Introduction to the Vaccine Discovery Process
The world is currently looking for a vaccine against SARS-CoV-2, the pathogen that causes the coronavirus. Until a few years ago, the development of a vaccine would have taken between 15 and 20 years to obtain approval. Nowadays, new technologies have made it possible to develop vaccines more quickly. But how does the development of a vaccine actually work?
Step one: Analysis of the virus
In order to develop a vaccine against a virus, the virus must first be analyzed. The most important question to be answered is what causes immune responses.
Step two: Vaccine design
The second step is about the vaccine design – What the vaccine actually contains needs to be defined.
Step three: Animal testing
The next step is to conduct animal testing. Several trials need to be conducted to find out whether the vaccine works and is well tolerated.
Step four: Testing on volunteers
To learn about safety and efficacy, the vaccine is tested on volunteers. This part consists of three phases. In phase one, 10 to 30 volunteers will be tested to determine if the vaccine is tolerated. Phase 2 is about testing 50 to 500 volunteers to verify dosage, immune response and tolerability. In the third phase, more than 1,000 volunteers are tested to find out how reliable the protective effect of the vaccine is.
Step five: Large-scale production
Parallel to the testing with volunteers, the large-scale production of the vaccine begins.
Step six: Approval
After a successfully completed test phase, the vaccine still has to be approved. The European Medicines Agency (EMA) is responsible for the approval in Europe and the US Food and Drug Administration (FDA) in the USA.
Step seven: Vaccine campaigns
In the event of a global pandemic, a vaccine should be widely known and available as quickly as possible. Global vaccination campaigns support the promotion and distribution of the vaccine.