NEWS 26 MARCH 2021 Researchers gave shots to politicians and family members, violating trial regulations — and damaging public trust. Source: Nature
Former Peruvian president Martín Vizcarra was the first prominent person identified by local media to have received a COVID-19 vaccine in violation of clinical-trial standards.Credit: Ernesto Benavides/AFP/Getty Source: Nature Shidonna Raven Garden and Cook
A clinical trial of COVID-19 vaccines in Peru has sparked outrage and triggered a series of high-profile resignations at universities and in government. Politicians, researchers and some of their family members who were not enrolled as trial participants nevertheless received vaccines — breaching standard protocols. Investigations are ongoing as the country struggles to inoculate its general population with limited doses.
The scandal emerged on 10 February, when local media revealed that in October 2020, then-president Martín Vizcarra had received two doses of a vaccine developed by the Chinese state-owned pharmaceutical group Sinopharm. At the time, a phase III clinical trial was under way to test the vaccine at two universities in Peru; Vizcarra was not part of the trial.
Days later, it emerged that a group of around 470 other people — including 100 high-profile individuals such as Peru’s minister of health and Vizcarra’s wife and brother — also got a jab while the trial was in progress. The shots came from a batch of about 2,000 doses that Peruvian officials reportedly negotiated with Sinopharm to protect the medical staff running the trial.
It is not standard practice to vaccinate anyone other than trial participants while a trial is under way — including the medical staff running it, says Euzebiusz Jamrozik, a bioethicist at the Ethox Centre at the University of Oxford, UK.
The laws regulating clinical trials in Peru state that imported, experimental research products such as unapproved vaccines are to be used exclusively for research.
One of the universities running the trial — the National University of San Marcos in Lima — issued a statement condemning the vaccinations of people not enrolled as participants. “Normative and ethical principles of the current regulations and good clinical practices [a set of international medical standards] have been flagrantly violated by using the vaccine in people who are not subjects of research,” said the university’s Faculty of Medicine.
On 19 February, Peru’s National Health Institute (INS) suspended the second university involved, Cayetano Heredia University in Lima, from running new clinical trials. Cayetano has since appointed a panel of former faculty members to investigate the breaches of protocol.
Both universities’ rectors were among the group of non-participants who received shots. Cayetano’s has resigned, but San Marcos’s has not, sparking student protests.
“We share the indignation and deep pain of the [university] community and Peruvian society over the events related to the administration of the additional batch of experimental vaccines sent by Sinopharm,” said Cayetano’s new rector and vice-rector of research in a press release on 1 March.
Nine members of Peru’s Congress have been appointed to oversee an investigation into the vaccinations.
The violation of protocol, and what is seen by many as an abuse of political power by senior officials, has dented confidence in Peru’s politicians and its scientific community, says Mateo Prochazka, a Peruvian epidemiologist working in the United Kingdom. “At a time when we’re creating policies to control the transmission of the virus, we need the public to trust institutions and science, so this is a huge blow for our pandemic control,” he says.
Negotiated doses
The scandal and investigations follow a period of political instability for Peru, in which Vizcarra was impeached and removed from office over bribery charges. The country is struggling to contain the COVID-19 pandemic: it has officially reported more than 1.4 million cases of COVID-19 and 50,000 deaths. That’s the largest number of deaths by population size in Latin America, according to the COVID-19 tracker run by Johns Hopkins University in Baltimore, Maryland.
A health-care worker in Peru receives a dose of the Sinopharm vaccine.Credit: Luka Gonzales/AFP/Getty Source: Nature
The public had seen the vaccine trial, and a subsequent deal for 38 million Sinopharm vaccine doses to distribute in Peru, as a turning point in the battle against COVID-19. As in other low- and middle-income countries, Peru paved a path for itself to obtain vaccines by running the trial. It began administering 300,000 of the Sinopharm doses to health-care workers in February.
