The offer to employees of the state oil giant was compelling: to be among the first in China to be vaccinated against the coronavirus.
PetroChina employees could use one of two vaccines “for emergency use” to protect themselves when working abroad as part of China’s ambitious infrastructure program, according to a copy of the notice, which was reviewed by The New York Times. They would effectively be guinea pigs to test unproven vaccines outside of official clinical trials.
The offer was backed by the government. He noted that data from clinical trials showed that the products, both manufactured by Sinopharm, were safe. He did not mention possible side effects, nor did he warn against the false sense of security of taking a vaccine that regulators had not approved.
“I don’t think this is ethically correct,” said Joan Shen, the Shanghai-based executive director of the pharmaceutical firm I-Mab Biopharma.
The unorthodox movement, to assess people separately from the normal regulatory approval process, reflects the formidable challenge China faces in its race to develop the world’s first coronavirus vaccine.
Eager to find a long-term solution to the outbreak and to polish their scientific credentials, Chinese companies are rushing to obtain as much data as possible about their vaccines to demonstrate that they are safe and effective. In China, they are selectively testing their vaccines on small groups of people, such as PetroChina employees, an approach that doesn’t count for the regulatory process, but could reinforce their own confidence in the vaccines. In Brazil and other countries, they are conducting clinical trials, following normal regulatory channels.
The dual strategy, however, is at risk of scientific setbacks and political backlash, which could undermine China’s efforts.
Such “emergency use” is rare, and the taking of unapproved vaccines is generally reserved for healthcare professionals. Although the government has emphasized that taking the vaccine is voluntary, state-owned workers and soldiers may feel pressure to participate.
As Chinese companies also look beyond their borders to test the vaccine, they are met with mistrust and skepticism. Health experts have wondered why the Canadian government is allowing CanSino Biologics, which has partnered with the People’s Liberation Army, to conduct human trials in the country. Rumors have spread about the authenticity of a Chinese-made vaccine being tested in Brazil, as supporters of President Jair Bolsonaro cast doubt.
Strategy is born out of necessity.
Chinese companies cannot find enough candidates at home to conclusively determine whether their vaccines would prevent infection, a problem facing research institutes and pharmaceutical manufacturers in countries that have largely dominated the coronavirus. Phase 3 trials, the final stage before approval, require vaccines to be tested on approximately tens of thousands of volunteers in locations with large, active outbreaks.
Along with testing at the oil company, Sinopharm, which has completed Phase 2 trials for two products, has injected the vaccine into its president and other top officials, according to the state-owned Asset Management and Oversight Commission, or SASAC , the government agency that administers all employees of state-backed companies. The Chinese government has allowed the CanSino military vaccine to be administered to its armed forces, the first for any country’s military.
Yang Zhanqiu, a virologist at Wuhan University, was skeptical about the decision to give vaccines to state employees for business trips.
“It doesn’t make much sense because the time it takes for employees to travel is not the same, the locations may be different, and it is not easy to do follow-up and monitoring,” said Dr. Yang. “It can be a psychological comfort to employees.”
An overseas-based PetroChina employee confirmed that his colleagues in China had been invited to take the vaccines. PetroChina, SASAC and Sinopharm did not respond to requests for comment.
Such tests do not help companies remove regulatory hurdles, as they are not part of official clinical trials. Mainly, Chinese companies could use it to make sure vaccines are safe, assuming they don’t discover any problems.
“If you are a regulatory body, if you follow the rules, if you are adamant, you say this is very wrong,” said Ray Yip, the former head of the Gates Foundation in China.
Dr. Yip added that it would be helpful for company executives to know that they had administered the dose to “a couple of thousand people, but that no one fell dead, so that’s pretty good.”
Dr. Yip said people who take the vaccines should read the safety data reports and make an informed decision. He said he would be willing to take it.
“If you offer me that by saying it’s safe and there is an 85 percent chance it will work, would I take it today?” he said. “You know what, I probably will. Because then I don’t have to worry. “
In a post on their official WeChat account, a government agency reported that “pre-vaccine testing” on Sinopharm employees showed that the antibody levels were high enough in the subjects to fight the coronavirus, indicating that it was safe and effective. The agency did not make clear what vaccine the employees had taken. The newspaper, a Shanghai government-owned newspaper, separately said 180 employees had taken the vaccine.
Last month, the Beijing Biological Products Institute, which is developing one of Sinopharm’s vaccines, published its preclinical data in an peer-reviewed journal, Cell, saying the vaccine induced high levels of antibodies in macaques and protected against Sars. -CoV-2, The virus that causes Covid-19.
The Sinopharm-owned Wuhan Institute said its vaccine had not caused adverse reactions among the volunteers, according to Xinhua, China’s official news agency. Volunteers achieved complete antibodies after two doses on a 28-day program.
Although the first results in these small groups are promising, Chinese companies must reach agreements in other countries to finally approve a regulatory meeting in China and the rest of the world.
In June, Sinopharm began the third phase of clinical trials in Beijing, Wuhan, and Abu Dhabi, becoming the first company to enter the final regulatory stage. Sinovac Biotech of China is partnering with the Butantan Institute in Brazil, which has the second highest number of cases in the world after the United States.
The process has been politically charged in Brazil, where Bolsonaro has minimized the threat, even when he later hired Covid-19. His son blamed China for the pandemic.
Soon after the deal with the vaccine, a fake meme began to spread that the vaccine had only been tested on monkeys and never on humans. “If this vaccine is so promising, why not try it in China, where this damn virus appeared, instead of testing it on the citizens of São Paulo?” She said.
Dimas Tadeu Covas, the director of Butantan, He said he was impressed with the preliminary Sinovac results and that the vaccine “has the greatest potential for success.” He cited the results of the Sinovac phase 1 trials that showed no adverse effects and the phase 2 trials that showed 90 percent protection against Sars-Cov2.
“I know about vaccines and I’m betting a lot on it,” said Dr. Covas.
Despite the political backlash, around 600,000 people registered for the trials just 24 hours after the recruitment process began this week.
João Doria, the governor of São Paulo, the state where the tests are conducted, said his priority was “to find tools that can help save lives.” “In the midst of a pandemic, you cannot prioritize ideology or political factors over life,” he said in an interview.
Ralcyon Teixeira, an infectious disease specialist and director of the medical division of the Emílio Ribas hospital in São Paulo, said he was concerned that the “politicization” of the Sinovac vaccine could hinder the introduction of what he believed could be an effective treatment.
“It has been four months of Covid,” he said. “We are tired of seeing so many deaths, so many bad and tragic situations, so I think we are looking for hope that this vaccine will work.”
Amber Wang and Liu Yi contributed to the investigation.
