COVID-19 is upon us and has been for a while now, and everybody appears to be waiting on the edge of their seats for a vaccine. In pandemic movies, other than Contagion, vaccines or cures are somewhat easily produced within the length of a film by a handful of people in a basement or hideout somewhere, but that is not a realistic representation of the vaccine development process. Creating a vaccine usually takes more than 10 years and can cost up to $500 million. To understand why the time and monetary cost of vaccine development is so great, you need to know what goes into the development of a vaccine.
What is a vaccine?
Google’s English Dictionary defines a vaccine as, “A substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease.” This can be a mouthful to the uninitiated. If the body’s immune system is compared to an army, the vaccine would be using a mock-up of a newly discovered enemy (that has never before seen weapons, camouflage and technologies) to train your army to combat the enemy so that if it ever encounters the real deal, it would be a piece of cake to deal with.
How do you develop a vaccine?
Developing a vaccine traditionally has 5 stages. During the initial stage, researchers develop about 100 vaccine candidates that get whittled down during the subsequent testing stages to 1 candidate.
- Discovery Research
During this phase potential vaccines are identified by their ability to elicit an immune response in a laboratory setting. Using the army analogy, this stage would test the mock-up’s ability to be detected by the army. This phase usually takes 2-5 years.
- Pre-clinical Stage
This stage is the first stage where the vaccine candidates are tested on animals and other laboratory models. The purpose is to determine whether the potential vaccine would bring harm if given to humans. Again, using the analogy of the army, this would be to test if the mock-up itself is not harmful to the country and the army that defends it. It would not be wise to use a mock-up that could be as dangerous as the enemy itself. This stage takes about 2 years.
- Clinical Development
This stage is broken up into an additional 3 stages and is the first stage where testing on humans is done.
- Phase I: During this phase, only 10-50 people are used in trials to determine whether it is safe for human use. This phase takes about 2 years
- Phase II: During this phase, hundreds of people are used in trials to help researchers understand the human immune response to the potential vaccines. Questions the researchers would like to get answers to would include, do most people develop antibodies to the vaccine? Do people develop an adverse immune response to the potential vaccines? This phase takes 2-3 years.
- Phase III: During this phase, thousands of people are used in trials to test whether the potential vaccines protect against the pathogen it is meant to protect against. In the army analogy, this would test that if the army fights and destroys the mock-up it would mean it should also successfully fight and destroy the new enemy. Vaccines could fail at this stage if the pathogen changes so fast that the vaccine doesn’t even look like the pathogen. This phase takes 5-10 years. There are currently 6 COVID-19 potential vaccines in this phase.
- Regulatory Review and Approval
Most countries have boards or councils where medications and vaccines are registered to enable pharmaceutical companies to manufacture, distribute and sell their products. During this phase, the companies would submit their data and information from the previous testing phases to the relevant councils to have their vaccines approved. This stage takes up to 2 years.
- Manufacturing and Delivery
This is the stage at which we will start to have access to the vaccine. This requires specialist factories that are heavily regulated and expensive. It should be noted that vaccines for every person on the planet cannot be manufactured at the same time so it should be expected that it would be made available to people in a staggered manner e.g. medical professionals and vulnerable people, then people in areas where the pathogen is spreading fast and then the rest of us.
Is a COVID-19 vaccine going to take 10 years?
No. The reaction to the COVID-19 pandemic has been unprecedented and a vaccine is expected to be developed in 12-18 months. Currently, information among researchers are shared relatively freely, so researchers can build on each other’s work. There are also a lot more funding available and governments are willing to rush the approval of the vaccines. This means that a COVID-19 vaccine will be developed much faster than other vaccines have been developed.
What is vaccine nationalism?
That is when the governments of the countries who developed or produced the vaccine try to keep the vaccine within the country by taking measures such as preventing the export of the vaccines. The World Health Organization has launched an initiative, the ACT-Accelerator, which aims to accelerate development, production and equitable access to COVID-19 treatments, tests and vaccines. This initiative has already been undersigned by New Zealand, Canada, France, United Kingdom, Saudi Arabia, Austria, Belgium, Morocco, Italy, Germany, Norway, Spain and South Africa. It is notable that the USA, Russia and China have not undersigned the initiative and that only 1 of the potential vaccines, that has reached phase III of the clinical trials, are not from one of these three countries.
Is the Russian vaccine credible?
It is unlikely that the vaccine Russia announced middle August has proceeded through the required test stages. It remains to be seen if the vaccine would indeed protect people from COVID-19 infection.
So, when can I expect a vaccine?
From the above, it should be clear that there are a lot of factors at play so it would be impossible to give a definitive answer. There are estimates that the first COVID-19 vaccines could be available by November/December 2020, but to the question, when will individuals have access to the vaccine? Well, that will depend on your occupation, health status, the country you live in, and possibly, even on who you know.