Domestic new coronavirus inactivated vaccine Phase III results announced: protection rate of 79.34%

According to the latest news on the official website of Beijing Biological Products Research Institute Co., Ltd., China Pharmaceutical Group China Bio-Statistical Analysis, New Coronavirus Inactivated Vaccine III. Phase III. Phase OF clinical trial analysis data show that: China National Pharmaceutical Group China Bio-Beijing Co., Ltd. new coronavirus inactivated vaccine safety is good, after two injections of immunization procedures, the vaccinators all produced high-titration antibodies, moderate The antibody impotence rate was 99.52%, and the protective effect of the vaccine on diseases caused by neo-coronavirus infection (COVID-19) was 79.34%, and the data results met the relevant technical standards of the World Health Organization and the relevant standard requirements of the Guidelines for Clinical Evaluation of Vaccines for The Prevention of New Coronavirus (Trial) issued by the National Drug Administration.
, China Bio-Beijing, a pharmaceutical group, has formally submitted a conditional listing application to the State Drug Administration.
As early as December 23, according to the State Drug Administration Drug Review Center information, China National Pharmaceutical Group China Bio-Beijing Company's new coronavirus inactivated vaccine listing application has been accepted, is currently the first in China to receive the new crown vaccine.
be approved as the first new crown vaccine to be accepted by the Drug Administration in China? Reportedly, "If it is in accordance with the approval of a special period, called rolling way, handed over the material in a timely manner, after reading the need to make up the material immediately supplement do not need to queue again, this is dedicated to the special period, if fast, two or three days would be good."
," said one drug expert.
In accordance with the Regulations on special approval and administration of new drug registration, the special approval and approval regulations set the special approval as a separate channel, giving priority to ensuring the review and approval of the whole process of special approval of new drug registration applications, and completing them within the time limit stipulated in the Measures for the Administration of Drug Registration.
when there is a threat of a public health emergency, and after a public health emergency, the new drugs required for emergency treatment of public health emergencies shall be handled in accordance with the Special Approval Procedure for Medicines of the State Food and Drug Administration.
The new crown vaccine to go to the special approval channel, how fast its approval speed, still need to be verified, but through the existing priority approval case, non-special approval channel HPV vaccine, in the priority approval channel, 8 days to obtain approval.
It is also worth noting that the new coronavirus inactivated vaccine application of China National Pharmaceutical Group China Bio-Beijing Company is conditional listing application, in November this year, the State Drug Administration CDE issued the "Drug Conditional Approval and Listing Technical Guidelines (Trial)", in which the Guiding Principles clearly define the drug clinical trial period, should deal with the major If a vaccine in urgent need of public health emergencies or other vaccines that the National Health Board determines is urgently needed, it may apply for conditional approval if it is assessed that the benefits outweigh the risks, and the Guiding Principles require that the drug be marked as "conditional approval" on the instructions for the drug concerned, and that the relevant contents of the drug label shall be consistent with the instructions.
, after the drug is on the market, applicants are required to commit to completing all clinical trials on time, and the document has been in effect since the date of publication.
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