Outrage Over Vaccine- Trial Scandal at Peruvian

News in focus director-general Tedros Adhanom Ghebreyesus of the non-profit research organization been infected in an experiment and spread (who was not directly involved with the investi- EcoHealth Alliance in New York City. “A thou- it to others. The Wuhan researchers also said gation) posted a statement saying that he looks sand samples is a great start, but there’s more they hadn’t kept any virus strains similar to forward to future studies of the virus’s animal to do,” he says. He points out that researchers SARS-CoV-2. And in their discussions with the origins — but that he wasn’t content with the traced farmed animals at the market back to team, they pointed out that similar viruses exist examination of a possible laboratory leak. “I do three provinces in China where pangolins and in animals in China, rather than in their lab. not believe that this assessment was extensive bats carrying coronaviruses similar to SARS- Nevertheless, the findings might be con- enough,” he wrote. “This requires further inves- CoV-2 had been found. Although the pangolin tested. A group of scientists have written to tigation, potentially with additional missions the media saying that they wouldn’t trust an involving specialist experts.” “A thousand samples investigation overseen by China’s government. Over 4 weeks from mid-January, 34 scien- But others say that the WHO’s conclusions tists from nations including China, Japan, the is a great start, but there’s seem solid. “I’m sure people will say that the United States and the United Kingdom gathered more to do.” Chinese researchers are lying, but it strikes me in Wuhan and assessed data. The team has now as honest,” argues Holmes. Matthew Kavanagh, published its findings in a 300-page report. and bat viruses proved too distant to be the a global-health researcher at Georgetown Uni- Much of it is devoted to cases occurring direct progenitors of SARS-CoV-2, Daszak says versity in Washington DC, says that he’s heard in December 2019 and January 2020. Of the that the animals might provide a clue that out- no evidence pointing to a lab. “But the sceptics 170-odd people who had symptoms in Decem- breaks among animals started in those places. are going to want a deeper investigation than ber, two-thirds reported having been exposed The WHO report also concludes that it’s the Chinese government allowed.” to live or dead animals shortly beforehand, and highly unlikely that the coronavirus escaped Some studies have suggested that COVID-19 10% had travelled outside Wuhan. from a lab at the Wuhan Institute of Virology. was spreading among people before Decem- Chinese researchers sequenced SARS-CoV-2 Most scientists say that evidence overwhelm- ber 2019. To explore that possibility, the report from some of the people in this group, finding ingly favours SARS-CoV-2 having spilled over authors looked at analyses of SARS-CoV-2 that eight of the earliest sequences were iden- from animals into humans, but a few have sequences collected from people in January tical, and that infected people were linked to backed the idea that the virus was intentionally 2020, and estimated that they evolved from the Huanan market. This suggests an outbreak or accidentally leaked from a lab. a common ancestor between mid-November there, according to the report. When the team visited the institute, its and early December of 2019. That estimate However, researchers also found that these scientists told them that no one in the lab roughly corroborates the findings of a report genomes varied slightly from those in a few had antibodies against SARS-CoV-2, ruling published in Science last month (J. Pekar et al. other early cases. Some linked to the market; out the possibility that someone there had Science https://doi.org/f4cm; 2021). others did not. This means that the coronavirus might have been spreading under the radar in communities, evolving along the way, and coincidentally occurring in people linked to the market, says the report. Another possibility is that an outbreak OUTRAGE OVER VACCINE- occurred at a farm that provided animals to the Huanan market, suggests Holmes. Several TRIAL SCANDAL AT infected animals — with slightly different vari- ations of SARS-CoV-2 — might have then been PERUVIAN UNIVERSITIES sold at markets in Wuhan, sparking multiple infections in humans. Researchers gave shots to politicians and Plenty of animals were sold at the Huanan market. Records from December 2019 list family members, violating trial regulations. poultry, badgers, rabbits, giant salamanders, two kinds of crocodile and more. Chinese offi- By Luke Taylor universities in Peru; Vizcarra was not part of cials said that the market didn’t sell live mam- the trial. mals or illegal wildlife, the report adds. But clinical trial of COVID-19 vaccines Days later, it emerged that a group of around it also references unverified media reports in Peru has sparked outrage and 470 other people — including 100 high-profile suggesting that such animals were sold, and triggered a series of high-profile individuals such as Peru’s minister of health refers to photographs that Holmes published resignations at universities and in and Vizcarra’s wife and brother — also got a after a trip there in 2014, of animals such as live government. Politicians, researchers jab while the trial was in progress. The shots raccoon dogs. Aand some of their family members who were came from a batch of about 2,000 doses that Chinese teams collected nearly 1,000 sam- not enrolled as trial participants nevertheless Peruvian officials reportedly negotiated ples from the Huanan market in early 2020, received vaccines — breaching standard proto- with Sinopharm to protect the medical staff swabbing doors, rubbish bins, toilets, stray cats cols. Investigations are ongoing as the country running the trial. and mice, and stalls that sold vegetables and struggles to inoculate its general population It is not standard practice to vaccinate any- animals. The majority of samples that tested with limited doses. one other than