China gives unproven COVID-19 vaccines to thousands, with risks unknown
By Sui-Lee Wee
First, workers at state-owned companies got dosed. Then government officials and vaccine company staff. Up next: teachers, supermarket employees and people traveling to risky areas abroad.
The world still lacks a proven coronavirus vaccine, but that has not stopped Chinese officials from trying to inoculate tens of thousands, if not hundreds of thousands, of people outside the traditional testing process. Three vaccine candidates are being injected into workers whom the government considers essential, along with many others, including employees of the pharmaceutical firms themselves.
Officials are laying out plans to give shots to even more people, citing emergency use, amounting to a big wager that the vaccines will eventually prove to be safe and effective.
China’s rush has bewildered global experts. No other country has injected people with unproven vaccines outside the usual drug trial process to such a huge scale. The vaccine candidates are in Phase 3 trials, or the late stages of testing, which are mostly being conducted outside China. The people in those trials are closely tracked and monitored. It is not clear that China is taking those steps for everyone who is getting the shots within the country.
The unproven vaccines could have harmful side effects. Ineffective vaccines could lead to a false sense of security and encourage behavior that could lead to even more infections.
The wide use of vaccines also raises issues of consent, especially for employees of Chinese vaccine makers and state-owned companies who might feel pressure to roll up their sleeves. The companies have asked people taking the vaccines to sign a nondisclosure agreement preventing them from talking about it to the news media.
“My worry for the employees of the companies is it may be difficult for them to refuse,” said Dr. Kim Mulholland, a pediatrician at the Murdoch Children’s Research Institute in Melbourne, Australia, who has been involved in the oversight of many vaccine trials, including those for a COVID-19 vaccine.
While China is racing the United States and other countries to develop a vaccine, its rivals are moving more cautiously. American companies have pledged to thoroughly vet a vaccine before wide use, despite pressure from President Donald Trump to go faster. In Russia, the first country to approve a vaccine even before trials were completed, authorities have yet to administer it to a large population, according to health officials and experts.
It is not clear how many people in China have received coronavirus vaccines. Sinopharm, a Chinese state-owned company with a vaccine candidate in late-stage trials, has said hundreds of thousands of people have received its shots. Sinovac, a Beijing-based company, said more than 10,000 people in Beijing had been injected with its vaccine. Separately, it said nearly all its employees — around 3,000 in total — and their families had taken it.
On Friday, Zheng Zhongwei, an official with China’s National Health Commission, said the government had “gained the understanding and support” of the World Health Organization after China’s Cabinet approved the emergency use program. A spokesperson for the WHO said Saturday that China had issued a “domestic emergency use authorization,” which are issued at the discretion of countries and are not subject to WHO approval.
The vaccine candidates in Phase 3 trials have been previously tested on smaller groups of people. Phase 3 involves administering a candidate and a placebo to hundreds more, to see whether they are safe to take and effective in stopping the coronavirus. Roughly 100,000 people are involved in those trials, based on Chinese company disclosures. Virtually all of them are in other countries, however, because the coronavirus has been largely tamed in China.
Still, the Chinese government had already approved three vaccines for emergency use on others at home. In July, it said it would prioritize medical workers, epidemic prevention personnel, border inspection officials and people who “ensure basic city operations” to receive vaccines.
Now, it appears that those groups could be expanding.
This month, the government of Shaoyang, a city in Zhejiang province, asked local officials to identify more people who could qualify as “emergency users.” People in schools, kindergartens and nursing homes were recommended for inclusion, as well as travelers heading to “medium- to high-risk areas.”
Other government notices have asked local officials to identify people as candidates for getting vaccinations, though it was not always clear whether they would be inoculated before or after vaccines had cleared Phase 3 trials.
A senior Chinese official said this month that a vaccine could be made available to the public as early as November. That same day, a spokeswoman for the United Arab Emirates’ Foreign Ministry said on Twitter that the government had authorized the Sinopharm vaccine to be given to its frontline workers after successful Phase 3 trials in the Emirates.
Raina MacIntyre, who heads the biosecurity program at the Kirby Institute of the University of New South Wales in Sydney, said she would not recommend the emergency use of vaccines before the conclusion of Phase 3 trials. AstraZeneca, the British-Swedish company, halted late-stage testing in the United States on a vaccine candidate this month after one volunteer fell seriously ill for unknown reasons.