A vaccine’s development route: Discover the process that goes into creating vaccines

Foundation

Medicine has always sought the most effective treatments for the various disease outbreaks humanity has faced. In this sense, vaccine development has been an important vehicle connecting scientific research and technology, and putting them at the service of public health and mankind’s well-being.

In the past, remarkable progress has been made thanks to vaccines: for instance, 40 years ago, the first contagious disease in history, smallpox, was eradicated[1]; and just last month, the WHO declared the African continent free of polio, precisely thanks to a vaccine[2].

Nowadays, vaccines are an essential health service that protects susceptible people from diseases that can be prevented by immunization. According to data from the WHO, UNICEF and the World Bank, only drinking water rivals vaccination in its ability to save lives: it is estimated that vaccines prevent between 2-3 million deaths per year worldwide and that five lives are saved each minute thanks to immunizations around the world.

Though it is not possible to prevent all diseases, vaccination benefits a number of people by preventing infections, delaying diseases’ evolution or alleviating them; therefore, it is an excellent example of prevention and health protection.

Perhaps never before in our lives have we talked so much about vaccines. In the context of the COVID-19 pandemic, the WHO has indicated that providing timely vaccines is key, now more than ever, for individuals and communities to remain protected and to decrease the likelihood of outbreaks of other diseases that can be prevented with vaccination. On the other hand, there is no doubt that humanity longs to discover a medication that can cure this disease, and / or to have an effective vaccine available to all; the “race” to develop a vaccine against COVID-19 has us all speculating when it might be available, but … will the world accept this vaccine?

It would be expected that once this vaccine is available, being such a long-awaited solution, the vast majority of people would be willing to be vaccinated. However, according to a recent study, not everyone agrees. A World Economic Forum survey indicated that 74% of people would be willing to receive the vaccine, while 26% said they did not agree to do so[3].

However, if we examine similar surveys in specific countries, the level of confidence in the development of this new vaccine varies: in the United States, for example, a survey found that around 50% of the respondents would be willing to be immunized;[4] in Germany, the proportion of people willing to be vaccinated against COVID-10 is also around 50%.[5]

What about Latin America? In countries such as Peru, Argentina and Mexico, although most people would be willing to get the vaccine, if one were available, about a quarter of those surveyed would refuse to get it.[6]

What is the cause of this lack of confidence? The same IPSOS study, conducted in 27 countries, suggests that the reasons for not getting vaccinated among those surveyed are linked beliefs about vaccines, specifically related to concerns about side effects or “other diseases” they may cause, or to skepticism about the efficacy of vaccines to prevent disease.[7] Although we do not have results of similar surveys in Panama, there is great expectation here for the German vaccine that is currently in its second phase of testing within the country.

Local experts believe that it is important to know the facts before making health decisions, especially with so much information available today, sometimes incorrect. They also emphasize that vaccine development is the result of an intense collaborative effort. According to Dr. Digna Wong, General Coordinator of INDICASAT, moving from the concept of a vaccine to the finished product, implies a process of different phases that can guarantee that the vaccine is safe and effective for human beings: among them, the exploratory stage, the preclinical stage, the committee bioethics, the clinical trials, and regulatory reviews and approval, as well as national immunization programs.

Dilsa Lara, PAHO / WHO Consultant on Immunizations, emphasizes that developing a vaccine requires the participation, in one way or another, of government research and health agencies, non-profit organizations promoting the public health, international organizations, academic research centers, small biotech startups, and large pharmaceutical companies, among others. No single organization or group can do everything. Without extensive and productive teamwork from all stakeholders, safe, effective, and widely available vaccines we need would not be produced.

Developing a vaccine takes many years – on average ten, and sometimes much longer than that. For this reason, it is understandable that some people doubt the coronavirus vaccine candidates, because they perceive that it is being developed on a hurried schedule.

In this sense, Dr. Eduardo Ortega-Barría, physician, clinical scientist, and currently Vice President and Director of Medical Affairs and Research and Clinical Development for Latin America and the Caribbean at GlaxoSmithKline Vaccines, explains that there were already some candidate vaccines from previous researches have been recovered. We are in a unique situation where people are willing to work collaboratively to achieve the vaccine. This, together with innovative technologies that continue to advance, has allowed us to have about 300 vaccines in the research phase, which has made it possible in a certain way to significantly accelerate the process, particularly in the preclinical research phase, as we did not start from scratch this time. “We have faced more difficult vaccines and that makes new technologies ready to face these more complex pathogen challenges,” he explained.

