BEIJING – In the global race to make a coronavirus vaccine, a Chinese state-owned company boasts that its employees, including top executives, received experimental vaccines even before the government approved tests on people.
“Help forge the victory sword,” reads an online SinoPharm post with images of company leaders who he says helped “pre-test” his vaccine.
Whether seen as a heroic sacrifice or a violation of international ethical standards, the claim underscores the huge stakes as China competes with American and British companies to be the first with a vaccine to help end the pandemic. , a feat that would be both scientific and scientific. political triumph
“Getting a COVID-19 vaccine is the new Holy Grail,” said Lawrence Gostin, an expert in global public health law at Georgetown University. “The political competition to be the first is no less important than the moon race between the United States and Russia.”
China has positioned itself to be a strong contender. Eight of the nearly two dozen potential vaccines at various stages of human testing worldwide are from China, most from any country. And SinoPharm and another Chinese company have already announced that they are entering the final tests.
Both China and SinoPharm have invested heavily in a tried and true technology: an “inactivated” vaccine produced by growing all the virus in a laboratory and then killing it, this is how polio vaccines are made. The main western competitors use newer and less proven technology to attack the “spike” protein that covers the virus.
That protein is “a good place to bet,” Dr. Gary Nabel, chief scientific officer of the French pharmaceutical company Sanofi, said at a meeting of the US biotech industry. But “it is good to have some diversity. I like the fact that there is a complete inactivated vaccine. That provides an alternative in case one of these fails. ”
SinoPharm’s claim that 30 “special volunteers” rolled up their sleeves even before the company obtained permission for its initial human study raises ethical concerns among Western observers. The company’s publication cites a “spirit of sacrifice” and shows seven men in suits and ties, a mix of scientists, businessmen, and a Communist Party official with experience in military propaganda.
“The idea of people willing to sacrifice themselves … is highly anticipated in China,” said Yanzhong Huang, a global health expert at the Council on Foreign Relations, a US nonprofit organization.
But with the vaccination of corporate and government officials, other employees “may feel pressure to participate. That would violate the voluntary principle,” which is a cornerstone of modern medical ethics, Huang said.
The first round of human testing, a Phase 1 trial, requires permission from a country’s drug regulators, who decide whether there are enough laboratory and animal tests to warrant the attempt.
SinoPharm, who declined to comment for this story, is testing two vaccine candidates who received government permission for Phase 1 trials in mid to late April. In a post on its subsidiary’s official WeChat account, the company says it conducted its “pretest” in late March “to get the vaccines to market as soon as possible.”
It would not be the only shortcut that China is taking. In late June, the government gave special approval for the military to use an experimental vaccine made by another company, CanSino Biologics, omitting the final tests necessary to demonstrate whether it really works. CanSino now says it is in talks with four other countries to do that research.
Some participants in the first CanSino clinical trial in March said in social media posts that the researchers for the project claimed they had been injected on February 29, before regulators gave the go-ahead to the study. An investigator said team leader Chen Wei, a renowned military virologist, was the first to receive the experimental vaccine, one of the participants told Beijing News.
CanSino and Chen’s Academy of Military Medical Sciences rejected requests for information and interviews. The National Administration of Medical Products, which approves vaccine trials, also declined to comment.
In May, a Russian scientist told the RIA Novosti news agency that he and other researchers had also been vaccinated before the approved studies. “It is in self-defense so that we can continue to work” on a vaccine, said Alexander Gintsburg of the Moscow-based Gamaleya research institute.
“Everyone is alive, well and happy,” he added.
The Association of Clinical Research Organizations of Russia condemned the action as a “serious violation of the foundations of clinical research, Russian law and universally accepted international regulations.” But about a month later, Russia launched its first vaccine study, using the Gamaleya product.
Examples of scientists experimenting on themselves abound in medical history.
Around 1900, Pierre Curie, the husband of Marie Curie, deliberately burned his arm with a radio as part of his radiation experiments. In the 1950s, Jonas Salk tested his successful polio vaccine on himself and his family. In the 1980s, Dr. Barry Marshall of Australia drank a bacteria-laden broth as part of his quest to demonstrate that germs, not stress, cause stomach ulcers. He was correct.
And in China in the 1970s, a researcher named Tu Youyou, who worked in a secret military program, discovered an important anti-malaria drug that he first tried on himself. In 2015, he won a Nobel Prize.
With a COVID-19 vaccine, national pride is at stake. President Xi Jinping promised that any vaccine made in China would be a “global public good.”
All of this is taking place as China struggles to overcome years of drug scandals, the latest in 2018 when authorities withdrew a rabies vaccine and then announced that batches of children’s DPT vaccines against diphtheria, whooping cough and Tetanus was not effective.
Giving the experimental injection early to SinoPharm employees “sends a signal to the Chinese people: ‘You should not worry about the safety of the vaccine,'” Huang said.
Scientists vehemently debate self-experimentation because what happens to one or some people outside of a well-designed study is an anecdote, not evidence. More than 600,000 school-age children in the US had to receive either the Salk vaccine or a dummy vaccine to test protection against polio. It took almost another decade to validate Marshall’s ulcer germ theory, which also earned her a Nobel.
Modern international ethical rules require that participants in medical research be fully informed and freely consent. In the US, studies involving people must be approved by a “research review board,” and most US research institutions explicitly state that there is no exception to approval. of the board for self-experimentation.
“Employees may not be the best volunteers because employees have an unequal relationship,” said Dr. Derrick Au, director of bioethics at the Chinese University of Hong Kong.
Still, he said, questions about China’s medical ethics may disappear if one of its COVID-19 vaccines finally works. “It’s hard to argue against success,” said Au.
William Lee of the Milken Institute, a group of experts in Santa Monica, California, that tracks the progress of the COVID-19 vaccine, said that due to China’s past scandals, “if they succeed as the first with a product Viable in the market, It better be so pristine, so pure that people outside of China are willing to buy it. “
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