Chinese health regulators on Thursday said they gave conditional approval to a coronavirus vaccine developed by state-owned Sinopharm.
The two-dose vaccine is the first to be approved for general use in China. The green light comes as the country has begun to vaccinate 50 million people ahead of the Lunar New Year holidays in February.
Conditional approval means the investigation is still ongoing, the company will have to submit both follow-up data and reports of any side effects after the vaccine has been sold in the market, Chen Shifei, the deputy commissioner of the National Medical Products Administration, told a news conference.
The company “must continuously update the vaccine’s instructions and labels and report it to the agency,” Shifei said.
The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of the state-owned Sinopharm. The company announced on Wednesday that preliminary data from final-stage trials had shown it to be 79.3% effective.
It is an inactive vaccine, which means that the virus was grown in a laboratory and then killed. The germ is then injected into the body to trigger an immune response.
Final proof of its effectiveness depends on the publication of more data.
Sinopharm is one of at least five Chinese developers in a global race to create vaccines for the disease that killed more than 1.8 million people.
In addition to emergency vaccinations already underway, China plans to start vaccinating high-risk populations, such as seniors and those with existing chronic diseases. Officials have not said what percentage of the population they will vaccinate in China.
“This is different in every country, but the general idea is that it must reach 60% to protect the entire population,” said Zeng Yixin, deputy minister of the National Health Commission.
With emergency use, 4.5 million doses have already been given, including 3 million in the past two weeks, Zeng said.
Practically speaking, the conditional approval means that the drug or product in question may be limited to certain age groups, said Tao Lina, a former government immunologist.
Officials declined to name a particular price and made contradictory statements about it. “It will certainly be within the limit of what people can afford,” said Zheng Zhongwei, another National Health Commission official.
A minute later, Zeng, the NHC official, stepped in and said the vaccines “will certainly be free to the public.”
The vaccine is already being mass-produced, although officials have not answered questions about its current production capacity.
Approval of the Chinese vaccine could also hold hope for countries around the world that may not have access to the Pfizer or Moderna shots, which have stricter cold chain requirements. Sinopharm’s vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), or normal refrigeration temperature.
Sinopharm’s vaccine has already been approved in the United Arab Emirates and Bahrain and is scheduled for use in Morroco.
Other countries also bought doses of another Chinese vaccine candidate made by Sinovac Biotech. Turkey received the shipments of 3 million doses this week. Indonesia and Brazil have all bought Sinovac’s vaccines.
China is eager to spread its vaccines worldwide, driven by a desire to repair the image damaged by the pandemic that started a year ago in the central city of Wuhan.
President Xi Jinping has vowed to donate the vaccine to the world as a public good, and China has joined COVAX, a global plan for equal distribution and access.
“We eagerly await Chinese vaccines to be included in COVAX’s vaccine bank soon and prequalification from WHO soon,” said Shen Bo, a State Department official.
The vaccine standards were developed in “close collaboration” with WHO, officials said.
Meeting WHO qualification could provide some assurance to the rest of the world of the quality and efficacy of Chinese vaccines, which already have a reputation problem at home. It would also open the way for Chinese vaccines to be distributed in COVAX and possibly in countries that do not have their own regulatory bodies.
“It is very exciting that there is yet another vaccine and one that can be distributed in locations where the cold chain does not exist,” said Ashley St. John, an immunologist at Duke-NUS Medical School in Singapore. “But at the same time, we need to temper the excitement. We need to understand long-term efficacy, effect on transmission and effect on serious disease. “