Chinese health regulators said on 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. The go-ahead came at a time when the country started vaccinating 50 million people before the Lunar New Year holiday in February.
Conditional approval means that the research is still ongoing, the company will be required to provide follow-up data, as well as reports of any adverse effects after the vaccine is sold on the market, Chen Shifei, deputy commissioner of the National Administration of Medical Products, said a press conference.
The company “must continually update vaccine instructions, labels and reports for the agency,” said Shifei.
The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of the state conglomerate Sinopharm. The company announced on Wednesday that preliminary data from the last stage tests showed 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 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 who are in a global race to create vaccines for the disease that killed more than 1.8 million people.
In addition to the emergency vaccinations already underway, China plans to start vaccinating the high-risk population, such as the elderly and also people with existing chronic diseases. Officials did not say what percentage of the population will vaccinate in China.
“This is different in each country, but the general thought is that it should reach 60% to protect the entire 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.
Practically, 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.
The authorities refused to quote a specific price and made conflicting statements about it. “It will certainly be at the limit of what people can afford,” said Zheng Zhongwei, another official at the National Health Commission.
A minute later, Zeng, the NHC official, intervened to say that the vaccines “will definitely be free to the public.”
The vaccine is already in mass production, although the authorities have not answered 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 vaccines, which have stricter requirements for the cold chain. The Sinopharm vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), or at normal refrigerated temperatures.
The Sinopharm vaccine has already been approved in the United Arab Emirates and Bahrain, and should be used in Morocco.
Other countries have also been buying doses of another Chinese candidate vaccine, made by Sinovac Biotech. Turkey received shipments this week of 3 million doses. Indonesia and Brazil bought vaccines from Sinovac.
China is eager to distribute its vaccines globally, driven by a desire to repair the damage to its image by the pandemic that started a year ago in the central city of 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 also obtaining WHO prequalification,” said Shen Bo, an official at the Ministry of Foreign Affairs.
The vaccine standards were developed in “close cooperation” with WHO, officials said.
Meeting the WHO qualification can help ensure the quality and effectiveness of Chinese vaccines to the rest of the world, which already face a reputation problem at home. It would also pave the way for Chinese vaccines to be distributed at COVAX and potentially 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 there is no cold chain,” said Ashley St. John, an immunologist at Duke-NUS Medical School in Singapore. “But at the same time, we have to moderate the emotion. We have to understand the long-term effectiveness, the effect on transmission and the effect on serious illness. “