In Coronavirus Vaccine Race, China Strays From the Official Paths

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In Coronavirus Vaccine Race, China Strays From the Official Paths

The offer to the employees of the state oil giant was convincing: be one of the first in China to take a coronavirus vaccine.

PetroChina employees could use one of two "emergency" vaccines to protect themselves when working abroad as part of China's ambitious infrastructure program. This is clear from a copy of the notice that has been reviewed by the New York Times. They would be effective guinea pigs to test the undetected vaccines outside of official clinical trials.

The offer was supported by the government. It was emphasized that data from clinical trials showed that the products manufactured by Sinopharm were safe. Neither the possible side effects were mentioned, nor was warned of the wrong feeling of safety when taking a vaccine that the regulatory authorities had not approved.

"I don't think that's ethical," said Joan Shen, Shanghai-based managing director of pharmaceutical company I-Mab Biopharma.

The unorthodox move to test people separately from the normal approval process reflects the tremendous challenge China faces when it comes to developing the world's first coronavirus vaccine.

Chinese companies are striving to find a long-term solution to the outbreak and improve their scientific skills. They strive to get as much data as possible about their vaccines to prove that they are safe and effective. In China, they selectively test their vaccines on small groups of people like PetroChina employees – an approach that does not apply to the regulatory process, but could increase their own confidence in the vaccines. In Brazil and other countries, they conduct clinical studies that go through the normal regulatory channels.

However, the dual strategy risks scientific setbacks and political backlash, and may undermine China's efforts.

Such “emergency use” is rare, and healthcare professionals are generally restricted to taking unauthorized vaccines. Although the government has emphasized that taking the vaccine is voluntary, government workers and soldiers may feel pressure to participate.

As Chinese companies look beyond their borders to test the vaccine, they encounter mistrust and skepticism. Health experts have questioned why the Canadian government, CanSino Biologics, which has partnered with the People's Liberation Army, has allowed people to be tested in the country. Rumors of the authenticity of a Chinese-made vaccine being tested in Brazil have spread when President Jair Bolsonaro's supporters raised doubts.

The strategy arises out of necessity.

Chinese companies cannot find enough candidates at home to definitively determine whether their vaccines would prevent infections, a problem that research institutes and pharmaceutical manufacturers face in countries that have largely tamed the coronavirus. In phase 3 studies, the final phase before approval, vaccines must 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, injected the vaccine into its chairman and other senior officials, according to the state asset monitoring and management commission [SASAC] agency, all of which Managed employees in government-sponsored companies. The Chinese government has allowed the CanSino military vaccine to be released to its armed forces, a first for a country's military.

Yang Zhanqiu, a virologist at Wuhan University, was skeptical about the decision to give government employees vaccines for business trips.

"It doesn't make a lot of sense at all because the time it takes employees to travel is not the same, locations can be different, and tracking and monitoring them is not easy," said Dr. Yang. "It can only be psychological comfort for the employees."

An overseas 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 comments.

Such tests do not help companies overcome regulatory hurdles as they are not part of the official clinical trials. Chinese companies, in particular, could use this to ensure that the vaccines are safe, provided they do not discover any problems.

"If you're a regulator, if you stick to the rules, if you're tough, you say this is very wrong," said Ray Yip, former head of the Gates Foundation in China.

Dr. Yip added that it would be useful for company executives to know that they gave the dose "to a few thousand people, but nobody fell dead, so that's pretty good."

Dr. Yip said the people taking the vaccines should read the safety data reports and make an informed decision. He said he was ready to take it.

"If you offer that to me and say it is safe and there is an 85 percent chance it will work, would I accept it today?" he said. "You know what, I'll probably do it. Because then I don't have to worry. "

In a post on her official WeChat account, a government agency reported that the "vaccine pre-test" at Sinopharm employees showed that the antibody levels in subjects were high enough to fight the coronavirus, indicating that it was safe and effective is. The agency did not make it clear which vaccine the employees had taken. The newspaper, a Shanghai government newspaper, said separately that 180 employees had taken the vaccine.

Last month, the Beijing Institute of Biological Products, which develops one of Sinopharm's vaccines, published its preclinical data in Cell magazine. The vaccine induced high antibody levels in macaques and was protected against Sars-CoV-2. the virus that causes Covid-19.

The Wuhan Institute, which owns Sinopharm, said its vaccine had not caused adverse reactions from volunteers, according to Xinhua, China's official news agency. Volunteers achieved complete antibodies after two doses in a 28-day program.

While the initial results in these small groups are promising, Chinese companies have to do business in other countries in order to ultimately meet regulatory requirements in China and the rest of the world.

In June Sinopharm started the third phase of clinical trials in Beijing, Wuhan and Abu Dhabi and was the first company to enter the last regulatory phase. China's Sinovac Biotech works with the Instituto Butantan in Brazil, which has the second highest number of cases in the world after the United States.

The process was politically tense in Brazil, where Mr. Bolsonaro downplayed the threat, although he later contracted Covid-19. His son blamed China for the pandemic.

Shortly after the vaccination agreement, a false meme spread that the vaccine had only been tested on monkeys and never on humans. "If this vaccine is so promising, why not test in China where this damn virus appeared instead of testing it on the citizens of São Paulo?" it said.

Dimas Tadeu Covas, the director of Butantan, said he was impressed with Sinovac's preliminary results and that the vaccine "has the greatest potential for success". He cited results from Sinovac's Phase 1 studies that showed no adverse effects and Phase 2 studies that showed 90 percent protection against Sars-Cov2.

"I know vaccines and I bet a lot on them," said Dr. Covas.

Despite the political backlash, around 600,000 people signed up for the lawsuit just 24 hours after the start of the recruitment process this week.

João Doria, the governor of São Paulo, the state in which tests are being carried out, said his priority was "finding tools that can help save lives." "In the middle of a pandemic, ideology or political factors cannot be given priority over life," he said in an interview.

Ralcyon Teixeira, an infectious disease specialist and director of the medical department at Emílio Ribas Hospital in São Paulo, said he was concerned that the "politicization" of the Sinovac vaccine could hamper the introduction of what he believed to be effective treatment.

"It was only four months from Covid," he said. "We are tired of seeing so many deaths, so many dire and tragic situations. I think we are looking for hope that this vaccine will work."

Amber Wang and Liu Yi contributed to the research.

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