Vaccine production in China is challenging because the disease has subsided, making it impossible to conduct human trials in the infected area.
As the corona virus pandemic quickly swept continents, medical researchers around the world began an unprecedented race to find drugs and vaccines to fight the new disease.
The process usually takes years or even decades of laboratory research and testing has been shortened to just a few months to quickly control the virus strain that has infected more than 3 million people worldwide.
Nine potential vaccine types have been tested in humans and more than 70 are undergoing clinical trials, according to the South China Morning Post. China has quickly joined the global effort, with 5 of the 9 vaccines developed by Chinese companies.
On the pharmaceutical front, testing of the anti-virus remdesivir by Gilead Science in the US showed that the results on April 29 could get urgent permission from the Food and Drug Administration. FDA).
But in China, two drug trials started in February were struggling due to a shortage of patients amid the outbreak of the disease in the country.
Vaccine production in China faces a similar hurdle – the disease settles, it is almost impossible to conduct the third and final phase of human testing, according to industry insiders.
The third stage usually involved more than 1,000 volunteers – the group received the vaccine, and then compared this group with a group that received a placebo in a common infection area. This is the most important data to prove the vaccine is safe, effective and highly protective.
“It will be very difficult for all 32 vaccines (developed by Chinese vaccine manufacturers) and more than 100 types to be developed worldwide to complete every stage,” said Zhu Fengcai, deputy director of the Testing Center. Disease Control and Prevention Jiangsu Province, China, said at a seminar on vaccine preparation technology last week.
Zhu said his team is keen to bring vaccine testing to countries where the Covid-19 epidemic is still spreading to carry out the tests. This will quickly produce effective data under real-world conditions, he said.
Sinovac Biotech, which is also testing the Covid-19 vaccine, says controlling the pandemic in China poses a challenge to third-stage clinical trials, according to Theapers.cn.
Yang Xiaoming, chairman of China National Biotec Group, where two inactivated vaccines are being clinically tested at subsidiaries, said China was no longer suitable for the third phase of the testing process. He said other countries “where virus outbreaks are serious” have agreed to conduct experiments with this group.
But this approach also presents challenges.
“This requires countries with human resources who have experience in clinical trials, resources to respond to the Covid-19 epidemic and have the ability to monitor health, and are willing to cooperate with China,” he said. Zhu said.
Such tests also require approval from your local pharmaceutical and medical regulatory authority. In addition to these factors, the language barrier is also an issue, which Zhu’s team encountered when conducting clinical trials of the Ebola vaccine in Sierra Leone.
Richard Hatchett, executive director of the Alliance for Disease Prevention Initiative (CEPI), an organization that has funded nine separate corona virus vaccine projects in many countries, said China would need international cooperation. to help evaluate the potential vaccines.
“If China succeeds, these potential vaccines will need to be tested in other parts of the world where the virus is spreading,” he said.
“I think those companies are working with international partners like CEPI, like the Gavi vaccine alliance, like the World Health Organization (WHO) to see if their vaccines are rated as effective. not very important “.
The WHO has launched the Solidarity Trial program to gather resources and data to accelerate development of safe and effective vaccines, including human trials.
A vaccine specialist who declined to be named said companies and governments should proactively find suitable locations for testing, rather than relying on WHO in such missions.
In addition to technical barriers, there are legal risks.
Overseas clinical trials for non-Chinese people are often not accredited by the Chinese drug regulatory authority, which means that vaccines cannot be properly registered, according to South. China Morning Post.
“Without the coordination and recognition of regulatory agencies’ third-stage clinical data, it would be very difficult for companies to spend such large amounts of money and take such risks at the stage trial. paragraph three, “said the expert.
“There are many (global) competitors and they may have a place to test because there is still a epidemic. Without the third phase test, the highest level of Chinese vaccines can be achieved is Conditional approval. Any progress that the Chinese vaccine has made will disappear. “
Two Chinese companies are cooperating with foreign companies to develop vaccines: Clover Biopharmaceuticals in Chengdu in cooperation with Australia, and Fosun Pharmaceutical in Shanghai in cooperation with Germany.
Meanwhile, Zhu at the CDC Jiangsu is thinking of a new way to find volunteers for human trials in China, including enlisting people returning from abroad.
But even that approach will not work at the moment because China still applies a 14-day isolation policy for Chinese entry.
“We believe this can be done but it will not be possible if the government does not relax the policies,” Zhu said.