Chinese health regulators said Thursday they had conditionally approved a coronavirus vaccine developed by state-owned Sinopharm.
The two-dose vaccine is the first approved for general use in China. Approval comes when the country has begun vaccinating 50 million people before the lunar New Year holidays in February.
Conditional approval means the investigation is still ongoing, that the company will have to submit follow-up data, as well as reports of adverse effects after selling the vaccine to the market, Chen Shifei, Deputy Commissioner of the National Administration of medical products, he said at a news conference.
The company “must continuously update the instructions, labels and report the vaccine 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 Wednesday that preliminary data from last-stage trials had shown it to be 79.3% effective.
It is an inactive vaccine, meaning the virus was cultured in a laboratory and then killed. The germ is injected into the body to generate an immune response.
The final test of its effectiveness will depend on the publication of more data.
Sinopharm is one of at least five Chinese developers who are 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 underway, China plans to start vaccinating high-risk populations, such as the elderly and people with existing chronic diseases. Officials did not say what percentage of the population will be vaccinated in China.
“This is different in all countries, 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.
Zeng said that in case of emergency, 4.5 million doses have already been administered, including 3 million in the last two weeks.
Practically, 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 specific price and gave contradictory statements in this regard. “It will certainly be at the limit of what people can afford,” said Zheng Zhongwei, another National Health Commission official.
A minute later, NHC official Zeng intervened to say the vaccines “will definitely be free for the public.”
The vaccine is already in mass production, although officials did not answer questions about current production capacity.
China’s vaccine approval may also mean hope for countries around the world that may not have access to Pfizer or Moderna features, 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 cooling temperature.
The Sinopharm vaccine has already been approved in the United Arab Emirates and Bahrain and is planned for use in Morocco.
Other countries have also been buying doses from another Chinese vaccine candidate, made by Sinovac Biotech. This week Turkey received shipments of 3 million doses. Indonesia and Brazil have bought Sinovac vaccines.
China is eager to distribute its vaccines worldwide, motivated by the 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 vowed to give 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 Chinese vaccines being soon included in COVAX’s vaccine bank and we will soon obtain WHO prequalification,” said Shen Bo, a Foreign Ministry official.
Vaccine standards were developed in “close cooperation” with the WHO, officials said.
Compliance with the WHO qualification could help ensure the quality and effectiveness of Chinese vaccines, which already have a reputation problem at home, in the rest of the world. It would also pave the way for the distribution of Chinese vaccines to COVAX and potentially to countries that do not have their own regulatory agencies.
“It’s very exciting to have another vaccine that can be distributed in places that don’t have the cold chain,” Ashley St. said. John, immunologist at Duke-NUS Medical School in Singapore. “But at the same time we have to temper the enthusiasm. We need to understand the long-term effectiveness, the effect on transmission and the effect on serious diseases. ”