China has taken a shortcut in the global sprint to develop and distribute vaccines for novel coronaviruses. Sinpharma, a state-owned company that developed two of China’s leading vaccine candidates, told China National Radio on Monday that it had already vaccinated hundreds of thousands of Chinese citizens – even though the company’s Phase 3 clinical trials have yet to be completed Has not happened.
Individuals received one of two Sinopharma vaccines in development in an emergency use program launched in late July by the Chinese government, which also authorizes Coronavac, a third vaccine developed by privately owned pharmaceutical manufacturer Sinovac Biotech. Under Chinese vaccine law, such authorization is allowed during a health emergency within a certain scope and time frame. China’s top vaccine officer mentioned front-line medical personnel and customs officials when they first announced the program, with these high-risk groups still preferred to receive experimental vaccines.
Phase 3 clinical trials, which look at the effectiveness of a vaccine candidate to prevent the spread of a vaccine candidate from spreading to a community, three Chinese vaccines had just begun overseas when they were approved for emergency use. In July, Sinopharm launched Phase 3 trials for two of its vaccine candidates in the United Arab Emirates; According to the Vaccine Tracker for the New York Times, testing of one of the vaccines also began in Morocco and Peru in August. Synovac launched Phase 3 trials of Coronavac in Brazil in July, followed by Indonesia the following month. (Trials are being conducted outside of China as the safety of vaccines can be better assessed in areas where the Kovid-19 transmission is high.)
China and Russia are the only countries to have provisionally greener vaccines yet to be considered safe and effective through phase 3 trials.
In the US, the Centers for Disease Control and Prevention has asked states to prepare to distribute vaccines to high-risk groups by late October or early November, raising concerns that vaccine approval may occur before the 2020 election The process can be politicized. However, nine major vaccine developers pledged not to submit their vaccines for approval until data from Phase 3 trials showed they met the predetermined safety and efficacy limits. No Chinese companies signed the pledge.
So far, China has not reported any serious issues with its emergency vaccine program. But vaccine experts told Vox that abandoning or shortening Phase 3 testing is risky and could subject citizens to ineffective or unsafe vaccines. The risks are even greater in China, where there is a history of scandals among vaccine producers and the media is largely unable to play the role of a watchdog due to state control.
Although transmission in China has reportedly been very low since February, controlling local hot spots is still a priority for the government, said Yanzhong Huang, professor of global health at Seton Hall and author of the report Poisonous politicsAn examination of China’s environmental health crisis. “They have this strong incentive to develop vaccines to show Chinese high-tech potential, and also [to] Give people a sense of national pride, ”Huang said.
Here we know how China’s emergency vaccine program has been going so far.
China’s Stealth Emergency Use Vaccine Program, Explained
Among the multitude of pharmaceutical companies jumping into the vaccine effort, Chinese companies got off to a fast and aggressive start. As of September 11, nine of the 211 vaccines worldwide are in Phase 3 trials, and four of the nine are from Chinese companies.
These tests allow scientists to determine the efficacy of vaccines and identify side effects that have not been revealed in Phase 1 or Phase 2 trials.
But instead of waiting for the results of the test, the Chinese government began allowing some workers to vaccinate on a different track.
The emergency program was only made public in late August during a carefully orchestrated segment on China’s vaccine development that aired on the country’s state television station CCTV. The program was approved by the State Council on 24 June and was officially launched on 22 July, China’s vaccine program leader Zheng Zhongwei explained on air.
Zheng said the program applies only to certain groups, pointing to medical personnel, customs officials, food market workers, transportation workers and some service industry personnel treating Kovid-19 and other diseases. The emergency use program is regulated through nine plans covering medical consent, monitoring side effects, and compensation, Zheng said.
The extent of the program was low until early September, when new information showed that participation was not as limited as the government had initially suggested. Sinopharm revealed that hundreds of thousands of people have received their vaccines as part of the program. The CEO of Synovac, another vaccine-making company, said that 90 percent of the company’s employees and their family members – up to 3,000 people – have volunteered to take the vaccine, Reuters reported. To justify the emergency use of the vaccine, the CEO pointed out that it would help ensure that company employees could continue to produce vaccines.
Who, exactly, the protocol for receiving the vaccine under the emergency program remains unclear. “It’s still shrouded in a lot of mystery,” Huang said.
Outside of this official emergency program, in late June the Chinese military authorized the use of a vaccine candidate created by CanSino Biologics for military personnel. Separately, workers from state-owned companies traveling abroad were also allowed to take one of the two cyanopharm vaccines in June.
