A little over a year ago (on May 5, 2023), Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (who), declared the end of the global public health emergency due to the COVID-19 pandemic. In a tweet, he wrote: “Yesterday, the Emergency Committee met for the 15th time and recommended to me that I declare an end to the public health emergency of international concern. I have accepted that advice” ¹.

WHO experts estimate that 14.9 million deaths can be associated with the pandemic, a total that includes the 6.2 million deaths from COVID-19 officially reported to the who by its 194 member countries. As of today (February 16, 2024), approximately seven million deaths due to the virus have been recorded, of which 5.272 occurred in China, where the virus originated. However, the Asian country is no longer the territory where the new coronavirus has claimed the most lives. The United States leads the ranking with nearly 1.2 million deaths, followed by Brazil, with around 704,795 ².

Many researchers, such as those at the Hospital Clinic de Barcelona, affirm that there is still no curative treatment for COVID-19, but there are already vaccines that, in many cases, prevent infection, and, if the disease is contracted, allow it to be mild. Others are still in development and aim to prevent transmission ³.

In December 2020, the who reported that more than 200 experimental vaccines against COVID-19 were being developed. Of these, at least 52 are in the phases of human trials. Many other vaccines are currently in phases I or II and will move to phase hi in the coming months (for more detailed information on the phases of clinical trials, please refer to the third part of our collection “Vaccines Under the Microscope”) ⁴.

The main types of COVID-19 vaccines currently available in the United States or being investigated include the following ⁵:

• Messenger RNA (mRNA) vaccines: This type of vaccine instructs cells on how to produce the spike protein found on the surface of the COVID-19 virus. After vaccination, muscle cells begin to produce the spike protein components and display them on the cell surface. This prompts the body to create antibodies. If later infected with the COVID-19 virus, these antibodies will fight the virus. Once the protein components are formed, the cells break down the instructions and discard them. The mRNA from the vaccine does not enter the cell’s nucleus, where DNA is stored. Both the Pfizer-BioNTech and Moderna COVID-19 vaccines use mRNA.

• Viral vector vaccines: In this type of vaccine, the material from the COVID-19 virus is placed in a modified version of a different virus (viral vector). This vector instructs cells to make copies of the COVID-19 spike protein. Once cells display the spike proteins on their surface, the immune system responds by creating antibodies and defensive white blood cells. If later the body is infected with the COVID-19 virus, the antibodies will fight the virus. Viral vector vaccines cannot cause infection with the COVID-19 virus or the viral vector virus. The Johnson & Johnson Janssen COVID-19 vaccine is a viral vector vaccine. AstraZeneca and the University of Oxford also have a viral vector vaccine against COVID-19.

• Protein subunit vaccines: Protein subunit vaccines include only the parts of a virus that best stimulate the immune system. This type of COVID-19 vaccine contains harmless spike proteins. Once the immune system recognizes the spike proteins, it creates antibodies and defensive white blood cells. If later the body is infected with the COVID-19 virus, the antibodies will fight it. The Novavax COVID-19 vaccine is a protein subunit vaccine.

The Ministry of Health and Social Protection of Colombia has reported the distribution of the following vaccines in the national territory to date ⁶:

• Pfizer: 10 million doses acquired for 5 million people

• AstraZeneca: Colombia bought 10 million doses for 5 million people.

• Janssen: 9 million doses for 9 million people.

• Moderna: The national government has just acquired 10 million doses for 5 million people.

• Sinovac: 7.5 million doses for 3,750,000 people.

The scandal surrounding the Oxford-AstraZeneca COVID-19 vaccine: An analysis published on February 19,2021, shows that the vaccine has an efficacy of 76% in preventing COVID-19 symptoms from 22 days after the first dose, increasing to 81.3% if a second dose is administered twelve weeks after the first. The vaccine has a good safety profile; some side effects include pain at the injection site, nausea, and headache, which usually dissipate over several days. Much less frequently, an anaphylactic reaction can occur, with 234 cases in 11.7 million vaccinations. A very rare link between the vaccine and several cases of thrombosis has also been identified: as of March 22, 2021, there were 86 cases in a total of 25 million vaccinations in the European Union and the United Kingdom ⁷.

In June 2020, the United States National Institute of Allergy and Infectious Diseases (NIAID) confirmed that phase three trials of possible vaccines developed by the University of Oxford and AstraZeneca would begin in July of that year. At that time, AstraZeneca partnered with IQVIA to accelerate clinical trials in the United States ⁸. On September 8, 2020, AstraZeneca announced the global suspension of the vaccine trial while investigating a possible adverse reaction in a participant in the United Kingdom.

On September 13, 2020, AstraZeneca and the University of Oxford resumed clinical trials in the United Kingdom after regulators concluded it was safe to do so. AstraZeneca faced criticism regarding the vaccines safety after experts raised concerns about the company’s refusal to provide details about serious neurological illnesses in two participants who received the experimental vaccine in Britain. While the trial resumed in the United Kingdom, Brazil, South Africa, Japan, and India, it remained on hold in the United States until October 23,2020, as the FDA investigated the illness of a patient that triggered the clinical suspension, according to Alex Azar, secretary of the HHS ⁹.

On April 30, 2024, AstraZeneca officially acknowledged in British courts that its COVID-19 vaccine could trigger thrombosis with Thrombocytopenia Syndrome (TTS) in extremely rare cases. This development emerged in the context of a class action lawsuit in the United Kingdom, filed by individuals claiming to have suffered severe injuries as a result of receiving the vaccine, developed in collaboration with the University of Oxford.