trial participants while a trial positive were from stalls that sold seafood, live- The scandal emerged on 10 February, when is under way — including the medical staff stock and poultry. The researchers also took local media revealed that, in October 2020, running it, says Euzebiusz Jamrozik, a bio samples from 188 animals across 18 species at then-president Martín Vizcarra had received ethicist at the Ethox Centre at the University the market, all of which tested negative. two doses of a vaccine developed by the of Oxford, UK. But these animals don’t represent Chinese state-owned pharmaceutical group The laws regulating clinical trials in Peru everything sold in the Huanan market, notes Sinopharm. At the time, a phase III clinical state that imported, experimental research WHO team member Peter Daszak, president trial was under way to test the vaccine at two 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 Center for Clin- ical 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. BENAVIDES/AFP/GETTY ERNESTO “We share the indignation and deep pain Martín Vizcarra received a vaccine during the clinical trial, but was not a participant. of the [university] community and Peruvian society over the events related to the adminis- study’s 12,000 participants — half of whom Málaga tells Nature: “We used as criteria the tration of the additional batch of experimental received placebos. protection of ‘study personnel and related per- vaccines sent by Sinopharm,” said Cayetano’s Nature’s requests for comment from sonnel’ in a broad way, and in that extension new rector and vice-rector of research in a Vizcarra went unanswered. In a press release we included the network of infections of the press release on 1 March. from February, Vizcarra said it was a “great sur- people we wanted to protect.” He admits that Members of Peru’s Congress are overseeing prise” that Cayetano had not included him as a this included members of his family, but points an investigation into the vaccinations. trial participant, and that he did not make his out that it also covered medical staff who were The violation of protocol, and what is seen vaccination public “since it would have jeop- working on the front line and thus, in his opin- by many as an abuse of political power by ardized the normal development” of the trial. ion, needed protection. senior officials, has dented confidence in The researcher leading the clinical trial was According to a press statement released by Peru’s politicians and its scientific community, Germán Málaga — an internal-medicine spe- the INS, Málaga and his staff also administered says Mateo Prochazka, a Peruvian epidemi- cialist at Cayetano who is a prominent figure three doses, rather than the prescribed two, ologist working in the United Kingdom. “At a in the medical community. to some individuals outside the trial, to see time when we’re creating policies to control He oversaw the administration of some of whether an extra booster shot would improve the transmission of the virus, we need the pub- the doses to politicians, including person- protection against the coronavirus. lic to trust institutions and science, so this is a ally attending the vaccination of Vizcarra In response to Nature’s queries about huge blow for our pandemic control,” he says. and his wife at the presidential palace after administering unauthorized doses, Málaga they requested it, he told a congressional defended his choice. He pointed out that when Negotiated doses committee investigating the vaccinations on he administered the shots last September and The scandal and investigations follow a period 16 February. He also gave shots to members December, the Sinopharm vaccine had not yet of political instability for Peru, in which of his own family. been proved efficacious, and thus trying out Vizcarra was impeached and removed from extra doses on individuals wouldn’t have been office over bribery charges. The country is “We need the public to trust taking them away from the public. struggling to contain the COVID-19 pandemic: “Including an additional dose is a serious, it has officially reported more than 1.5 million institutions and science, so arbitrary breach of protocol” and violates the cases of COVID-19 and 51,000 deaths. this is a huge blow for our “fundamental principles of medical ethics”, The public had seen the vaccine trial, and pandemic control.” says Ignacio Maglio, coordinator of science a subsequent deal for 38 million Sinopharm ethics for the UNESCO Bioethics Network, who vaccine doses to be distributed in Peru, as a is based in Buenos Aires. turning point in the battle against COVID-19. Cayetano has suspended Málaga from his Clarifying how and why vaccinations were As in other low- and middle-income countries, role as principal investigator of the trial, and administered outside the trial could help Peru paved a path for itself to obtain vaccines from all university activities. restore confidence in Peru’s science commu- by running the trial. It began administering Málaga denies that he broke protocol in nity, says Prochazka, but investigations are 300,000 of the Sinopharm doses to health- administering vaccines to researchers and complicated by the fact that so many institu- care workers in February. prominent people. He points out that the trial tions are implicated. When news of Vizcarra’s vaccination came protocol he wrote states that the additional The events in Peru aren’t the only instances out, he said he had made the “brave decision” batch of vaccines would be “administered vol- in which members of the elite have jumped to volunteer for the trial. But Cayetano and the untarily to the research team and study-related vaccine queues during the pandemic. In Argen- INS have since confirmed that he and the other personnel”. tina, for example, a similar list has emerged, prominent people who received vaccinations The INS approved this protocol. It did not resulting in the health minister’s resignation from October onwards were not among the respond to Nature’s requests for comment. and a national investigation.