity, produce antigens and a line of defense. So, if we get infected with coronavirus, our bodies are ready to fight and get rid of it. Even if we show symptoms, they would be very mild and won't be as fierce and intense as it would be if we were exposed and had no immunity. After an exhausting journey of scientific research and a vigorous race against the clock, SFDA scientific teams have recommended a conditional approval to register the first vaccine in Saudi Arabia.
Today, in continuation of these efforts, Saudi Food and Drug Authority announces its conditional approval for the registration of the coronavirus vaccine, Pfizer-BioNTech, in the Kingdom of Saudi Arabia, by which Saudi health authorities will be able to import and use the vaccine. In the next morning, the Saudi Minister of Health announces live on air the good news to everyone, spreading the light of hope after a grim year. I am pleased to announce to all the citizens and residents the arrival of the first batch of vaccine this morning. This is a sample of the vaccine, and we are happy to have it.
By Allah’s Will, this is the beginning of the crisis breakthrough, and the vaccine will be soon available to everyone. Registration station is not the conclusion of the vaccine journey. It is rather the beginning of a new, lively story of monitoring, analyzing and following-up. According to SFDA’s approved policies and procedures, any shipment of pharmaceutical products arriving at the Saudi ports of entry is subject to sampling during inspection. These samples represent the entire shipment that has arrived, and are subject to the required tests in SFDA's laboratories, through which the safety and quality of imported pharmaceutical products are verified.
I cannot really describe my feelings; I am overwhelmed with pride and happiness. It is hard to express my feelings when I received the first call. When the vaccine truck arrived downstairs where samples are received, I personally went down and received the first vaccine, the first vial which I still keep since then. I feel so proud whenever I look at it.
I do pray that it is the beginning of the crisis conclusion. I'm proud of my country which is one of the first countries to get the vaccine. I'm happy, very happy. Here, at the biomedical laboratory, different kinds of vaccines have been received, and several important tests are conducted on them. These tests include impurity tests, product or vaccine efficacy tests, active substance tests, and preservatives tests. According to these key tests, certificates of release are issued, and the shipments go afterwards to the vaccination center.
Perhaps one of the things that falls on SFDA and increases its responsibilities in decision making when approving vaccines and pharmaceutical products is keeping alert and vigilant to monitoring all expected and emergency side effects. Thus, a national center for preventive measures has been established, so as to avoid the consequences of side effects that may develop. We've been working at the National Center since 2007 to monitor the safety of all medicines marketed in Saudi Arabia, most importantly, vaccines. All vaccine-related side effect cases are monitored, locally and globally.
They are carefully assessed and studied, and all benefits and risks are examined. Afterwards, they are reviewed by committees of specialized physicians and pharmacists who develop recommendations and take the appropriate measures. The most prominent side effects monitored lately are symptoms usually caused by vaccines, such as fever or pain and swelling at the injection site. So far, no side effects have been monitored that require product withdrawal or suspension. The hectic race to obtain vaccines continues globally until the crisis ends.
However, the Kingdom has been quick to receive files from the most prominent companies in this fierce competition, and took the initiative to facilitate importing vaccines as soon as possible. Actually, now in recent years, there have been multiple vaccinations against polio, measles, smallpox, and tuberculosis. We have accepted them with confidence because our government looks for the best, not for substandard or controversial vaccines. Thanks to Allah, we see [the result] in our children.
Many diseases have ceased to exist, such as polio, measles and many other diseases. If it were not for Allah’s Will and vaccination, misfortunes might have happened. Praise be to Allah, now all the citizens are convinced, and are confident that our country provides the best, and that the vaccines are the best. If you read now and follow the world, you’ll find that what we use is the best. Our country does not care about the price. No matter less or more, it has chosen the best types of vaccines for us.
May Allah grant them success and reward them on our behalf. Conspiracy stories are still an excuse for those who hesitate to take the vaccine, yet, on the other hand, its safety and efficiency are officially confirmed. People with doubts, anxiety, hesitation, and low determination in taking a step forward, decide to not take a decision. This is a decision, yet it is the wrong decision.
Unfortunately, they have put together a number of illusions and fallacies around which they have woven a conspiracy and spread it among others. Yet, eventually, all fall apart because the truth prevails, accumulated true information emerge, and confidence is restored in the right people who are keen on true info and on society... I’m talking about the medical issues in particular, regarding conspiracies and so on.
So, people in the end follow the light and step away from darkness. Even those who weave conspiracies, we've seen them one by one and group after the other, back down from their decision and get vaccinated. They [vaccines] are obviously safe, and because they are safe, effective and reliable, they are a safety valve and the most powerful weapon in facing this pandemic.
There has been a massive rise and big demand for vaccination after the Custodian of the Two Holy Mosques and his Crown Prince have been aired on media taking the vaccine registered in the Kingdom. I am one of the 20 million inhabitants. I am nothing without them. They are the ones who inspire me and push me forward.
Therefore, I clearly and honestly say, if the Saudi Food and Drug Authority has not approved these vaccines, we would never advise the people, nor ourselves and those we love, to take them. What the SFDA approves is effective and safe by Allah’s Will. Concrete lessons prove that our leadership is the example, and that confidence in the scientific and research capabilities of the Saudi people has no limits. All speakers and behind-the-scene participants in this work have received COVID-19 vaccine. A Vaccine
2021-05-17