The who explained the event as follows: “A new very rare adverse event, known as thrombosis with (TTS), has been reported following the administration of this vaccine. This syndrome involves severe and rare blood clotting disorders associated with low platelet counts. In countries currently experiencing sarS-CoV-2 transmission, the benefits of vaccination far outweigh the risks, given the protection the vaccine offers against COVID-19” ¹⁰.

AstraZeneca withdrew its COVID-19 vaccine worldwide due to low demand; the vaccine is no longer manufactured, supplied, or authorized for use in Europe. Experts say this is because it could not be updated for the new variants.

And what about bioethics? Bioethics resembles philosophy in that it does not emerge until reality has completed its formation process and is realized. This natural condition of tardiness in philosophy is explained by the metaphor of the owl of Minerva, which takes flight at dusk.

The WHO proposed eight ethical criteria for direct exposure studies of potential vaccines to be accepted, among the most important are ¹¹:

Scientific justification: There must be a strong scientific justification for conducting studies with the sarS-CoV-2 virus. This means that the results cannot be obtained as efficiently or quickly with studies based on other designs, involving a lower risk to participants, and thus, result in greater and more immediate public health benefits.

1) Risk and potential benefit assessment: The expected potential benefits must far outweigh the risks. The quantifiable risks and benefits must be assessed in three main groups: (a) the participants; (b) society at large; and (c) those in contact with the participants.

2) Site selection: Studies must be located where research can meet the highest scientific, clinical, and ethical standards; they must ensure that they can provide high-quality medical care, including intensive care services, long-term participant follow-up, and full compensation for any harm related to the study.

3) Participant selection: Researchers must ensure that the selection criteria for participants limit and minimize risks. Initial studies should be limited to groups of young, healthy adults, aged 18-30 years, and exclude those at higher risk of infection based on origin, resulting in social injustice and exploitation, or who are vulnerable in any way.

4) Informed consent: Studies must include a rigorous informed consent process. The process must be based on the best available data on the risks, ensuring that participants fully understand all relevant information. Consent should be reaffirmed periodically when important new information arises to confirm participants’ good understanding and voluntary adherence to the study.

This leads me to wonder if bioethics did not foresee what was coming with the approval of multiple COVID-19 vaccines. It relied entirely on the results of effectiveness and safety studies from human clinical trials. However, the decisions that drug regulatory agencies (FDA, Invima, etc.) had to make were never free; they were under the pressure of deaths worldwide, the pressure from powerful governments to produce the “first cure” for the pandemic, and, above all, the enormous business that the manufacture of these vaccines generated for the pharmaceutical industry.

I believe that this case of the Oxford-AstraZeneca COVID-19 vaccines should be analyzed through the lenses of biopolitics and biojuridical categories, and it will provide many bioethical lessons.

References

Ghebreyesus, TA [@DrTedros #COVID19]. Breaking COVID-19 Global health emergency is over. Twitter. [Internet]. 5 de mayo de 2023. Disponible en: https://twitter.com/hashtag/COVID19?src=hashtag_click

OMS. [Internet]. 2024, 16 de febrero. Disponible en: https://www.paho.org/es/temas/coronavirus

Hospital Clinic de Barcelona. Tratamiento del Coronavirus SARS-CoV-2. [Internet]. [Consultado el 28 de mayo de 2024]. Disponible en: Disponible en: https://www.clinicbarcelona.org/asistencia/enfermedades/covid-19/tratamiento#:~:text=Todav%C3%ADa%20no%20hay%20un%20tratamiento%20curativo%20para%20el,desarrollo%20y%20tienen%20como%20objetivo%20evitar%20la%20transmisi%C3%B3n.

OMS. Los distintos tipos de vacunas que existen. [Internet]. 2021, 12 de enero. Disponible en: https://www.who.int/es/news-room/feature-stories/detail/the-race-for-a-covid-19-vaccine-explained

Mayo Clinic, Diferentes tipos de vacunas contra la COVID-19: cómo funcionan. [Internet]. [Consultado el 28 de mayo de 2024]. Disponible en: Disponible en: https://www.mayoclinic.org/es/diseases-conditions/coronavirus/in-depth/different-types-of-covid-19-vaccines/art-20506465-

Ministerio de salud y protección social. Vacunación contra COVID-19. [Internet]. [Consultado: el 28 de mayo de 2024]. Disponible en: Disponible en: https://www.minsalud.gov.co/salud/publica/Vacunacion/Paginas/Vacunacion-covid-19.aspx

«Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOxl nCoV-19 (AZD1222) vaccine: apooled analysis of four randomised trials». February 2021;Lancet 397(10277):881-891. PMC 7894131. PMID 33617777. DOI: 10.1016/S0140-6736(21)00432-3. https://doi.org/10.1016/S0140-6736(21)00432-3

Exeter College. «Exeter Fellow Dr Catherine Green leads the production of a potential COVID-19 vaccine in Oxford». 6 de abril de 2020. [Consultado el 24 de abril de 2024]

Wu, Katherine J, Thomas, K. «AstraZeneca Pauses Vaccine Trial for Safety Review». The New York Times. [8 de septiembre de 2020]. ISSN 0362-4331. [Consultado el 10 de mayo de 2024].

OMS. Todo lo que se debe saber sobre la vacuna ChAdOx1-S (recombinante) de Oxford/AstraZeneca contra la COVID-19. [Internet]. 13 de junio de 2022. Disponible en: https://www.who.int/es/news-room/feature-stories/detail/the-oxford-astrazeneca-covid-19-vaccine-what-you-need-to-know#:~:text=La%20vacuna%20de%20AstraZeneca%20protege,normalizadas%20con%20un%20intervalo%20qu

Georgina C. A vaccine for Covid-19? Nursing New Zealand (Wellington, N Z: 1995). 1.° de junio de 2020;26(5):29