China News Service, Beijing, May 28 (Reporter Zhang Ni) Recently, China Biosciences released the results of phase III clinical trials of two new crown inactivated vaccines: the effective rates of the two vaccine groups were 72.8% and 78.1%, respectively. The protective effect of severe new coronary pneumonia is 100%.

This is also the world's first officially published Phase III clinical trial result of the new crown inactivated vaccine.

Data map: Medical staff are preparing vaccines.

Photo by China News Agency reporter Hou Yu

Announcement of Phase III clinical trial results of Sinopharm Vaccine: Effective rate exceeds 70%

　　Recently, the international medical journal "Journal of the American Medical Association" published "Evaluation of the Protective Efficacy of Two Novel Coronavirus Inactivated Vaccines Against Adult COVID-19 Infection" published by Sinopharm Sino Biotech.

　　This is the world's first officially published Phase III clinical trial results of the new crown vaccine, and this is the first time the results of the Phase III clinical trial of China's new crown vaccine have been published.

　　According to the information released by the official WeChat account of Sinopharm Group, the results of this study are an interim analysis of a randomized, double-blind, placebo-controlled phase III clinical trial of two new coronary inactivated vaccines from China Biologics.

　　Since July 16, 2020, 40,411 subjects were enrolled and randomly divided into three groups, namely the aluminum adjuvant group, the new crown vaccine WIV04 group and the new crown vaccine HB02 group.

The subjects received two intramuscular injections on day 0 and day 21.

　　14 days after the second dose of vaccination, a total of 142 effective cases were confirmed (95 in the aluminum adjuvant group, 26 in the WIV04 group, and 21 in the HB02 group). The effective rates of the two vaccine groups were 72.8% and 78.1%, respectively.

There were 2 severe cases in the aluminum adjuvant group, and no severe cases in the two vaccine groups.

　　In the 7 days after vaccination, the total adverse reaction rate was 46.5% in the aluminum adjuvant group, 44.2% in the WIV04 group, and 41.7% in the HB02 group.

There was no significant difference in serious adverse events among the three groups.

　　In both vaccine groups, the seroconversion rate was higher than 99.0% (neutralizing antibody titer increased by at least 4 times compared with baseline), while it was 2.3% in the aluminum adjuvant group.

At present, the research is still in progress, and the long-term protection and safety are still being evaluated.

The picture shows citizens being vaccinated against the new coronavirus.

Photo by Yu Jing

Large sample size, more than 40,000 subjects

　　It is worth noting that in the results of the Phase III clinical trial announced this time, the sample size is very large.

　　According to Sinopharm, 46270 subjects were screened in this project, 40411 subjects were randomly assigned to aluminum adjuvant group (13471), WIV04 group (13470), HB02 group (13470).

　　In the end, 40,382 subjects completed the first injection: 13,458 in the aluminum adjuvant group, 13,459 in the WIV04 group, and 13,465 in the HB02 group; 39,223 subjects completed the second injection, with 13,071 in each group. , 13066 people and 13,086 people.

　　The average age of the subjects in the project was 36.1 years old, and 84.4% were men.

25,634 (67.1%) were from Abu Dhabi, UAE, 5,135 (13.4%) were from Sharjah, UAE, and 7,437 (19.5%) were from Bahrain.

There were no significant differences in all characteristics among the groups.

　　Among the collected cases, only 2 severe cases occurred in the aluminum adjuvant group, and no severe cases occurred in the two vaccine groups, so the vaccine group has a 100% protective effect on severe cases of new coronary pneumonia.

　　However, given the small number of severe cases, the results have yet to be collected.

There were no deaths during the entire follow-up period.

Data map: Pre-filled syringes on the packaging line for vaccines.

Photo by China News Agency reporter Hou Yu

Multiple technical routes in parallel, China is still in the first team of research and development

　　Vaccination is the most effective and thorough measure to prevent and control the epidemic. In terms of the development of new crown vaccines, China has always been at the forefront of the world.

　　China laid out five technical routes in the early stages of the epidemic: inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines, and nucleic acid vaccines.

　　As of February this year, there were already 17 vaccines in clinical trials in China.

　　Judging from the use of vaccines in China, the new coronavirus vaccines currently in use in China include three inactivated vaccines that are conditionally marketed, one adenovirus vaccine, and three emergency vaccines, which contain one protein subunit. Vaccines, two inactivated vaccines.

　　"Our country's entire new crown vaccine research and development is in the first international legion, which not only provides vaccine support for our country, but also for the people of more than 50 other countries."

　　Shao Yiming, a researcher at the Chinese Center for Disease Control and Prevention, commented on China's vaccine development progress at a press conference held by the Joint Prevention and Control Mechanism of the State Council in April this year.

On May 27, citizens were vaccinated at the Community Health Service Center of Shipai Street, Tianhe District, Guangzhou City.

Photo by China News Agency reporter Chen Chuhong

A total of more than 560 million doses inoculated in China may establish a herd immunity barrier within the following year

　　As the first country to start clinical trials, China's domestic new crown vaccine vaccination work has also made positive progress.

　　In July 2020, China became the first country to approve the emergency use of vaccines. In December of the same year, China officially launched the vaccination of key populations.

　　According to the latest data from the National Health Commission, as of May 26, 31 provinces (autonomous regions and municipalities) and the Xinjiang Production and Construction Corps have reported a total of more than 560 million doses of COVID-19 vaccine.

　　In addition, from the perspective of total inoculation doses, Hainan, Guangdong, Shandong, Beijing, Shanghai, Hubei, Hunan, Zhejiang, Henan, Anhui, Chongqing, Sichuan, Tianjin, Guangxi and other provinces have exceeded the number of new crown vaccination doses. Ten million.

　　Among them, the cumulative number of inoculations in Guangdong Province alone has exceeded 50 million doses.

　　In a recent interview with the media, Shao Yiming also said that with the substantial increase in vaccine production capacity in the middle of the year, especially in the second half of the year, the corresponding vaccination rate will also increase. He believes that the goal of establishing a herd immunity barrier will be achieved within the year.

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