Chinese health regulators have given conditional approval to a coronavirus vaccine developed by a state-owned company.
The two-dose Covid-19 vaccine is the first approved for general use in China. The approval comes as the country has started to vaccinate 50 million people before the Lunar New Year holiday in February.
Chen Shifei, the deputy commissioner of China’s National Medical Products Administration, told a news conference that conditional approval means research is still ongoing and the company will be required to submit follow-up data as well as reports of any adverse effects after the vaccine is sold on the market.
The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of state-owned conglomerate Sinopharm. The company announced that preliminary data from last-stage trials had shown it to be 79.3% effective.
It 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.
Final proof of its effectiveness will depend on publication of more data.
Sinopharm is one of at least five Chinese developers that 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 under way, China plans to start vaccinating high-risk people such as seniors and those with existing chronic illnesses. Officials did not say what percentage of the population they will vaccinate in China.
“This is different in every country but the general thinking is that it has to reach 60% to protect the entire population,” said Zeng Yixin, vice minister of the National Health Commission.
Under emergency use, 4.5 million doses have already been given, including 3 million in the past two weeks, Mr Zeng said.
Practically, the 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.
The vaccine is already under mass production, though officials did not answer questions about current production capacity.
Approval of China’s vaccine could also mean hope for countries around the world who may not have access to the Pfizer or Moderna shots, which have stricter cold chain requirements. Sinopharm’s vaccine is able to be stored between 2C to 8C, or a normal refrigeration temperature.
Sinopharm’s vaccine has already been approved in the United Arab Emirates and Bahrain, and is slated for use next in Morocco.
Other countries have also been buying doses of another Chinese vaccine candidate, made by Sinovac Biotech. Turkey received the shipments this week of 3 million doses. Indonesia and Brazil have all purchased Sinovac’s vaccines.
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 city of Wuhan.
President Xi Jinping has vowed to donate the vaccine as a public good to the world and China has joined Covax, a global plan for equal distribution and access.
