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During the last weeks, we have lived through a scenario that seems to be taken from a Hollywood movie.
A worldwide pandemic is causing hundreds of people to be infected with the SARS-CoV-2 coronavirus, which causes COVID-19 disease, producing mild symptoms, such as a sore throat, cough, and fever.
In more severe cases, it can lead to respiratory difficulties and even death.
It should be noted that around 80% of people recover from the disease without the need for any special treatment. [1]
In order to reduce the number of infections and avoid a collapse in health centers, educational establishments were closed, flights were canceled, the borders of the countries were closed, and it was recommended to quarantine, in some places, voluntarily and / or mandatory.
Probably, we had never imagined living a situation like this and we only thought that this type of pandemic occurred in the past, and it was something that we can only learn in history books.
For this reason, many people have asked themselves, How can it be that we still do not have a vaccine to prevent COVID-19 with all the scientific knowledge, professionals in the area and infrastructure that we currently have worldwide?
Does scientists have not been able to decipher the virus?
In order to resolve these questions, it is important to understand the process of developing a vaccine.
Finding a vaccine for a new pathogen, in this case a coronavirus, is not simple, it requires certain stages for its development and each one requires a certain time.
In addition, investment and approval of technical and ethical regulations should be considered.
According to the CDC: The Centers for Disease Control and Prevention, there are 6 stages to developing, testing, and approving a vaccine. [2]
1. Exploratory stage
The pathogen that causes the disease must be identified, in this case the virus, and what immune response is needed to neutralize it.
The pathogen is then characterized and the virus genome is sequenced.
This reveals the sequence of nucleotides in a gene, like the letters of the alphabet in words [3].
After, understanding how the virus works, we look for viral components (parts of the virus or the weakened virus) that can be used as a target so that our immune system can recognize it.
2.Pre-clinical stage
At this stage, tests are performed on cell cultures and then animal tests are performed to assess whether the vaccine works and whether it is safe for use in mammals.
3.Clinical development
An application must be sent for the new drug or vaccine that is being developed, summarizing how it was created and tested. Once approved, it passes the human test:
Phase I: The potential vaccine is tested in a group of less than 100 people, in order to determine if it is safe and the responses it may provoke in individuals.
Phase II: The potential vaccine is tested with a larger number of people for more information, such as immunogenicity and dosage.
Phase III: It can include thousands of individuals and the purpose is to measure safety, evaluate if side effects appear and analyze the effectiveness of the candidate vaccine.
4. Regulatory review and approval
If the vaccine goes through all 3 phases of clinical development, a license application can be submitted.
5.Manufacture
Major drug manufacturers provide the infrastructure, personnel and equipment necessary to produce vaccines on a large scale.
6.Quality control
Procedures must be followed to track whether a vaccine is working as expected. Also, phase IV clinical studies may be included. The purpose is to be able to monitor the performance, safety and effectiveness of the approved vaccine.
Considering these stages, you can understand why it takes time to develop a vaccine and to have one within the next 18 months, it would be a record.
It should be noted that the scientific community has worked together as never before.
For this reason, and as long as we do not have a vaccine, we must continue to maintain the recommended hygiene measures such as: constant hand washing, keep social distance between people, avoid being in crowded places and if possible, stay at home and go out only once a week, when is necessary.
We must learn to be responsible, empathetic and caring.
Perhaps this pandemic will help us to reflect, to be more humane, more simple, will help us to change our consumption habits and to value things that we took for granted.
On the positive side, we have seen how the level of pollution has decreased in different parts of the world and we have allowed some species of animals to return to their natural habitat.
This period will teach us to be resilient, flexible, and adaptable to change. Challenging the status quo of our thoughts and our behavior as human beings.
[1] https://www.who.int/en/emergencies/diseases/novel-coronavirus-2019/advice-for-public/q-a-coronaviruses#:~:text=symptoms
[2] https://www.cdc.gov/vaccines/basics/test-approve.html
[3] https://espanol.cdc.gov/enes/flu/about/professionals/genetic-characterization.htm
Column written by Romina Paillao, Biotechnologist, Allbiotech Project Sub-Director.
Research Assistant of Andrés Bello University and Ingenious Volunteer.