Letter to Editor

Accelerated arrival of COVID-19 vaccines, some ethical issues to consider

Nevis Amin-Blanco^{1  *} 
http://orcid.org/0000-0001-8723-3963

¹Instituto Finlay de Vacunas, La Habana, Cuba.

In December, 2019, Wuhan city, the capital of Hubei province in China, became the center of an outbreak of pneumonia of unknown cause. It was later diagnosed as severe acute respiratory syndrome (SARS) caused by a coronavirus called SARS-CoV-2.¹ At the beginning of March 2020, the World Health Organization (WHO) reported almost 100,000 positive cases and 3,880 deaths in 47 countries, evaluating that the coronavirus disease 2019, COVID-19 could be characterized as a pandemic.²

The COVID-19 pandemic has brought a great impact on the lives of people and society as a whole and has caused damage to the global economy, affecting sectors such as tourism, recreation, international travel, education, among others. It has had repercussion in human health in terms of disease burden, hospitalizations, disability and high number of deaths, as well as the complex questions imposed on science to stop the impact of this terrible disease.

The implementation of a strategy aimed at mitigating the spread of the disease includes public health actions such us: cleaning your hands, the widespread and mandatory wearing a mask, social distancing, and vaccination.³

A vaccine against COVID-19, so eagerly awaited by the world, must be safe and effective in order to restart a "normal" lifestyle, free from the recommended restriction measures and avoiding the collapse of health services. The race for COVID-19 vaccine invention and development has not precedent in the modern era and involves science like never before, leading to the mobilization and exchange of data in a very short period of time, to the coordination of processes for the development of vaccines and drugs and to the creation of international collaboration frameworks that include, together with WHO, the Global Alliance for Vaccines (GAVI), the Coalition for the Promotion of Innovations for Epidemic Preparedness (CEPI) and the Fund for Global Access for COVID-19 Vaccines (COVAX).⁴

Traditionally, vaccine development is a lengthy and expensive process. Most vaccines took 10 years on average from discovery of research molecule to marketing as a product, with cost around millions of dollars. Shortening the time in this process is one of the most important challenges, where the clinical development stage is the one that is under the most pressure at all times.¹

The trial process for vaccines consists of several steps which need to be conducted systematically. In particular, for COVID-19 vaccine, the studies overlapped and shortened the usual timeline. Several vaccines have already received authorizations for emergency use and are being used to immunize people.⁵⁾ Unfortunately, streamlining may have consequences for the traditional ethics related to vaccine research, development and the stages of distribution and equitable access to them.

For research on human beings to be ethically justified, there must be a favorable balance of benefits for the subject and society in relation to the risks to which the individual is exposed. Among the ethical dilemmas faced by researchers, one of the most complex in the case of vaccines against COVID-19, is the use of a control group or placebo in clinical studies, considering that this is a new disease, with limited treatment options, and high mortality, all of which imply a high risk for this group. According to the study design, the participants included in the placebo group could become infected depending on the length of stay in that group, the local transmission rate where the clinical trial is carried out and the preventive measures adopted by each of the participants.

One of the scenarios that a researcher could face when using placebo is that the treatment (drug or vaccine) is effective, then a part of the participants lose the opportunity to receive that benefit, which would lead us to decide that all the volunteers receive prophylaxis and sacrifice the knowledge and social value provided by studies with placebo group.⁸ Currently, some vaccine developers have outlined the ethical obligation to offer the vaccine to participants who have received placebo in clinical trials to be protected against COVID-19 and also for the contribution to research.⁸

Another topic of global discussion that concerns bioethics related to vaccines against COVID-19, is the fair distribution within a population once the vaccines are already available on the market. What criteria should be used? Which people should receive it first within a population? Who has priority, and why? It is a general criterion among specialists that health personnel who are on the front lines of the battle against COVID-19 should be the first to access the vaccine, which prevents direct and indirect damage to them by preventing the spread of SARS-CoV-2 in medical facilities, thus protecting the groups of patients who most frequently visit hospitals with a diagnosis of cancer or with hemodialysis treatment.⁶

The global health crisis caused by SARS-CoV-2 is unprecedented and access to the vaccine has proven difficult from the start. It is a fact that developed countries have been rushing since pre-commercialization to purchase and contract sufficient quantities of vaccines for their populations, making the outlook even bleaker for low-income countries.⁶ Due to the pandemic, vaccine logistics operations are also affected, thus becoming obstacles to ensuring global distribution in a coordinated and interconnected manner (manufacturing, supply chain distribution, cold chain, warehousing, etc.). Hence, the constant call of the WHO to achieve and maintain the commitment of governments to guarantee equitable access and to collaborate in multinational plans such as COVAX, CEPI and GAVI to ensure the manufacture and distribution of vaccines against COVID-19.

In order to do good for all and in the face of the rush to obtain effective therapeutic results to confront and mitigate the pandemic, scientific standards, the integrity and transparency of the vaccine review process must not be sacrificed and the fundamental ethical principles required in human research.

Referencias/References

1. Funk CD, Laferrière C, Ardakani A. A Snapshot of the global race for vaccines targeting SARS-CoV-2 and the COVID-19 Pandemic. Front Pharmacol. 2020, 11:937. doi: https://10.3389/fphar.2020.00937.

2. Director General de la OMS. Alocución de apertura del Director General de la OMS en la rueda de prensa sobre la COVID-19 celebrada el 11 de marzo de 2020. Ginebra: OMS; 2020. Disponible en: https://www.who.int/es/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020. Consultado en línea: 3 de mayo del 2020.

3. CDC. Clinical questions about COVID-19: questions and answers. Atlanta: US Department of Health and Human Services, CDC; 2020. Disponible en: https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html.

4. COVAX. Colaboración para un acceso equitativo mundial a las vacunas contra la COVID-19. Geneva: OMS. Disponible en: https://www.who.int/es/initiatives/act-accelerator/covax/.

5. Comisión Federal para la Protección contra Riesgos Sanitarios (COFREPIS). Autorización para uso de emergencia a vacuna Astrazeneca COVID-19. Ciudad de México: COFREPIS;2021. Disponible en: https://www.gob.mx/cofepris/articulos/autorizacion-para-uso-de-emergencia-a-vacuna-astrazeneca-covid-19?idiom=es.

6. Zonenszain-Laiter Y. Las vacunas contra el Covid-19: dos dilemas éticos a considerar. Medicina y Ética. 2021;32(1):215-31. doi:https://10.36105/mye.2021v32n1.06.

7. Rid A, Lipsitch M, Miller FG. The ethics of continuing placebo in SARS-CoV-2 vaccine trials. JAMA. 2021;325(3):219-20. doi:https://10.1001/jama.2020.250532020.

8. Wendler D, Ochoa J, Millum J, Grady C, Taylor HA. COVID-19 vaccine trial ethics once we have efficacious vaccines. Science. 2020;370:1277-9. doi:https://10.1126/science.abf5084.

Received: March 01, 2021; Accepted: March 19, 2021