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Zhifei Biological releases key clinical data of phase III recombinant new crown vaccine: total protection efficiency 82%, Delta protection rate 78%

 Last Update: 2021-09-10
 Source: Internet
 Author: User

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Zhifei Biological Announcement

On the evening of August 27th, Zhifei Biological issued an announcement stating that the recombinant new coronavirus vaccine developed in cooperation with the Institute of Microbiology of the Chinese Academy of Sciences has obtained key data from phase III clinical trials

According to the announcement, the vaccine will start international multi-center phase III clinical trials in Hunan Province, Uzbekistan, Indonesia, Pakistan and Ecuador since December 12, 2020.

The vaccine began on December 12, 2020, and international multi-center phase III clinical trials have been carried out successively in Hunan Province, Uzbekistan, Indonesia, Pakistan and Ecuador.

A total of 28,500 people were actually enrolled, of which 14,251 were in the vaccine group and 14,249 were in the placebo group

: The protective effect of Alpha mutant strain is 92.

Comparing the phase III clinical data of the world's major approved new crown vaccines and emergency use of new crown vaccines, Zhifei biological recombinant new crown vaccines have the highest comprehensive protection rate, and it is the only new crown vaccine that has completed a complete phase three clinical trial of wild strains and major mutant strains

Zhifei Bio-Recombinant New Coronary Vaccine has the highest comprehensive protection rate, and it is the only New Coronary Vaccine that has completed a complete Phase III clinical trial of wild strains and major mutant strains

ZF2001 neutralizes the antibody titer level of three SARS-CoV-2 mutant pseudovirus serum samples

Antibody levels in serum samples of subjects who received three doses of ZF2001

On July 15th, Zhifei and the Institute of Microbiology of the Chinese Academy of Sciences published experimental results on the pre-publishing platform bioRxiv, saying that the test was performed with simulated Delta variant particles.

However, the researchers pointed out that the highly sensitive vaccine of these new variants to ZF2001 supports the current opportunity for mass immunization to establish herd immunity

Humoral immune response in phase 1 and phase 2 trials, doi:https://doi.

Humoral immune response in Phase 1 and Phase 2 trials, doi:https://doi.

Clinical trial results in line with expectations, the vaccine showed good safety and immune immunogenicity

The Gaofu team of the Chinese Center for Disease Control and Prevention released in bioRxiv the domestically-made recombinant protein subunit COVID-19 vaccine that is undergoing phase 3 clinical trials and the domestically-made inactivated COVID-19 vaccine (the BBIBP-CorV inactivated COVID-19 jointly developed by the Beijing Institute of Biological Products) The protective effect of the vaccine) on the new South African variant (501Y.

According to the article, the researchers selected 12 serum samples from clinical trial participants for each vaccine.

Group A (Zhifei recombinant protein vaccine): Compared with the original strain, the geometric mean titer (GMT) of the South African mutant strain dropped from 106.

Compared with the original strain, the geometric mean titer (GMT) of the South African mutant strain dropped from 106.
1 to 66.
6, a decrease of 1.
6 times; relative to the popular strain, GMT dropped from 93.
2 to 66.
6
.
Compared with the original strain, the geometric mean titer (GMT) of the South African mutant strain dropped from 106.
1 to 66.
6, a decrease of 1.
6 times; relative to the popular strain, GMT dropped from 93.
2 to 66.
6
.

Although the Phase III clinical trial detailed data are not yet available, but Zhi Fei biological announcement three key data again confirmed ZF2001 has a good safety and immune immunogenicity of this, the new crown Chi fly biology recombinant vaccines
.
In the future, more real-world verification is needed
.

ZF2001 has a good safety and immune immunogenicity ZF2001 has a good safety and immune immunogenicity immunity

Zhifei’s ZF2001 vaccine has been urgently authorized for use in China and Uzbekistan, and more than 100 million doses have been produced
.

Reference materials:

Neutralization of recombinant RBD-subunit vaccine ZF2001-elicited antisera to SARS-CoV-2 variants including Delta bioRxiv preprint doi: https://doi.
org/10.
1101/2021.
07.
15.
452504

Neutralization of recombinant RBD-subunit vaccine ZF2001-elicited antisera to SARS-CoV-2 variants including Delta bioRxiv preprint doi: https://doi.
org/10.
1101/2021.
07.
15.
452504 https://doi.
org/10.
1101/2021.
07.
15.
452504

Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials, doi: https://doi.
org/ 10.
1101/2020.
12.
20.
20248602

Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069

Neutralization of SARS-CoV-2 VOC 501Y.
V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines, doi: https://doi.
org/10.
1101/2021.
02.
01.
429069

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