Kexing Bio: Understand the Brazilian regulation, the clinical research of the new corona vaccine is scientifically standardized_ 东方 财 网

Original title: Kexing Bio: Understanding Brazilian supervision, clinical research of the new corona vaccine has been scientifically tested and standardized

On the night of November 11, Beijing Kexing Zhongwei Biotechnology Co., Ltd.the companyHe said that on the morning of November 11, local time, the National Sanitary Supervision Agency of Brazil (Anvisa) announcedAuthorizationTo resume the phase III clinical study of the new inactivated crown Kellyford vaccine with the support of its partner Butantan Institute.

　　Kexing BioSaid as far as I knowAnvisa had not previously received thereportThe clinical study was urgently suspended on the night of November 9.On November 10, the Butantan Institute and Anvisa held acommunication, Data security auditCommitteeThe (DSMB) report was also presented to Anvisa on the same day. After evaluating the new data, Anvisa made the decision to resume the clinical investigation in a timely manner.

Anvisa said that the suspension and resumption of the investigation are common events in clinical research.Pause does not necessarily mean what is being studiedproductTo havequality, Safety or efficacy issues.

　　Kexing BioThis incident is believed to fully demonstrate that Anvisa’s clinical research oversight is responsive, timely, and effective, and Kexing is very pleased to see Kellife’s clinical research.jobsApproved by Anvisa, National Research and Ethics Committee (Conep), DSMB andpublic, Media reviewProven to be scientific and standardized.

Kexing emphasized that he has full confidence in the safety of the vaccines, fully understands and appreciates Anvisa’s strict supervision and timely resumption of clinical research, and expresses his full understanding and appreciation to the Butantan Institute professional partner.work attitudeThank you for your hard work and dedication, “We believe that only by advancing clinical research in strict accordance with high standards is it possible to guarantee the safety and efficacy of the vaccine. We hope that the strictadministrationComplete the follow-up clinical investigation as soon as possible and finally block the epidemic through the use of vaccines. “

Earlier on November 10, foreign media reported that Brazilian health agencies stopped using the CORONAVAC vaccine.testThe vaccine is an inactivated vaccine, developed by Kexing Zhongwei, and is currently conducting phase III clinical trials in Brazil, Indonesia, and other countries.

That same day, Kexing responded to the suspension incident, stating that after communicating with the Brazilian partner Instituto Butantan, the head of the institute considered that the incident had nothing to do with the vaccine.

(Source: The Paper)

(Responsible editor: DF522)