Scandal over COVID vaccine trial at Peruvian universities spurs outrage

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[7] released by the INS, Málaga and his staff also administered three doses, rather than the prescribed two, to some individuals outside of the trial, to see whether an additional booster shot would improve protection against the coronavirus.

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[8].

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.”

References

  1. ^ local media revealed (andina.pe)
  2. ^ state that (busquedas.elperuano.pe)
  3. ^ issued a statement (medicina.unmsm.edu.pe)
  4. ^ sparking student protests (larepublica.pe)
  5. ^ in a press release (www.cayetano.edu.pe)
  6. ^ a press release from February (twitter.com)
  7. ^ a press statement (web.ins.gob.pe)
  8. ^ a national investigation (www.aa.com.tr)

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