BEIJING (AP) – Chinese health regulators on Thursday said they had given conditional approval to a coronavirus vaccine developed by state-owned Sinopharm.
The two-dose vaccine is the first approval for general use in China. The prospect comes as the country begins vaccinating 50 million people ahead of the lunar New Year holiday in February.
Conditional approval means that research is still ongoing, and that the company must submit follow-up information, as well as reports of any adverse effects after the vaccine has been sold on the market, Chen Shifei, the Deputy Commissioner of the National Medical Products Administration on a news conference said.
The company “must continuously update the instructions, labels and tags of the vaccine to the agency,” Shifei said.
The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of the state-owned conglomerate Sinopharm. The company announced on Wednesday that preliminary data from trials in the last stage showed that it was 79.3% effective.
It is an inactive vaccine, which means that the virus was cultured in a laboratory and then killed. The germ is then injected into the body to generate an immune response.
The final proof of its effectiveness depends on the publication of more data.
Sinopharm is one of at least five Chinese developers worldwide that are creating vaccines for the disease that has killed more than 1.8 million people.
In addition to the emergency vaccinations already underway, China plans to begin vaccinating high-risk populations, such as the elderly as well as people with pre-existing chronic diseases. Officials did not say what percentage of the population they will vaccinate in China.
“It differs in each country, but the general thinking is that it should reach 60% to protect the entire population,” said Zeng Yixin, deputy minister of the National Health Commission.
Under emergency use, 4.5 million doses have been given, including 3 million in the past two weeks, Zeng said.
In practice, the conditional approval means that the drug or product in question may be restricted to certain age groups, according to Tao Lina, a former government immunologist.
Officials did not want to name a specific price and made conflicting statements about it. “It will definitely be within the limits of what people can afford,” said Zheng Zhongwei, another National Health Commission official.
A minute later, Zeng, the NHC official, stepped in to say that the vaccines would ‘definitely be free to the public’.
The vaccine is already under mass production, although officials have not answered questions about current production capacity.
Approval of China’s vaccine could also mean hope for countries around the world that may not have access to the Pfizer or Moderna shots, which have stricter requirements for cold chain. The Sinopharm vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), or a normal cooling temperature.
The Sinopharm vaccine has already been approved in the United Arab Emirates and Bahrain, and is subsequently used in Morroco.
Other countries have also purchased doses from another Chinese vaccine candidate, made by Sinovac Biotech. Turkey received the shipments of 3 million doses this week. Indonesia and Brazil all purchased Sinovac’s vaccines.
China is eager to distribute its vaccines worldwide, driven by the desire to repair the damage to its image through the pandemic that began a year ago in central Wuhan city.
President Xi Jinping has promised 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 are eagerly awaiting the inclusion of Chinese vaccines in the COVAX vaccine bank and the forthcoming WTO qualification,” said Shen Bo, a Foreign Ministry official.
The vaccine standards have been developed in ‘close cooperation’ with the WHO, officials said.
Meeting the WTO qualification can assure the rest of the world about the quality and effectiveness of Chinese vaccinations, which already have a reputation issue. back home. It will also pave the way for the distribution of Chinese vaccines in COVAX and possibly in countries that do not have their own regulatory agencies.
“It is very exciting that there is another vaccine that can be distributed in places where the cold chain is not,” said Ashley St. John, an immunologist at Duke-NUS Medical School in Singapore, said. “But at the same time, we need to temper the excitement. We need to understand the long-term efficacy, the effects on transmission and the effects on serious diseases. ”
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Wu reported from Taipei, Taiwan.
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The name of China’s drug regulator has been corrected to the National Medical Products Administration, not the Medical Production Administration.