Israel Developed COVID-19 Vaccine Enters Phase 3 Study

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Excerpt

NRx Pharmaceuticals ,a clinical stage pharmaceutical company, announced the conclusion of high-level meetings in Hungary and confirmed the pivotal clinical trial of the BriLife COVID-19 vaccine would soon launch. Regulatory clearance for the BriLife trial is expected by the end of 2021. The company reported Hungary would be the first European Nation to host a clinical trial site for the registrational phase 2b/3 trial of the BriLife COVID-19 vaccine.

Article Summary

The completion of high-level discussions in Hungary indicated the key clinical study of the BriLife COVID-19 vaccine would begin soon, according to NRx Pharmaceuticals. The BriLife experiment is scheduled to receive regulatory approval by the end of 2021.

Hungary will be the first European country to host a clinical trial site for the BriLife COVID-19 vaccine’s registrational phase 2b/3 study, according to the company.

NRx has been asked to submit a paediatric trial protocol, which might include injectable and nasal spray delivery of the COVID-19 vaccine candidate, in addition to the already-developed trial plan.

Senior regulatory and academic medical authorities will lead Hungary’s NRx effort. The BriLife experiment is scheduled to receive regulatory approval by the end of 2021.

Hungarian health officials have also agreed on a regulatory approach for the Central European region’s Emergency Use of ZYESAMI® (aviptadil), which will commence with a compassionate care programme by the end of 2021. The programme is based on the FDA-approved Expanded Access Protocol, which has previously been implemented in the United States. Under this initiative, a confirmatory evidence of clinical effect, along with safety and efficacy data, will be submitted in support of an Emergency Use Authorization in Hungary. COVID-19 is resurgent in Europe, as it is in much of the world, with more than 15,000 people infected and more than 200 people dying each day in Hungary.

 

Source: NRx Pharmaceuticals, 2021

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