Risk of bypassing Phase 3 tests
After China’s initial outbreak peaked in February, the government rapidly brought it under control, reporting zero local cases by mid-March. Since then, new hot spots have emerged in areas such as Beijing and Xinjiang. In Xinjiang, where more than one million Uigars and other ethnic minorities have been detained in the past three years, the Chinese government has imposed a strict lockdown to curb proliferation, and some residents have been forced to drink Chinese traditional medicine Is reported.
Outside these hot spots, transmission in China is very limited since March.
“Ironically, in China, infection rates are actually very low at the moment,” said John Moore, an immunologist at Weil Cornell Medical College. “They are actually in a position where they can wait for the results of ongoing Phase 3 trials, without compromising their populations, properly understanding safety and efficacy.”
With occasional clusters of domestic transmission and imported cases, China still has an incentive to roll out a vaccine. However, having the vaccine prematurely poses serious dangers. Phase 3 trials require a large group of people, in part so that the rare side effects discovered in earlier trials cannot be identified. Vaccinating hundreds of thousands of people before the conclusion of Phase 3 trials means that those people may suffer harm from any of these possible side effects. The World Health Organization recently emphasized that Phase 3 trials are necessary to evaluate the safety and efficacy of Kovid-19 vaccine candidates.
“There is a need to carefully conduct sufficient-sized clinical trials with sufficient time for follow-up, look at both efficacy and safety, and begin to vaccinate people outside of carefully designed clinical trials. Those figures should be reviewed very carefully first., “Said Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins.
So far, Sinopharma reports that no one who received their vaccines through the emergency program has experienced obvious adverse effects, and no one has been infected with Kovid-19. Interim results from the company’s Phase 1 and 2 trials developed by the vaccine, a subsidiary of the Wuhan Institute of Biological Products, showed lower rates of adverse effects. Cyanopharma is yet to publish results from Phase 1 and 2 trials of its other vaccines developed by the Beijing Institute of Biological Products.
Synovac has not published a peer-reviewed study of its Phase 1 and 2 data, but it reveals no serious side effects in those trials, and the company’s CEO told Reuters that the rate of adverse reactions is far too low for all. Vaccinated people.
When China first began allowing workers traveling abroad to vaccinate, some Chinese academics and a pharmaceutical executive expressed concern about the practicality and ethics of the decision, as reported by the New York Times. But Huang said he has not seen explicit criticism of the emergency use program from Chinese scientists.
Will the Chinese vaccine makers be held accountable if safety issues arise with the Kovid-19 vaccine?
The recent history of Sinopharma and Synovac questions their ability to produce safe vaccines. In 2018, Wuhan Institute of Biological Products – a subsidiary of the Sinopharma Group developing one of its vaccines – found that 400,000 defective diphtheria, whooping cough, and tetanus vaccines were sold in two Chinese provinces.
The company was fined and nine employees were punished. Production in their factories resumed later that year after inspection, and China’s National Food and Drug Control Institute resolved to double its oversight of the vaccine industry.
Synovac also has a checkered past. The New York Times reported that the company was accused of bribing a Chinese official from 2002 to 2014 for drug approvals.
Huang said that this history is “not good for the quality of Kovid vaccines,” especially “in a hurry to develop a vaccine without following specific protocols.”
China’s chokeholds on the media can prevent accountability for any issues with the emergency use program. Huang pointed to the government’s strict media censorship, which could block reports about vaccine side effects or poor reactions.
China’s vaccine program is moving forward on two different tracks
More Chinese people will likely be eligible for the Emergency Use Program in the coming months, according to Zheng Zhongwei’s CCTV interview. “To prevent disease spreading in the fall and winter, we are considering a moderate expansion in the program,” Zheng said. “The objective would be to first build an immune barrier between particular groups in the population.”
Airline industry workers in China have already been informed that they will soon be vaccinated on a voluntary basis, Reuters reported last week.
China’s vaccine development has been a source of national pride on social media, Seton Hall’s Huang said, and deals with Chinese vaccine shipments are already being offered to China’s allies. But if there is ” [are] Suggesting that the vaccine is not effective, or could cause serious or adverse reactions, “Huang said,” it tarnishes the reputation of Chinese vaccines. “
Lily Pike is a Master of Science, Health, and Master Reporting (SHERP) student at NYU and a freelance journalist with a focus on China.
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