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Dr. Yin Weidong, chief executive of the Chinese vaccine maker Sinovac Biotech, told Reuters on Sunday that 90% of Sinovac’s employees—as many as 3,000 workers—and their families have been injected with the company’s leading COVID-19 vaccine candidate even though it hasn’t completed late-stage trials.
Sinovac and other Chinese firms are currently in the pole position in the global race for a vaccine, contributing to five of the nine vaccine efforts that have reached late-stage phase three trials. Sinovac’s announcement demonstrates how Chinese firms are pushing the envelope in developing a potential vaccine, engaging in unorthodox and potentially troubling methods to reach the finish line first.
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Yin showcased his company’s vaccine candidate to the public for the first time at a trade show in Beijing on Sunday. He said that he and Sinovac employees had been injected with the vaccine as a safety protocol to ensure that a potential COVID-19 outbreak wouldn’t impede Sinovac’s research and manufacturing processes.
“As a vaccine developer and manufacturer, a new outbreak could directly impact our vaccine production,” Yin said at the trade show.
Yin said the distribution of the vaccine to Sinovac workers and their families occurred under China’s emergency use vaccine program, a government policy that allows specific populations of people to receive unproven inoculations.
At least two other Chinese vaccine makers have distributed their vaccines under the emergency program.
In late June, the Chinese vaccine maker Cansino announced that its vaccine candidate had been approved for use in the Chinese military. Chinese state media reported in late July that a vaccine developed by Sinopharm, a state-owned vaccine maker, was being distributed to frontline medical workers.
China’s government, however, didn’t confirm the existence of the emergency program until Aug. 25 when Zheng Zhongwei, head of China’s coronavirus vaccine task force, said that the government had started approving unnamed vaccine candidates for emergency use in late July. The emergency program is intended to vaccinate high-risk groups like medical workers, pandemic response officials, and border inspection agents, Zheng said. He said that China was considering expanding it to cover workers at produce markets, transport industry officials, and service workers.
Sinovac’s candidate, named CoronaVac, has already begun large-scale, phase three human trials in Brazil and Indonesia. Yin told Reuters on Sunday that the company had received approval to begin trials in Turkey and Bangladesh too.
The company says it will eventually be able to produce 300 million CoronaVac doses annually; each patient requires two doses of the vaccine. It recently signed an agreement with Indonesia to supply the country with 40 million doses by March 2021.
Observers have questioned the ethics of China deploying vaccine candidates before the conclusion of phase three trials, which include tens of thousands of human volunteers and are intended to test for efficacy and turn up any rare side effects.
“If you are a regulatory body, if you play by the rules, if you are hard-nosed about it, you say this is very wrong,” Ray Yip, the former head of the Gates Foundation in China, told the New York Times following reports that China had distributed vaccines to employees of state-owned companies.
China’s emergency use vaccine program is taking place as the U.S. debates whether to introduce a similar policy.
Last week, the U.S. Centers for Disease Control told states that they should prepare for the distribution of a potential vaccine by Nov. 1, a timeline that raised the prospect of a vaccine getting early, emergency clearance from the government.
Some U.S. officials have cautioned that no vaccine should be given even to select groups until it completes clinical trials and is proven safe and effective.
“The one thing that you would not want to see with a vaccine is getting an EUA [emergency use authorization[ before you have a signal of efficacy,” Anthony Fauci, director of the U.S. National Institute of Allergy and infectious diseases told Reuters on Aug. 25. Beyond not being safe, he said that rolling out a vaccine under emergency guidelines would undermine the U.S.’s other efforts to produce a vaccine. “If you prematurely let a vaccine out… it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci said.
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