[ad_1]
(CNN) – The global push to develop a coronavirus vaccine is accelerating, but much to the frustration of US President Donald Trump, the caution exercised by US drug makers and regulators has put China at the forefront … by now.
Moderna, a leading manufacturer of coronavirus vaccines, said this month that it will not be ready to apply for emergency use authorization until at least November 25. Meanwhile, the US-based test sites of another pioneer, AstraZeneca, have suspended testing after a participant in Britain developed a serious illness last month, further undermining Trump’s hopes of that a vaccine would be ready in time for Election Day on November 3.
Stringent US security protocols have turned the so-called vaccine race in China’s favor, where, for better or worse, political will has a far greater influence over state, commercial and individual actions, potentially doubling rules or regulations as needed.
China’s leader Xi Jinping has repeatedly urged the country’s scientists to speed up research and development of coronavirus vaccines. Chinese drugmakers have also been told to treat their work as an “important political task,” and they are doing their best to follow that directive.
And while the successful development of a vaccine will not prevent other countries from continuing their own research, China has placed special emphasis on being the first.
In October, four of the 10 Covid-19 candidate vaccines that have entered phase 3 clinical trials around the world – the last and most important testing step before regulatory approval is sought – were developed by Chinese companies.
Two are from China National Biotec Group (CNBG), a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm). Another candidate, CoronaVac, was developed by pharmaceutical company Sinovac Biotech, and the rest were jointly developed by the Beijing Institute of Biotechnology, linked to the Chinese military, and the vaccine company CanSino Biologics.
CNBG president Yang Xiaoming said last month that the progress of his vaccines was “faster than expected.” The company has carried out phase 3 trials in countries such as the United Arab Emirates, Bahrain, Peru, Morocco and Argentina, with a total of 42,000 participants.
“We are only a mile away from eventual success,” he recently told a bio-industry conference in the Chinese city of Wuhan, where the coronavirus was first detected last December.
Wu Guizhen, the chief biosafety expert at the China Center for Disease Prevention and Control, told state broadcaster CCTV last month that the country’s coronavirus vaccines could be ready for general public use as early as November.
“I think they are very likely to be the first to announce the successful development of a vaccine,” said Yanzhong Huang, senior global health researcher at the Washington-based Council on Foreign Relations.
“But the key question is how well international society, especially the scientific community, will recognize it.”
“Spirit of sacrifice”
A vaccine usually takes years to develop. But to stop a virus that has killed more than a million people around the world, scientists are developing Covid-19 vaccines at unprecedented speed. In China, efforts to speed up that process have included controversial testing of hundreds of thousands of people outside the normal regulatory approval process.
Since July, Chinese drugmakers have been administering experimental vaccines to people working in “high-risk” professions, including medical workers and border agents, under a government-approved emergency use program, which allows candidate vaccines to be used on a limited basis. scale before its safety and efficacy have been fully proven by clinical trials.
Vaccine candidates approved for emergency use are still in phase 3 trials. Some experts worry that speeding up the normal approval process could expose participants to unknown side effects, and Chinese drug manufacturers are taking risks that contravene international ethics and safety standards.
“Despite official claims that vaccines are safe and effective, it may not be a wise decision to inoculate so many people on such a large scale before systematic data from phase 3 clinical trials are available,” he said Huang, the world health expert.
However, Chinese pharmaceutical companies were already taking controversial and risky measures months before the launch of the emergency use program.
CNBG chairman Yang said at a conference in Wuhan last month that more than 100 people had received the company’s early-stage coronavirus candidate vaccine before it was approved for human trials on April 12, including himself. same.
“I’m not wearing (a mask today), because I went to inject this vaccine on March 22,” Yang said. “We are called the pioneers. Before the approval of the clinical (trials), we had four people in the first batch, 38 people in the second batch and with the third batch a total of 138 people participating to test its safety and efficacy. “
In late May, Sinopharm said in an online statement that its employees, including top executives, received experimental injections as a “pretest” before clinical trials.
“It’s like the legendary Shennong trying hundreds of herbs himself,” the statement said, referring to the mythological father of TCM who eventually died after ingesting a toxic plant.
