BEIJING (AP) – Chinese health regulators said on Thursday they had given conditional approval to a state-run coronavirus vaccine developed by Sinopharm.
The two-dose vaccine is the first approved for general use in China. The statement comes as the country began vaccinating 50 million people before the celebration of the Lunar New Year in February.
Conditional approval means the investigation is still ongoing, the company will have to submit follow-up data, as well as reports of any side effects after the vaccine is sold on the market, Chen Shifei, deputy commissioner of the National Medical Administration said at a conference of press.
The company “must continuously update vaccine instructions, labels and report to the agency,” Shifei said.
The vaccine was developed by the Beijing Institute of Organic Products, a subsidiary of the state-owned Sinopharm conglomerate. The company announced on Wednesday that preliminary data from studies in the last stage showed that it is 79.3% efficient.
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 generate an immune response.
The final proof of its effectiveness will depend 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 has killed more than 1.8 million people.
In addition to the emergency vaccinations already under way, China intends to start vaccinating the high-risk population, such as the elderly and people with existing chronic diseases. Officials have not said what percentage of the population will be vaccinated in China.
“This is different in every country, but the general thinking is that it must reach 60% to protect the entire population,” said Zeng Yixin, deputy minister of the National Health Commission.
In emergencies, 4.5 million doses have already been administered, including 3 million in the past two weeks, Zeng said.
Basically, conditional approval means that the drug or product in question can be restricted to certain age groups, according to Tao Lina, a former government immunologist.
Officials refused to name a certain price and made contradictory statements about it. “It will certainly be within the limits of what people can afford,” said Zheng Zhongwei, another National Health Commission official.
One minute later, Zeng, the NHC official, intervened to say that the vaccines “will definitely be free for the public.”
The vaccine is already in mass production, although officials have not answered questions about current production capacity.
Approving China’s vaccine could also mean hope for countries around the world that may not have access to Pfizer or Moderna photos, which have stricter cold chain requirements. The Sinopharm vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), or at a normal refrigeration temperature.
The Sinopharm vaccine has already been approved in the United Arab Emirates and Bahrain and is to be used in Morocco.
Other countries have also bought doses of another Chinese vaccine candidate made by Sinovac Biotech. Turkey received shipments of 3 million doses this week. Indonesia and Brazil have purchased all Sinovac vaccines.
China is eager to distribute its vaccines globally, driven by a desire to repair its image damage from a pandemic that began a year ago in central Wuhan.
President Xi Jinping has promised to donate the vaccine as a public good to the world, and China has joined COVAX, a global plan for equal distribution and access.
“We look forward to the Chinese vaccines being included in the COVAX vaccine bank soon and to obtaining WHO pre-qualification soon,” said Shen Bo, a foreign ministry official.
Vaccine standards were developed in “close co-operation” with the WHO, officials said.
Meeting WHO’s qualifications could go a long way toward reassuring the rest of the world about the quality and effectiveness of Chinese vaccines, which are already facing a reputation problem. back home. It would also pave the way for Chinese vaccines to be distributed in COVAX and potentially in countries that do not have their own regulatory agencies.
“It’s very interesting that there’s another vaccine and one that can be distributed in locations that don’t have a cold chain,” said Ashley St. John, immunologist at Duke-NUS School of Medicine in Singapore. “But at the same time, we have to temper the emotion. We need to understand the long-term efficacy, the effect on transmission and the effect on severe diseases. ”
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Wu reported from Taipei, Taiwan.
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The name of the Chinese drug regulator has been corrected to the National Medical Administration, not the Medical Administration.