Dr. Ali Sultan, Professor of Microbiology and Immunology at Weill Cornell Medicine-Qatar, explains how a vaccine is developed - and emphasizes the importance of scientific ethics being prioritized over individual national interests
As the world awaits an effective and safe vaccine for COVID-19, and researchers and scientists work to develop a defense against the disease that can be made available to the largest possible number of people around the world, countries are competing to own it.
It has reached the point where the term ‘vaccine nationalism’ has come into use, meaning that the first stage of vaccine production and distribution may be exclusive to developed and rich nations, while poorer countries wait their turn.
And between a vaccine that Russia announced in August 2020 – making it the first country to take this step – the US vaccine that President Donald Trump has requested to be ready by November. The vaccine that researchers at Oxford University in the UK are working on, and other endeavors by countries such as China, Germany, and Turkey, many questions remain unanswered.
They range from which vaccine will secure World Health Organization endorsement, how a vaccine will be approved and who will approve it, and the difference between a Russian, American, Chinese, British, and German vaccine, to why researchers and scientists in this field do not unite their efforts to develop one or two effective vaccines that can be produced in most countries, whether a vaccine will be the property of a particular country or international company, and if scientific can co-exist with political and economic competition.
How a vaccine is developed
Dr. Ali Sultan, Professor of Microbiology and Immunology at Qatar Foundation partner university Weill Cornell Medicine-Qatar, explains vaccines as being “a substance that is usually used to stimulate the human body’s immune response to produce antibodies and provide immunity that can fight against one or several pathogen-causing infectious diseases.”
The vaccine can be injected into the muscle, or underneath the skin or can be taken orally. When enters the human body, the antigenic component of the vaccine, stimulates the immune system to learn to recognize invading viruses or bacteria as foreign invaders, produce antibodies and other immune cells, and remember them for the future.
“Vaccines can be made up of natural or synthetically-prepared substance,” says Dr. Sultan. “For example, in the case of hepatitis B vaccine, envelope proteins were taken from the virus and the vaccine was synthetically prepared by adding ‘boosting’ elements to increase its effectiveness.
“The components of the vaccine could be natural, taken from a weakened form of the bacteria, virus, or parasite itself, but retaining enough ability to stimulate immunity by developing the antibodies required to fight this virus.”
On the steps that vaccines usually go through before being approved, marketed, and distributed, Dr. Sultan says: “A vaccine is discovered and developed through different, lengthy stages that take 10-15 years.
To produce enough vaccine for the world’s population of about seven billion people, we may need 14 billion doses, if you have to give each person two doses per person. So, the vaccine market is big, complex and challenging
“One of the quickest vaccines to be discovered and developed was for mumps, a contagious viral disease that attacks the parotid glands. It only took five years, but researchers were lucky to take such a short time to develop it, because the virus was of one type and unchanging. With COVID-19 virus, there are reports that a vaccine will take about 1-2 years to be discovered and developed, but this is very challenging.
“The first stage is exploration, which includes essential lab research, and sometimes uses computational modeling to determine the number of epitopes or antigens that can be used as a candidate vaccine. The second stage is the preclinical stage, which includes testing it on animals to ensure the safety of the vaccine for animals and humans, its ability to stimulate an immune response, and the number of doses required to ensure effective protection. If results are promising, researchers submit a request to initiate human clinical trials.
“In every research center or institute, there is a department or entity responsible for receiving the results of researchers related to vaccine discovery and research results, and then there is an independent council that supervises clinical trials. In Qatar, the Ministry of Public Health is responsible; in the US, it’s the FDA; in Europe, it’s the European Medicines Agency. Every country has a specific entity that issues approval for human clinical trials.”
As for performing clinical trials on humans, Dr. Sultan said: “The first stage of clinical trials is conducted to confirm the safety of the vaccine by giving the appropriate dose to a limited sample of healthy individuals – between 20 and 100 - whose ability to produce a normal immune response is intact.
“The second stage broadens the safety range by giving the vaccine to 200-1,000 people, who can be divided according to demographics and age groups. Everyone who takes the vaccine must be a volunteer, who is aware of the purpose of performing this trial and the expected symptoms. As for the third stage, it reflects the vaccine efficacy (VE), which is defined as the percentage by which the rate of disease incidence is reduced in vaccinated groups as compared to placebo. A desirable vaccine efficacy is 70 percent or more.”