“For more than a hundred years, it has been a tradition for CNBG employees to test drugs on themselves. Also, it is a spirit of sacrifice that is passed down from generation to generation.”
Huang said that the sacrifice of individual welfare for the interest of the collective, or the state, has been encouraged by the government for a long time and dates back to Chinese history.
Emergency use
The sense of self-sacrifice may also partially explain the large number of people willing to take the risk and get vaccinated under the emergency use program.
Yang, president of CNBG, said that some 350,000 people had taken experimental photos of his company.
CNBG’s two candidate coronavirus vaccines were approved for emergency use and offered to medical professionals, diplomats deployed to high-risk countries and employees of state-owned companies working overseas under China’s Belt and Road Initiative, according to a statement posted on the Sinopharm website this month.
The candidate vaccine developed by Sinovac is also included in the emergency use program, according to Reuters.
The company has injected 90% of its employees and relatives, between 2,000 and 3,000 people, with its experimental vaccine.
Separately, the Chinese government also approved the use of the CanSino Biologics coronavirus vaccine for the country’s military in June.
Chinese health officials say the emergency use program has its legal basis in the country’s vaccine law and participation is completely voluntary.
But since many participants are civil servants or civil servants and state-owned company workers, some may have felt politically pressured to sign up, Huang said, especially when their bosses and colleagues have done so.
“I always feel like I’m not sure to what extent they should be considered ‘volunteers’ as defined by the West,” he said of the participants.
National pride
There is also the question of the need for emergency testing in China, given that the country has not reported any cases of locally transmitted symptomatic coronavirus for more than a month.
For some observers, there could be other factors underlying China’s push for the vaccine race.
“The government’s efforts to aggressively develop and promote vaccines are increasingly driven by political and foreign policy considerations,” Huang said.
In addition to scientific prestige and national pride, a safe and effective Covid-19 vaccine could also have geopolitical implications.
The Chinese government has faced strong criticism, particularly from the United States, for its initial handling of the coronavirus outbreak. His subsequent “masked diplomacy,” an effort to send medical supplies to countries struggling with Covid-19, also fueled suspicion that he was trying to change the coronavirus narrative.
Being the first to provide a vaccine to the world would provide China with an opportunity to shore up its global position by positioning itself as a leader in the fight against the pandemic, filling the void left by the United States and consolidating its position as a true superpower.
It would also offer a degree of diplomatic influence. China has promised a growing list of countries, mostly developing countries that have helped Chinese companies conduct phase 3 trials, including Beijing’s strategic allies, priority access to a Chinese vaccine if it is shown to be safe. and effective.
But China’s vaccine industry has a troubled safety record. Over the past decade, China has been hit by a series of vaccine scandals.
In 2018, Changsheng Biotechnology Co. was fined for manufacturing vaccine production and inspection data. In 2017, the same company was found to have produced ineffective diphtheria, pertussis, and tetanus (DPT) vaccines for children. The Wuhan Institute for Biologicals, a CNBG subsidiary behind one of the vaccines in Phase 3 trials, was also found to manufacture faulty DPT vaccines.
“Recipe for Disasters”
In the US, as much as Trump wants to speed up the development process, any move that undermines the safety and efficacy of a future vaccine is likely to face strong pushback from drug experts, regulators and manufacturers. .
Amid growing concerns that a vaccine could be rushed by political pressure to obtain an emergency use authorization (USA) before Election Day without proper safety controls, the US Food and Drug Administration. It published a new guide this week, saying it would like to see two months of safety data. after volunteers receive their second dose of vaccine before companies can apply for the EUA, something that would make it impossible to get a EUA before November 3.
In the first presidential debate, Trump said that he had spoken to the major vaccine manufacturers, including Moderna, and they had told him that a vaccine might soon be available.
Moderna chief executive Stéphane Bancel told a conference organized by the Financial Times last week that he has received no political pressure, in either direction.
“No one, since we started this race against the virus in early January, from any party, from any branch of government, from any country, has asked us to go faster or slower,” he said.
This story was first published on CNN.com, “China is doubling the global push for a coronavirus vaccine.”
[ad_2]
