On February 5 this year, the State Drug Administration approved it according to law,It is also the second new crown vaccine approved for marketing in China.
More than 260 million doses.
On April 29, at the special meeting of the World Health Organization (who) Advisory Group on immunization strategy (SAGE), Kexing holding biology, together with experts from the Ministry of health of Chile, shared the clinical research data and real world research results of Klebsiella vaccine, involving the safety, immunogenicity and protective efficacy of the vaccine. Sage also released the evaluation report after the meeting.
The interim results of phase III clinical study showed that,In Brazil, Indonesia, Turkey and Chile, the overall protective efficacy of klerford is 51% - 84%, which is higher than 50% of the World Health Organization's requirements for the protective efficacy of new crown vaccine.
In Chile, real-world studies have shown that the protective effect of klerford on hospitalized cases is 85%.
Brazil phase III clinical research information
The phase III clinical study conducted in Brazil focused on the protective efficacy of vaccines in general and different subgroups, and the data of protective efficacy in different age groups, different immunization procedures and different health conditions.
The results showed that in the analysis of different population subgroups in Brazil,
In terms of safety,
Novel coronavirus pneumonia was found in 2 of the 3 deaths. One case in the vaccine group died of suicide.
Studies in the elderly group showed that,
Since the majority of countries approved the kerrefour vaccination, the priority group is the elderly, so the majority of adverse events reports after vaccination come from the elderly.
Real world clinical research information in Chile
In the result analysis, the protection effect information of asymptomatic infection, morbidity, hospitalization, ICU admission and death cases among different groups of people with different immune status was included.
According to the Kaplan Meier curve, the improvement of various clinical outcomes after the whole course of Klebsiella vaccination has obvious effect.
In real world research in Chile,The novel coronavirus pneumonia novel coronavirus pneumonia infection was 14 days after inoculation with Kerr's second dose. The protective effect was 67% for the patients with symptomatic new crown pneumonia, and 85% for the hospitalized cases. The protective effect for ICU hospitalization cases was 89%, and the protective effect for 80% cases of new crown pneumonia death cases was 80%.
Compared with another new crown vaccine used in Chile, the proportion of adverse events reported by klerford was lower, and the proportion of serious adverse events reported was also lower.
Brazil phase IV clinical research information
In Brazil, the results of phase IV clinical studies have been reported, which focus on the study of kleifer for medical staff and priority vaccinated population, and involve the effectiveness information for the new coronavirus P.1 variant.
Since the outbreak of novel coronavirus pneumonia in the world, the variation of COVID-19's domestic COVID-19 varieties has been alternately dominant, so the effectiveness of the vaccine for the mutant has attracted much attention.
The results of phase IV clinical study were from Manaus, Brazil. The main purpose of this study was to evaluate the protective effect of at least one dose of Klebsiella on medical staff or priority vaccinated population. The research method was test negative design (TND).
Through the results from October 2020 to may 2021, it can be seen that with the increase of the coverage rate of kerrefour, the number of infections and diseases among medical staff and priority vaccinated population shows a downward trend.
The results of the study on the new coronavirus mutants showed that: 1In Manaus, Brazil, the protective effect of at least one dose of vaccine after 14 days was 49.6% (95% CI 11.3,71.4)At that time, about 75% of the virus genotypes were P.1.
The results suggest that kleinfer has a protective effect on the new crown caused by P. 1 variant in Brazil.
Another Chilean study (P.1 and b.1.1.7 were circulating at the time of the study) noted that:The protective effect of the vaccine was 67% (95% CI 65,69) 14 days after two doses of Klebsiella.
Based on the above information,
According to the sage report, there is still a lack of evidence for Klebsiella pneumoniae, including immune persistence, enhanced immunity, VDE risk, protective effect on mutant strains, safety of vaccination for pregnant women, safety and effectiveness of elderly and other potential disease groups, and evaluation of rare adverse events after approved use.
At present, the ongoing or planned research of kerrefour includes:
1. Indonesia: long term safety, immunogenicity and effectiveness
2. Brazil and Turkey: phase III clinical follow-up
3. China: immunogenicity and safety in children
4. Brazil: phase IV clinical trial
5. Safety and immunogenicity of special groups (people with AIDS or HIV infection, rheumatism, chronic liver disease, breast cancer or lung cancer, etc.)
6. Retrospective study on pregnant women and lactation, including abortion, teratoma, fetal arrest, pregnancy or delivery complications
7. Co vaccination with ppsv23 or other inactivated vaccines
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