Bringing a vaccine into the market
At present, 8-9 of the COVID-19 vaccine candidates which have being developed have already entered the third stage, involving testing their effectiveness in clinical trials, as with those announced by Russia, America and China. The vaccine regulatory authorities can give a permission to combine some of these stages due to the emergency nature of the pandemic, by combining the first and second stages of clinical trials to accelerate vaccine development of the vaccine.
However, Dr. Ali Sultan emphasizes the importance of two additional stages that traditionally should be conducted after the third stage of clinical trials: publishing peer-reviewed research in scientific journals, and reviewing and verifying the results and the research methods by the vaccine data and safety monitoring board. Additionally, the vaccine manufacturing and marketing should be monitored before authorizing the vaccine usage in the targeted populations, to ensure a vaccine’s effectiveness among millions of people around the world. Human genetic make-up differs between people in different countries and continents, so it is necessary to ensure that the rate of a vaccine’s effectiveness does not decrease.
The issue of vaccine nationalism is very serious. It is not only unethical, but also completely wrong when we are trying to reduce the risk of infection transmission between countries
"The vaccine market is relatively limited and small, unlike the pharmaceutical market,” says Dr. Sultan. “It depends on supply and demand, but in a pandemic you need to produce very large numbers to vaccinate people all over the world.
“To produce enough vaccine for the world’s population of about seven billion people, we may need 14 billion doses, if you have to give each person two doses per person. So, the vaccine market is big, complex and challenging.”
The risks of vaccine exclusivity
While the hope is that a COVID-19 vaccine may end the pandemic, Dr. Sultan warns: “What is worrying is the ‘my nation first’ concept and the “vaccine nationalism”. Which we are beginning to see in a number of countries around the world.
“The issue of vaccine nationalism is very serious. It is not only unethical, but also completely wrong when we are trying to reduce the risk of infection transmission between countries. For example, if developed countries acquired a vaccine exclusively, without providing it to poorer countries, the economy of those countries will be further affected and incidences of infection will definitely increase. Today, as the world has become a small global village, this “vaccine nationalism” may contribute to the re-spreading of the pandemic.”
He also emphasized the importance of “fair and rapid distribution” of a vaccine and providing healthcare equipment and supplies to control the pandemic. In June 2020, a “Global Vaccine Summit” hosted by UK, in collaboration with the “Vaccine Alliance” was held with the aim of protecting children in poor countries, with more than 50 countries participating – including Qatar, which pledged US$20 million as part of a global effort.
However, several leading countries did not participate in the conference, which Dr. Sultan says was "very worrying". And another cause of concern lies in the fact that leading pharmaceutical and biotech companies in the field of drug and vaccine production, are planning to give the priority to certain countries when it comes to COVID-19 distribution.
In the end, the vaccine is the same. What may differ from one producing country to another are the methods of production and technology
As for the differences between the vaccines developed by each country, Dr. Sultan explains: “The virus is the same, whether in China, India, Brazil, Russia, the US, the UK, Germany, Africa, Middle Eastern countries, or anywhere else – we have seen mutations in the virus, and we may see more mutations of this virus, but so far we cannot say whether this would affect a future COVID-19 vaccine or not.”
"In the end, the vaccine is the same. What may differ from one producing country to another are the methods of production and technology. But the goal is the same, because the antibodies and other immune cells produced by the human immune system to fight the virus are the same.”
To many, the issue of certain countries potentially getting the vaccine before others flies in the face of the ethics of science, which transcend individual national interests, conflicts between countries, and the use of vaccines or researchers as a political tool. As Dr. Sultan says: “Vaccine nationalism has many harmful implications”.
“Experts in epidemiology, virology, infectious disease experts, health economics, and social and human sciences, as well as other specialized researchers, need to be able to take the initiative, rather than decisions being left to politicians. They need to be allowed to develop science-based strategies to distribute a vaccine in a safe, effective manner through innovative financing mechanisms and to unify the efforts of governmental and non-governmental organizations.
“We are all against one enemy – and that enemy is the coronavirus.”