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Chinese health regulators said on Thursday they had given conditional approval to a coronavirus vaccine developed by state-owned Sinopharm.
The two-dose vaccine is the first approved for general use in China. The green light comes as the country began vaccinating 50 million people ahead of the Lunar New Year holiday in February.
Conditional approval means research is still ongoing, the company will be required to submit follow-up data as well as reports on any adverse reactions after the vaccine is sold in the market, Chen Shifei, deputy commissioner of National Medical Products Administration, said at a press conference.
The company “must continually update the instructions, vaccine labels and report to the agency,” Shifei said.
The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of state conglomerate Sinopharm. The company said on Wednesday that preliminary data from last-stage trials showed it to be 79.3 percent effective.
This is an inactive vaccine, which means the virus was grown in a lab 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 against the disease that has killed more than 1.8 million people.
In addition to the emergency vaccinations already underway, China plans to start vaccinating high-risk populations, such as the elderly as well as people with existing chronic diseases. Officials did not say what percentage of the population they would vaccinate in China.
“It is different in each country, but the general opinion is that it is necessary to reach 60% to protect the whole population,” said Zeng Yixin, deputy minister of the National Health Commission.
In emergency use, 4.5 million doses have already been administered, including 3 million in the past two weeks, Zeng said.
In practice, conditional approval means that the drug or product in question may be restricted for certain age groups, according to Tao Lina, a former government immunologist.
Officials declined to name a particular award and have made conflicting statements about it. “It will certainly be within the limits of what people can afford,” said Zheng Zhongwei, another official with the National Health Commission.
A 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.
The approval of the Chinese vaccine could also mean hope for countries around the world that may not have access to Pfizer or Moderna vaccines, which have more stringent cold chain requirements. Sinopharm vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) or at normal refrigeration temperature.
Sinopharm’s vaccine has already been approved in the United Arab Emirates and Bahrain, and is expected to be used in Morocco soon.
Other countries have also purchased doses of another Chinese vaccine candidate, manufactured by Sinovac Biotech. Turkey received shipments of 3 million doses this week. Indonesia and Brazil have all purchased the vaccines from Sinovac.
China is eager to distribute its vaccines around the world, driven by a desire to repair the damage caused to its image by the pandemic that began a year ago in the central city of Wuhan.
President Xi Jinping has pledged 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 COVAX’s vaccine bank soon and getting WHO prequalification soon,” said Shen Bo, a foreign ministry official.
The vaccine standards were developed in “close cooperation” with the WHO, officials said.
Obtaining WHO qualification could help assure the rest of the world of the quality and effectiveness of Chinese vaccines, which already face a reputation problem at home. It would also pave the way for the distribution of Chinese vaccines in COVAX and potentially in countries that do not have their own regulatory agencies.
“It’s very exciting that there is another vaccine and a vaccine that can be distributed to places that don’t have a cold chain,” said Ashley St. John, immunologist at Duke-NUS Medical School at Singapore. “But at the same time, we have to temper the excitement. We need to understand the long-term efficacy, the effect on transmission and the effect on serious illnesses. “
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