When news of Vizcarra’s vaccination came out, he said he had made the “brave decision” to volunteer for the trial. But Cayetano and the INS have since confirmed that he and the other prominent people who received vaccinations from October onwards were not among the study’s 12,000 participants — half of whom received placebos.
Nature’s requests for comment from Vizcarra went unanswered. In a press release from February, Vizcarra said it was a “great surprise” that Cayetano had not included him as a trial participant, and that he did not make his vaccination public “since it would have jeopardized the normal development” of the trial.
Trial oversight
The researcher leading the clinical trial was Germán Málaga — an internal medicine specialist at Cayetano who is a prominent figure in the medical community.
He oversaw the administration of some of the doses to politicians, including personally attending the vaccination of Vizcarra and his wife at the presidential palace after they requested it, he told a congressional committee investigating the vaccinations on 16 February. He also gave shots to members of his own family.
Cayetano has suspended Málaga from his role as principal investigator of the trial, and from all university activities.
Málaga denies that he broke protocol in administering vaccines to researchers and prominent people. He points out that the trial protocol he wrote states that the additional batch of vaccines would be “administered voluntarily to the research team and study-related personnel”.
The INS approved this protocol. It did not respond to Nature’s requests for comment.
Málaga tells Nature: “We used as criteria the protection of ‘study personnel and related personnel’ in a broad way, and in that extension we included the network of infections of the people we wanted to protect.” He admits that this included members of his family but points out that it also covered medical staff who were working on the front line and thus, in his opinion, needed protection.
According to a press statement released by the INS, Málaga and his staff also administered three doses, rather than the prescribed two, to some inidividuals outside of the trial, to see whether an additional booster shot would improve protection against the coronavirus.
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In response to Nature’s queries about administering unauthorized doses, Málaga defended his choice. He pointed out that when he administered the shots last September and December, the Sinopharm vaccine had not yet been proved efficacious, and thus trying out extra doses on individuals wouldn’t have been taking them away from the public.
“Including an additional dose is a serious, arbitrary breach of protocol” and violates the “fundamental principles of medical ethics,” says Ignacio Maglio, coordinator of science ethics for the UNESCO Bioethics Network who is based in Buenos Aires, Argentina. “It’s a clear example of malpractice in scientific study that could affect the safety of patients and puts at risk the dignity, the integrity and the safety of the research subjects.”
Failed transparency
Clarifying how and why vaccinations were administered outside the trial could help restore confidence in Peru’s science community, says Prochazka, but investigations are complicated by the fact that so many institutions are implicated.
The events in Peru aren’t the only instances in which members of the elite have jumped vaccine queues during the pandemic. In Argentina, for example, a similar list has emerged, resulting in the health minister’s resignation and a national investigation.
Arthur Caplan, head of New York University’s Division of Medical Ethics, says it makes sense to prioritize state leaders such as presidents and prime ministers for vaccines, but there has to be “a clear, principled approach to distribution” — and transparency.
“The Peruvian case seems to be at the extreme of ethical outrage,” he says. “Vaccinations have to be built on trust, not who you know.”doi: https://doi.org/10.1038/d41586-021-00576-0
Historically the health care industry is riddled across the world with unauthorized and unethical testing and experimentation. COVID-19 as we can see is no exception. When such things come to the public often an apology and reparations ensue, and many would like to tell us that such behavior is apart of the past and trust these new vaccines such as COVID-19. As we can see these things occur today amidst the COVID-19 Vaccine. Often when the unknowing participants are made aware of their involvement in medical trails or experiments, the damage has already been done and in some cases that is death. In fact some medical professionals blame the results of medical treatments on pre-existing conditions. How can this be disclosed if the person does not know they are in a trail or being experimented on.
Should people be told when they are apart of clinical trails? How can someone unaware of their own medical history properly communicate and manage their current and historical health? What disclosure and protections be in place? What happens when they fail?
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