Chinese executives get 'pre-test' injections in COVID-19 vaccine race

In global race to make a coronavirus vaccine, a state-owned Chinese company is boasting that its employees, including top executives, received experimental shots even before government approved testing in people.

“Giving a helping hand in forging sword of victory,” res an online post from SiPharm with pictures of company leers it says helped “pre-test” its vaccine.

Wher it’s viewed as heroic sacrifice or a violation of international ethical rms, claim underscores ermous stakes as China competes with U.S. and British companies to be first with a vaccine to help end pandemic — a feat that would be both a scientific and political triumph.

“Getting a COVID-19 vaccine is new Holy Grail,” said Lawrence Gostin, a global public health law expert at Georgetown University. “ political competition to be first is less consequential than race for moon between United States and Russia.”

China has positioned itself to be a strong contender. Eight of nearly two dozen potential vaccines in various sts of human testing worldwide are from China, most of any country. And SiPharm and ar Chinese company alrey have anunced y’re entering final testing.

Both China and SiPharm have invested heavily in a tried-and-true techlogy — an “inactivated” vaccine me by growing whole virus in a lab and n killing it, which is how polio shots are me. Leing Western competitors use newer, less proven techlogy to target “spike” protein that coats virus.

That protein is “a good place to make our bet,” Dr. Gary Nabel, chief scientific officer of French pharmaceutical company Safi, said at a U.S. biotechlogy industry meeting. But “it’s good to have some diversity. I like fact that re is an inactivated, whole vaccine. That provides an alternative in case one of se should fail.”

SiPharm’s claim that 30 “special volunteers” rolled up ir sleeves even before company got permission for its initial human study raises ethical concerns among Western observers. company’s post cites a “spirit of sacrifice” and shows seven men in suits and ties — a mix of scientists, businessmen and one Communist Party official with a background in military propaganda.

“ idea of people willing to sacrifice mselves ... is pretty much expected in China,” said Yanzhong Huang, a global health expert at Council on Foreign Relations, a U.S. nprofit organization.

But with corporate and government officials getting vaccinated, or employees “might feel pressure to participate. That would violate voluntary principle” that is a bedrock of modern medical ethics, Huang said.

first round of human testing — a Phase 1 trial — requires permission from a country’s drug regulators, who decide wher re is eugh laboratory and animal evidence to justify attempt.

SiPharm, which declined to comment for this story, is testing two vaccine candidates that received government permission for Phase 1 trials in mid- to late April. In a post on its subsidiary’s official WeChat account, company says it conducted its “pre-test” at end of March “to make vaccines hit market as early as possible.”

It would t be only shortcut China is taking. In late June, government gave special approval for military to use an experimental vaccine me by ar company, CanSi Biologics, skipping final testing needed to prove if it really works. CanSi w says it’s in talks with four or countries about doing that research.

Some participants in first CanSi clinical trial in March said in social media posts that researchers on project claimed y h been injected Feb. 29, before regulators gave study go-ahe. A researcher said team leer Chen Wei, a rewned military virologist, was first to receive experimental vaccine, one of participants told state-owned Beijing News.

CanSi and Chen’s Acemy of Military Medical Sciences turned down requests for information and interviews. National Medical Products ministration, which approves vaccine trials, also declined to comment.

In May, a Russian scientist told RIA vosti news ncy that he and fellow researchers also h vaccinated mselves ahe of approved studies. “It’s self-defense in order for us to continue working” on a vaccine, said Alexander Gintsburg of Moscow-based Gamaleya research institute.

“Everyone is alive and well and cheerful,” he ded.

Russia’s Association of Clinical Research Organizations condemned action as a “crude violation of very foundations of clinical research, Russian law and universally accepted international regulations.” But about a month later, Russia launched its first vaccine study, using Gamaleya product.

Examples of scientists experimenting on mselves abound in medical history.

Around 1900, Pierre Curie, Marie Curie’s husband, deliberately burned his arm with rium as part of ir riation experiments. In 1950s, Jonas Salk tested his ultimately successful polio vaccine on himself and his family. In 1980s, Australia’s Dr. Barry Marshall drank a bacteria-len broth as part of his quest to prove germs, t stress, cause stomach ulcers. He was right.

And in China in 1970s, a researcher named Tu Youyou, working in a secret military program, discovered an important anti-malaria drug that she first tested on herself. In 2015, she won a bel Prize.

With a COVID-19 vaccine, national pride is at stake. President Xi Jinping pledged that any Chinese-me vaccine would be a “global public good.”

All this is taking place as China strives to overcome years of drug scandals — latest coming in 2018 when authorities recalled a rabies vaccine and later anunced batches of children’s DPT vaccines, for diphria, pertussis and tetanus, were ineffective.

Giving experimental shot early to SiPharm’s employees “sends a signal to Chinese people, ‘You guys should t worry about safety of vaccine,’” Huang said.

Scientists vehemently debate self-experimenting because what happens to one or a few people outside of a well-designed study is anecdote, t evidence. More than 600,000 U.S. schoolchildren h to be given Salk’s vaccine or a dummy shot to prove polio protection. It took almost ar dece to validate Marshall’s ulcer germ ory, which earned him a bel as well.

Modern international ethics rules require participants in medical research to be fully informed and to freely consent. In U.S., studies involving people must receive approval from an “investigational review board,” and most U.S. research institutions explicitly state re is exception to board approval for self-experimenting.

“Employees may t be best volunteers because employees are in a relationship which is t equal,” said Dr. Derrick Au, bioethics director at Chinese University of Hong Kong.

Still, he said questions about China’s medical ethics might disappear if one of its COVID-19 vaccines ultimately proves to work. “It’s difficult to argue against success,” Au said.

William Lee of Milken Institute, a think tank in Santa Monica, California, that is tracking COVID-19 vaccine progress, said that because of China’s past scandals, “if y are successful as being first with a workable product on market, it h better be so pristine, so pure that people who are outside of China would be willing to buy into it.”