Tuesday, 26 September 2023

UAE approves late stage trial of Jiangsu's COVID-19 vaccine

13 April 2022 | News

Receipt of approval from the UAE For phase II/III clinical trial of sequential booster vaccination For ReCOV

Image credit: shutterstock

Image credit: shutterstock

China's Jiangsu Recbio Technology has received approval from the Ministry of Health and Prevention of the United Arab Emirates (UAE) (Clinical Trial Approval) to conduct a Phase II/III clinical study of sequential booster vaccination for its recombinant protein COVID-19 vaccine ReCOV to evaluate the immunogenicity and safety of ReCOV as a heterologous booster in adult subjects.

This clinical trial is a multi-center, randomized, observer-blinded, active-controlled phase II/III study on persons who have previously completed two doses of inactivated COVID-19 vaccine for primary vaccination and whose last vaccination is 3 to 12 months away from heterologous booster of ReCOV. It is expected that approximately 1,950 adult subjects will be enrolled.

The study's safety and immunogenicity data are expected to be published in 2022, supporting the submission to the UAE Emergency Use Authorization (EUA) for ReCOV as a heterologous booster. 

In May 2020, Recbio, together with Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu CDC) and Taizhou Medical New & High-tech Industrial Development Zone, jointly developed a recombinant two-component COVID-19 vaccine (ReCOV).

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