The Chinese government has granted conditional approval to its first homegrown coronavirus vaccine developed by state-owned pharmaceutical giant Sinopharm, health officials announced Thursday.
The China’s National Health Commission said at a news conference the vaccine will be provided free to the public under the national vaccine program.
The go-ahead for the two-dose vaccine comes after Sinopharm said on Wednesday that it is 79.34% effective, citing an interim analysis of Phase 3 clinical trials. The vaccine was developed by the Beijing Institute of Biological Products, a subsidiary of Sinopharm.
The Beijing Institute of Biological Products on Wednesday said people who received the vaccine produced a high level of antibodies against the virus at a rate of 99.52%. The product has met the standards of the World Health Organization and China’s own regulator, the National Medical Products Administration.
Sinopharm’s two-dose vaccine uses chemically inactivated virus that is unable to replicate in human cells but can trigger an immune response, clinical trial registration data showed.
Earlier this month, The United Arab Emirates became the first foreign country to approve a China-developed Covid-19 vaccine, saying it was 86% effective based on interim results of a Phase 3 trial.
China has been rapidly developing its vaccine program as it prepares to inoculate 50 million people before the Chinese New Year holidays in February as well as a global rollout. Since December 15, officials have administered more than 3 million jabs to key groups in the country, vice-minister of China’s National Health Commission Zeng Yixin said on Thursday.
The number is on top of the 1.5 million doses administered on “high-risk groups” by the end of November, he added.
Conditional approval means that research is still ongoing, and regulators can request additional safety and effectiveness data about certain populations with different health profiles, Tao Lina, a former government immunologist, said at the news conference. This often means that a drug or product may be restricted for certain age groups, he added.
Sinovac and CanSino Biologics, two other Chinese pharmaceutical companies, are also developing vaccines.
Meanwhile, rival companies Pfizer-BioNTech and Moderna’s vaccines have been shown to have an efficacy rate of about 95% while Russia’s Sputnik V vaccine has a 91.4% efficacy rate. Pfizer-BioNTech has received authorization in more than 40 countries while Moderna has been authorized in the United States and Canada.