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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^[1] 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^[2] 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^[3] 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 Center for Clinical Studies at 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^[4].

“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^[5] 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.

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^[6], 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.