This research stage is key to evaluating the efficacy of vaccines according to Dr. Juan Miguel Pascale, Director of the GORGAS Memorial Institute. According to Pascale, “checkpoints are not being evaded, adverse events are being evaluated. We’re advancing fast, but that does not mean we are forgetting safety. That is an important message to convey, the scientific community requires safe and effective vaccines,” he adds.

Dr. Argentina Ying, President of the National Council for Research Bioethics since 2017, agrees that, although the vaccine development processes up until before the COVID-19  pandemic have taken years, the level of technological development has accelerated processes, “so science must give a timely response, without the swiftness of the response inducing us to skip phases that put the scientific rigor of the processes at risk.”

In this regard, the role of bioethics committees comes to light, they are in charge of evaluating, precisely, that the research is ethical and that it has scientific validity, but also social validity. In other words, “vaccine development must have a solid methodological design and be relevant to respond to a health problem. We cannot put our trust in science at risk and that will depend on the consolidation of a culture of prevention through research,” added Dr. Ying.

Experts thus agree on the need to reinforce the importance of letting the population know that, although hard work is being carried out urgently to develop this vaccine, the safety protocols and parameters relating to the testing and regulation stages are already being rigorously fulfilled.

Panama’s vaccination scheme is one of the most recognized and robust in Latin America, but rejection of vaccinations can have serious consequences and, in fact, threatens to reverse the advances that have been made in recent decades in the fight against preventable diseases. For this same reason, it is important that we aspire to work so that the correct information reaches the people: “efficacy, safety and tolerance is the focal point of vaccine studies in all phases,” says Dr. Digna Wong, General Coordinator of INDICASAT.

It is vital to get information from trusted sources about the vaccine development process and how they work, in order to make informed decisions about prevention and health. However, it is clear that the facts and scientific evidence are only part of the puzzle. Just like with the development of a vaccine, teamwork is also required, where professionals from different areas – for example, medical professionals, journalists, technologists, civil society organizations, etc.-can join forces to really challenge and combat misinformation.

“Developing a vaccine is a challenge, a meticulous process. PAHO / WHO, in this regard to guarantee the safety of vaccines, is very rigorous. The established technical group makes an exhaustive review of the reports in each phase and thus the production process is evaluated,” points out Dilsa Lara, PAHO / WHO consultant on immunizations.

Jorge Arosemena, Executive President of the City of Knowledge Foundation, stresses that Panama already has a place on the map of vaccine research and development. In the last 20 years, Panamanian researchers and institutions have participated in multiple scientific studies to evaluate the efficacy and safety of vaccines. From Panama, clinical and biomedical research is developed for the advancement of science and the well-being of humanity. “Right now, at a critical time for the country and the world, the City of Knowledge is honored to be the home of important organizations dedicated to research and development that participate in this collective effort to develop vaccines; we remain committed to generating spaces for generation and exchange of knowledge” he added.

Developing a vaccine is a process where ethics must go hand in hand with science, and where safety and human rights must be put first in every sense.  Only in this way will we be able to ensure that this preventive health action is not something that divides us, but, on the contrary, unites us; especially at times when we may need to rely on them the most.

[1] https://vacunasaep.org/profesionales/noticias/hace-40-anos-desde-la-erradicacion-de-la-viruela

[2] https://www.bbc.com/news/world-africa-53887947

[3] https://www.weforum.org/agenda/2020/09/covid-19-coronavirus-vaccine-opinion-survey/

[4] https://apnews.com/article/dacdc8bc428dd4df6511bfa259cfec44

[5] https://www.dw.com/en/survey-only-half-of-germans-keen-to-vaccinate-against-coronavirus/a-53649377

[6] https://gestion.pe/peru/covid-19-peru-el-segundo-pais-de-america-latina-con-mas-ciudadanos-dispuestos-a-vacunarse-noticia/

[7] https://www.ipsos.com/sites/default/files/ct/news/documents/2020-08/encuesta_nacional_urbana_agosto_2020_-_vacuna_y_mitos.pdf

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