BEIJING
(AP) — In the 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 the government
approved testing in people.
“Giving
a helping hand in forging the sword of victory,” reads an online post
from SinoPharm with pictures of workers it says helped “pre-test” its
vaccine.
Whether
it’s viewed as heroic sacrifice or a violation of international ethical
norms, the claim underscores the enormous stakes as China competes with
U.S. and British companies to be the first with a vaccine to help end
the pandemic — a feat that would be both a scientific and political
triumph.
“Getting
a COVID-19 vaccine is the new Holy Grail,” said Lawrence Gostin, a
global public health law expert at Georgetown University. “The political
competition to be the first is no less consequential than the race for
the moon between the United States and Russia.”
China
has positioned itself to be a strong contender. Eight of the nearly two
dozen potential vaccines in various stages of human testing worldwide
are from China, the most of any country. And SinoPharm and another
Chinese company already have announced they’re entering final testing.
Both
China and SinoPharm have invested heavily in a tried-and-true
technology — an “inactivated” vaccine made by growing the whole virus in
a lab and then killing it, which is how polio shots are made. Leading
Western competitors use newer, less proven technology to target the
“spike” protein that coats the virus.
That
protein is “a good place to make our bet,” Dr. Gary Nabel, chief
scientific officer of the French pharmaceutical company Sanofi, said at a
U.S. biotechnology industry meeting. But “it’s good to have some
diversity. I like the fact that there is an inactivated, whole vaccine.
That provides an alternative in case one of these should fail.”
SinoPharm’s
claim that 30 “special volunteers” rolled up their sleeves even before
the company got permission for its initial human study raises ethical
concerns among Western observers. The 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.
“The
idea of people willing to sacrifice themselves ... is pretty much
expected in China,” said Yanzhong Huang, a global health expert at the
Council on Foreign Relations, a U.S. nonprofit organization.
But
with corporate and government officials getting vaccinated, other
employees “might feel pressure to participate. That would violate the
voluntary principle” that is a bedrock 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 is enough laboratory
and animal evidence to justify the attempt.
SinoPharm,
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, the company says it conducted its “pre-test” at the end of
March “to make the vaccines hit the market as early as possible.”
It
would not be the only shortcut 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, skipping the final
testing needed to prove if it really works. CanSino now says it’s in
talks with four other countries about doing that research.
Some
participants in the first CanSino clinical trial in March said in
social media posts that researchers on the project claimed they had been
injected Feb. 29, before regulators gave the study the go-ahead. A
researcher said team leader Chen Wei, a renowned military virologist,
was the first to receive the experimental vaccine, one of the
participants told state-owned Beijing News.
CanSino
and Chen’s Academy of Military Medical Sciences turned down requests
for information and interviews. The National Medical Products
Administration, which approves vaccine trials, also declined to comment.
In
May, a Russian scientist told the RIA Novosti news agency that he and
fellow researchers also had vaccinated themselves ahead of approved
studies. “It’s self-defense in order for us to continue working” on a
vaccine, said Alexander Gintsburg of the Moscow-based Gamaleya research
institute.
“Everyone is alive and well and cheerful,” he added.
Russia’s
Association of Clinical Research Organizations condemned the action as a
“crude violation of the very 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, Marie Curie’s husband, deliberately burned his arm
with radium as part of their radiation experiments. In the 1950s, Jonas
Salk tested his ultimately successful polio vaccine on himself and his
family. In the 1980s, Australia’s Dr. Barry Marshall drank a
bacteria-laden broth as part of his quest to prove germs, not stress,
cause stomach ulcers. He was right.
And
in China in the 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 Nobel Prize.
With
a COVID-19 vaccine, national pride is at stake. President Xi Jinping
pledged that any Chinese-made vaccine would be a “global public good.”
All
this is taking place as China strives to overcome years of drug
scandals — the latest coming in 2018 when authorities recalled a rabies
vaccine and later announced batches of children’s DPT vaccines, for
diphtheria, pertussis and tetanus, were ineffective.
Giving
the experimental shot early to SinoPharm’s employees “sends a signal to
the Chinese people, ‘You guys should not worry about the safety of the
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, not evidence.
More than 600,000 U.S. schoolchildren had to be given Salk’s vaccine or a
dummy shot to prove polio protection. It took almost another decade to
validate Marshall’s ulcer germ theory, which earned him a Nobel as well.
Modern
international ethics rules require participants in medical research to
be fully informed and to freely consent. In the U.S., studies involving
people must receive approval from an “investigational review board,” and
most U.S. research institutions explicitly state there is no exception
to board approval for self-experimenting.
“Employees
may not be the best volunteers because employees are in a relationship
which is not equal,” said Dr. Derrick Au, bioethics director at the
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 the 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 they are successful as being the first with a
workable product on the market, it had better be so pristine, so pure
that people who are outside of China would be willing to buy into it.”
___
Neergaard
reported from Alexandria, Va. AP video producer Olivia Zhang in
Beijing, science writer Victoria Milko in Jakarta, Indonesia, and
correspondent Daria Litvinova in Moscow contributed to this report.
